79C3C34C52B45572883A05D425EB0F82
National Ethical Guidelines for Biomedical and Ethical Guidelines Involving Human Participants
https://icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
http://leaux.net/URLS/ConvertAPI Text Files/4DC8DB5EF26C5A34A671F884FE48A8CE.en.txt
Examining the file media/Synopses/4DC8DB5EF26C5A34A671F884FE48A8CE.html:
This file was generated: 2020-12-01 07:32:47
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
...
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
...
Political / Indigenous
Searching for indicator indigenous:
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p.000135: RESEARCH
p.000135:
p.000135: Biological Materials,
p.000135: Biobanking and Datasets
p.000135:
p.000135: the next of kin or closest relative or friend.
p.000135: 11.5.5 The information in the informed consent document should state what tissue/organ will be retained, who will be
p.000135: the custodian, duration of storage of sample, what type of research would be conducted and method for disposal of the
p.000135: remains.
p.000135: 11.5.6 Genetic research or revelation of any other stigmatizing factors like HIV, etc. in the deceased may have
p.000135: implications for family members. In such instances, all ethical requirements as in the case of live
p.000135: participants should be followed.
p.000135: 11.5.7 The role of the EC is to review and approve the type of consent – broad, tiered with or without option to
p.000135: opt-out or specific and to assess from whom it would be taken – the family, closest relative or friend – or whether
p.000135: sample anonymization should be done.
p.000135: 11.6 Governance of biobank/biorepository
p.000135: Institutions where data are collected and archived must have an established governance structure with the following
p.000135: requirements for regulation.
p.000135: 11.6.1 Each biorepository should have its own technical authorization committee with representation of both
p.000135: science and ethics and external members. This committee should function in tandem with the EC.
p.000135: 11.6.2 A technical authorization committee, indigenous to the biorepository, should govern collection of specimens,
p.000135: disbursement of biospecimens and data to researchers. The same committee should also oversee regulatory aspects like
p.000135: execution of MTA or data transfer agreement (DTA) for transfer of biospecimens and/or data to other institutions.
p.000135: 11.6.3 Stand-alone huge repositories should have separate technical authorization committees and ECs to undertake the
p.000135: above-mentioned tasks.
p.000135: 11.6.4 The biobank should have well-structured SOPs and clear guidelines for collection, coding,
p.000135: anonymization, storage, access, retrieval and sharing of biospecimens and data.
p.000135: 11.6.5 The technical authorization committee/governance committee could comprise members such as clinicians,
p.000135: geneticists, lawyers, basic scientists, sociologists, epidemiologists, statisticians and ethicists.
p.000135: 11.7 Special issues related to datasets
p.000135: 11.7.1 With increasing ease of establishing and maintaining large repositories the primary objective of data collection
p.000135: and storage in some of these databases may not be research but with advances in information technology (IT) and
p.000135: decreasing costs, they offer a huge potential for subsequent research as well as commercialization. Whenever such
p.000135: repositories are used for purposes of research or for subsequent commercialization, it must follow the expected
p.000135: requirements of any other health-related research with due
p.000135: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000135: 135
p.000136:
p.000136: Biological Materials,
p.000136: Biobanking and Datasets
p.000136:
p.000136: diligence, including review by an EC.
p.000136: 11.7.2 There is also a proliferation of data mining and other data science tools that can be employed on existing
...
p.000156: not greater than that ordinarily encountered in routine daily life activities of a healthy individual or general
p.000156: population or during the performance of routine physical or psychological examinations or tests. However, in some
p.000156: cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but
p.000156: this may be within the range of minimal risk for the research participant since it would be undertaken as
p.000156: part of current everyday life.
p.000156:
p.000156: 42 Non-
p.000156: therapeutic trial
p.000156: A trial which is unlikely to produce any direct benefit to the
p.000156: participants involved. The aim of a non-therapeutic trial is to obtain knowledge which may contribute
p.000156: towards the future development of new forms of treatment or procedures.
p.000156: 43 Ostracization To exclude, by general consent, from society, friendship,
p.000156: conversation, privileges, etc.
p.000156:
p.000156: 44 Particularly vulnerable tribal group (PVTG)
p.000156: These are a special class of tribal groups, classified as such by the Government of India, due to their
p.000156: especially low development indices when compared to other local tribes. These were classified under the Dhebar
p.000156: Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
p.000157: uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of
p.000157: adequate size, and whenever possible, double-blind.
p.000157:
p.000157: 47 Post-marketing
p.000157: surveillance
p.000157:
p.000157: 48 Professional competence
p.000157: 49 Principal
p.000157: investigator
p.000157:
p.000157:
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Political / person under arrest
Searching for indicator arrested:
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p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
...
Political / political affiliation
Searching for indicator party:
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p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
...
Searching for indicator political:
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p.000009: 2.6.4 In investigator initiated research/student research, the investigator/institution where the research is
p.000009: conducted becomes the sponsor.
p.000009: • It is the responsibility of the host institution to provide compensation and/or cover for insurance for
p.000009: research related injury or harm to be paid as decided by the EC.
p.000009: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000009: 9
p.000010:
p.000010:
p.000010: General Ethical Issues
p.000010:
p.000010: • The institution should create in-built mechanism to be able to provide for
p.000010: compensation, such as a corpus fund in the institution.
p.000010: • In the applications for research grants to funding agencies – national or international,
p.000010: government or non-government agencies – the researcher should keep a budgetary provision for insurance coverage
p.000010: and/or compensation depending upon the type of research, anticipated risks and proposed number of participants.
p.000010: 2.7 Ancillary care
p.000010: 2.7.1 Participants may be offered free medical care for non-research-related conditions or incidental findings if
p.000010: these occur during the course of participation in the research, provided such compensation does not amount to undue
p.000010: inducement as determined by the EC.
p.000010: 2.8 Conflict of interest
p.000010: Conflict of interest (COI) is a set of conditions where professional judgement concerning a primary interest such as
p.000010: participants welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or
p.000010: non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or
p.000010: sponsors. If COI is inherent in the research, it is important to declare this at the outset and establish appropriate
p.000010: mechanisms to manage it.
p.000010: 2.8.1 Research institutions must develop and implement policies and procedures to identify, mitigate conflicts of
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
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p.000013: research team. Without trust between scientists and the public, or within research teams, meaningful research is
p.000013: compromised. Researchers should be aware that the resources of biomedical research are precious and to be used
p.000013: judiciously. Whereever possible they should also seek oppurtunities to plan translation of research findings into
p.000013: public health outcomes.
p.000013: 3.1.2 Contemporary ethical issues in biomedical and health research
p.000013: Emerging new areas of research give rise to new ethical issues. Among the contemporary
p.000013: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000013: 13
p.000014:
p.000014:
p.000014: Responsible Conduct of Research
p.000014:
p.000014: issues recently under debate are the use of underprivileged and vulnerable groups as participants, post-trial access of
p.000014: research benefits to participants and their communities, research on emerging technologies, etc. Continuing
p.000014: education is necessary to keep researchers apprised of contemporary issues.
p.000014: 3.1.3 Sensitivity to societal and cultural impact of biomedical and health research
p.000014: To understand the social and cultural impact of research, one must analyse how the health sector and general public
p.000014: engage with the results of biomedical and health research. It is essential that researchers bear this in mind
p.000014: while planning, conducting and evaluating research as it will improve public accountability and enhance public, private
p.000014: and political advocacy.
p.000014: 3.1.4 Mentoring
p.000014: Mentoring is one of the primary means for one generation of scientists to pass on their knowledge, values and
p.000014: principles to succeeding generations. Mentors, through their experience, can guide researchers in ways above and beyond
p.000014: what can be gathered from reading textbooks. The relationship between mentors and trainees should enable trainees to
p.000014: become responsible researchers. Mentors should ensure their trainees conduct research honestly, do not interfere
p.000014: with the work of other researchers and use resources judiciously. A mentor should be knowledgeable, teach and lead by
p.000014: example and understand that trainees differ in their abilities. She/he should devote sufficient time and be
p.000014: available to discuss, debate and guide trainees ably. A mentor should encourage decision making by the
p.000014: trainees and the trainee should take an active role in communicating her/his needs.
p.000014: 3.2 Policies
p.000014: 3.2.1 The protection of human participants
p.000014: Institutions must establish policies and mechanisms for the protection of human research participants. Such policies
p.000014: should assign responsibilities to the institution, the EC and the researchers. Additionally, there should be mechanisms
p.000014: and policies for monitoring research including data capture, management , conflicts of interest, reporting of
p.000014: scientific misconduct, and appropriate initial and continuing training of researchers and EC members.
p.000014: Policies can be made available on the websites of the institutes or organizations. Researchers should also follow their
p.000014: respective professional codes of conduct.
p.000014: 3.2.2 Animal experimentation
p.000014: Those involved in experimentation on animals must follow all the existing regulations and guidelines including the
p.000014: Prevention of Cruelty to Animals Act, 1960, amended in
p.000014: 14 INDIAN COUNCIL OF
p.000015: MEDICAL RESEARCH
p.000015:
p.000015:
p.000015: Responsible Conduct of Research
p.000015:
p.000015: 1982, the Breeding and Experimentation Rules, 1998, amended in 2001 and 2006, the Guidelines for Care and Use of
p.000015: Animals in Scientific Research (Indian National Science Academy, 1982, amended in 2000), ICMR Guidelines on
p.000015: Humane Care and Use of Laboratory Animals, 2006, Committee for the Purpose of Control and Supervision of
p.000015: Experiments on Animals (CPSCSEA) Guidelines for Laboratory Animal Facilities, 200318 and Guidelines for Rehabilitation
p.000015: of Animals used in Research, 2010.
p.000015: 3.3 Planning and conducting research – Specific Issues
p.000015: 3.3.1 Conflict of interest issues
p.000015: COI refers to a set of conditions whereby professional judgement concerning a primary interest, such as participant’s
p.000015: welfare or the validity of research either is, or perceived to be unduly influenced by a secondary interest. The
p.000015: secondary interest may be financial or non-financial, personal, academic or political. This is not inherently wrong,
p.000015: but COI can influence the choice of research questions and methods, recruitment and retention of participants,
p.000015: interpretation and publication of data and the ethical review of research. It is, therefore, necessary to develop and
p.000015: implement policies and procedures to identify, mitigate and manage such COI which can be at the level of researcher,
p.000015: ethics committee or at the level of institution. Research institutions, researchers and research ECs must follow the
p.000015: steps given in Box 3.1.
p.000015: Box 3.1 Identifying, mitigating and managing COI
p.000015: The broad responsibilities of those involved in research, with respect to COI, are given below:
p.000015: 1. Research institutions must:
p.000015: • develop policies and SOPs to address COI issues that are dynamic, transparent and actively
p.000015: communicated;
p.000015: • implement policies and procedures to address COI and conflicts of commitment, and
p.000015: educate their staff about such policies;
p.000015: • monitor the research or check research results for accuracy and objectivity; and
p.000015: • not interfere in the functioning and decision making of the EC.
p.000015: 2. Researchers must:
p.000015: • ensure that documents submitted to the EC include disclosure of COI (financial or non-
p.000015: financial) that may affect their research;
p.000015: • guard against conflicts of commitment that may arise from situations that place competing
p.000015: demands on researchers’ time and loyalties; and
p.000015: • prevent intellectual and personal conflicts by ensuring they do not serve as reviewers for
p.000015: grants and publications submitted by close colleagues, relatives and/or students.
p.000015:
p.000015:
...
p.000103: medical care and other benefits, besides financial incentives.
p.000103: 8.6.3 ECs have to consider these issues proactively and mindfully. Specific measures should also be established to
p.000103: protect the welfare of related community members who have not participated.
p.000103: 8.7 Stakeholders in public health research
p.000103: 8.7.1 It is important for ethical conduct of research to engage with all stakeholders, such as researchers, public
p.000103: health providers/professionals, sponsors, government agencies, participants, ECs, institutions, NGOs, and others
p.000103: who are involved in public health research in any manner.
p.000103: 8.7.2 The involved stakeholders must make every effort to provide post-research public health interventions,
p.000103: post-research use of the findings, or sustainability of the public health action.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000103: 103
p.000104:
p.000104: SECTION 9
p.000104:
p.000104: SOCIAL AND BEHAVIOURAL SCIENCES RESEARCH FOR HEALTH
p.000104: 9.0 The context of health research using methods from the social and behavioural sciences is often
p.000104: different from clinical, biomedical and public health research. Social and behavioural sciences include, but are
p.000104: not limited to, anthropology, sociology, psychology, philosophy, political science, economics, history,
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
...
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
p.000140: data/sample collection that are likely to rapidly deteriorate or perish may be allowed while the review process is
p.000140: underway.
p.000140: • Available protocol templates could be reviewed to expedite the process.
p.000140: • Re-review should be done if the emergency situation changes.
p.000140: • In situations where members of local ECs are unavailable due to the emergency, the ethics review may be
p.000140: conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its
p.000140: meeting. ECs should develop procedures to ensure appropriate and timely review and monitoring of the approved research.
p.000140: On a case-by-case basis, some protocols may require re- review as the emergency situation may change with time and
p.000140: circumstances.
p.000140: 12.5.4 The EC should closely monitor the conduct and outcome of research.
p.000140: 12.6 Post-research benefit
p.000140: Sponsors and researchers should strive to continue to provide beneficial interventions, which were part of the research
p.000140: initiative even after the completion of research and till the local administrative and social support system is
p.000140: restored to provide regular services.
p.000140: 12.7 Special considerations
p.000140: Humanitarian emergencies lead to fragile political environments with disruption of health systems and social
p.000140: situations.
p.000140:
p.000140:
p.000140: 140 INDIAN COUNCIL OF MEDICAL
p.000141: RESEARCH
p.000141:
p.000141: Research during Humanitarian Emergencies and
p.000141: Disasters
p.000141:
p.000141: 12.7.1 The researchers should undertake steps to maintain participant and community trust.
p.000141: 12.7.2 Efforts should be made to engage the community in the conduct of research in a culturally sensitive manner to
p.000141: ensure public trust.
p.000141: • The research team should preferably describe a preliminary community mapping/
p.000141: scoping exercise.
p.000141: • Wherever possible, community representatives or advocates should be involved in conceptualization, review,
p.000141: research and dissemination of research results in such settings.
p.000141: 12.7.3 In case of an outbreak of infectious diseases, monitored emergency use of unregistered and experimental
p.000141: interventions (MEURI) may be approved with the following precautions:
p.000141: • A thorough scientific review should be conducted, followed by an ethics review
p.000141: by a national level EC constituted for this purpose.
p.000141: • Oversight by a local EC is necessary.
p.000141: • Only a product complying with GMP should be used.
p.000141: • Rescue medicines and supportive treatment should be accessible.
p.000141: • Sharing data on safety and efficacy would be beneficial to reduce delay for other
p.000141: researchers.
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p. x: Preface by Chairperson, Central Ethics Committee on Human Research xii
p. x: Message from Chairperson, Advisory Group xiii
p. x: Acknowledgement
p. xiv: xiv
p. xv: Introduction
p.000001: 1
p.000002: Scope
p.000002: 2
p.000003: Section 1 Statement of general principles 3
p.000003: 1.1 General principles 3
p.000003: Section 2 General ethical issues
p.000005: 5
p.000006: 2.1 Benefit-risk assessment 5
p.000006: 2.2 Informed consent process 5
p.000006: 2.3 Privacy and confidentiality 7
p.000006: 2.4 Distributive justice 8
p.000006: 2.5 Payment for participation 8
p.000006: 2.6 Compensation for research related harm 8
p.000006: 2.7 Ancillary care 10
p.000006: 2.8 Conflict of interest 10
p.000006: 2.9 Selection of vulnerable and special groups as research participants
p.000010: 10
p.000011: 2.10 Community engagement 11
p.000011: 2.11 Post research access and benefit sharing 12
p.000011: Section 3 Responsible conduct of research 13
p.000011: 3.1 Values of research 13
p.000011: 3.2 Policies 14
p.000011: 3.3 Planning and conducting research - specific issues 15
p.000011:
p.000011: 3.4 Reviewing and reporting research 17
p.000011: 3.5 Responsible authorship and publication 18
p.000011: 3.6 Research misconduct and policies for handling misconduct 19
p.000011: 3.7 Registration with Clinical Trials Registry- India 20
p.000011: 3.8 Collaborative research 21
p.000011: Section 4 Ethical review procedures 25
p.000011: 4.1 Terms of reference for ethics committees (EC) 25
p.000011: 4.2 Special situations 26
p.000011: 4.3 Composition of an EC 27
p.000011: 4.4 Terms of reference for EC members 31
...
p.000011: 5.1 Requisites 49
p.000011: 5.2 Essential information for prospective research participants 49
p.000011: 5.3 Responsibility of researchers 51
p.000011: 5.4 Documentation of informed consent process 52
p.000011: 5.5 Electronic consent 53
p.000011: 5.6 Specific issues in clinical trials 53
p.000011: 5.7 Waiver of consent 53
p.000011: 5.8 Re-consent or fresh consent 54
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
p.000057: 7.12 Clinical trials of interventions in HIV/AIDS 82
p.000057:
p.000057: 7.13 Clinical trials on traditional systems of medicine 83
p.000057: 7.14 Trials of diagnostic agents 84
...
p.000003: around the world. While conducting biomedical and health research, the four basic ethical principles namely; respect
p.000003: for persons (autonomy), beneficence, non-maleficence and justice have been enunciated for protecting the dignity,
p.000003: rights, safety and well-being of research participants. These four basic principles have been expanded into 12 general
p.000003: principles described below, and are to be applied to all biomedical, social and behavioural science research for
p.000003: health involving human participants, their biological material and data.
p.000003: 1.1 General Principles
p.000003: 1.1.1 Principle of essentiality whereby after due consideration of all alternatives in the light of existing
p.000003: knowledge, the use of human participants is considered to be essential for the proposed research. This should be duly
p.000003: vetted by an ethics committee (EC) independent of the proposed research.
p.000003: 1.1.2 Principle of voluntariness whereby respect for the right of the participant to agree or not to agree to
p.000003: participate in research, or to withdraw from research at any time, is paramount. The informed consent process
p.000003: ensures that participants’ rights are safeguarded.
p.000003: 1.1.3 Principle of non-exploitation whereby research participants are equitably selected so that the benefits and
p.000003: burdens of the research are distributed fairly and without arbitrariness or discrimination. Sufficient safeguards to
p.000003: protect vulnerable groups should be ensured.
p.000003: 1.1.4 Principle of social responsibility whereby the research is planned and conducted so as to avoid creation or
p.000003: deepening of social and historic divisions or in any way disturb social harmony in community relationships.
p.000003: 1.1.5 Principle of ensuring privacy and confidentiality whereby to maintain privacy of the potential
p.000003: participant, her/his identity and records are kept confidential and access
p.000003: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000003: 3
p.000004:
p.000004:
p.000004: Statement of General Principles
p.000004:
p.000004: is limited to only those authorized. However, under certain circumstances (suicidal ideation, homicidal tendency, HIV
p.000004: positive status, when required by court of law etc.) privacy of the information can be breached in consultation with
p.000004: the EC for valid scientific or legal reasons as the right to life of an individual supersedes the right to privacy of
p.000004: the research participant.
p.000004: 1.1.6 Principle of risk minimization whereby due care is taken by all stakeholders (including but not limited to
p.000004: researchers, ECs, sponsors, regulators) at all stages of the research to ensure that the risks are minimized and
p.000004: appropriate care and compensation is given if any harm occurs.
p.000004: 1.1.7 Principle of professional competence whereby the research is planned, conducted, evaluated and monitored
p.000004: throughout by persons who are competent and have the appropriate and relevant qualification, experience and/or
p.000004: training.
...
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
p.000008: 2.5.1 If applicable, participants may be reimbursed for expenses incurred relating to their participation in
p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
p.000008: is applicable to all participants, including those in comparator/control groups.
p.000008: 2.5.3 If there are provisions, participants may also receive additional medical services at no cost.
p.000008: 2.5.4 When the LAR is giving consent on behalf of a participant, payment should not become an undue inducement and to
p.000008: be reviewed carefully by the EC. Reimbursement may be offered for travel and other incidental expenses incurred due to
...
p.000010: and/or compensation depending upon the type of research, anticipated risks and proposed number of participants.
p.000010: 2.7 Ancillary care
p.000010: 2.7.1 Participants may be offered free medical care for non-research-related conditions or incidental findings if
p.000010: these occur during the course of participation in the research, provided such compensation does not amount to undue
p.000010: inducement as determined by the EC.
p.000010: 2.8 Conflict of interest
p.000010: Conflict of interest (COI) is a set of conditions where professional judgement concerning a primary interest such as
p.000010: participants welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or
p.000010: non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or
p.000010: sponsors. If COI is inherent in the research, it is important to declare this at the outset and establish appropriate
p.000010: mechanisms to manage it.
p.000010: 2.8.1 Research institutions must develop and implement policies and procedures to identify, mitigate conflicts of
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
...
p.000013: stakeholders, including undergraduate and postgraduate students. SOPs should be in place to address all the major
p.000013: components of RCR as outlined in the following sections.
p.000013: 3.1 Values of research
p.000013: RCR is guided by shared values including honesty, accuracy, efficiency, fairness, objectivity, reliability,
p.000013: accountability, transparency, personal integrity, and knowledge of current best practices, and these should be
p.000013: reflected in the policies related to RCR.
p.000013: 3.1.1 The scientist as a responsible member of society
p.000013: Scientific research is vital to improving our understanding of various health related problems and their solutions.
p.000013: All research components depend on cooperation and shared expectations as part of inter-professional ethics.
p.000013: Unethical behaviour in scientific research can destroy the public’s trust in science and have a negative impact on the
p.000013: research team. Without trust between scientists and the public, or within research teams, meaningful research is
p.000013: compromised. Researchers should be aware that the resources of biomedical research are precious and to be used
p.000013: judiciously. Whereever possible they should also seek oppurtunities to plan translation of research findings into
p.000013: public health outcomes.
p.000013: 3.1.2 Contemporary ethical issues in biomedical and health research
p.000013: Emerging new areas of research give rise to new ethical issues. Among the contemporary
p.000013: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000013: 13
p.000014:
p.000014:
p.000014: Responsible Conduct of Research
p.000014:
p.000014: issues recently under debate are the use of underprivileged and vulnerable groups as participants, post-trial access of
p.000014: research benefits to participants and their communities, research on emerging technologies, etc. Continuing
p.000014: education is necessary to keep researchers apprised of contemporary issues.
p.000014: 3.1.3 Sensitivity to societal and cultural impact of biomedical and health research
p.000014: To understand the social and cultural impact of research, one must analyse how the health sector and general public
p.000014: engage with the results of biomedical and health research. It is essential that researchers bear this in mind
p.000014: while planning, conducting and evaluating research as it will improve public accountability and enhance public, private
p.000014: and political advocacy.
p.000014: 3.1.4 Mentoring
p.000014: Mentoring is one of the primary means for one generation of scientists to pass on their knowledge, values and
p.000014: principles to succeeding generations. Mentors, through their experience, can guide researchers in ways above and beyond
p.000014: what can be gathered from reading textbooks. The relationship between mentors and trainees should enable trainees to
p.000014: become responsible researchers. Mentors should ensure their trainees conduct research honestly, do not interfere
p.000014: with the work of other researchers and use resources judiciously. A mentor should be knowledgeable, teach and lead by
p.000014: example and understand that trainees differ in their abilities. She/he should devote sufficient time and be
...
p.000034: 18. Institutional Committee for Stem Cell Research (IC-SCR) approval (if applicable)
p.000034: 19. MoU in case of studies involving collaboration with other institutions (if applicable)
p.000034: 20.Clinical trial agreement between the sponsors, investigator and the head of the institution(s) (if
p.000034: applicable)
p.000034: (Contd.)
p.000034: 34 INDIAN COUNCIL OF
p.000035: MEDICAL RESEARCH
p.000035:
p.000035:
p.000035: Ethical Review Procedures
p.000035:
p.000035:
p.000035: 21. Documentation of clinical trial registration (preferable)
p.000035: 22. Insurance policy (it is preferable to have the policy and not only the insurance certificate)for study
p.000035: participants indicating conditions of coverage, date of commencement and date of expiry of coverage of risk (if
p.000035: applicable)
p.000035: 23. Indemnity policy, clearly indicating the conditions of coverage, date of commencement and date of
p.000035: expiry of coverage of risk (if applicable)
p.000035: 24. Any additional document(s), as required by EC (such as other EC clearances for multicentric studies)
p.000035: 25. Protocol
p.000035:
p.000035: Box 4.4 (b) Details of documents to be included in the protocol
p.000035:
p.000035: The protocol should including the following:
p.000035: 1. the face page carrying the title of the proposal with signatures of the investigators;
p.000035: 2. brief summary/ lay summary;
p.000035: 3. background with rationale of why a human study is needed to answer the research question;
p.000035: 4. justification of inclusion/exclusion of vulnerable populations;
p.000035: 5. clear research objectives and end points (if applicable);
p.000035: 6. eligibility criteria and participant recruitment procedures;
p.000035: 7. detailed description of the methodology of the proposed research, including sample size (with
p.000035: justification), type of study design (observational, experimental, pilot, randomized, blinded, etc.), types of
p.000035: data collection, intended intervention, dosages of drugs, route of administration, duration of treatment and
p.000035: details of invasive procedures, if any;
p.000035: 8. duration of the study;
p.000035: 9. justification for placebo, benefit–risk assessment, plans to withdraw. If standard therapies are to be
p.000035: withheld,
p.000035: justification for the same;
p.000035: 10. procedure for seeking and obtaining informed consent with a sample of the patient/participant information
p.000035: sheet and informed consent forms in English and local languages. AV recording if applicable; informed consent for
p.000035: stored samples;
p.000035: 11. plan for statistical analysis of the study;
p.000035: 12. plan to maintain the privacy and confidentiality of the study participants;
p.000035: 13. for research involving more than minimal risk, an account of management of risk or injury;
...
p.000036: correction of typographical errors and change in researcher(s);
p.000036: • revised proposals previously approved through expedited review, full
p.000036: review or continuing review of approved proposals;
p.000036: • minor deviations from originally approved research causing no risk or
p.000036: minimal risk;
p.000036: • progress/annual reports where there is no additional risk, for example activity limited to data analysis.
p.000036: Expedited review of SAEs/unexpected AEs will be conducted by SAE subcommittee; and
p.000036: • for multicentre research where a designated main EC among the participating sites has reviewed
p.000036: and approved the study, a local EC may conduct only an expedited review for site specific requirements in addition to
p.000036: the full committee common review.
p.000036: • research during emergencies and disasters (See Section 12 for further details).
p.000036: (Contd.)
p.000036: 36 INDIAN COUNCIL OF
p.000037: MEDICAL RESEARCH
p.000037:
p.000037:
p.000037: Ethical Review Procedures
p.000037:
p.000037:
p.000037: 3 Full committee review
p.000037: All research proposals presenting more than minimal risk that are not covered under exempt or expedited review
p.000037: should be subjected to full committee review, some examples are;
p.000037: • research involving vulnerable populations, even if the risk is minimal;
p.000037: • research with minor increase over minimal risk (see Table 2.1 for further
p.000037: details);
p.000037: • studies involving deception of participants (see section 5.11 for further
p.000037: details);
p.000037: • research proposals that have received exemption from review, or have undergone expedited review/undergone
p.000037: subcommittee review should be ratified by the full committee, which has the right to reverse/or modify any decision
p.000037: taken by the subcommittee or expedited committee;
p.000037: • amendments of proposals/related documents (including but not limited
p.000037: to informed consent documents, investigator’s brochure, advertisements, recruitment methods, etc.) involving an
p.000037: altered risk;
p.000037: • major deviations and violations in the protocol;
p.000037: • any new information that emerges during the course of the research for deciding whether or not to
p.000037: terminate the study in view of the altered benefit–risk assessment;
p.000037: • research during emergencies and disasters either through an expedited
p.000037: review/ scheduled or unscheduled full committee meetings. This may be decided by Member Secretary depending on the
p.000037: urgency and need;
p.000037: • prior approval of research on predictable emergencies or disasters before
...
p.000039: consider the aggregate of harm and benefits of the study as a whole.
p.000039: • The EC should review plans for risk management, including withdrawal criteria with rescue medication or procedures.
p.000039: • The EC should give advice regarding minimization of risk/
p.000039: discomfort wherever applicable.
p.000039: • Adequate provisions must be made for monitoring and auditing the conduct of the research, including
p.000039: the constitution of a Data and Safety Monitoring Board (DSMB) if applicable (for example in clinical trials)
p.000039:
p.000039: 4 Selection of the study population and
p.000039: recruitment of research participants
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: 5 Payment for participation
p.000039: • Recruitment should be voluntary and non-coercive. Participants should be fairly selected
p.000039: as per inclusion and exclusion criteria. However, selection of participants should be distributive such
p.000039: that a particular population or tribe or economic group is not coerced to participate or benefit.
p.000039: • Participants should be able to opt out at any time without their
p.000039: routine care being affected.
p.000039: • No individual or group of persons must bear the burden of participation in research without accruing
p.000039: any direct or indirect benefits.
p.000039: • Vulnerable groups may be recruited after proper justification
p.000039: is provided.
p.000039: • Plans for payment for participation, reimbursement of incurred costs, such as travel or lost wages,
p.000039: incidental expenses and other inconveniences should be reviewed.
p.000039:
p.000039:
p.000039: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000039: (Contd.)
p.000039: 39
p.000040:
p.000040:
p.000040: Ethical Review Procedures
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 6 Protection of research participants’ privacy and confidentiality
p.000040:
p.000040: 7 Community considerations
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 8 Qualifications of researchers and adequacy assessment of study sites
p.000040: 9 Disclosure or declaration of potential COI
p.000040:
p.000040:
p.000040:
p.000040: 10 Plans for medical management and compensation for study related injury
p.000040: 11 Review of the informed consent process
p.000040: • There is a need to determine that payments are not so large as to encourage prospective participants to participate
p.000040: in the research without due consideration of the risks or against their better judgement. No undue inducement must be
p.000040: offered.
p.000040: • ECs should examine the processes that are put in place to
p.000040: safeguard participants’ privacy and confidentiality.
p.000040: • Research records to be filed separately than routine clinical
p.000040: records such as in a hospital setting.
p.000040: • The EC should ensure that due respect is given to the community, their interests are
p.000040: protected and the research addresses the community’s needs.
p.000040: • The proposed research should not lead to any stigma or
p.000040: discrimination. Harm, if any, should be minimized.
p.000040: • Plans for communication of results to the community at the
p.000040: end of the study should be carefully reviewed.
p.000040: • It is important to examine how the benefits of the research will
p.000040: be disseminated to the community.
p.000040: • The EC should look at the suitability of qualifications and experience of the PI to conduct the proposed
p.000040: research along with adequacy of site facilities for participants.
p.000040: • The EC should review any declaration of COI by a researcher
p.000040: and suggest ways to manage these.
p.000040: • The EC should manage COI within the EC and members with COI should leave the room at the time of decision making in
p.000040: a particular study.
p.000040: • The proposed plan for tackling any medical injuries or
p.000040: emergencies should be reviewed.
p.000040: • Source and means for compensation for study related injury
p.000040: should be ascertained.
p.000040: The informed consent process must be reviewed keeping in mind the following:
p.000040: • the process used for obtaining informed consent, including the
p.000040: identification of those responsible for obtaining consent and the procedures adopted for vulnerable populations;
p.000040: • the adequacy, completeness and understandability of the
p.000040: information to be given to the research participants, and when appropriate, their LARs;
p.000040:
p.000040: (Contd.)
p.000040:
p.000040: 40 INDIAN COUNCIL OF
p.000041: MEDICAL RESEARCH
p.000041:
p.000041:
p.000041: Ethical Review Procedures
p.000041:
p.000041: • contents of the patient/participation information sheet including the local language
p.000041: translations (See section 5 for further details);
p.000041: • back translations of the informed consent document in English,
p.000041: wherever required;
p.000041: • provision for audio-visual recording of consent process, if
p.000041: applicable, as per relevant regulations; and
p.000041: • if consent waiver or verbal/oral consent request has been asked for, this should be reviewed by assessing
p.000041: whether the protocol meets the criteria. See section 5 for further details.
p.000041: 4.9 Full committee meeting
p.000041: 4.9.1 All proposals that are determined to undergo full committee review must be deliberated and the
p.000041: decision about the proposal taken at a full committee meeting.
p.000041: 4.9.2 ECs should conduct regular full committee meetings to deliberate proposals in accordance with a
p.000041: pre-decided schedule, as described in the SOPs.
p.000041: 4.9.3 A meeting will be considered valid only if the quorum is fulfilled. This should be maintained throughout
...
p.000045: reports of all research activities.
p.000045: 4.11.3 Clinical trials under the purview of a licensing authority must comply with all regulations
p.000045: applicable to SAEs. The EC should also ensure compliance by the researcher. For academic and other trials, an
p.000045: institutional policy should be established.
p.000045: 4.11.4 The EC should examine the measures taken for medical management of SAEs. Participants should not
p.000045: have to bear costs for the management of study-related injury whether they are in the intervention arm or the control
p.000045: arm.
p.000045: 4.11.5 Compensation must be given for research-related injuries if applicable, as determined by the EC and as per
p.000045: regulatory requirement (if applicable).
p.000045: 4.11.6 For protocol deviations/violations the EC should examine the corrective actions. If the violations are
p.000045: serious the EC may halt the study. The EC may report to the institutional head/government authorities where there is
p.000045: continuing non-compliance to ethical standards.
p.000045: 4.11.7 Reports of monitoring done by the sponsor and DSMB reports may also be sought.
p.000045: 4.12 Site monitoring
p.000045: 4.12.1 It is recommended that ECs should follow mechanisms described in a SOP to monitor the approved study site
p.000045: until completion of the research to check for compliance or improve the function.
p.000045:
p.000045: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000045: 45
p.000046:
p.000046:
p.000046: Ethical Review Procedures
p.000046:
p.000046: 4.12.2 Monitoring can be routine or “for cause” and must be decided at a full committee meeting. For research that
p.000046: involves higher risk or vulnerable participants or if there is any other reason for concern, the EC at the time of
p.000046: initial review or continuing review can suggest that routine monitoring may be conducted at more frequent intervals.
p.000046: Some causes for monitoring are given in Box 4.6.
p.000046: Box 4.6 Examples of “for cause” monitoring
p.000046:
p.000046: The following situations may justify “for cause” monitoring:
p.000046:
p.000046: • high number of protocol violations/
p.000046: deviations;
p.000046: • large number of proposals carried out at
p.000046: the study site or by the same researcher;
p.000046: • large number of SAE reports;
p.000046: • high recruitment rate;
p.000046: • complaints received from participants;
p.000046: • any adverse media report;
p.000046: • adverse information received from any
p.000046: other source;
p.000046: • non-compliance with EC directions;
p.000046: • misconduct by the researcher; and
p.000046: • any other cause as decided by the EC.
p.000046:
p.000046: 4.13 Record keeping and archiving
p.000046: 4.13.1 All documentation and communication of an EC should be dated, filed and preserved according to written
p.000046: procedures.
p.000046: 4.13.2 Confidentiality should be maintained during access and retrieval procedures by designated persons.
p.000046: 4.13.3 All active and inactive (closed) files should be appropriately labelled and archived separately in
p.000046: designated areas.
p.000046: 4.13.4 Records can be maintained in hard copies as well as soft copies.
p.000046: 4.13.5 All records must be archived for a period of at least 3 years after the completion/ termination of the
p.000046: study.
p.000046: 4.13.6 Documents related to regulatory clinical trials must be archived for 5 years after the
...
p.000055:
p.000055: 5.9.3 The original PIS and ICF should be archived as per the requirements given in the guidelines and regulations.
p.000055: 5.10 Special situations
p.000055: 5.10.1 Gatekeepers
p.000055: Permission of the gatekeepers, that is, the head/leader of the group or culturally appropriate authorities,
p.000055: may be obtained in writing or audio/video recorded on behalf of the group and should be witnessed.
p.000055: 5.10.2 Community consent
p.000055: In certain populations, the community plays an important role in the consent process. Some participants may not
p.000055: participate in the research unless the community’s consent is available. There may be situations when individual
p.000055: consent cannot be obtained as it will change the behaviour of the individual (see section 8 for further details). In
p.000055: such situations community consent is required. When permission is obtained from an organization that represents the
p.000055: community, the quorum required for such a committee must be met. For example, in a village panchayat the number of
p.000055: members ordinarily required to conduct a meeting must be present while giving consent. Individual consent is important
p.000055: and required even if the community gives permission.
p.000055: 5.10.3 Consent from vulnerable groups
p.000055: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own interests
p.000055: and providing valid informed consent. The list of vulnerable populations/communities is given in Box 6.2.
p.000055: 5.11 Consent for studies using deception
p.000055: Some types of research studies require deception due to nature of research design. A true informed consent may lead to
p.000055: modification and may defeat the purpose of research. Such research may be carefully reviewed by the EC before
p.000055: implementation.
p.000055: 5.11.1 True informed consent in studies involving deception is difficult due to the nature of research. A two-step
p.000055: procedure may be required comprising an initial consent and a debriefing after participation.
p.000055: 5.11.2 The possibility of unjustified deception, undue influence and intimidation should be avoided at all costs.
p.000055: Although deception is not permissible, approval may be taken from the EC in circumstances where some information
p.000055: requires to be withheld for validation until the completion of the research.
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
p.000056: • incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or
p.000056: permanently, for example people who are unconscious, differently abled;
p.000056: • able to give consent, but whose voluntariness or understanding is compromised due to
p.000056: their situational conditions; or
p.000056: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000056: refusal to participate which may lead them to give consent.
p.000056:
p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
p.000059: Researchers • Recognize the vulnerability of the participant and ensure additional
p.000059: safeguards are in place for their protection.
p.000059: • Justify inclusion/exclusion of vulnerable populations in the study.
p.000059: • COI issues must be addressed.
p.000059: • Have well defined procedures (SOPs) to ensure a balanced benefit-risk
p.000059: ratio.
p.000059: • Ensure that prospective participants are competent to give informed
p.000059: consent.
p.000059: • Take consent of the LAR when a prospective participant lacks the capacity
p.000059: to consent.
p.000059: • Respect dissent from the participant.
p.000059: • Seek permission of the appropriate authorities where relevant, such as
p.000059: for institutionalized individuals, tribal communities, etc.
p.000059: • Research should be conducted within the purview of existing relevant
p.000059: guidelines/regulations.
p.000059: Ethics Committees • During review, determine whether the prospective participants for a
p.000059: particular research are vulnerable.
p.000059: • Examine whether inclusion/exclusion of the vulnerable population is
p.000059: justified.
p.000059: • Ensure that COI do not increase harm or lessen benefits to the participants.
p.000059: • Carefully determine the benefits and risks to the participants and advise
p.000059: risk minimization strategies wherever possible.
p.000059: • Suggest additional safeguards, such as more frequent review and
p.000059: monitoring, including site visits.
p.000059: • Only the full committee should do initial and continuing review of such proposals. It is desirable to have
p.000059: empowered representatives from the specific populations during deliberations.
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
p.000059: as minimal as possible and are clearly spelt out in the ICD.
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
...
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
...
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
...
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
...
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
p.000068: or populations in conflict zones, riot areas or disaster situations. Additional precautions should be taken to
p.000068: avoid exploitation/retaliation/ reward/credits and other inducements when such individuals are to be recruited as
p.000068: research participants.
p.000068: 6.11.1 Autonomy of such individuals is already compromised and researchers have to justify their inclusion.
p.000068: 6.11.2 ECs have to satisfy themselves with the justification provided to include these participants and record the same
p.000068: in the proceedings of the EC meeting.
p.000068: 6.11.3 Additional safety measures suggested earlier in the guidelines should be strictly followed by the ECs.
p.000068: 6.11.4 The informed consent process should be well documented. There should not be any undue coercion or incentive for
p.000068: participation. A person’s refusal to participate should be respected and there should be no penalization.
p.000068: 6.11.5 The EC should also carefully determine the benefits and risks of the study and examine risk minimization
p.000068: strategies.
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: 68 INDIAN COUNCIL OF
p.000069: MEDICAL RESEARCH
p.000069:
p.000069: SECTION 7
p.000069:
...
p.000070: (2013 or later versions as applicable), National Guidelines for Biomedical and Health Research Involving Human
p.000070: Participants (2017), the Drugs and Cosmetics Act (1940), and Rules (1945), and applicable amendments (including
p.000070: Schedule Y), and other relevant regulations and guidelines, wherever applicable.
p.000070: 7.1.4 A participant’s right to agree or decline consent to take part in a clinical trial must be respected and
p.000070: her/his refusal should not affect routine care.
p.000070: 7.1.5 At all times, the privacy of a participant must be maintained and any information gathered from
p.000070: the participant be kept strictly confidential.
p.000070: 7.1.6 Therapeutic misconception in potential participants must be avoided (for example, by having a
p.000070: co-investigator who is not the primary treating physician administer the consent).
p.000070: 7.1.7 At least one member of the research team must have the qualifications and adequate research experience in the
p.000070: subject on which the trial is planned.
p.000070: 7.1.8 All clinical trials must be approved by an EC that is constituted and functions in accordance
p.000070: with these guidelines and applicable regulations.
p.000070: 7.1.9 Applicable regulatory approvals must be taken (if required).
p.000070: 7.1.10 All clinical trials must be registered with the Clinical Trial Registry -India (CTRI).28
p.000070: 7.1.11 Written informed consent must be obtained from each participant before any research related procedure is
p.000070: performed.
p.000070: 7.1.12 If the trial is planned in a vulnerable population, it should be undertaken only with due justification and with
p.000070: all possible participant protections in place.
p.000070: 7.1.13 Procedures to assure the quality of every aspect of the trial should be implemented.
p.000070: 7.1.14 SAEs must be reported for all trials and if applicable timelines as specified by regulators to be followed
p.000070: (within 24 hours to the sponsor, EC and regulator, if applicable, followed by a due analysis report in 14 days).
p.000070: 7.1.15 Free medical management of AEs and SAEs, irrespective of relatedness to the clinical trial, should be given for
p.000070: as long as required or till such time as it is established that the injury is not related to the clinical trial,
p.000070: whichever is earlier.
p.000070: 7.1.16 In addition, compensation must be given if the SAE is proven to be related to the trial.
p.000070: 7.1.17 Ancillary care may be provided to clinical trial participants for non-study/trial related illnesses arising
p.000070: during the period of the trial. This could be in the form of medical care or reference to facilities, as may be
p.000070: appropriate.
p.000070: 70 INDIAN COUNCIL OF
p.000071: MEDICAL RESEARCH
p.000071:
p.000071: Clinical Trials of Drugs and
p.000071: other Interventions
p.000071:
p.000071: 7.1.18 Institutional mechanisms must be established to allow for insurance coverage of trial related or unrelated
p.000071: illnesses (ancillary care) and compensation wherever deemed necessary by the EC.
p.000071: 7.2 Clinical drug/vaccine development
p.000071: 7.2.1 The broad aim of the process of clinical development of a new drug or vaccine, (referred to as an IP) is to
...
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
p.000089: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000089: 89
p.000090:
p.000090: Clinical Trials of Drugs and
p.000090: other Interventions
p.000090:
p.000090: disadvantaged populations may participate in the research to gain free access to an intervention. It is important to
p.000090: ensure that the participant has understood that this is research and the benefits expected may be small or they may not
p.000090: occur at all.
p.000090: 7.19.3 Participants must be made to understand that they may be randomized to a placebo group and therefore receive
p.000090: an inert drug, in case of a placebo-controlled study.
p.000090: 7.19.4 If the trial is a placebo- or active-controlled trial, all the groups must be given the current standard of
p.000090: care to which the IP, placebo or active control is added.
p.000090: 7.19.5 Perceptions of benefits and risks may be different for patients, healthcare workers and EC members. All
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
...
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
p.000095: • Principle of reciprocity – This principle requires that individuals or communities, who have borne a
p.000095: disproportionate share of burden or risks for the benefit of others be given some form of benefit. The benefit should
p.000095: be context specific such as protection from further exposure, access to food, healthcare, clothing and
p.000095: shelter, communication or compensation for lost income.
p.000095: • Principle of solidarity – Public health research should respect the intra- and inter- dependence among
p.000095: members of communities leading to solidarity for collective welfare or the common good.
p.000095: • Principle of accountability and transparency – The conduct of research must be fair, honest and transparent.
p.000095: The results should be made available in the public domain.
p.000095: In order to undertake a review of public health research, an EC must carefully consider the points given in Box 8.1.
p.000095: Box 8.1 Public health research proposal review
p.000095:
...
p.000099: of knowledge and power relationships which should be considered.
p.000099: 8.2.5 Demonstration projects
p.000099: A demonstration project tests the effects of a new policy approach on the health system in a real-world situation. By
p.000099: their very nature, such projects change the status quo of existing public programmes, affecting communities,
p.000099: users/beneficiaries, providers, and expenditures. They help policymakers to learn about the potential impact
p.000099: and operational challenges of a new policy/programme or modification of the existing policy to a public health system,
p.000099: but in a more controlled environment and on a limited basis. Demonstration projects affect a large population – a
p.000099: district or cluster of districts or a state, thus involving hundreds of thousands of people (users and health
p.000099: providers) with substantial resource investment.
p.000099: • A number of key issues must be considered in designing, implementing and evaluating demonstration
p.000099: projects. This most often requires some level of research for cultural and geographical appropriateness (formative
p.000099: research) to support their development and evaluation to report to the policy makers on recommendations regarding the
p.000099: proposed approach.
p.000099: • All demonstration projects should be subject to ethical scrutiny.
p.000099: Some of the key questions that the EC should raise are:
p.000099: • Why is the demonstration project being undertaken?
p.000099: • How is this designed/being initiated/implemented?
p.000099: • What impact is the project likely to have on broader health systems?
p.000099: • Will there be issues involving equity and vulnerable populations?
p.000099: • What is the range of design and implementation situations on the ground?
p.000099: • Should a decision on the exemption from review and consent waiver be taken on
p.000099: a case- by-case basis?
p.000099:
p.000099:
p.000099: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000099: 99
p.000100:
p.000100:
p.000100: Public Health Research
p.000100:
p.000100: 8.2.6 Community Trials
p.000100: These are trials carried out at the community level or on groups and the treatment or intervention is allocated to
p.000100: communities rather than individuals. These could both be interventional or observational studies. Such studies may be
p.000100: carried out for conditions that are influenced due to social reasons and the interventions may be directed at group
p.000100: behaviour as well. These studies target the community as a whole and the randomization is also at community level and
p.000100: usually the method is useful in order to study public health interventions or disease prevention models.
p.000100: • The studies require review and monitoring by EC as for other research.
p.000100: • Informed consent issues are complex and details in section 8.4 may be seen.
p.000100: 8.3 Use of administrative and other data sources for research
p.000100: Administrative data refer to systematically collected or compiled information designed to assist in programmatic and
p.000100: organizational operations. There is a shift in use of these data sets, from primarily managing and monitoring
p.000100: programmes and performing audits, to conducting research and informing policy. Large volume of data may be accessible
p.000100: from state health departments, national surveys, commercial sources and other data repositories and big data sources.
...
p.000108: influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
p.000108: support and conditions for self-respect. Accordingly, concerns about social justice must be central to any
p.000108: adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the
p.000108: vulnerable status of prospective participants during review, for example, a woman asking her husband or family before
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
p.000108: practices. See section 5.7 for further details.
p.000108: 108 INDIAN COUNCIL OF MEDICAL
p.000109: RESEARCH
p.000109:
p.000109: Social and Behavioural Sciences
p.000109: Research for Health
p.000109:
p.000109: 9.2.7 Privacy and confidentiality
p.000109: Privacy and confidentiality of research participants should be considered while selecting sites for data collection,
p.000109: choosing sensitive research areas, specific contexts and settings. In some circumstances participants become more
p.000109: vulnerable in research because of heightened psychological, social, physical or legal risks. Breach of
p.000109: confidentiality in these types of research may cause serious harm to vulnerable participants. It is important to
p.000109: protect study participants from potential future risks and harm by establishing culturally sensitive and context
p.000109: specific safeguards.
p.000109: 9.2.8 Duty to disclose sensitive information
p.000109: As mentioned in Box 9.1, researcher(s) may come across certain facts detrimental to a participant’s self or others,
p.000109: such as suicidal tendency/ideation, notifiable diseases. In such a situation, researchers have a responsibility to
p.000109: disclose this information to relevant persons/authorities to save life or prevent damage contemplated by the
p.000109: participant. Measures to be taken in such instances are given below:
p.000109: • If there is a high likelihood of getting sensitive incidental findings during the research
p.000109: process, then the ways to handle these at individual, family and community levels should be discussed and mentioned in
p.000109: the protocol.
p.000109: • Researchers and the EC should have a basic understanding of the legal provisions in the related area. Persons
p.000109: with the necessary domain knowledge and experience can be special invitees to EC meetings.
p.000109: 9.2.9 Studies Using Deception
p.000109: Deception occurs when researchers provide false or incomplete information to participants for the purpose of
p.000109: misleading them so as to achieve the study objectives and for larger public good. Research employing any type of
p.000109: deception should undergo full committee review.
...
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
...
p.000133: 1. whether the proposed use is aligned with the original consent given for the earlier research and scrutinize the
p.000133: validity of the objectives of the new research;
p.000133: 2. whether provisions for ensuring anonymity of the samples for secondary use are stated;
p.000133: 3. whether the permission of LAR is obtained for post-mortem uses of samples;
p.000133: 4. whether the consent form mentions retention and various possible future uses of tissues in the form of a tiered
p.000133: consent; and
p.000133: 5. Whether provisions have been made for allowance of waiver of consent if the donor is not traceable or the
p.000133: sample/data is anonymized or it is impractical to conduct the research.
p.000133:
p.000133: 11.4.4 Return of research results to individual/groups
p.000133: There are several possibilities which may be appropriate for a particular research and, according to the suitability,
p.000133: could be included in the participant information sheet/ informed consent document for biobanking.
p.000133: • Results of the study should be communicated back to the providers of samples/
p.000133: data.
p.000133: • If the findings are in an aggregate form, the participant will not be able to receive
p.000133: any feedback on individual data.
p.000133: • Wherever applicable, research findings in aggregate form (which does not reveal individual results) must
p.000133: be discussed with the community, especially when research involves populations who are more vulnerable, such as
p.000133: tribal populations, ethnic groups and people living with certain diseases.
p.000133: • In the absence of an appropriate mechanism to deal with informational harm that can occur if participants are
p.000133: provided feedback when they are not prepared to face it or if it is not actionable or when such information is
p.000133: unrelated, a lot of distress could be caused to participants concerned.
p.000133: • At the time of sample collection, it may be a good approach to offer donors the choice of receiving the
p.000133: results of the research whether they are beneficial or not. Participants may also choose not to be contacted about
p.000133: their results. Another alternative is to give participants the option of receiving an aggregate report of all the
p.000133: results of the study which could become a shared benefit for the community. The aforementioned options may be
p.000133: incorporated in a tiered consent.
p.000133:
p.000133: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000133: 133
p.000134:
p.000134: Biological Materials,
p.000134: Biobanking and Datasets
p.000134:
p.000134: 11.4.5 Benefit sharing
p.000134: Biological materials and/or data have potential commercial value but the participants’ contribution and their share in
p.000134: this benefit is very often not known to them. The informed consent document should emphasize this aspect with necessary
p.000134: clauses for clarity about benefit sharing. See Box 11.5 for further details.
p.000134: Box 11.5 Considerations for benefit sharing
p.000134:
p.000134: 1. The document should describe whether donors, their families, or communities would receive any financial or
...
p.000138: protections might be required in special cases, for example,
p.000138:
p.000138: 138 INDIAN COUNCIL OF MEDICAL
p.000139: RESEARCH
p.000139:
p.000139: Research during Humanitarian Emergencies and Disasters
p.000139:
p.000139: children with untraceable or deceased relatives. In these situations, the consent should be obtained from an individual
p.000139: who is not part of the research team who should be designated by the institution/agency conducting research.
p.000139: 12.2.7 For seeking waiver of consent, the researchers should give the rationale justifying the waiver. EC should
p.000139: approve such a waiver after careful discussion on the issue. See section 5 for further details.
p.000139: 12.2.8 When consent of the participant/LAR/assent is not possible due to the situation, informed consent
p.000139: must be administered to the participant/LAR at a later stage, when the situation allows. However, this should be done
p.000139: only with the prior approval of the EC.
p.000139: 12.3 Risk-minimization and equitable distribution of benefits and risks
p.000139: 12.3.1 Considerations for fair selection of participants are described in Box 12.1.
p.000139:
p.000139: Box 12.1 Considerations for fair selection of participants
p.000139:
p.000139: 1. The overall effort is not to over-sample, particularly vulnerable segments of the population.
p.000139: 2. Explicit selection criteria or prioritization of participants with proper justification should be provided in the
p.000139: protocol.
p.000139: 3. Efforts should be taken to ensure that research participants are not exploited during the research project by
p.000139: imposing additional burdens on them.
p.000139: 4. It is desirable to set up a DSMB to frequently review the data to check on risk quantum.
p.000139:
p.000139: 12.3.2 Efforts should be made to see that the positive results of a specific research are applicable to future similar
p.000139: disaster situations.
p.000139: 12.3.3 Whenever possible, a priori agreement could be reached between researcher(s) and disaster affected communities
p.000139: for benefit sharing, which could be extended to future disaster affected communities wherever applicable.
p.000139: 12.4 Privacy and confidentiality
p.000139: 12.4.1 Disruption of governance, infrastructure and communication networks and inflow of visitors during emergencies
p.000139: can lead to a breach of privacy and confidentiality. In some situations, there can be stigmatization and discrimination
p.000139: which should be minimized at all stages of research.
p.000139: 12.4.2 Special efforts (culturally appropriate and scientifically valid) are required to maintain dignity, privacy and
p.000139: confidentiality of individuals and the communities.
p.000139:
p.000139: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000139: 139
p.000140:
p.000140: Research during Humanitarian Emergencies and
p.000140: Disasters
p.000140:
...
p.000144: and Cultural Organization’s General Conference; 2005.
p.000144: 18. Guidelines for laboratory animal facilities. Committee for the Purpose of Control and Supervision of
p.000144: Experiments on Animals; 2003.
p.000144: 19. Guidelines for international collaboration/research projects in health research [homepage on the
p.000144: Internet]. Indian Council of Medical Research. Available from: http://www.icmr.nic.in/guide.htm (accessed 31 Aug 2017).
p.000144: 20. Environmental Protection Act, 1986, India [statute of the Internet]. Available from:
p.000144: http://envfor.nic.in/legis/env/env1.html (accessed 31 Aug 2017).
p.000144: 21. The Biological Diversity Act, 2002, India [statute on the Internet]. Available from:
p.000144: http://www.bamu.ac.in/Portals/0/3_%20The%20biological%20Diversity%20 act%2C%202002.pdf (accessed 31 Aug 2017).
p.000144: 22. Foreign Contribution (Regulation) Act, 2010, India [statute on the Internet]. Available from:
p.000144: http://lawmin.nic.in/ld/regionallanguages/THE%20FOREIGN%20
p.000144: CONTRIBUTION%20(REGULATION)%20ACT,2010.%20(42%20OF%202010).pdf (accessed 13 Sept 2017).
p.000144: 23. Defining the role of authors and contributors [homepage on the Internet]. International Committee of Medical
p.000144: Journal Editors. Available from: http://www.icmje.org/
p.000144: recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors- and-contributors.html (accessed 02 Sept
p.000144: 2017).
p.000144: 24. National ethical guidelines for bio-medical research involving children, 2017.
p.000144: 25. Particularly vulnerable tribal groups [homepage on the Internet]. Ministry of Tribal Affairs. Available from:
p.000144: http://tribal.nic.in/pvtg.aspx (accessed 31 Aug 2017).
p.000144: 26. The Mental Healthcare Act, 2017, India [statute on the Internet]. Available from: http://
p.000144: www.prsindia.org/uploads/media/Mental%20Health/Mental%20Healthcare%20 Act,%202017.pdf (accessed 12 Sept 2017).
p.000144: 27. G.S.R. 313(E) dated 16th Mar 2016. New Delhi: Gazette of India. Available from: http://
p.000144: www.cdsco.nic.in/writereaddata/GSR%20313%20(E)%20dated%2016_03_2016.pdf (accessed 12 Sept 2017).
p.000144: 28. Clinical Trials Registry - India [homepage on the Internet]. Available from: http://
p.000144:
p.000144: 144 INDIAN COUNCIL OF MEDICAL
p.000145: RESEARCH
p.000145:
p.000145:
p.000145: List of references
p.000145:
p.000145: www.ctri.nic.in (accessed 12 Sept 2017).
p.000145: 29. GSR 918 (E) dated 30th Nov 2015. New Delhi : Gazette of India. Available from: http://
p.000145: www.cdsco.nic.in/writereaddata/GSR%20918-E-dated-30-11-2015.pdf (accessed 13th Sept 2017).
p.000145: 30. Guidelines for Good Clinical Laboratory Practices (GCLP).New Delhi. Indian Council of Medical Research.
p.000145: Available from: http://icmr.nic.in/guidelines/GCLP.pdf (accessed 18 May 2017).
p.000145: 31. Good Manufacturing Practices. New Delhi: Central Drugs Standard Control Organization. Available
p.000145: from:http://www.cdsco.nic.in/writereaddata/ schedulem(gmp)6.pdf (accessed 12 Sept 2017).
p.000145: 32. Good Clinical Practice Guidelines for clinical trials of ASU Medicine. New Delhi: Department of AYUSH,
p.000145: Ministry of Health and Family Welfare, Government of India; 2013. Available from:
...
p.000155: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000155: 155
p.000156:
p.000156:
p.000156: Glossary
p.000156: 39 Maleficence The act of committing harm or a harmful act.
p.000156:
p.000156: 40 Marginalized communities
p.000156: A group of people actively separated or excluded from the rest of society.
p.000156: 41 Minimal risk Probability of harm or discomfort anticipated in the research is
p.000156: not greater than that ordinarily encountered in routine daily life activities of a healthy individual or general
p.000156: population or during the performance of routine physical or psychological examinations or tests. However, in some
p.000156: cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but
p.000156: this may be within the range of minimal risk for the research participant since it would be undertaken as
p.000156: part of current everyday life.
p.000156:
p.000156: 42 Non-
p.000156: therapeutic trial
p.000156: A trial which is unlikely to produce any direct benefit to the
p.000156: participants involved. The aim of a non-therapeutic trial is to obtain knowledge which may contribute
p.000156: towards the future development of new forms of treatment or procedures.
p.000156: 43 Ostracization To exclude, by general consent, from society, friendship,
p.000156: conversation, privileges, etc.
p.000156:
p.000156: 44 Particularly vulnerable tribal group (PVTG)
p.000156: These are a special class of tribal groups, classified as such by the Government of India, due to their
p.000156: especially low development indices when compared to other local tribes. These were classified under the Dhebar
p.000156: Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
...
p.000160: 2 Constituting an Ethics Committee
p.000160: 3 Confidentiality Agreements
p.000160: 4 Conflict of Interest Agreements
p.000160: 5 Training Personnel and EC Members
p.000160: 6 Selection of Independent Consultants
p.000160: 7 Procedures for Allowing a Guest or Observer
p.000160: 8 Categorization of Submitted Protocols for Ethics Review
p.000160: a. Initial Full Committee Review of New Research Protocols
p.000160: b. Expedited Review of Research Protocols
p.000160: c. Exemption from Ethics Review of Research Protocols
p.000160: 9 Agenda Preparation, Meeting Procedures and Minutes
p.000160: 10 Review of New Medical Device Studies
p.000160: 11 Review of Resubmitted Protocols
p.000160: 12 Review of Protocol Amendments
p.000160: 13 Continuing Review of Protocols
p.000160: 14 Review of Final Reports
p.000160: 15 Review of Serious Adverse Events (SAE) Reports
p.000160: 16 Review of Study Completion Reports
p.000160: 17 Management of Premature Termination, Suspension, Discontinuation of the Study
p.000160: 18 Waiver of Written or Verbal/oral Informed Consent
p.000160: 19 Site Monitoring Visits
p.000160: 20 Dealing with Participants’ Requests and Complaints
p.000160: 21 Emergency Meetings
p.000160: 22 Communication Records
p.000160: 23 Maintenance of Active Study Files
p.000160: 24 Archive and Retrieval of Documents
p.000160: 25 Maintaining Confidentiality of EC’s Documents
p.000160: 26 Reviewing Proposals involving Vulnerable Populations
p.000160: 27 Review and Inspection of the EC
p.000160: 28 Audio Visual Recording of the Informed Consent Process
p.000160:
p.000160: 160 INDIAN COUNCIL OF MEDICAL
p.000161: RESEARCH
p.000161:
p.000161: ANNEX 2
p.000161:
p.000161: LIST OF MEMBERS OF COMMITTEES INVOLVED IN REVISION OF GUIDELINES (2015-2017)
p.000161:
p.000161: A. Members of Central Ethics Committee on Human Research
p.000161: P. N. Tandon (Chairperson), National Brain Research Centre, Manesar
p.000161: B. N. Dhawan (Late), Formerly at Central Drug Research Institute, Lucknow
p.000161: Sunil K. Pandya, Jaslok Hospital, Mumbai
p.000161: Madhav Menon, Bar Council of Kerala, M.K.Nambyar Academy for Continuing Legal Education, Kochi
p.000161: G. Padmanaban, Indian Institute of Science, Bengaluru
p.000161: Lt. Gen. D. Raghunath, Formerly at Sir Dorabji Tata Centre for Research in Tropical Diseases, Bengaluru
p.000161: K.N. Chaturvedi, Supreme Court, New Delhi
p.000161: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000161: C.A.K. Yesudian, Formerly at Tata Institute of Social Sciences, Mumbai
p.000161: Vinod K. Paul, All India Institute of Medical Sciences, New Delhi
p.000161: Mira Shiva, Initiative for Health & Equity in Society, New Delhi
p.000161: Vasantha Muthuswamy, Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR,
p.000161: New Delhi
p.000161: Amar Jesani, Indian Journal of Medical Ethics, Mumbai
p.000161: Amita Singh, Jawaharlal Nehru University, New Delhi
...
Searching for indicator vulnerability:
(return to top)
p.000011: Section 5 Informed consent process 49
p.000011: 5.1 Requisites 49
p.000011: 5.2 Essential information for prospective research participants 49
p.000011: 5.3 Responsibility of researchers 51
p.000011: 5.4 Documentation of informed consent process 52
p.000011: 5.5 Electronic consent 53
p.000011: 5.6 Specific issues in clinical trials 53
p.000011: 5.7 Waiver of consent 53
p.000011: 5.8 Re-consent or fresh consent 54
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
...
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p. xi: xi
p. xii:
p. xii: PREFACE
p. xii: Medical profession is probably the oldest one to prescribe ethical guidelines. Such guidelines for practically all
p. xii: aspect of professional conduct were provided both in Caraksamhita and Susrutasamhita. Rapid advances in
p. xii: the whole field of biomedical sciences have added newer responsibilities and complex dilemmas for medical persons –
p. xii: both practitioner and researchers. It would be correct to say that every advance in medical science results in added
p. xii: moral responsibility. ICMR has always been on the forefront to set the standards for ethics in biomedical and health
p. xii: research. The Council brought out a policy document in 1980, which was revised in 2000 and further revised in 2006. The
p. xii: latest version of guidelines has addressed the newer emerging ethical issues keeping in view the social, cultural,
p. xii: economic, legal and religious aspects of our country. Ethics is a subject of discussions and debates and each and every
p. xii: word and line in the revised guidelines have been deliberated upon by a group of experts and have gone through a
p. xii: process of consultation and debate before it has been finalized. The new expanded document has separate sections on
p. xii: Responsible Conduct of Research, Informed Consent Process, Vulnerability, Public Health Research, Social and
p. xii: Behavioural Sciences Research for Health, Biological materials, Biobanking and Datasets, International Collaboration
p. xii: and Research during Humanitarian Emergencies and Disasters. The guidelines also highlight the need for capacity
p. xii: building in the area of ethics in order to improve the ethical conduct of research. These Guidelines are a result of
p. xii: in-depth discussions and debates, involving the diverse stake-holders and also the public. The ICMR ethical guidelines
p. xii: are well respected not only in India but a number of other countries. The new “National Ethical Guidelines for
p. xii: Biomedical and Health Research involving Human Participants, 2017” will serve as a guide to answer and meet the
p. xii: challenges and concerns raised by the emerging ethical issues.
p. xii: I wish that the society will be enormously benefitted by these revised guidelines in general and biomedical scientist
p. xii: in particular.
p. xii:
p. xii:
p. xii:
p. xii:
p. xii:
p. xii: New Delhi April 2017
p. xii: Dr. P N Tandon
p. xii: Chairperson
p. xii: Central Ethics Committee on Human Research
p. xii:
p. xii:
p. xii: xii
p. xiii:
p. xiii: MESSAGE FROM CHAIRPERSON ADVISORY GROUP
p. xiii: ICMR brought out the ‘Policy Statement on Ethical Considerations Involved in Research on Human Subjects’ in 1980 under
p. xiii: the chairmanship of Hon'ble Justice H R Khanna. These guidelines were revised in 2000 as the ‘Ethical Guidelines for
p. xiii: Biomedical Research on Human Subjects’ under the chairmanship of Hon'ble Justice M N Venkatachaliah. In view of the new
p. xiii: developments in the field of science and technology, another revision was carried out as Ethical Guidelines for
p. xiii: Biomedical Research on Human Participants in 2006. Bioethics is a dynamic area and over the last 10 years many new
p. xiii: concerns and issues have evolved internationally over the ethical dilemmas faced by the scientific and ethics
p. xiii: committees in the conduct and review of biomedical research; hence, an exercise was taken up over a period of one year
p. xiii: with national and international consultation to come up with this new set of state of art guidelines. It was a
p. xiii: challenging task to decide which of the best practices we should incorporate in this revised version. A wide range of
p. xiii: stakeholders in the country consult the ICMR ethical guidelines as gold standard and these are also looked upon by many
p. xiii: developing countries.
p. xiii: The new guidelines have many new sections added up and many changes incorporated in the existing sections. There are
p. xiii: now a total of 12 sections including Responsible Conduct of Research, Informed Consent Process, Vulnerability,
p. xiii: Public Health Research, Social and Behavioural Sciences Research for Health, Biological materials,
p. xiii: Biobanking and Datasets and Research during Humanitarian Emergencies and Disasters. Many new issues have been added
p. xiii: up as subsections e.g. sexual minorities (LGBT), multicentric studies, research using datasets etc. The section on
p. xiii: ethics review process has been elaborated to help the many ethics committees who have doubt about the various
p. xiii: procedures to be followed. The support given to the drafting committee by ICMR to complete the work within the
p. xiii: stipulated time needs appreciation.
p. xiii: With the emergence of new technologies and knowledge that can potentially transform society, it has become necessary to
p. xiii: constantly update the ethical guidelines to protect the rights and safety of the research participants involved in
p. xiii: clinical research. I hope the scientific community, the regulatory agencies and all the stakeholders at large involved
p. xiii: in biomedical research will be enormously benefitted by this revised new guidelines.
p. xiii:
p. xiii:
p. xiii:
p. xiii: Coimbatore September 2017
p. xiii: Dr Vasantha Muthuswamy
p. xiii: Chairperson, Advisory Group
p. xiii:
p. xiii:
p. xiii: xiii
p. xiv:
p. xiv: ACKNOWLEDGEMENT
p. xiv:
p. xiv: We acknowledge with gratitude the inspiration and patronage of Dr Soumya Swaminathan, Director General ICMR
p. xiv: and Secretary Department of Health Research, to update and revise the ICMR Ethical Guidelines for Biomedical Research
...
p. xv: and the Nuffield Council of Bioethics, United Kingdom (2002)16 released recommendations/guidelines relevant
p. xv:
p. xv: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000001: 1
p.000002:
p.000002:
p.000002: Introduction
p.000002: to research in developing countries. UNESCO’s Universal Declaration on Bioethics and Human Rights (2005)17 and
p.000002: other international instruments on human rights further defined the Universal Codes of Ethics to be adopted by
p.000002: the member countries. The revised ICMR ethical guidelines have adapted important guidance points from these
p.000002: international guidelines keeping in mind the diverse socio-cultural milieu of our country.
p.000002: The socio-cultural ethos in India and its varying standards of healthcare pose unique challenges to the application of
p.000002: universal ethical principles to biomedical and health research. The last decade has seen emerging ethical issues
p.000002: necessitating further revision of the earlier guidelines and preparation of the current National Ethical Guidelines for
p.000002: Biomedical and Health Research Involving Human Participants, 2017. These guidelines have covered some newer areas like
p.000002: public health research, social and behavioural sciences research for health and responsible conduct of research, and
p.000002: research during humanitarian emergencies and disasters while a few other specialized areas like informed consent
p.000002: process, biological materials, biobanking and datasets and vulnerability have been expanded into separate sections.
p.000002: Scope
p.000002: These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in
p.000002: India involving human participants, their biological material and data. The purpose of such research should be:
p.000002: i. directed towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian
p.000002: cultural, social and natural environment;
p.000002: ii. conducted under conditions such that no person or persons become mere means for the betterment of others and
p.000002: that human beings who are participating in any biomedical and/ or health research or scientific experimentation are
p.000002: dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional
p.000002: fair treatment and transparency; and
p.000002: iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of
p.000002: the results thereof.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2 INDIAN COUNCIL OF
p.000003: MEDICAL RESEARCH
p.000003:
p.000003: SECTION 1
p.000003:
p.000003: STATEMENT OF GENERAL PRINCIPLES
p.000003: 1.0 Research on human participants pertains to a broad range of scientific enquiry aimed at developing
p.000003: generalizable knowledge that improves health, increases understanding of disease and is ethically justified by its
...
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
...
p.000021: 3.8 Collaborative research
p.000021: Researchers are increasingly collaborating with colleagues who have the expertise and/or for resources needed to carry
p.000021: out particular research. This could be inter-departmental/ inter-institutional or international and also multicentre
p.000021: involving public and/or private research centres and agencies. The main ethical issues surrounding
p.000021: collaborations pertain to sharing techniques, ownership of materials and data, IPRs, joint publications, managing
p.000021: research findings, managing COI and commercializing research outcomes. Researchers should familiarize themselves with
p.000021: all aspects including local, national and international requirements for research collaboration including necessary
p.000021: approvals, memorandums of understanding (MoUs) and material transfer agreements (MTA) and EC approval of collaborating
p.000021: institutes.
p.000021: 3.8.1 Ethical considerations in collaborative research
p.000021: Collaborative studies should take into account the values/benefits expected from the research as compared to the risks
p.000021: involving the persons/population being studied.
p.000021: • The participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of
p.000021: ownership of samples and data, analysis, dissemination, publication and IPR as appropriate. There must be free flow of
p.000021: knowledge and capacity at bilateral/multilateral levels.
p.000021: • Careful consideration should be given to protecting the dignity, rights, safety and well-being of the
p.000021: participants in cases where the social contexts of the proposed research can create foreseeable conditions for their
p.000021: exploitation or increase their vulnerability to harm.
p.000021: • The nature, magnitude and probability of all foreseeable harm resulting from participation in a collaborative
p.000021: research programme should be specified in the research protocol and well explained to the participants.
p.000021: • The benefits and burdens should be equally distributed amongst participants
p.000021: recruited by all collaborating institutions.
p.000021: • All participants in collaborative research should have access to the best nationally
p.000021: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000021: 21
p.000022:
p.000022:
p.000022: Responsible Conduct of Research
p.000022:
p.000022: available standard of care.
p.000022: • If there is exchange of biological material involved between collaborating sites, the EC may require
p.000022: appropriate MoU and/or MTA to safeguard the interests of participants and ensure compliance while addressing
p.000022: issues related to confidentiality, sharing of data, joint publications, benefit sharing, etc.
p.000022: 3.8.2 Responsibilities of ethics committees, researchers and institutions
p.000022: The review, conduct and monitoring of collaborative research should be overseen and stakeholders must be aware of
p.000022: the requirements of various regulatory and funding agencies.
p.000022: • An EC should review the protocols in the local social and cultural context and ensure respect for
p.000022: sensitivities and values of participants and communities at collaborative sites.
p.000022: • A mechanism for communication between the ECs of different participating centres should be
...
p.000055: and providing valid informed consent. The list of vulnerable populations/communities is given in Box 6.2.
p.000055: 5.11 Consent for studies using deception
p.000055: Some types of research studies require deception due to nature of research design. A true informed consent may lead to
p.000055: modification and may defeat the purpose of research. Such research may be carefully reviewed by the EC before
p.000055: implementation.
p.000055: 5.11.1 True informed consent in studies involving deception is difficult due to the nature of research. A two-step
p.000055: procedure may be required comprising an initial consent and a debriefing after participation.
p.000055: 5.11.2 The possibility of unjustified deception, undue influence and intimidation should be avoided at all costs.
p.000055: Although deception is not permissible, approval may be taken from the EC in circumstances where some information
p.000055: requires to be withheld for validation until the completion of the research.
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
p.000056: • incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or
p.000056: permanently, for example people who are unconscious, differently abled;
p.000056: • able to give consent, but whose voluntariness or understanding is compromised due to
p.000056: their situational conditions; or
...
p.000056: refusal to participate which may lead them to give consent.
p.000056:
p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
...
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
...
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
p.000059: Researchers • Recognize the vulnerability of the participant and ensure additional
p.000059: safeguards are in place for their protection.
p.000059: • Justify inclusion/exclusion of vulnerable populations in the study.
p.000059: • COI issues must be addressed.
p.000059: • Have well defined procedures (SOPs) to ensure a balanced benefit-risk
p.000059: ratio.
p.000059: • Ensure that prospective participants are competent to give informed
p.000059: consent.
p.000059: • Take consent of the LAR when a prospective participant lacks the capacity
p.000059: to consent.
p.000059: • Respect dissent from the participant.
p.000059: • Seek permission of the appropriate authorities where relevant, such as
p.000059: for institutionalized individuals, tribal communities, etc.
p.000059: • Research should be conducted within the purview of existing relevant
p.000059: guidelines/regulations.
p.000059: Ethics Committees • During review, determine whether the prospective participants for a
p.000059: particular research are vulnerable.
p.000059: • Examine whether inclusion/exclusion of the vulnerable population is
p.000059: justified.
p.000059: • Ensure that COI do not increase harm or lessen benefits to the participants.
p.000059: • Carefully determine the benefits and risks to the participants and advise
p.000059: risk minimization strategies wherever possible.
p.000059: • Suggest additional safeguards, such as more frequent review and
p.000059: monitoring, including site visits.
p.000059: • Only the full committee should do initial and continuing review of such proposals. It is desirable to have
p.000059: empowered representatives from the specific populations during deliberations.
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
p.000059: as minimal as possible and are clearly spelt out in the ICD.
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
...
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
...
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
...
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
p.000063: Box 6.5 Consent of parent/LAR
p.000063:
p.000063: 1. The EC should determine if consent of one or both parents would be required before a child could be enrolled.
p.000063: 2. Generally, consent from one parent/LAR may be considered sufficient for research involving no more than
p.000063: minimal risk and/or that offers direct benefit to the child. Consent from both parents may have to be obtained when the
p.000063: research involves more than minimal risk and/or offers no benefit to the child.
p.000063: 3. Only one parent’s consent is acceptable if the other parent is deceased, unknown, incompetent, not
...
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
p.000064: definitely benefit the child but would be available only if the child participates in the study, waiver of assent could
p.000064: be allowed. However, this situation should be accepted only in exceptional cases where all forms of assent/consent have
p.000064: failed. In such cases, approval of the EC should be obtained.
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
...
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
...
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
...
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
p.000068: or populations in conflict zones, riot areas or disaster situations. Additional precautions should be taken to
p.000068: avoid exploitation/retaliation/ reward/credits and other inducements when such individuals are to be recruited as
p.000068: research participants.
p.000068: 6.11.1 Autonomy of such individuals is already compromised and researchers have to justify their inclusion.
p.000068: 6.11.2 ECs have to satisfy themselves with the justification provided to include these participants and record the same
p.000068: in the proceedings of the EC meeting.
p.000068: 6.11.3 Additional safety measures suggested earlier in the guidelines should be strictly followed by the ECs.
p.000068: 6.11.4 The informed consent process should be well documented. There should not be any undue coercion or incentive for
p.000068: participation. A person’s refusal to participate should be respected and there should be no penalization.
p.000068: 6.11.5 The EC should also carefully determine the benefits and risks of the study and examine risk minimization
...
p.000105: relationships. See section 3.8.3 for further details.
p.000105: 9.1.6 Appropriate experts/expertise of EC members in the social and behavioural sciences domain are an essential
p.000105: aspect to address the above challenges.
p.000105: 9.2 Addressing the ethical challenges
p.000105: 9.2.1 Design and conduct of the study is important for a meaningful outcome in social and behavioural research. See
p.000105: Box 9.2 for further details.
p.000105:
p.000105: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000105: 105
p.000106:
p.000106: Social and Behavioural Sciences
p.000106: Research for Health
p.000106: Box 9.2 Consideration for appropriate design and conduct of study
p.000106:
p.000106: 1. Like any other research, the researchers must ensure that the proposed studies are scientifically sound, built
p.000106: on an adequate prior knowledge base, and are likely to generate valuable information.
p.000106: 2. In socially stratified groups and communities, researchers must spend time to become conversant with
p.000106: cultural norms and practices in order to develop strategies to build trust and negotiate power in ways that do not put
p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
p.000106: from some other nearby village so that her/his vulnerability and perceived threat from other participants can be
p.000106: mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested
p.000106: communication plan.
p.000106: 4. The information about these norms/practices should be collected from reliable and multiple sources including
p.000106: multiple persons/groups, which should be mentioned in detail. This knowledge should be considered while
p.000106: deciding the group of participants and style of interview/investigation. However, the final decision about
p.000106: recruiting the participant should be based on the participant’s and her/his family’s opinion about
p.000106: norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or
p.000106: restrictive communities.
p.000106: 5. Field work challenges for research team – Research team members may sometimes be subjected to unforeseen
p.000106: situations which may involve trauma, humiliation and threats of violence. Training should be given to the
p.000106: research team to meet such challenges.
p.000106: 9.2.2 Ethical review
p.000106: There are some unique features of social and behavioural sciences research which need to be considered by the EC on a
p.000106: case-by-case basis. See Box 9.3 for further details.
p.000106: Box 9.3 Considerations by the EC for ethical review
p.000106: 1. Social and behavioural sciences research approaches are not always positivist and, therefore,
...
p.000129: 1. The procedure of anonymization minimizes the connection between the identifiers and the stored sample or medical
p.000129: data by delinking the person from her/his biological material.
p.000129: 2. Maintaining confidentiality of data and respecting ethnic identity is of prime importance, especially
p.000129: in population based genetic studies.
p.000129: 3. More precautions should be sought when the research pertains to stigmatizing diseases.
p.000129: 4. When data pertains to epidemiological and public health practice or research, it may be dealt with in the manner
p.000129: described in section 8.
p.000129:
p.000129: 11.2.2 Under certain circumstances, some degree of identifiability may have to be retained for reasons related to the
p.000129: research. For example, anonymized data or specimens will not allow later withdrawal of consent by an individual, while
p.000129: in the coded category, this will be possible. In the latter scenario, the custodians of the respective biorepository or
p.000129: biobank have a greater responsibility to take adequate measures to safeguard the
p.000129:
p.000129: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000129: 129
p.000130:
p.000130: Biological Materials,
p.000130: Biobanking and Datasets
p.000130:
p.000130: codes and the data so as to respect the privacy and confidentiality of individual research participants.
p.000130: 11.2.3 Permissibility of a certain research design, acceptability of benefits versus risks, and adequacy of the
p.000130: informed consent, will thus have to be assessed by the EC on a case- by-case basis, taking into account specific
p.000130: contextual and potential vulnerability factors of the participants and the sensitive nature of the proposed research.
p.000130: 11.3 Ethical issues related to donors
p.000130: 11.3.1 Informed consent for biobanking poses specific ethical issues as the aims of scientific study based on which
p.000130: biospecimens are collected and stored in a biorepository are not defined clearly at the time of collection when there
p.000130: are no specific end points and there is a time lag between the collection of the sample and its use in research.
p.000130: 11.3.2 The issues involve multiple stages at which consent needs to be administered – storage, analysis of the
p.000130: biospecimens/samples, use of data linked to the sample, incidental findings, return of results to the
p.000130: participant, sharing of the sample/data with other researchers/national or international institutions, multicentre
p.000130: and multinational collaborations and potential commercialization. These raise issues of access and benefit sharing.
p.000130:
p.000130: Box 11. 2 Example of multiple options in a multi-layered consent
p.000130:
p.000130: Please pick one of the choices below:
p.000130: a. I agree to allow my sample/biospecimen to be stored for future use for any biomedical research.
p.000130: b. I agree to allow my sample/biospecimen to be stored for future use for specific disease such as cancer
p.000130: research.
p.000130: c. I agree to allow my sample/biospecimen to be stored for future use for other pre- specified health problems, such
p.000130: as diabetes, heart disease.
...
p.000138: 12.1 Pre-emptive research preparation for future humanitarian emergency
p.000138: A natural disaster of cyclical frequency is an expected phenomenon. The following will be acceptable if a research is
p.000138: planned to study various implications on humans and ecological effects on humans in these circumstances.
p.000138: 12.1.1 Researchers and sponsors could make arrangements about research questions to be addressed in the design,
p.000138: collection of samples and data, and sharing mechanisms much in advance of a future humanitarian emergency.
p.000138: 12.1.2 Researchers could screen available and/or relevant draft research protocols to expedite the review process.
p.000138: 12.1.3 The EC could review proposals prior to the occurrence of the emergency and determine who could be an
p.000138: acceptable LAR in the absence of intended LARs (authorized/ acceptable) in such situations.
p.000138: 12.2 Informed consent requirements
p.000138: 12.2.1 Obtaining valid informed consent in humanitarian emergencies is a challenge as the decisional capacity of the
p.000138: participants would be so low that they may not be able to differentiate between reliefs offered and research
p.000138: components. This should be very clearly distinguished during the informed consent process.
p.000138: 12.2.2 Additional safeguards are required for participants due to their vulnerability, for example,
p.000138: counselling, psychological help, medical advice and process of stakeholder consultation.
p.000138: 12.2.3 The potential research participants might be under duress and traumatized. Researchers should be sensitive to
p.000138: this situation and are obligated to ensure that the informed consent process is conducted in a respectful manner.
p.000138: 12.2.4 Researchers should strive to identify and address barriers to voluntary informed consent and not resort to
p.000138: inducements for research participation.
p.000138: 12.2.5 The different roles of researchers, caregivers and volunteer workers must always be clarified, and potential COI
p.000138: declared.
p.000138: 12.2.6 If research involves incompetent individuals (such as minors), then the LAR should give consent. Additional
p.000138: protections might be required in special cases, for example,
p.000138:
p.000138: 138 INDIAN COUNCIL OF MEDICAL
p.000139: RESEARCH
p.000139:
p.000139: Research during Humanitarian Emergencies and Disasters
p.000139:
p.000139: children with untraceable or deceased relatives. In these situations, the consent should be obtained from an individual
p.000139: who is not part of the research team who should be designated by the institution/agency conducting research.
...
p.000158: A simple oral or written test designed to identify if the participant
p.000158: has understood the details related to her/his voluntary participation in research before signing
p.000158: the ICD form. (Questions such as “If you decide not to take part in this research study, do you know what your options
p.000158: are?”, “Do you know that you do not have to take part in this research study, if you do not wish to?”, “Do you have any
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
p.000159: 66 Undue inducement
p.000159:
p.000159: 67 Unexpected ADR
p.000159: Offer of disproportionate benefit in cash or kind that compromises judgement which may lead to acceptance of
p.000159: serious risks that threaten fundamental interests.
p.000159: An adverse reaction, the nature or severity of which is not
p.000159: described in the informed consent/information sheet or the applicable product information, such as an
p.000159: investigator’s brochure for the unapproved IP or package insert/summary of product characteristics for an
p.000159: approved product.
p.000159: 68 Vulnerability Vulnerability in research pertains to individuals who are relatively
p.000159: or absolutely incapable of protecting their own interests because of personal disability, environmental burdens or
p.000159: social injustice, lack of power, understanding or ability to communicate or are in a situation that prevents them from
p.000159: doing so.
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000159: 159
p.000160:
p.000160: ANNEX 1
p.000160:
p.000160: STANDARD OPERATING PROCEDURES (SOPs)
p.000160:
p.000160: S. No. List of SOPs
p.000160: 1 Writing, Reviewing, Distributing and Amending Standard Operating Procedures for ECs
p.000160: 2 Constituting an Ethics Committee
p.000160: 3 Confidentiality Agreements
p.000160: 4 Conflict of Interest Agreements
p.000160: 5 Training Personnel and EC Members
p.000160: 6 Selection of Independent Consultants
p.000160: 7 Procedures for Allowing a Guest or Observer
p.000160: 8 Categorization of Submitted Protocols for Ethics Review
p.000160: a. Initial Full Committee Review of New Research Protocols
p.000160: b. Expedited Review of Research Protocols
p.000160: c. Exemption from Ethics Review of Research Protocols
p.000160: 9 Agenda Preparation, Meeting Procedures and Minutes
p.000160: 10 Review of New Medical Device Studies
...
Health / Cadavers
Searching for indicator cadavers:
(return to top)
p.000134: ECs play a key role in oversight and use of the bio- and data repositories for research, scientific and public health
p.000134: programmes. Research proposals, which require biorepository services including material transfer and available data
p.000134: sets, should be reviewed by the EC, either an institutional one or that of the biorepository.
p.000134: 11.5 Biological material/data in forensic departments of laboratories
p.000134: Specimens collected for forensic purposes and related or unrelated data (DNA profiling) offer a good source for
p.000134: academic research after the initial purpose has been served. Data sharing with researchers across the globe is a common
p.000134: practice for refining techniques to develop biomarkers, which could identify missing persons in most difficult
p.000134: circumstances (for example, highly decomposed bodies, disaster situations). In academic institutions, there is a demand
p.000134: for organs and tissues for education, training and research purposes.
p.000134: 11.5.1 Informed consent: If there is no written consent by the deceased person permitting use of organs or tissues, the
p.000134: family can be approached for consent for use of left-over organs or tissues.
p.000134: 11.5.2 No consent would be required if sample or data is anonymized.
p.000134: 11.5.3 If the deceased has no claimant then forensic officials will be authorized to give permission for
p.000134: use of material/data from its sources and be responsible for use of unclaimed cadavers.
p.000134: 11.5.4 The quantity of tissue taken should ideally be minimal, particularly if it is seen externally on the body in
p.000134: order to preserve the dignity of the dead and be culturally acceptable by
p.000134:
p.000134: 134 INDIAN COUNCIL OF MEDICAL
p.000135: RESEARCH
p.000135:
p.000135: Biological Materials,
p.000135: Biobanking and Datasets
p.000135:
p.000135: the next of kin or closest relative or friend.
p.000135: 11.5.5 The information in the informed consent document should state what tissue/organ will be retained, who will be
p.000135: the custodian, duration of storage of sample, what type of research would be conducted and method for disposal of the
p.000135: remains.
p.000135: 11.5.6 Genetic research or revelation of any other stigmatizing factors like HIV, etc. in the deceased may have
p.000135: implications for family members. In such instances, all ethical requirements as in the case of live
p.000135: participants should be followed.
p.000135: 11.5.7 The role of the EC is to review and approve the type of consent – broad, tiered with or without option to
p.000135: opt-out or specific and to assess from whom it would be taken – the family, closest relative or friend – or whether
p.000135: sample anonymization should be done.
p.000135: 11.6 Governance of biobank/biorepository
p.000135: Institutions where data are collected and archived must have an established governance structure with the following
p.000135: requirements for regulation.
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000010: non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or
p.000010: sponsors. If COI is inherent in the research, it is important to declare this at the outset and establish appropriate
p.000010: mechanisms to manage it.
p.000010: 2.8.1 Research institutions must develop and implement policies and procedures to identify, mitigate conflicts of
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
...
p.000059: to consent.
p.000059: • Respect dissent from the participant.
p.000059: • Seek permission of the appropriate authorities where relevant, such as
p.000059: for institutionalized individuals, tribal communities, etc.
p.000059: • Research should be conducted within the purview of existing relevant
p.000059: guidelines/regulations.
p.000059: Ethics Committees • During review, determine whether the prospective participants for a
p.000059: particular research are vulnerable.
p.000059: • Examine whether inclusion/exclusion of the vulnerable population is
p.000059: justified.
p.000059: • Ensure that COI do not increase harm or lessen benefits to the participants.
p.000059: • Carefully determine the benefits and risks to the participants and advise
p.000059: risk minimization strategies wherever possible.
p.000059: • Suggest additional safeguards, such as more frequent review and
p.000059: monitoring, including site visits.
p.000059: • Only the full committee should do initial and continuing review of such proposals. It is desirable to have
p.000059: empowered representatives from the specific populations during deliberations.
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
p.000059: as minimal as possible and are clearly spelt out in the ICD.
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
...
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
...
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
...
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
...
p.000153:
p.000153: 11. Case record/
p.000153: report form (CRF)
p.000153: 12. Clinical
p.000153: research
p.000153: Case record form orcase report form is a printed, opticalor electronic
p.000153: document designed to record all the required information in the protocol on each study participant for reporting to the
p.000153: sponsor.
p.000153: Research that directly involves a particular person or group of
p.000153: people to study the effect of interventions, or uses materials/data from humans indirectly, such as their
p.000153: behaviour or samples of their tissue for prevention, treatment and diagnosis of a disease condition/health disorder.
p.000153: 13. Clinical trial As per amended Schedule Y (2005) of the Drugs and Cosmetics
p.000153: Rules, 1945, a clinical trial refers to a systematic study of new drugs in human subjects to
p.000153: generate data for discovering and/or verifying the clinical, pharmacological (including
p.000153: pharmacodynamic and pharmacokinetic) and /or adverse effect with the objectives determining safety and/or
p.000153: efficacy of a new drug. The academic clinical trial as per GSR 313 (e) dated 16 March 2016 is a clinical trial
p.000153: intended for academic purposes in respect of approved drug formulations for any new indication or new route of
p.000153: administration or new dose or new dosage form.
p.000153:
p.000153: 14 Clinical trial
p.000153: registry
p.000153: An official platform for registering a clinical trial, such as Clinical
p.000153: Trial Registry-India
p.000153: 15 Clinician A person with recognized medical qualification and expertise/ training.
p.000153:
p.000153: 16 Cognitive
p.000153: impairment
p.000153: When a person has trouble remembering, learning new things,
p.000153: concentrating, or making decisions that affect their everyday life.
p.000153:
p.000153: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000153: 153
p.000154:
p.000154:
p.000154: Glossary
p.000154: 17 Coercion An overt or implicit threat of harm to a participant which is intentional to
p.000154: force compliance.
p.000154:
p.000154: 18 Collaborative
p.000154: research
p.000154: An umbrella term for methodologies that actively engage
p.000154: researchers, communities and/ or policy makers in the research process from start to finish.
p.000154: 19 Compensation Provision of financial payment to the research participants or their
p.000154: legal heirs when temporary or permanent injury or death occurs due to participation in biomedical and health research.
p.000154: 20 Confidentiality Keeping information confidential which an individual has disclosed
p.000154: in a relationship of trust and with the expectation that it shall not be divulged to others without permission.
p.000154:
p.000154: 21 Confidentiality
p.000154: agreement
p.000154:
p.000154: 22 Contract
p.000154: Research Organization (CRO)
p.000154: Secrecy or non-disclosure agreements designed to protect trade
p.000154: secrets, information and expertise from being misused by those who have learned about them.
p.000154: An institution or service organization which represents a sponsor
...
Searching for indicator impaired:
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p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
...
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
...
p.000063: research involves more than minimal risk and/or offers no benefit to the child.
p.000063: 3. Only one parent’s consent is acceptable if the other parent is deceased, unknown, incompetent, not
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
...
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
...
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
p.000113: confidentiality in certain circumstances and the anticipated consequences of breach of confidentiality.
p.000113: 10.3.2 The researcher can delink data to maintain confidentiality and safeguard the information for basic research.
...
Searching for indicator impairment:
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p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
p.000008: is applicable to all participants, including those in comparator/control groups.
p.000008: 2.5.3 If there are provisions, participants may also receive additional medical services at no cost.
p.000008: 2.5.4 When the LAR is giving consent on behalf of a participant, payment should not become an undue inducement and to
p.000008: be reviewed carefully by the EC. Reimbursement may be offered for travel and other incidental expenses incurred due to
p.000008: participation of the child/ward in the research.
p.000008: 2.5.5 ECs must review and approve the payments (in cash or kind or both) and free services and the processes
p.000008: involved, and also determine that this does not amount to undue inducement.
p.000008: 2.6 Compensation for research-related harm
p.000008: Research participants who suffer direct physical, psychological, social, legal or economic harm as a result of their
p.000008: participation are entitled, after due assessment, to financial or other assistance to compensate them equitably
p.000008: for any temporary or permanent impairment or disability. In case of death, participant’s dependents are
p.000008: entitled to
p.000008:
p.000008: 8 INDIAN COUNCIL OF
p.000009: MEDICAL RESEARCH
p.000009:
p.000009:
p.000009: General Ethical Issues
p.000009:
p.000009: financial compensation. The research proposal should have an in-built provision for mitigating research related harm.
p.000009: 2.6.1 The researcher is responsible for reporting all SAEs to the EC within 24 hours of knowledge.
p.000009: Reporting of SAE may be done through email or fax communication (including on non-working days). A report on
p.000009: how the SAE was related to the research must also be submitted within 14 days.
p.000009: 2.6.2 The EC is responsible for reviewing the relatedness of the SAE to the research, as reported by the researcher,
p.000009: and determining the quantum and type of assistance to be provided to the participants.
p.000009: • For clinical trials under the purview of CDSCO, the timeline and procedures as
p.000009: notified from time to time may be followed.
p.000009: • All research participants who suffer harm, whether related or not, should be offered appropriate
p.000009: medical care, psycho-social support, referrals, clinical facilities, etc.
p.000009: • Medical management should be free if the harm is related to the research.
p.000009: • Compensation should be given to any participant when the injury is related to the research. This is
p.000009: applicable to participants in any of the arms of research, such as intervention, control and standard of care.
...
p.000010: sponsors. If COI is inherent in the research, it is important to declare this at the outset and establish appropriate
p.000010: mechanisms to manage it.
p.000010: 2.8.1 Research institutions must develop and implement policies and procedures to identify, mitigate conflicts of
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
...
p.000059: • Respect dissent from the participant.
p.000059: • Seek permission of the appropriate authorities where relevant, such as
p.000059: for institutionalized individuals, tribal communities, etc.
p.000059: • Research should be conducted within the purview of existing relevant
p.000059: guidelines/regulations.
p.000059: Ethics Committees • During review, determine whether the prospective participants for a
p.000059: particular research are vulnerable.
p.000059: • Examine whether inclusion/exclusion of the vulnerable population is
p.000059: justified.
p.000059: • Ensure that COI do not increase harm or lessen benefits to the participants.
p.000059: • Carefully determine the benefits and risks to the participants and advise
p.000059: risk minimization strategies wherever possible.
p.000059: • Suggest additional safeguards, such as more frequent review and
p.000059: monitoring, including site visits.
p.000059: • Only the full committee should do initial and continuing review of such proposals. It is desirable to have
p.000059: empowered representatives from the specific populations during deliberations.
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
p.000059: as minimal as possible and are clearly spelt out in the ICD.
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
...
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
...
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
p.000152: 152 INDIAN COUNCIL OF MEDICAL
p.000153: RESEARCH
p.000153:
p.000153:
p.000153: Glossary
p.000153:
p.000153:
p.000153: 8. Biomedical and health research
p.000153: Research including studies on basic, applied and operational research designed primarily to increase the
p.000153: scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and
p.000153: evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical
p.000153: research.
p.000153: 9. Beneficence To try to do good or an action which weighs the risks against
p.000153: benefits to prevent, reduce or remove harm for the welfare of the research participant(s) in any type of research.
p.000153: 10. Caregivers A caregiver or carer is an unpaid or paid person who helps another
p.000153: individual with illness or impairment with daily activities/ performance.
p.000153:
p.000153: 11. Case record/
p.000153: report form (CRF)
p.000153: 12. Clinical
p.000153: research
p.000153: Case record form orcase report form is a printed, opticalor electronic
p.000153: document designed to record all the required information in the protocol on each study participant for reporting to the
p.000153: sponsor.
p.000153: Research that directly involves a particular person or group of
p.000153: people to study the effect of interventions, or uses materials/data from humans indirectly, such as their
p.000153: behaviour or samples of their tissue for prevention, treatment and diagnosis of a disease condition/health disorder.
p.000153: 13. Clinical trial As per amended Schedule Y (2005) of the Drugs and Cosmetics
p.000153: Rules, 1945, a clinical trial refers to a systematic study of new drugs in human subjects to
p.000153: generate data for discovering and/or verifying the clinical, pharmacological (including
p.000153: pharmacodynamic and pharmacokinetic) and /or adverse effect with the objectives determining safety and/or
p.000153: efficacy of a new drug. The academic clinical trial as per GSR 313 (e) dated 16 March 2016 is a clinical trial
p.000153: intended for academic purposes in respect of approved drug formulations for any new indication or new route of
p.000153: administration or new dose or new dosage form.
p.000153:
p.000153: 14 Clinical trial
p.000153: registry
p.000153: An official platform for registering a clinical trial, such as Clinical
p.000153: Trial Registry-India
p.000153: 15 Clinician A person with recognized medical qualification and expertise/ training.
p.000153:
p.000153: 16 Cognitive
p.000153: impairment
p.000153: When a person has trouble remembering, learning new things,
p.000153: concentrating, or making decisions that affect their everyday life.
p.000153:
p.000153: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000153: 153
p.000154:
p.000154:
p.000154: Glossary
p.000154: 17 Coercion An overt or implicit threat of harm to a participant which is intentional to
p.000154: force compliance.
p.000154:
p.000154: 18 Collaborative
p.000154: research
p.000154: An umbrella term for methodologies that actively engage
p.000154: researchers, communities and/ or policy makers in the research process from start to finish.
p.000154: 19 Compensation Provision of financial payment to the research participants or their
p.000154: legal heirs when temporary or permanent injury or death occurs due to participation in biomedical and health research.
p.000154: 20 Confidentiality Keeping information confidential which an individual has disclosed
p.000154: in a relationship of trust and with the expectation that it shall not be divulged to others without permission.
p.000154:
p.000154: 21 Confidentiality
p.000154: agreement
p.000154:
p.000154: 22 Contract
p.000154: Research Organization (CRO)
p.000154: Secrecy or non-disclosure agreements designed to protect trade
p.000154: secrets, information and expertise from being misused by those who have learned about them.
p.000154: An institution or service organization which represents a sponsor
p.000154: in providing research support/services on a contractual basis nationally or internationally.
...
p.000157: psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or
p.000157: depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.
p.000157: 51 Quorum Minimum number and/or kind of EC members required for
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
p.000157: related injury
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
p.000157: it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the
p.000157: intervention, whenever they occur, as well as any medical injury caused due to procedures.
p.000157: 53 Risk Probability of harm or discomfort to research participants.
p.000157: Acceptable risk differs depending on the conditions inherent in the conduct of research.
p.000157:
p.000157: 54 Serious adverse
p.000157: event (SAE)
p.000157: An adverse event is serious when the research outcome for
p.000157: the participant is death, life-threatening injury requiring hospitalization, prolongation of
p.000157: hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to
p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
...
Health / Drug Dependence
Searching for indicator dependence:
(return to top)
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
p.000095: • Principle of reciprocity – This principle requires that individuals or communities, who have borne a
p.000095: disproportionate share of burden or risks for the benefit of others be given some form of benefit. The benefit should
p.000095: be context specific such as protection from further exposure, access to food, healthcare, clothing and
p.000095: shelter, communication or compensation for lost income.
p.000095: • Principle of solidarity – Public health research should respect the intra- and inter- dependence among
p.000095: members of communities leading to solidarity for collective welfare or the common good.
p.000095: • Principle of accountability and transparency – The conduct of research must be fair, honest and transparent.
p.000095: The results should be made available in the public domain.
p.000095: In order to undertake a review of public health research, an EC must carefully consider the points given in Box 8.1.
p.000095: Box 8.1 Public health research proposal review
p.000095:
p.000095: When reviewing public health research proposals, ECs should consider the followings aspects:
p.000095: 1. Are the objectives of the study scientifically sound and linked to the achievement of public health goals?
p.000095: 2. Is individual written informed consent required?
p.000095: • If not, is gatekeeper consent/permission sufficient? Who is a gatekeeper and how is this
p.000095: decided?
p.000095: • Is it a two-stage process – initially a gatekeeper consent/permission followed by individual
p.000095: consent?
p.000095: 3. If applicable, is respect for the community applied through community engagement? If so, is the methodology
p.000095: appropriate?
p.000095: 4. Which segments of the population are likely beneficiaries and what are the expected benefits?
p.000095: 5. Is individual harm overriding the potentially larger societal benefit?
p.000095: • If so, is it justified?
p.000095: • What are the different types of potential harm?
p.000095: • Who would be harmed?
...
Searching for indicator dependency:
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p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
...
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
...
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
p.000057: 7.12 Clinical trials of interventions in HIV/AIDS 82
p.000057:
p.000057: 7.13 Clinical trials on traditional systems of medicine 83
p.000057: 7.14 Trials of diagnostic agents 84
p.000057: 7.15 Radioactive materials and X-rays 85
p.000057: 7.16 Investigator initiated clinical trials 86
p.000057: 7.17 Clinical trials on contraceptives 87
...
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
p.000006: obtained. If a participant or LAR is illiterate, a literate impartial witness should also be present during the
p.000006: informed consent process.
p.000006:
p.000006: 6 INDIAN COUNCIL OF
p.000007: MEDICAL RESEARCH
p.000007:
p.000007:
p.000007: General Ethical Issues
p.000007:
p.000007: 2.2.2 In certain circumstances audio/audio-visual recording of the informed consent process may be required, for
p.000007: example in certain clinical trials as notified by CDSCO.
...
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
p.000012: General Ethical Issues
p.000012:
p.000012: representative, local institution or the government department from where the data was collected to help in
p.000012: dissemination of the results to the entire community.
p.000012: See sections 8 and 9 for further details.
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
p.000012: 2.11.1 Efforts should be made to communicate the findings of the research study to the
p.000012: individuals/communities wherever relevant.
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
p.000013: RESPONSIBLE CONDUCT OF RESEARCH
p.000013:
p.000013: 3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a
p.000013: significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide
p.000013: by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members
p.000013: of a research team are expected to maintain high standards and to uphold the fundamental values of research. The
p.000013: responsible conduct of research (RCR) involves the following major components: values; policies; planning and
p.000013: conducting research; reviewing and reporting research; and responsible authorship and publication.
...
p.000025: with the initial review of research proposals prior to their initiation, and also have a continuing responsibility to
p.000025: regularly monitor the approved research to ensure ethical compliance during the conduct of research. The EC should be
p.000025: competent and independent in its functioning.
p.000025: 4.0.1 The institution is responsible for establishing an EC to ensure an appropriate and sustainable
p.000025: system for quality ethical review and monitoring.
p.000025: 4.0.2 The institution is responsible for providing logistical support, such as infrastructure, staff, space, funds,
p.000025: adequate support and protected time for the Member Secretary to run the EC functions.
p.000025: 4.0.3 The EC is responsible for scientific and ethical review of research proposals. Although ECs may obtain
p.000025: documentation from a prior scientific review, they must determine that the research methods are scientifically sound,
p.000025: and should examine the ethical implications of the chosen research design or strategy.
p.000025: 4.0.4 All types of biomedical and health research (whether clinical, basic science, policy,
p.000025: implementation, epidemiological, behavioural, public health research, etc) must be reviewed by an EC before it
p.000025: is conducted.
p.000025: 4.1 Terms of reference (TOR) for ECs
p.000025: 4.1.1 The TOR for the EC and its members should be clearly specified by the institution in the EC SOPs (Annex 1 for
p.000025: the List of SOPs).
p.000025: 4.1.2 Every EC should have written SOPs according to which the committee should function. The EC can refer to
p.000025: ICMR guidelines in preparing the SOPs for all biomedical and health research and to CDSCO guidelines for drug
p.000025: and device trials under the purview of the licensing authority. The SOPs should be updated periodically to reflect
p.000025: changing requirements. A copy of the latest version of SOPs should be made available to each member and they should be
p.000025: trained on the SOPs. The SOPs must be available in the secretariat of the EC as both hard and soft copies.
p.000025: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000025: 25
p.000026:
p.000026:
p.000026: Ethical Review Procedures
p.000026:
p.000026: 4.1.3 The scope, tenure and renewal policy of the EC should be stated.
p.000026: 4.1.4 Members of the EC should not have any known record of misconduct.
p.000026: 4.1.5 The EC should be registered with the relevant regulatory authorities, for example, ECs approving clinical
p.000026: trials under the ambit of Drugs and Cosmetics Act should be registered with CDSCO.
p.000026: 4.2 Special situations
p.000026: 4.2.1 Institutions can have one or more than one EC. They can have multiple ECs to review large numbers of research
p.000026: proposals. Each EC can function as a stand-alone committee which should follow all the SOPs and TORs of that
p.000026: institution.
p.000026: 4.2.2 An institution that does not have its own EC (user institution) may utilize the services of the EC of another
p.000026: institution (host institution) preferably in the adjoining/nearby area. Relevant requirements must be fulfilled before
p.000026: they do so. See Box 4.1 for further details.
p.000026: Box 4.1 Utilizing the services of an EC of another institution
p.000026:
p.000026: The following requirements must be fulfilled by institutions that use the services of an EC from another institution:
p.000026: • The two institutions (host and user) should enter into an MoU for utilizing the services of the EC of the host
...
p.000028: review or full review.
p.000028:
p.000028: (Contd.)
p.000028:
p.000028: 28 INDIAN COUNCIL OF
p.000029: MEDICAL RESEARCH
p.000029:
p.000029:
p.000029: Ethical Review Procedures
p.000029:
p.000029:
p.000029: • Should be able to devote adequate time to this activity which should be protected by the institution
p.000029: 3. Basic Medical Scientist(s) Affiliated/ non-affiliated Qualifications -
p.000029: • Non-medical or medical person with qualifications in basic medical sciences
p.000029: • In case of EC reviewing
p.000029: clinical trials with drugs, the basic medical scientist should preferably be a pharmacologist
p.000029: 4. Clinician(s)
p.000029:
p.000029: Affiliated/ non-affiliated Qualifications -
p.000029: • Should be individual/s
p.000029: with recognized medical qualification, expertise and training
p.000029:
p.000029: 5. Legal expert/s Affiliated/ non-affiliated Qualifications -
p.000029: • Should have a basic degree in Law from a recognized university, with experience
p.000029: • Desirable: Training in medical
p.000029: law.
p.000029: • Assess the need to obtain prior scientific review, invite independent consultant, patient or
p.000029: community representatives.
p.000029: • Ensure quorum during the meeting and record discussions
p.000029: and decisions.
p.000029: • Scientific and ethical review with special emphasis on the intervention, benefit-risk analysis, research
p.000029: design, methodology and statistics, continuing review process, SAE, protocol deviation, progress and completion
p.000029: report
p.000029: • For clinical trials, pharmacologist to review the drug
p.000029: safety and pharmacodynamics.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: • Scientific review of protocols including review of the intervention, benefit-risk analysis, research
p.000029: design, methodology, sample size, site of study and statistics
p.000029: • Ongoing review of the protocol (SAE, protocol deviation
p.000029: or violation, progress and completion report)
p.000029: • Review medical care, facility and appropriateness of the principal investigator, provision for
p.000029: medical car, management and compensation.
p.000029: • Thorough review of protocol, investigators brochure (if applicable) and all other protocol details and
p.000029: submitted documents.
p.000029: • Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial
p.000029: Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s
p.000029: undertaking, protocol specific other permissions, such as, stem cell committee for stem cell research, HMSC
p.000029: for international collaboration, compliance with guidelines etc.
p.000029: • Interpret and inform EC members about new regulations
p.000029: if any
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000029: (Contd.)
p.000029:
p.000029: 29
p.000030:
p.000030:
p.000030: Ethical Review Procedures
p.000030:
p.000030:
p.000030: 6. Social scientist/ philosopher/ ethicist/theologian
p.000030: Affiliated/ non-affiliated
p.000030:
p.000030: Qualifications -
...
p.000034: 4.7.13 The EC should participate in continuing education activities in research ethics and get updated on relevant
p.000034: guidelines and regulations.
p.000034: 4.7.14 The EC may see that conduct of same/similar research by different investigators from same institution
p.000034: is harmonized. ‘Me too’ research (replicative) should not to be encouraged and submission of same research to different
p.000034: funding agencies should not be accepted.
p.000034: 4.8 Submission and review procedures
p.000034: 4.8.1 Researchers should submit research proposals as soft or hard copies to the Secretariat for review in the
p.000034: prescribed format and required documents as per EC SOPs. The EC should prepare a checklist for the required documents
p.000034: as given in Box 4.4 (a) and 4.4 (b). This list is subject to modifications, depending on the type of research, EC SOPs
p.000034: and institutional policies.
p.000034: Box 4.4 (a) Details of documents to be submitted for EC review
p.000034:
p.000034: 1. Cover letter to the Member Secretary
p.000034: 2. Type of review requested
p.000034: 3. Application form for initial review
p.000034: 4. The correct version of the informed consent document (ICD) in English and the local language(s).
p.000034: Translation and back translation certificates (if applicable)
p.000034: 5. Case record form/questionnaire
p.000034: 6. Recruitment procedures: advertisement, notices (if applicable)
p.000034: 7. Patient instruction card, diary, etc. (if applicable)
p.000034: 8. Investigator’s brochure (as applicable for drug/biologicals/device trials)
p.000034: 9. Details of funding agency/sponsor and fund allocation (if applicable)
p.000034: 10. Brief curriculum vitae of all the study researchers
p.000034: 11. A statement on COI, if any
p.000034: 12. GCP training certificate (preferably
p.000034: within 5 years) of investigators (clinical trials)
p.000034: 13. Any other research ethics/other training evidence, if applicable as per EC SOP
p.000034: 14. List of ongoing research studies undertaken by the principal investigator (if applicable)
p.000034: 15. Undertaking with signatures of investigators
p.000034: 16. Regulatory permissions (as applicable)
p.000034: 17. Relevant administrative approvals (such as HMSC approval for International trials)
p.000034: 18. Institutional Committee for Stem Cell Research (IC-SCR) approval (if applicable)
p.000034: 19. MoU in case of studies involving collaboration with other institutions (if applicable)
p.000034: 20.Clinical trial agreement between the sponsors, investigator and the head of the institution(s) (if
p.000034: applicable)
p.000034: (Contd.)
p.000034: 34 INDIAN COUNCIL OF
p.000035: MEDICAL RESEARCH
p.000035:
p.000035:
p.000035: Ethical Review Procedures
p.000035:
p.000035:
p.000035: 21. Documentation of clinical trial registration (preferable)
p.000035: 22. Insurance policy (it is preferable to have the policy and not only the insurance certificate)for study
p.000035: participants indicating conditions of coverage, date of commencement and date of expiry of coverage of risk (if
p.000035: applicable)
...
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
...
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
p.000062: 7. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is
p.000062: age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
...
p.000064: be allowed. However, this situation should be accepted only in exceptional cases where all forms of assent/consent have
p.000064: failed. In such cases, approval of the EC should be obtained.
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
...
p.000069: MEDICAL RESEARCH
p.000069:
p.000069: SECTION 7
p.000069:
p.000069: CLINICAL TRIALS OF DRUGS AND OTHER INTERVENTIONS
p.000069:
p.000069: 7.0 A clinical trial is any research/study that prospectively assigns human participants or groups of humans
p.000069: to one or more health-related intervention(s) to evaluate the effects on health outcomes. The intervention
p.000069: could be drugs, vaccines, biosimilars, biologics, phytopharmaceuticals, radiopharmaceuticals, diagnostic agents,
p.000069: public health interventions, socio-behavioural interventions, technologies, devices, surgical techniques or
p.000069: interventions involving traditional systems of medicine, etc.
p.000069: Clinical trials are usually well-controlled studies. They use a design that allows comparison of
p.000069: participants treated with an investigational product (IP)/any intervention to a control population (receiving placebo
p.000069: or an active comparator), so that the effect of the IP/intervention can be determined and differentiated from effects
p.000069: of other influences, such as spontaneous change, placebo effect, concomitant treatment/intervention or observer
p.000069: expectations.
p.000069: As per the amended Schedule Y (2005) of the Drugs and Cosmetics Rules, 1945, a clinical trial refers to a systematic
p.000069: study of new drugs on human subjects to generate data for discovering and/or verifying the clinical, pharmacological
p.000069: (including pharmacodynamic and pharmacokinetic) and/or adverse effect with the objectives determining safety
p.000069: and/or efficacy of a new drug. The academic clinical trial as per GSR 313 (E) dated 16
p.000069: March 201627 is a clinical trial intended for academic purposes in respect of approved
p.000069: drug formulations for any new indication or new route of administration or new dose or new dosage form. An EC has to
p.000069: approve such studies after due consideration of benefits and risks and all other ethical aspects and the licensing
p.000069: authority has to be informed as per the prescribed procedures.
p.000069: 7.1 General guidelines
p.000069: 7.1.1 All clinical trials must be planned, conducted and reported in a manner that ensures that the dignity, rights,
p.000069: safety and well-being of participants are protected.
p.000069: 7.1.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000069: benefit (direct or indirect) for the individual trial participant and/or society. A trial should be initiated and
p.000069: continued only if the anticipated benefits justify the risks.
p.000069:
p.000069: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000069: 69
p.000070:
p.000070: Clinical Trials of Drugs and
p.000070: other Interventions
p.000070:
p.000070: 7.1.3 All clinical trials must be conducted in accordance with the Indian GCP guidelines, the Declaration of Helsinki
p.000070: (2013 or later versions as applicable), National Guidelines for Biomedical and Health Research Involving Human
p.000070: Participants (2017), the Drugs and Cosmetics Act (1940), and Rules (1945), and applicable amendments (including
p.000070: Schedule Y), and other relevant regulations and guidelines, wherever applicable.
p.000070: 7.1.4 A participant’s right to agree or decline consent to take part in a clinical trial must be respected and
p.000070: her/his refusal should not affect routine care.
...
p.000070: performed.
p.000070: 7.1.12 If the trial is planned in a vulnerable population, it should be undertaken only with due justification and with
p.000070: all possible participant protections in place.
p.000070: 7.1.13 Procedures to assure the quality of every aspect of the trial should be implemented.
p.000070: 7.1.14 SAEs must be reported for all trials and if applicable timelines as specified by regulators to be followed
p.000070: (within 24 hours to the sponsor, EC and regulator, if applicable, followed by a due analysis report in 14 days).
p.000070: 7.1.15 Free medical management of AEs and SAEs, irrespective of relatedness to the clinical trial, should be given for
p.000070: as long as required or till such time as it is established that the injury is not related to the clinical trial,
p.000070: whichever is earlier.
p.000070: 7.1.16 In addition, compensation must be given if the SAE is proven to be related to the trial.
p.000070: 7.1.17 Ancillary care may be provided to clinical trial participants for non-study/trial related illnesses arising
p.000070: during the period of the trial. This could be in the form of medical care or reference to facilities, as may be
p.000070: appropriate.
p.000070: 70 INDIAN COUNCIL OF
p.000071: MEDICAL RESEARCH
p.000071:
p.000071: Clinical Trials of Drugs and
p.000071: other Interventions
p.000071:
p.000071: 7.1.18 Institutional mechanisms must be established to allow for insurance coverage of trial related or unrelated
p.000071: illnesses (ancillary care) and compensation wherever deemed necessary by the EC.
p.000071: 7.2 Clinical drug/vaccine development
p.000071: 7.2.1 The broad aim of the process of clinical development of a new drug or vaccine, (referred to as an IP) is to
p.000071: find out whether there is a dose range and schedule at which the drug can be shown to be simultaneously safe and
p.000071: effective, to the extent that the benefit–risk relationship is acceptable. Phases of drug development are given in Box
p.000071: 7.1.
p.000071:
p.000071: Box 7.1 Phases of drug development
p.000071:
p.000071: Phase 0
p.000071: A Phase 0 study is an exploratory study, conducted to find out whether an investigational new drug (IND) can modulate
p.000071: its intended target in human beings, and to identify its distribution in the body, or describe its metabolism. This
p.000071: study involves very limited human exposure, and has no therapeutic or diagnostic intent. It is conducted early in the
p.000071: process of drug development and allows for human use of an IND with less preclinical data and in lower doses than is
p.000071: required for a conventional Phase I study. This is invariably part of a regulatory study.
p.000071: Phase I
p.000071: Phase I starts with the initial administration of an investigational new drug/vaccine into humans. These
p.000071: studies usually have non-therapeutic objectives. Phase I studies are conducted on healthy participants or patients, in
p.000071: the case of drugs with significant potential toxicity, such as cytotoxic drugs.
p.000071: Studies conducted in Phase I typically involve:
p.000071: a) estimation of initial safety and tolerability;
p.000071: b) pharmacokinetics;
p.000071: c) assessment of pharmacodynamics (biological effects for vaccines); or early measurement of drug activity (including
p.000071: immunogenicity in case of vaccines).
p.000071: Phase II
p.000071: Phase II starts with the initiation of studies in which the primary aim is to explore therapeutic efficacy
p.000071: (immunogenicity in case of vaccines) in patients/participants. Phase II studies are conducted on a group of
p.000071: patients or participants who are selected according to relatively narrow criteria, and are closely monitored.
p.000071: Early studies in Phase II are designed to estimate the dose response. Later studies are planned to confirm the dose
p.000071: response.
p.000071:
p.000071: (Contd.)
p.000071:
p.000071: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000071: 71
p.000072:
p.000072: Clinical Trials of Drugs and
p.000072: other Interventions
p.000072:
p.000072: Phase III
p.000072: Phase III begins with the initiation of studies in which the primary objective is to demonstrate or confirm therapeutic
p.000072: benefit or protection rate (in case of vaccines). Such studies are:
p.000072: a) designed to confirm the evidence from Phase II studies about the safety and efficacy of a drug or vaccine for use
p.000072: in the intended indication and recipient population;
p.000072: b) planned to provide an adequate basis for impact on clinical practice or for obtaining marketing approval, where
p.000072: applicable;
p.000072: c) conducted to explore new uses of an already marketed drug for a new indication, dosage form, dosage
p.000072: regimen, or route of administration. If such studies are intended for ultimate commercial use of the drug, they require
p.000072: regulatory approval. Research on off label use comes under this category. See section 7.16.4 for further details; and
p.000072: d) planned as bridging trials and pivotal trials.
p.000072: Phase IV
p.000072: Phase IV begins after product approval and is related to the use of the intervention for the approved indications.
p.000072: These studies are important for optimizing the use of the product. They may include:
p.000072: a) post-marketing surveillance – the practice of monitoring the safety of a product after it has been released in the
p.000072: market;
p.000072: b) Phase IV clinical trials – a study conducted to assess safety, tolerability and effectiveness of a marketed
p.000072: product when prescribed in the usual manner in accordance with the terms of the marketing authorization, such as the
p.000072: efficacy and safety in special populations.
p.000072: c) outcomes research – which aim to study the effectiveness and efficiency of the intervention after its
p.000072: introduction for human use; and
p.000072: d) registries – which propose to maintain data about patients with certain shared characteristics and who
p.000072: have received a particular intervention (for example a stent) that collects ongoing and supporting data over time on
p.000072: well-defined outcomes of interest.
p.000072: 7.2.2 Ethical considerations
p.000072: All clinical trials should be scientifically and ethically sound. The sponsor of the study, the researcher,
p.000072: institution, EC, and regulatory authority (if applicable) are responsible for ethical conduct of a study. Before any
p.000072: clinical trial is initiated, adequate data from preclinical investigations or previous clinical studies should
...
p.000073: discomfort;
p.000073: • evaluation of available data to decide if the IP or procedures proposed in the protocol have been associated with
p.000073: SAEs and steps taken to prevent or minimize such risks; and
p.000073: • careful monitoring of the condition of participants and intervention to manage adverse
p.000073: events.
p.000073:
p.000073: m A Phase I study unit must have robust resources and tested procedures for immediate resuscitation and maintenance
p.000073: of life support and onward transfer to an intensive care unit, if necessary.
p.000073:
p.000073: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000073: 73
p.000074:
p.000074: Clinical Trials of Drugs and
p.000074: other Interventions
p.000074:
p.000074: m A Phase I study with a high-risk IP, such as first-in-human, biologic should be carried out in a hospital where
p.000074: experienced personnel and facilities are immediately available to manage medical emergencies.
p.000074: m Medical pharmacologist/physicians trained in clinical pharmacology should be involved in Phase I studies.
p.000074: • Phase II, III and IV studies
p.000074: m All Phase II and III studies require EC approval and applicable regulatory approvals.
p.000074: m In the case of Phase IV studies, the following are some examples of studies that require EC approval:
p.000074: (i) Phase IV clinical trials
p.000074: (ii) Outcome research
p.000074: (iii) Registries
p.000074: (iv) Data that is used to answer any research question
p.000074: (v) New use/route/dose/dosage form/combination/regimen of a marketed drug for non-commercial purpose such as
p.000074: academic research
p.000074: m In addition to EC approval, a Phase IV clinical trial on drugs with a market authorization of less than 4 years
p.000074: requires regulatory approval (CDSCO).
p.000074: m Routine post-marketing surveillance (PMS) may not require EC approval. See Box 7.1 for further details.
p.000074: • Vaccine studies
p.000074: Vaccines can be prophylactic and/or therapeutic in nature. The guidelines for conducting clinical trials on
p.000074: investigational vaccines are similar to those governing a drug trial. However, the phases of these trials differ from
p.000074: drug trials as given below:
p.000074: m Phase I is for the study of dose and route of administration for determining its safety and biological effects,
p.000074: including immunogenicity, and should involve low risk.
p.000074: m Bridging studies in vaccine trials are conducted to support clinical comparability of efficacy, safety and
p.000074: immunogenicity of new formulations when there is a change in vaccine composition with regard to adjuvant,
p.000074: preservative, or a change in manufacturing process, site or scale. These are
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p.000075:
p.000075: performed either before or after product licensure.
p.000075: m Combination vaccines – The main goal in efficacy trial design of such vaccines is to evaluate the efficacy of each
p.000075: antigenic component. Non-inferiority trials should be conducted to demonstrate that the combination vaccine is
p.000075: not inferior in terms of immunogenicity or efficacy to vaccines with individual components.
p.000075: m Vaccines administered simultaneously with combination vaccines – Immunogenicity and safety data should be
p.000075: obtained in Phase III (pre-licensure) studies to support the simultaneous administration of a new vaccine with already
p.000075: licensed vaccines that would be given to the same target population using the same (or overlapping) schedule. Types of
p.000075: vaccines are listed in Box 7.3.
p.000075: Box 7.3 Types of vaccines
p.000075: • Live and attenuated vaccines (measles, mumps, rubella and chickenpox)
p.000075: • Inactivated vaccine (flu vaccine)
p.000075: • Toxoid vaccines (diphtheria and tetanus vaccines)
p.000075: • DNA vaccines
p.000075: • Recombinant vector vaccines
p.000075:
p.000075: m Some vaccines that contain active or live (attenuated) micro-organisms can possibly possess a small risk of
p.000075: producing that particular infection. The participant to be vaccinated should be informed of this.
p.000075: m The participants in control groups, or when subjected to ineffective vaccines, run a risk of contracting the
p.000075: disease. In such an event, provisions be made to provide free treatment for the disease.
p.000075: m For recombinant DNA vaccines and products, applicable governmental guidelines and regulations should be
p.000075: followed.
p.000075: m Post-trial, the control group should receive the complete dose of an effective vaccine (either one that is already
p.000075: available or the investigational vaccine).
p.000075: 7.3 Bioavailability/bioequivalence study
p.000075: Bioavailability (BA) is the measurement of the proportion of the total administered dose of a therapeutically active
p.000075: drug that reaches the systemic circulation and is therefore available at the site of action.
p.000075: Bioequivalence (BE) is a term used in pharmacokinetics when there are two or more
p.000075:
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p.000076:
p.000076: Clinical Trials of Drugs and
p.000076: other Interventions
p.000076:
p.000076: medicinal products (proprietary preparations of a drug), containing the same active substance that need to be compared
p.000076: in vivo for biological equivalence. These comparative studies are used to assess if the new version (generic) produces
p.000076: the same concentration in the systemic circulation when given to human participants. If two products are
p.000076: said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
p.000076: BE studies are used as surrogates for clinical effectiveness data for generic drugs where no clinical difference is
p.000076: anticipated between the two products.
p.000076: 7.3.1 Ethical issues
p.000076: • All BA/BE studies should be scientifically sound and conducted in compliance with principles of ethical
p.000076: conduct described earlier for a Phase I study.
p.000076: • Ethical conduct of BA/BE study requires evaluation of the benefit–risk profile of:
p.000076: a. the reference (comparator) and investigational (generic) product; and
p.000076: b. the study procedures such as indoor stay, fasting, screening, blood sampling.
p.000076: • BA/BE studies are usually conducted in healthy volunteers. Hence, they have no direct benefit to the
p.000076: participant but may pose risks due to the adverse effects of the drug. Therefore, all safeguards to protect
p.000076: participants must be in place.
p.000076: • The EC must carefully review the recruitment methods, payment for participation and consent procedures.
p.000076: Volunteers often regularly participate in such studies at the cost of their health and care should be taken that taking
p.000076: part in multiple trials is avoided by maintaining volunteer registries, biometry, follow up, etc. Care must be taken to
p.000076: maintain confidentiality of biometric data.
p.000076: • The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study
p.000076: design and the EC should take specific note on the amount of blood drawn depending on whether the individual is a
p.000076: healthy adult or a child or a patient.
p.000076: 7.4 Ethical implications of study designs
p.000076: Clinical trials have a wide range of methodological approaches. ECs need to look into the details of the ethical
p.000076: concerns involved.
p.000076: 7.4.1 If a SAE occurs in a blinded study, and it is imperative, in the interest of managing the event to know what
p.000076: the patient was receiving, unblinding mechanisms should be available to the researcher.
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p.000077: 2. Use an add-on trial design where the IP or placebo are added to standard of care.
p.000077: 3. Expose fewer patients to placebo groups, for example by having 2:1 randomization with 2 participants
p.000077: receiving IP against 1 getting placebo (unbalanced randomization).
p.000077: 4. An active comparator as an additional arm may also be included in such trials where randomization can be,
p.000077: for example, 2:2:1 (IP: active comparator: placebo).
p.000077: 5. Ensure transition to standard of care/active medicine for study participants after research is completed,
p.000077: including post-trial arrangements for implementing any positive trial results.
p.000077:
p.000077: 7.5 Multicentric trials
p.000077: Multicentric trials are carried out with a primary aim of providing a sound basis for the subsequent generalization of
p.000077: its results.
p.000077: 7.5.1 ECs of all sites should follow all applicable regulatory guidelines, including registration with regulating
p.000077: bodies.
p.000077:
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p.000078:
p.000078: Clinical Trials of Drugs and
p.000078: other Interventions
p.000078:
p.000078: 7.5.2 The ethical review procedure for common review of multicentric research is given in section 4.10. Not
p.000078: applicable for clinical trials under Drugs and Cosmetic Act.
p.000078: 7.6 Phytopharmaceutical drugs
p.000078: The Drugs and Cosmetics Rules, 8th Amendment, 2015,29 defines a new class of drugs called phytopharmaceutical drug as
p.000078: “purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and
p.000078: quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings
p.000078: or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include
p.000078: administration by parenteral route”. All details described in 7.2 also apply to this group of drugs.
p.000078: 7.7 Device trials
p.000078: 7.7.1 A medical device is defined as a medical tool which does not achieve its primary intended action in or on
p.000078: the human body by pharmacological, immunological, or metabolic means but which may be assisted in its intended
p.000078: function by such means. It may be an instrument, apparatus, appliance, implant, material or other article, whether used
p.000078: alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for
p.000078: human beings or animals for one or more of the specific purposes of:
p.000078: (i) detection, diagnosis, prevention, monitoring;
p.000078: (ii) treatment or alleviation of any physiological condition or state of health, or illness;
p.000078: (iii) replacement or modification or support of the anatomy or congenital deformity;
p.000078: (iv) supporting or sustaining life;
p.000078: (v) disinfection of medical devices; or
p.000078: (vi) control of conception.
p.000078: • Clinical trials should be conducted in accordance with the ethical principles described in these
p.000078: guidelines, Indian GCP as well as applicable regulations for medical and medicated devices, that is, GSR 78 (E)
p.000078: dated 31.1.2017 or as per amendments/modifications issued from time-to-time.
p.000078: • Safety data of the medical device in animals should be obtained and likely risks posed by the device should
p.000078: be considered in the same way as for a new drug under the Drugs and Cosmetics Rules, 1945.
p.000078: • Apart from safety considerations of the device, the procedures to introduce the
p.000078:
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p.000079: medical device in the patient should also be evaluated for safety.
p.000079: • Devices should be provided free of cost or, if expensive, at feasible reduced rates.
p.000079: • Avoid therapeutic misconceptions.
p.000079: • Any AE/SAE should be reported within timelines as per the schedule for a new drug. Here user error could also
p.000079: be the cause of AE/SAE.
p.000079: • If the participant wants to withdraw from a trial, it may not be possible to remove the internal device. This
p.000079: must be explained to the participant before enrolling her/him. The participant, however, should be allowed to opt out
p.000079: of continuing in the trial without prejudice to her/his ongoing treatment.
p.000079: • If feasible, post-trial obligations should be emphasized with the sponsor.
p.000079: • The duration of follow-up should be long enough to detect late onset adverse reactions, especially when the
p.000079: device is implanted within the body.
p.000079: 7.7.2 Devices could be used internally or externally for diagnosis, treatment, mitigation or prevention of disease or
p.000079: disorder. Depending upon risks involved, devices (other than in vitro diagnostic devices) are classified as given in
p.000079: Table 7.1:
p.000079: Table 7.1 Classification of medical devices
p.000079: Class Level of risk Device examples
p.000079: A Low Thermometers/ bandages /tongue depressors
p.000079: B Low–moderate Hypodermic needles /suction equipment C Moderate–high Lung
p.000079: ventilator /bone fixation plate
p.000079: D High Heart valves/implantable defibrillator
p.000079:
p.000079: 7.7.3 Devices used for in vitro diagnosis could be a reagent, calibrator, control material, kit, instrument,
p.000079: apparatus, equipment, system, or specimen receptacle, whether used alone or in combination with any other such devices,
p.000079: that is intended by its manufacturer to be used in vitro for examination of any specimen, including any
p.000079: blood or tissue donation derived from the human body solely or principally for the purpose of providing information.
p.000079: The information could be related to:
p.000079: (i) a physiological or pathological state;
p.000079: (ii) congenital deformity;
p.000079: (iii) determining the safety and compatibility of any blood or tissue donation with a potential recipient thereof;
p.000079: or
p.000079: (iv) monitoring of therapeutic measures.
p.000079:
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p.000080:
p.000080: Clinical Trials of Drugs and
p.000080: other Interventions
p.000080: • Diagnostics devices can be notified and non-notified. Notified are in vitro diagnostic devices for
p.000080: testing HIV, HBsAg, HCV and blood grouping. Non-notified are those for testing malaria, TB, dengue, chikungunya,
p.000080: typhoid, syphilis, cancer markers, etc.
p.000080: 7.8 Biologicals and biosimilars
p.000080: Biologics (biopharmaceutical drug) can be composed of sugars, proteins, nucleic acids or complex combinations of these
p.000080: substances, or may be living cells or tissues. This section applies to products that are produced by means of
p.000080: biological processes with or without recombinant DNA technology. All aspects that are described in section 7.1 are also
p.000080: applicable to biologics.
p.000080: 7.8.1 As these are biologic substances, special care must be taken to review all data generated. Special expertise
p.000080: may be sought for such reviews so that foreseeable risks are well identified.
p.000080: 7.8.2 A thorough benefit-risk assessment must be carried out with available data.
p.000080: 7.8.3 If the study involves biosimilars, the product quality (manufacturing and characterization), preclinical data
p.000080: and bioassay must demonstrate similarity with a reference biologic.
p.000080: 7.8.4 All applicable and current regulations must be followed.
p.000080: 7.9 Clinical trials with stem cells
p.000080: In recent years, stem cell research has undergone rapid developments promising new leads in the treatment of several
p.000080: incurable diseases. According to the source and degree of expected risk to human participants, stem cell research is
p.000080: categorized into permissible (adult and cord blood), restricted (embryonic) and prohibited (reproductive cloning) areas
p.000080: of research. In India, only permissible and restricted areas of research are permitted with appropriate approvals. It
p.000080: is necessary to ensure that donors are not exploited and commodified.
...
p.000081: the responsibility of the institution to ensure that all current standards are applied.
p.000081: 7.9.4 All clinical trials must be approved by IC-SCR, which in turn should be registered with NAC-SCRT. All such
p.000081: studies should also be registered with CTRI. The EC should give final approval before initiation of the clinical trial.
p.000081: 7.10 Surgical interventions
p.000081: Surgical interventions that are being studied systematically must be considered as research and follow all
p.000081: general principles described in these guidelines.
p.000081: 7.10.1 In any protocol where an established surgical intervention is to be studied, the researcher must provide
p.000081: references for the procedure and describe the most likely complications in the protocol for the EC to review and
p.000081: perform benefit-risk assessment. The frequency of each complication should also be mentioned.
p.000081: 7.10.2 In trials where a modification of the established surgical intervention is to be tested, the protocol and ICD
p.000081: must specify the need for this modification and the expected complications, if any. It is preferable that a
p.000081: comparative study be conducted where the conventional method is compared to the test surgical intervention.
p.000081: 7.10.3 In trials where an entirely new surgical intervention is being tested, the EC may insist on some animal
p.000081: data/modeling data which establishes the efficacy and safety of the technique or case reports/case series that indicate
p.000081: benefits and describe risks.
p.000081: 7.10.4 During the conduct of a surgical interventional trial all adverse events must be reported to the EC and sponsor
p.000081: as applicable, within the specified timelines as described for drug trials.
p.000081: 7.10.5 Provision of free treatment and compensation for any study-related injury must be ensured for the
p.000081: trial participant. The EC must determine the compensation amount after the investigator has described the relatedness.
p.000081: 7.10.6 Due to inherent ethical issues, sham surgery should not be included in the design of clinical trials, except
p.000081: in cases where there are strong scientific reasons. Under such circumstances, certain conditions must be met.
p.000081: See Box 7.6 for further details.
p.000081:
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p.000082:
p.000082: Clinical Trials of Drugs and
p.000082: other Interventions
p.000082:
p.000082: Box 7.6 Conditions for sham surgery
p.000082: 1. There has to be a clear description of the justifications to include a sham surgery group in the protocol, which
p.000082: must be assessed by the EC.
p.000082: 2. There should be no serious harm caused by the sham surgery.
p.000082: 3. The participant must get access to appropriate, relevant intervention at the end of the trial.
p.000082:
p.000082: 7.11 Community trials (public health interventions)
p.000082: Community trials are studies involving whole communities and are conducted to evaluate preventive strategies like mass
p.000082: drug administration (MDA) trials, fortification of food, etc. Such studies typically involve the whole community. The
p.000082: study unit could be a group, area, institution, village, block, district, etc. and the whole population is expected to
p.000082: participate in the study. In such studies, different communities are randomized and allocated to different arms (see
p.000082: section 8 for further details).
p.000082: 7.12 Clinical trials of interventions in HIV/AIDS
p.000082: Clinical trials in HIV positive patients could be for the evaluation of new drugs, vaccines, other
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
p.000082: 7.12.1 Global studies in HIV/AIDS in specific communities should receive approval from the relevant national
p.000082: authority and any other relevant authority, such as the HMSC, where applicable, in addition to approval from the EC.
p.000082: 7.12.2 When testing for HIV is done, consent and pre-test- and post-test counselling should be done as per National
p.000082: AIDS Control Organization (NACO) guidelines.
p.000082: 7.12.3 Issues that may arise because of discordant couples should be addressed before initiating any
p.000082: study in people living with HIV/AIDS.
p.000082: 7.12.4 As HIV is a sexually transmitted disease and is potentially life-threatening, the right to life of the
p.000082: sexual partner must be respected over the right to privacy of the HIV positive individual.
p.000082: 7.12.5 Phase I studies are permissible in patients with HIV/AIDS if the drug under study cannot be tested in
p.000082: healthy participants due to expected toxicity of the IP.
p.000082:
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p.000083: other Interventions
p.000083:
p.000083: 7.12.6 A combined Phase I/II or Phase II study can be conducted in this population when other therapeutic options
p.000083: have been exhausted.
p.000083: 7.12.7 When a trial with a preventive HIV vaccine is conducted, it can result in positive serology. This does
p.000083: not indicate HIV infection but can create problems for travel and employment. Under such circumstances, the
p.000083: project investigator should issue a certificate stating that the person in question was a participant in a vaccine
p.000083: trial and provide clarification on the result.
p.000083: 7.12.8 Research that involves sexual minorities or IV drug users should have community engagement (community
p.000083: leaders) throughout the life of the project, until completion and dissemination of results.
p.000083: 7.12.9 The EC may also consider co-opting a member from this community, if relevant for initial and continuing
p.000083: review of proposals.
p.000083: 7.12.10 Where possible, for example, if the drug is found useful, standard of care is not available or regulatory
p.000083: permissions are in place, the EC should ensure post-trial access of the IP for the participants.
p.000083: 7.12.11 For HIV positive persons, any research may be misconstrued as research on anti-HIV treatment and make them
p.000083: willing to participate. Therefore, the full implications in simple terms should be explained to HIV positive
p.000083: participants about any other research being done on them, such as research on hepatitis B.
p.000083: 7.13 Clinical trials on traditional systems of medicine
p.000083: Although traditional systems of medicine (termed complementary and alternate systems in the west) are
p.000083: known for their long history of safe and effective use, validation of safety and efficacy using scientific and
p.000083: evidence-based methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners
p.000083: and satisfaction of end users in the products. Government of India has recognized Ayurveda, Siddha, Unani, Yoga,
p.000083: Naturopathy and Homeopathy as traditional Indian systems of medicine. In 2012, Sowa Rigpa (Amchi or Tibetan medicine)
p.000083: was also added to the list. Ministry of AYUSH (Ayurveda, Unani, Siddha and Homeopathy) governs and regulates these
p.000083: systems. Drugs under these systems come under the Drugs and Cosmetics Act, 1940, as ASU and H drugs. Drugs/formulations
p.000083: under these systems of medicine are classified into two groups. See Box 7.7 for further details:
p.000083: 7.13.1 Research on AYUSH and ASU interventions of traditional medicines (TM) including external
...
p.000085: 7.14.3 These trials are usually comparative, the comparator being the reference/gold standard test to diagnose the
p.000085: disease. Hence, the protocol must state clearly the choice of the reference with justification. Likewise, omission of a
p.000085: reference standard as comparator must also be justified.
p.000085: 7.14.4 A placebo may be used as comparator when the response to a diagnostic test is being assessed using
p.000085: subjective evaluation criteria, for example, skin changes in a skin prick test or for the assessment of
p.000085: tolerability. There have to be clear justifications in the protocol for the use of a placebo and no irreversible harm
p.000085: should occur to the participant. Post-trial access to the standard of care diagnostic test must be assured.
p.000085: 7.14.5 Safety follow-up of patients in these trials should not be limited to the duration of the diagnostic
p.000085: procedure but may be extended for a longer period according to the pharmacokinetic and pharmacodynamic properties of
p.000085: the diagnostic agent.
p.000085: 7.14.6 Long-term safety (when appropriate) should be assessed especially for agents accumulating in the
p.000085: body, such as deposits of gadolinium in bones and skin.
p.000085: 7.15 Radioactive materials and X-rays
p.000085: Radioactive substances contain a radioactive isotope, and may be used for therapeutic or diagnostic purposes. If the
p.000085: radioactive substance is to be tested as a drug then all the ethical considerations described in previous sections will
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
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p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
...
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
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p.000087: other Interventions
p.000087:
p.000087: auditing, DSMB, etc.
p.000087: 7.16.4 When academic clinical trials are planned for “off-label” use of a drug (when a drug that is marketed is
p.000087: being used for a new indication/new dose/formulation/route) for purely academic purposes and not for commercial use,
p.000087: then such clinical trials designed by researchers/academicians may not currently require regulatory approval. However,
p.000087: an EC has to approve such studies after due consideration of benefits and risks and all other ethical aspects and the
p.000087: licensing authority has to be informed as per GSR 313(e) dated 16.3.2016 issued by CDSCO.
p.000087: 7.16.5 The trials must be registered in CTRI and there should be mechanism for appropriate methods for informed
p.000087: consent, conduct of trial and proper follow-up of patients.
p.000087: 7.16.6 For student conducting clinical trials as part of their academic thesis, the guide and the academic
p.000087: institution should take up the responsibilities of the sponsor.
p.000087: 7.17 Clinical trials on contraceptives
p.000087: Several methods of contraception are available including, barrier methods, hormonal methods, emergency contraception,
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
...
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
...
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
p.000089: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000089: 89
p.000090:
p.000090: Clinical Trials of Drugs and
p.000090: other Interventions
p.000090:
p.000090: disadvantaged populations may participate in the research to gain free access to an intervention. It is important to
p.000090: ensure that the participant has understood that this is research and the benefits expected may be small or they may not
p.000090: occur at all.
p.000090: 7.19.3 Participants must be made to understand that they may be randomized to a placebo group and therefore receive
p.000090: an inert drug, in case of a placebo-controlled study.
p.000090: 7.19.4 If the trial is a placebo- or active-controlled trial, all the groups must be given the current standard of
p.000090: care to which the IP, placebo or active control is added.
p.000090: 7.19.5 Perceptions of benefits and risks may be different for patients, healthcare workers and EC members. All
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
p.000090: 7.19.8 A post-trial access plan must be in place for patients who show benefit from an IP. In case it is a placebo
p.000090: controlled trial, those participants who have been in the placebo group may be offered post-trial access to the IP if
p.000090: found effective in other patients.
p.000090: 7.20 Clinical trials of products using any new technology
p.000090: If any product using new technologies (such as nanotechnology) is developed for human use and is to be evaluated in
p.000090: human beings, the following ethical issues have to be taken into consideration in addition to all the general ethical
p.000090: guidelines for clinical trials as elaborated in the guidelines.
...
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
p.000120: embryos. This obviates the need for invasive testing for associated risks and also termination of the affected foetus,
p.000120: which is traumatic for the family.
p.000120: • Advanced techniques like chromosomal micro array (CMA) are being used for
p.000120:
p.000120: 120 INDIAN COUNCIL OF MEDICAL
p.000121: RESEARCH
p.000121:
p.000121: Human
p.000121: Genetics Testing and Research
p.000121:
p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
p.000121: intervention for management.
p.000121: • The family should have a choice to decide if they would like to be part of newborn screening program with
p.000121: appropriate consent explaining the requirements and implications of the screening with provision to “optout”.
p.000121: • Community education and advocacy regarding NBS should precede the initiation
p.000121: of the programme.
p.000121: • Availability of facilities for confirmatory diagnosis and experts for management
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
...
p.000123: identified copy number variation (CNV) may be a variation of unknown significance (VOUS) which may be reported or
p.000123: unreported and may not explain the phenotype.
p.000123: 10.15.2 Whole exome sequencing and whole genome sequencing
p.000123: These high throughput next generation sequencing techniques are used for sequencing all the exons (WES) or the whole
p.000123: genome including introns (WGS). These techniques are increasingly being used in clinical practice, particularly WES,
p.000123: and have raised a new challenge for counsellors as well as patients.
p.000123: • These genomic techniques identify pathogenic mutations or variations of unknown significance in many other
p.000123: genes, hidden genetic disorders or cancers which may manifest later. The individual should be informed and asked
p.000123: whether she/he will like to know about unrelated genetic mutations. The results should always be interpreted keeping in
p.000123: mind the coverage of genes of interest.
p.000123: • Families/individuals opting for the test should be counselled regarding grey areas in these upcoming
p.000123: technologies prior to testing. They should be aware that WES/WGS may not give conclusive results.
p.000123: 10.15.3 Gene editing technology – Clustered, regularly interspaced, short palindromic repeat (CRISPR)
p.000123: This is a powerful technology which efficiently edits DNA with immense value for accurate and precise genome editing to
p.000123: alter human genes to cure and eliminate certain genetic based diseases. Experiments done so far have shown that the
p.000123: technique can be used to rapidly, easily and efficiently modify genes in a wide variety of cell types and in organisms.
p.000123: Somatic cell genome editing has an immediate clinical translational potential and can be used in a variety of areas
p.000123: such as drug development, gene surgery,
p.000123: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000123: 123
p.000124:
p.000124: Human
p.000124: Genetics Testing and Research
p.000124:
p.000124: understanding genetic variation, and it also has implications for biomaterial, fuels, food etc. CRISPR works as a pair
p.000124: of DNA scissors, and Cas9 is the protein in the system that unzips DNA and finds the target by matching the DNA
p.000124: sequence against a snippet of its guide RNA. When Cas9 finds its target and snips it, there are concerns about
p.000124: associated risks, which blur the excitement about its usefulness. Similar concerns are there for the use of other
p.000124: genome editing technologies such as zinc finger nucleases (ZFN) and transcription activator-like effector nuclease
p.000124: (TALEN). Today therapeutic applications are possible for a wide range of indications, in preclinical models or in
p.000124: clinical settings through clinical trials in humans. There are some considerations related to the use of this
p.000124: technology.
p.000124: • The risks are irreversible changes in germline, risks of inaccurate genome editing, implications for future
p.000124: generations, interactions with other genetic variations and environment, and the fear that once the genetic change is
p.000124: introduced it may be permanent which would have long-term effects.
p.000124: • Despite the promise of the technique, there is a possibility of encountering error in genetic engineering which
p.000124: has unforeseen implications. Cas9 will sometimes identify a wrong target even when up to five of the guide RNAs do not
p.000124: match the DNA – hence the off-target mutations may cause disease or alter germline or DNA of future generations of
p.000124: humans.
p.000124: • It could be used to change harmless genes, as for eye colour, leading to designer possibilities. There are also
...
p.000149: Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical.
p.000149: International Committee of Medical Journal Editors; 2006. Available from:
p.000149: http://www.icmje.org/recommendations/archives/2008_urm.pdf (accessed 09 Sept 2017).
p.000149:
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p.000149: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000149: 149
p.000150:
p.000150: ABBREVIATIONS AND ACRONYMS
p.000150:
p.000150: AAHRPP Association for the Accreditation of Human Research Protection Programmes
p.000150: AE adverse event
p.000150: ART assisted reproductive technology
p.000150: AYUSH Ayurveda, Unani, Siddha and Homeopathy
p.000150: BA/BE bioavailability / bioequivalence
p.000150: CAB/ CAG community advisory board/ community advisory group
p.000150: CDSCO Central Drugs Standard Control Organization
p.000150: COI conflict of interest
p.000150: CPCSEA Committee for the Purpose of Control and Supervision of Experiments on Animals
p.000150: CRO contract research organization
p.000150: CRT cluster randomized trials
p.000150: CTRI Clinical Trial Registry-India
p.000150: DCGI Drug Controller General of India DGFT Directorate General of Foreign Trade DGHS
p.000150: Directorate General of Health Services DSMB Data and Safety Monitoring Board DTA
p.000150: data transfer agreement
p.000150: EC ethics committee
p.000150: ELSI ethical, legal and social issues
p.000150: GCP good clinical practice
p.000150: GLP good laboratory practices
p.000150: GMP good manufacturing practices
p.000150: GOI Government of India
p.000150: HMSC Health Ministry’s Screening Committee
p.000150: ICD informed consent document
p.000150: ICF informed consent form
p.000150: ICH International Conference on Harmonization
p.000150: ICJME International Committee of Medical Journal Editors
p.000150:
p.000150:
p.000150:
p.000150: 150 INDIAN COUNCIL OF MEDICAL
p.000151: RESEARCH
p.000151:
p.000151:
p.000151: Abbreviations and acronyms
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: ICMR Indian Council of Medical Research
p.000151: IC-SCR institutional committee for stem cell research
p.000151: IND investigational new drug
p.000151: Ind EC independent ethics committee
p.000151: IP investigational product
p.000151: IPR intellectual property rights
p.000151: LAR legally acceptable/authorized representative MoHFW Ministry of Health and Family
p.000151: Welfare MOU memorandum of understanding
p.000151: MTA material transfer agreement
p.000151: MTP medical termination of pregnancy
p.000151: NABH National Accreditation Board for Hospitals and Healthcare Providers NABL National
p.000151: Accreditation Board for Testing and Calibration Laboratories NACO National AIDS Control Organization
p.000151: NAC-SCRT National Apex Committee for Stem Cell Research and Therapy
p.000151: PGD/ PGS pre-implantation genetic diagnosis/screening
p.000151: PIS participant information sheet
p.000151: RCR responsible conduct of research
p.000151: SAE serious adverse events
p.000151: SIDCER Strategic Initiative for Developing Capacity in Ethical Review
p.000151: SOP standard operating procedure
p.000151: TM traditional medicines
p.000151: TOR terms of reference
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000151: 151
p.000152:
p.000152: GLOSSARY
...
p.000152:
p.000152: 3. Appellate
p.000152: authority
p.000152: It decides on the appeal filed against a decision of the lower authority. Its mandate is to ensure
p.000152: that due process of law is followed.
p.000152: 4. Assent To agree or approve after thoughtful consideration an idea or suggestion to
p.000152: participate in research by a young person below the age of 18 years who is old enough to understand the implications of
p.000152: any proposed research but not legally eligible to give consent. The assent has to be corroborated with informed consent
p.000152: of parent/ LAR.
p.000152: 5. Audit A systematic and independent examination of research activities and documents to
p.000152: determine whether the review and approval activities were conducted, data recorded and accurately reported as per
p.000152: applicable guidelines and regulatory requirements.
p.000152: 6. Autonomy The ability and capacity of a rational individual to make an independently
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
p.000152: 152 INDIAN COUNCIL OF MEDICAL
p.000153: RESEARCH
p.000153:
p.000153:
p.000153: Glossary
p.000153:
p.000153:
p.000153: 8. Biomedical and health research
p.000153: Research including studies on basic, applied and operational research designed primarily to increase the
p.000153: scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and
p.000153: evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical
p.000153: research.
p.000153: 9. Beneficence To try to do good or an action which weighs the risks against
p.000153: benefits to prevent, reduce or remove harm for the welfare of the research participant(s) in any type of research.
p.000153: 10. Caregivers A caregiver or carer is an unpaid or paid person who helps another
p.000153: individual with illness or impairment with daily activities/ performance.
p.000153:
p.000153: 11. Case record/
p.000153: report form (CRF)
p.000153: 12. Clinical
p.000153: research
p.000153: Case record form orcase report form is a printed, opticalor electronic
p.000153: document designed to record all the required information in the protocol on each study participant for reporting to the
p.000153: sponsor.
p.000153: Research that directly involves a particular person or group of
p.000153: people to study the effect of interventions, or uses materials/data from humans indirectly, such as their
p.000153: behaviour or samples of their tissue for prevention, treatment and diagnosis of a disease condition/health disorder.
p.000153: 13. Clinical trial As per amended Schedule Y (2005) of the Drugs and Cosmetics
p.000153: Rules, 1945, a clinical trial refers to a systematic study of new drugs in human subjects to
p.000153: generate data for discovering and/or verifying the clinical, pharmacological (including
p.000153: pharmacodynamic and pharmacokinetic) and /or adverse effect with the objectives determining safety and/or
p.000153: efficacy of a new drug. The academic clinical trial as per GSR 313 (e) dated 16 March 2016 is a clinical trial
p.000153: intended for academic purposes in respect of approved drug formulations for any new indication or new route of
p.000153: administration or new dose or new dosage form.
p.000153:
p.000153: 14 Clinical trial
p.000153: registry
p.000153: An official platform for registering a clinical trial, such as Clinical
p.000153: Trial Registry-India
p.000153: 15 Clinician A person with recognized medical qualification and expertise/ training.
p.000153:
p.000153: 16 Cognitive
p.000153: impairment
p.000153: When a person has trouble remembering, learning new things,
p.000153: concentrating, or making decisions that affect their everyday life.
p.000153:
p.000153: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000153: 153
p.000154:
p.000154:
p.000154: Glossary
p.000154: 17 Coercion An overt or implicit threat of harm to a participant which is intentional to
p.000154: force compliance.
p.000154:
p.000154: 18 Collaborative
p.000154: research
p.000154: An umbrella term for methodologies that actively engage
p.000154: researchers, communities and/ or policy makers in the research process from start to finish.
p.000154: 19 Compensation Provision of financial payment to the research participants or their
p.000154: legal heirs when temporary or permanent injury or death occurs due to participation in biomedical and health research.
p.000154: 20 Confidentiality Keeping information confidential which an individual has disclosed
p.000154: in a relationship of trust and with the expectation that it shall not be divulged to others without permission.
p.000154:
p.000154: 21 Confidentiality
p.000154: agreement
...
p.000156: conversation, privileges, etc.
p.000156:
p.000156: 44 Particularly vulnerable tribal group (PVTG)
p.000156: These are a special class of tribal groups, classified as such by the Government of India, due to their
p.000156: especially low development indices when compared to other local tribes. These were classified under the Dhebar
p.000156: Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
p.000157: uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of
p.000157: adequate size, and whenever possible, double-blind.
p.000157:
p.000157: 47 Post-marketing
p.000157: surveillance
p.000157:
p.000157: 48 Professional competence
p.000157: 49 Principal
p.000157: investigator
p.000157:
p.000157:
p.000157: 50 Psychosocial harm
p.000157: The practice of monitoring the safety of a pharmaceutical drug or
p.000157: medical device after it has been released on the market. This is an important part of the science of pharmacovigilance.
p.000157: The broad professional knowledge, attitude and skills required in
p.000157: order to work in a specialized area or profession.
p.000157: An individual or the leader of a group of individuals who initiates and takes full responsibility for the conduct of
p.000157: biomedical health research; if there is more than one such individual, they may be called co-principal investigators/
p.000157: co-investigators.
p.000157: Research, particularly psychology studies, can put participants in
p.000157: situations that may make them feel uncomfortable while learning about their reaction to a situation. The result can be
p.000157: psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or
p.000157: depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.
p.000157: 51 Quorum Minimum number and/or kind of EC members required for
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
p.000157: related injury
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
p.000157: it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the
p.000157: intervention, whenever they occur, as well as any medical injury caused due to procedures.
p.000157: 53 Risk Probability of harm or discomfort to research participants.
...
p.000160: 10 Review of New Medical Device Studies
p.000160: 11 Review of Resubmitted Protocols
p.000160: 12 Review of Protocol Amendments
p.000160: 13 Continuing Review of Protocols
p.000160: 14 Review of Final Reports
p.000160: 15 Review of Serious Adverse Events (SAE) Reports
p.000160: 16 Review of Study Completion Reports
p.000160: 17 Management of Premature Termination, Suspension, Discontinuation of the Study
p.000160: 18 Waiver of Written or Verbal/oral Informed Consent
p.000160: 19 Site Monitoring Visits
p.000160: 20 Dealing with Participants’ Requests and Complaints
p.000160: 21 Emergency Meetings
p.000160: 22 Communication Records
p.000160: 23 Maintenance of Active Study Files
p.000160: 24 Archive and Retrieval of Documents
p.000160: 25 Maintaining Confidentiality of EC’s Documents
p.000160: 26 Reviewing Proposals involving Vulnerable Populations
p.000160: 27 Review and Inspection of the EC
p.000160: 28 Audio Visual Recording of the Informed Consent Process
p.000160:
p.000160: 160 INDIAN COUNCIL OF MEDICAL
p.000161: RESEARCH
p.000161:
p.000161: ANNEX 2
p.000161:
p.000161: LIST OF MEMBERS OF COMMITTEES INVOLVED IN REVISION OF GUIDELINES (2015-2017)
p.000161:
p.000161: A. Members of Central Ethics Committee on Human Research
p.000161: P. N. Tandon (Chairperson), National Brain Research Centre, Manesar
p.000161: B. N. Dhawan (Late), Formerly at Central Drug Research Institute, Lucknow
p.000161: Sunil K. Pandya, Jaslok Hospital, Mumbai
p.000161: Madhav Menon, Bar Council of Kerala, M.K.Nambyar Academy for Continuing Legal Education, Kochi
p.000161: G. Padmanaban, Indian Institute of Science, Bengaluru
p.000161: Lt. Gen. D. Raghunath, Formerly at Sir Dorabji Tata Centre for Research in Tropical Diseases, Bengaluru
p.000161: K.N. Chaturvedi, Supreme Court, New Delhi
p.000161: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000161: C.A.K. Yesudian, Formerly at Tata Institute of Social Sciences, Mumbai
p.000161: Vinod K. Paul, All India Institute of Medical Sciences, New Delhi
p.000161: Mira Shiva, Initiative for Health & Equity in Society, New Delhi
p.000161: Vasantha Muthuswamy, Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR,
p.000161: New Delhi
p.000161: Amar Jesani, Indian Journal of Medical Ethics, Mumbai
p.000161: Amita Singh, Jawaharlal Nehru University, New Delhi
p.000161: N. Sarojini, SAMA- Resource Group for Women & Health, New Delhi
p.000161: Sanjiv Datta, Former Financial Advisor, Indian Council of Medical Research, New Delhi
p.000161: Vijay Kumar, Indian Council of Medical Research, New Delhi
p.000161: Roli Mathur, Indian Council of Medical Research, National Centre for Disease Informatics and Research, Bengaluru
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000161: 161
p.000162:
p.000162:
p.000162:
p.000162: B. Chaipersons of Sub-Committees and Members of Advisory Group Vasantha Muthuswamy (Chairperson)
p.000162: Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR, New Delhi and President,
...
p.000162: in India (FERCI)
p.000162: Narendra K Arora
p.000162: Executive Director, The INCLEN (International Clinical Epidemiology Network) Trust International, New Delhi and
p.000162: Formerly professor, Dept of Paediatrics, AIIMS, New Delhi
p.000162: Urmila Thatte
p.000162: Professor and Head, Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai
p.000162: Vijay Kumar
p.000162: Scientist - G & Head, Division of BMS, Indian Council of Medical Research, New Delhi
p.000162: Roli Mathur
p.000162: Scientist E, Division of BMS, Indian Council of Medical Research, New Delhi (2015-2016) and presently Head, ICMR
p.000162: Bioethics Unit, National Centre for Disease Informatics and Research, Bengaluru
p.000162: C. Members of Sub-Committees / Invited Experts
p.000162: Amit K Dinda, All India Institute of Medical Sciences, New Delhi
p.000162: Aditi Iyer, Public Health Foundation of India, Bengaluru Anant Bhan, International AIDS Vaccine Initiative, New Delhi
p.000162: Anura Kurpad, St John’s Medical College, Bengaluru
p.000162:
p.000162:
p.000162:
p.000162: 162 INDIAN COUNCIL OF MEDICAL
p.000163: RESEARCH
p.000163:
p.000163:
p.000163:
p.000163: Arun Bhatt, Indian Society for Clinical Research, Mumbai
p.000163: Brogen Singh Akoijam, Regional Institute of Medical Sciences, Imphal
p.000163: Dorothy Lall, Institute of Public Health, Bengaluru
p.000163: G.D. Ravindran, St. John's Medical College, Bengaluru
p.000163: Jameela George, Emmanuel Hospital Association, New Delhi
p.000163: Jitender K Sharma, Formerly at National Health Systems Resource Center, New Delhi
p.000163: J.S. Srivastava, Formerly at Central Drug Research Institute, Lucknow
p.000163: Lalitha Savardekar, National Institute of Research in Reproductive Health, Mumbai
p.000163: Madhulika Kabra, All India Institute of Medical Sciences, New Delhi
p.000163: Mala Ramanathan, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
p.000163: Manish Singh Chundawat, The INCLEN Trust International, New Delhi
p.000163: Manoj Das, The INCLEN Trust International, New Delhi
p.000163: Meenakshi Bhat, Centre for Human Genetics, Bengaluru
p.000163: Mukesh Kumar, Indo French Centre for the Promotion of Advanced Research, New Delhi
p.000163: Nabeel M.K., Academy of Medical Sciences, Kannur
p.000163: Neena Valecha, National Institute of Malarial Research, New Delhi
p.000163: Nimesh Verma, Government Medical College, Surat
p.000163: Peush Sahni, All India Institute of Medical Sciences, New Delhi
p.000163: Poonam Natarajan, National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple
p.000163: Disabilities Empowerment, New Delhi Prabha Desikan, Bhopal Memorial Hospital and Research centre, Bhopal
p.000163: Prashant Mathur, National Center for Disease Informatics and Research, Bengaluru
p.000163: Prathiba Pereira, Jagadguru Sri Shivarathreeshwara Medical College, Mysore
p.000163: Praveen Vemula, National Center for Biological Sciences, Bengaluru
p.000163:
p.000163:
p.000163:
p.000163: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000163: 163
p.000164:
p.000164:
p.000164:
p.000164: Raakhi Tripathi, Seth GS Medical College & King Edward Memorial Hospital, Mumbai
p.000164: Rema Devi, Clinical Epidemiology Resource & Training Centre, Medical College,
p.000164: Thiruvananthapuram
p.000164: Sandeep Bavdekar, Topiwala National Medical College and BYL Nair Hospital, Mumbai
p.000164: Sangeeta Desai, Tata Memorial Centre, Mumbai
...
Searching for indicator influence:
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p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
p.000006: obtained. If a participant or LAR is illiterate, a literate impartial witness should also be present during the
p.000006: informed consent process.
p.000006:
p.000006: 6 INDIAN COUNCIL OF
p.000007: MEDICAL RESEARCH
p.000007:
p.000007:
p.000007: General Ethical Issues
p.000007:
p.000007: 2.2.2 In certain circumstances audio/audio-visual recording of the informed consent process may be required, for
p.000007: example in certain clinical trials as notified by CDSCO.
p.000007: 2.2.3 Verbal/oral consent/waiver of consent/re-consent may be obtained under certain conditions after due
p.000007: consideration and approval by the EC. See section 5 for further details.
p.000007: 2.3 Privacy and confidentiality
p.000007: Privacy is the right of an individual to control or influence the information that can be collected and stored and by
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
p.000007: community.
p.000007: 2.3.2 Potential limitations to ensure strict confidentiality must be explained to the participant. Researchers must
p.000007: inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,
p.000007: it may not be possible to do so under certain circumstances.
p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
...
p.000014: Policies can be made available on the websites of the institutes or organizations. Researchers should also follow their
p.000014: respective professional codes of conduct.
p.000014: 3.2.2 Animal experimentation
p.000014: Those involved in experimentation on animals must follow all the existing regulations and guidelines including the
p.000014: Prevention of Cruelty to Animals Act, 1960, amended in
p.000014: 14 INDIAN COUNCIL OF
p.000015: MEDICAL RESEARCH
p.000015:
p.000015:
p.000015: Responsible Conduct of Research
p.000015:
p.000015: 1982, the Breeding and Experimentation Rules, 1998, amended in 2001 and 2006, the Guidelines for Care and Use of
p.000015: Animals in Scientific Research (Indian National Science Academy, 1982, amended in 2000), ICMR Guidelines on
p.000015: Humane Care and Use of Laboratory Animals, 2006, Committee for the Purpose of Control and Supervision of
p.000015: Experiments on Animals (CPSCSEA) Guidelines for Laboratory Animal Facilities, 200318 and Guidelines for Rehabilitation
p.000015: of Animals used in Research, 2010.
p.000015: 3.3 Planning and conducting research – Specific Issues
p.000015: 3.3.1 Conflict of interest issues
p.000015: COI refers to a set of conditions whereby professional judgement concerning a primary interest, such as participant’s
p.000015: welfare or the validity of research either is, or perceived to be unduly influenced by a secondary interest. The
p.000015: secondary interest may be financial or non-financial, personal, academic or political. This is not inherently wrong,
p.000015: but COI can influence the choice of research questions and methods, recruitment and retention of participants,
p.000015: interpretation and publication of data and the ethical review of research. It is, therefore, necessary to develop and
p.000015: implement policies and procedures to identify, mitigate and manage such COI which can be at the level of researcher,
p.000015: ethics committee or at the level of institution. Research institutions, researchers and research ECs must follow the
p.000015: steps given in Box 3.1.
p.000015: Box 3.1 Identifying, mitigating and managing COI
p.000015: The broad responsibilities of those involved in research, with respect to COI, are given below:
p.000015: 1. Research institutions must:
p.000015: • develop policies and SOPs to address COI issues that are dynamic, transparent and actively
p.000015: communicated;
p.000015: • implement policies and procedures to address COI and conflicts of commitment, and
p.000015: educate their staff about such policies;
p.000015: • monitor the research or check research results for accuracy and objectivity; and
p.000015: • not interfere in the functioning and decision making of the EC.
p.000015: 2. Researchers must:
p.000015: • ensure that documents submitted to the EC include disclosure of COI (financial or non-
p.000015: financial) that may affect their research;
p.000015: • guard against conflicts of commitment that may arise from situations that place competing
p.000015: demands on researchers’ time and loyalties; and
p.000015: • prevent intellectual and personal conflicts by ensuring they do not serve as reviewers for
p.000015: grants and publications submitted by close colleagues, relatives and/or students.
p.000015:
p.000015:
p.000015: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000015: (Contd.)
p.000015: 15
p.000016:
p.000016:
...
p.000051: she/he has understood the information given in the PIS and is volunteering to be included in that research.
p.000051: 5.2.3 Adequate time should be given to the participant to read the consent form, if necessary discuss it with family
p.000051: and friends, and seek clarification of her/his doubts from the researchers/research team before deciding to enroll in
p.000051: the research.
p.000051: 5.2.4 Essential elements of an informed consent document are given in Box 5.1.
p.000051: 5.3 Responsibility of researchers
p.000051: 5.3.1 The researcher should only use the EC approved version of the consent form, including its local
p.000051: translations.
p.000051: 5.3.2 Adequate information necessary for informed consent should be communicated in a language and manner easily
p.000051: understood by prospective participants.
p.000051: 5.3.3 In case of differently abled participants, such as individuals with physical, neurological or mental
p.000051: disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for
p.000051: the visually impaired.
p.000051: 5.3.4 There should be no restriction on the participant’s right to ask questions related to the study or to
p.000051: discuss with family and friends or take time before coming to a decision.
p.000051: 5.3.5 The researcher should not give any unjustifiable assurances or influence or intimidate a prospective
p.000051: participant to enroll in the study.
p.000051: 5.3.6 The researcher must ensure that the participant is competent and has understood all aspects of the study and
p.000051: that the consent is given voluntarily. Where the participant and/or the LAR are illiterate, an impartial literate
p.000051: person, not connected to the research, should be present throughout the consent process as witness.
p.000051: 5.3.7 The researcher should administer a test of understanding whenever possible for sensitive studies.
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
p.000051: so, then verbal/oral consent may be taken on approval by the EC, in the presence of an impartial witness who should
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
p.000051: the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be
p.000051: taken in exceptional circumstances and for specific, justifiable reasons with the approval of the EC. It should not to
p.000051: be practiced routinely.
p.000051: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000051: 51
p.000052:
p.000052:
...
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
...
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
...
p.000092: American Society for Testing and Materials (ASTM)36 international standards until Indian standards for biomaterials are
p.000092: in place. The testing of such standards shall be done in a laboratory certified by the National Accreditation Board for
p.000092: Testing and Calibration Laboratories (NABL).
p.000092: • Appropriate training for safety of healthcare workers should be given and they should be provided periodic
p.000092: health check-ups due to exposure to occupational risks.
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: 92 INDIAN COUNCIL OF
p.000093: MEDICAL RESEARCH
p.000093:
p.000093: SECTION 8
p.000093:
p.000093: PUBLIC HEALTH RESEARCH
p.000093:
p.000093: 8.0 Public health raises a complex relationship between the state, its policies and society involving individuals
p.000093: and organizations with a precautionary approach. Ethics in public health apply to both practice and research,
p.000093: both of which utilize epidemiology and methods of other disciplines to ensure better societal conditions for
p.000093: healthier lives. Therefore, public health protects both the individual and the population at large, since
p.000093: the benefits and risks are not limited to an individual, but influence communities, populations and the
p.000093: environment. It is important to realize that public health interventions have the potential to expose and perhaps
p.000093: exploit the vulnerabilities of communities and segments of the population. Public health research investigations and
p.000093: interventions should therefore be conducted through a process of ethical reflection, together with establishment of
p.000093: appropriate protections, oversight procedures and governance mechanisms.
p.000093: Defining boundaries between public health practice and research remains a challenge in public health ethics as the
p.000093: purpose or intent of the investigation may overlap. Public health practice involves data collection through
p.000093: surveillance, vital statistics, disease reporting and registries; investigation of outbreaks including contact
p.000093: tracing, use of preventive interventions and health promotion; monitoring and programme evaluation; and enforcing of
p.000093: mandatory requirements, such as screening, treatment, immunization, notifying diseases and, sometimes, quarantine
p.000093: depending upon the situation. By using epidemiological designs, sampling techniques and analysis, some of these
p.000093: activities could create generalizable knowledge, which is the primary intent of research. Considering these
p.000093: difficulties in clear delineation of boundaries between practice and research, both requiring ethical oversight and
p.000093: governance of public health information, an EC may have to differentiate this to determine its role with more clarity.
p.000093: This section however, highlights the specific ethical issues pertaining to research on public health. The EC will
p.000093: determine if a particular protocol pertains to public health practice or research.
...
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
p.000095: • Principle of reciprocity – This principle requires that individuals or communities, who have borne a
p.000095: disproportionate share of burden or risks for the benefit of others be given some form of benefit. The benefit should
p.000095: be context specific such as protection from further exposure, access to food, healthcare, clothing and
p.000095: shelter, communication or compensation for lost income.
p.000095: • Principle of solidarity – Public health research should respect the intra- and inter- dependence among
p.000095: members of communities leading to solidarity for collective welfare or the common good.
p.000095: • Principle of accountability and transparency – The conduct of research must be fair, honest and transparent.
p.000095: The results should be made available in the public domain.
p.000095: In order to undertake a review of public health research, an EC must carefully consider the points given in Box 8.1.
p.000095: Box 8.1 Public health research proposal review
p.000095:
p.000095: When reviewing public health research proposals, ECs should consider the followings aspects:
p.000095: 1. Are the objectives of the study scientifically sound and linked to the achievement of public health goals?
p.000095: 2. Is individual written informed consent required?
p.000095: • If not, is gatekeeper consent/permission sufficient? Who is a gatekeeper and how is this
p.000095: decided?
...
p.000102: • on routinely collected data under programme conditions, including research involving linkage to large
p.000102: anonymous databases of information that has been routinely collected such as administrative data and through
p.000102: surveillance activities. However, at the time of collection people concerned may have been told that the data would be
p.000102: used for other purposes, including research;
p.000102: • in circumstances where obtaining consent is impractical, such as for stored anonymous data/ biological samples,
p.000102: surveillance and administrative data or personal non-identifiable data/ material available from public health
p.000102: programmes;
p.000102: • for studies performed within the scope of regulatory and public health authorities, such as process and impact
p.000102: evaluations of national policies and programmes, including neonatal screening programmes or diabetes screening
p.000102: as part of national programme activities may be exempt from the requirement for informed consent;
p.000102: • when the primary purpose is refinement and improvement of the public health programmes;
p.000102: • for studies using health-related registries that are authorized under national regulations; or
p.000102: • when it is not practical or meaningful to obtain consent in large geographical clusters in cluster
p.000102: randomization trials and several IRs.
p.000102:
p.000102: 8.4.5 Re-consenting in longitudinal studies: There is need for re-consenting when there is a change in protocol, new
p.000102: information is sought, a new intervention is introduced, or new information is available which has likely influence on
p.000102: the safety of participants. If there is no change in the study protocol there is no need for re-consent. Other
p.000102: guidelines for re-consent, as described in section 5, should be followed.
p.000102: 8.5 Role of the EC
p.000102: 8.5.1 ECs should ensure that the researcher has taken adequate measures for data security, confidentiality of
p.000102: information, disclosure permissions, and stated appropriate use of the accessed data.
p.000102: 8.5.2 EC members need to give appropriate importance to the social benefit, public good and public health impact
p.000102: these studies may be addressing. The ECs must take decisions regarding consent on a case- by-case basis.
p.000102: 8.5.3 EC membership should include experts in public health or the EC should get comments from, or invite experts
p.000102: for, the relevant meeting.
p.000102: 8.5.4 ECs should consider the following while assessing a public health research:
p.000102: • standards of care in public health;
p.000102:
p.000102: 102 INDIAN COUNCIL OF MEDICAL
p.000103: RESEARCH
p.000103:
p.000103:
p.000103: Public Health Research
p.000103:
p.000103: • ancillary care in public health;
p.000103: • stakeholder engagement – identifying and defining stakeholders’ roles especially
p.000103: in IR, health systems and policy research; and
p.000103: • responsibility of the researcher to scale-up, advocate, promote uptake, or sustain
p.000103: the public health intervention.
p.000103: 8.6 Protecting participants and communities
...
p.000104: different from clinical, biomedical and public health research. Social and behavioural sciences include, but are
p.000104: not limited to, anthropology, sociology, psychology, philosophy, political science, economics, history,
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
p.000104: evident due to multi-religious, caste, class, endogamic, gender and geo-ethnic variations which are important
p.000104: characteristics of society that need to be considered in socio-behavioural research proposals. In view of the above,
p.000104: ECs should be aware of the challenges that may be encountered in the process of conducting such studies.
p.000104: 9.1 Some key features
p.000104: 9.1.1. Conventional social science research on health underscores the importance of bringing contemporary contexts to
p.000104: biomedical and health research.
p.000104: 9.1.2. It has now emerged as a cross-cutting area of enquiry relevant to almost every type of
p.000104:
p.000104: 104 INDIAN COUNCIL OF MEDICAL
p.000105: RESEARCH
p.000105:
p.000105: Social and Behavioural Sciences
p.000105: Research for Health
p.000105:
p.000105: medical, biomedical, clinical and health research such as clinical trials, epidemiological research, programme
p.000105: evaluations, implementation research, genetics, research on disaster and conflict contexts.
p.000105: 9.1.3. The principles of social science research ethics, with rights and responsibilities of the different
p.000105: stakeholders including participants, researchers, reviewers, publishers, etc., are similar to those for biomedical and
p.000105: public health research.
...
Searching for indicator substance:
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p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
...
p.000075: • DNA vaccines
p.000075: • Recombinant vector vaccines
p.000075:
p.000075: m Some vaccines that contain active or live (attenuated) micro-organisms can possibly possess a small risk of
p.000075: producing that particular infection. The participant to be vaccinated should be informed of this.
p.000075: m The participants in control groups, or when subjected to ineffective vaccines, run a risk of contracting the
p.000075: disease. In such an event, provisions be made to provide free treatment for the disease.
p.000075: m For recombinant DNA vaccines and products, applicable governmental guidelines and regulations should be
p.000075: followed.
p.000075: m Post-trial, the control group should receive the complete dose of an effective vaccine (either one that is already
p.000075: available or the investigational vaccine).
p.000075: 7.3 Bioavailability/bioequivalence study
p.000075: Bioavailability (BA) is the measurement of the proportion of the total administered dose of a therapeutically active
p.000075: drug that reaches the systemic circulation and is therefore available at the site of action.
p.000075: Bioequivalence (BE) is a term used in pharmacokinetics when there are two or more
p.000075:
p.000075: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000075: 75
p.000076:
p.000076: Clinical Trials of Drugs and
p.000076: other Interventions
p.000076:
p.000076: medicinal products (proprietary preparations of a drug), containing the same active substance that need to be compared
p.000076: in vivo for biological equivalence. These comparative studies are used to assess if the new version (generic) produces
p.000076: the same concentration in the systemic circulation when given to human participants. If two products are
p.000076: said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
p.000076: BE studies are used as surrogates for clinical effectiveness data for generic drugs where no clinical difference is
p.000076: anticipated between the two products.
p.000076: 7.3.1 Ethical issues
p.000076: • All BA/BE studies should be scientifically sound and conducted in compliance with principles of ethical
p.000076: conduct described earlier for a Phase I study.
p.000076: • Ethical conduct of BA/BE study requires evaluation of the benefit–risk profile of:
p.000076: a. the reference (comparator) and investigational (generic) product; and
p.000076: b. the study procedures such as indoor stay, fasting, screening, blood sampling.
p.000076: • BA/BE studies are usually conducted in healthy volunteers. Hence, they have no direct benefit to the
p.000076: participant but may pose risks due to the adverse effects of the drug. Therefore, all safeguards to protect
p.000076: participants must be in place.
p.000076: • The EC must carefully review the recruitment methods, payment for participation and consent procedures.
...
p.000085: body (in vivo use). Special expertise may be co-opted in the EC for review of such products.
p.000085: 7.14.3 These trials are usually comparative, the comparator being the reference/gold standard test to diagnose the
p.000085: disease. Hence, the protocol must state clearly the choice of the reference with justification. Likewise, omission of a
p.000085: reference standard as comparator must also be justified.
p.000085: 7.14.4 A placebo may be used as comparator when the response to a diagnostic test is being assessed using
p.000085: subjective evaluation criteria, for example, skin changes in a skin prick test or for the assessment of
p.000085: tolerability. There have to be clear justifications in the protocol for the use of a placebo and no irreversible harm
p.000085: should occur to the participant. Post-trial access to the standard of care diagnostic test must be assured.
p.000085: 7.14.5 Safety follow-up of patients in these trials should not be limited to the duration of the diagnostic
p.000085: procedure but may be extended for a longer period according to the pharmacokinetic and pharmacodynamic properties of
p.000085: the diagnostic agent.
p.000085: 7.14.6 Long-term safety (when appropriate) should be assessed especially for agents accumulating in the
p.000085: body, such as deposits of gadolinium in bones and skin.
p.000085: 7.15 Radioactive materials and X-rays
p.000085: Radioactive substances contain a radioactive isotope, and may be used for therapeutic or diagnostic purposes. If the
p.000085: radioactive substance is to be tested as a drug then all the ethical considerations described in previous sections will
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
p.000057: 7.12 Clinical trials of interventions in HIV/AIDS 82
p.000057:
p.000057: 7.13 Clinical trials on traditional systems of medicine 83
p.000057: 7.14 Trials of diagnostic agents 84
p.000057: 7.15 Radioactive materials and X-rays 85
p.000057: 7.16 Investigator initiated clinical trials 86
p.000057: 7.17 Clinical trials on contraceptives 87
p.000057: 7.18 Pregnancy and clinical trials 88
p.000057: 7.19 Clinical trials in oncology 89
p.000057: 7.20 Clinical trials of products using any new technology 90
p.000057: 7.21 Synthetic biology 91
p.000057: Section 8 Public health research
p.000093: 93
p.000094: 8.1 Principles of public health research ethics 93
p.000094: 8.2 Ethical issues of epidemiological and
p.000094: public health research study designs 96
p.000094: 8.3 Use of administrative and other data sources for research 100
p.000094: 8.4 Informed consent 100
p.000094: 8.5 Role of EC 102
p.000094: 8.6 Protecting participants and communities 103
...
p.000003: knowledge, the use of human participants is considered to be essential for the proposed research. This should be duly
p.000003: vetted by an ethics committee (EC) independent of the proposed research.
p.000003: 1.1.2 Principle of voluntariness whereby respect for the right of the participant to agree or not to agree to
p.000003: participate in research, or to withdraw from research at any time, is paramount. The informed consent process
p.000003: ensures that participants’ rights are safeguarded.
p.000003: 1.1.3 Principle of non-exploitation whereby research participants are equitably selected so that the benefits and
p.000003: burdens of the research are distributed fairly and without arbitrariness or discrimination. Sufficient safeguards to
p.000003: protect vulnerable groups should be ensured.
p.000003: 1.1.4 Principle of social responsibility whereby the research is planned and conducted so as to avoid creation or
p.000003: deepening of social and historic divisions or in any way disturb social harmony in community relationships.
p.000003: 1.1.5 Principle of ensuring privacy and confidentiality whereby to maintain privacy of the potential
p.000003: participant, her/his identity and records are kept confidential and access
p.000003: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000003: 3
p.000004:
p.000004:
p.000004: Statement of General Principles
p.000004:
p.000004: is limited to only those authorized. However, under certain circumstances (suicidal ideation, homicidal tendency, HIV
p.000004: positive status, when required by court of law etc.) privacy of the information can be breached in consultation with
p.000004: the EC for valid scientific or legal reasons as the right to life of an individual supersedes the right to privacy of
p.000004: the research participant.
p.000004: 1.1.6 Principle of risk minimization whereby due care is taken by all stakeholders (including but not limited to
p.000004: researchers, ECs, sponsors, regulators) at all stages of the research to ensure that the risks are minimized and
p.000004: appropriate care and compensation is given if any harm occurs.
p.000004: 1.1.7 Principle of professional competence whereby the research is planned, conducted, evaluated and monitored
p.000004: throughout by persons who are competent and have the appropriate and relevant qualification, experience and/or
p.000004: training.
p.000004: 1.1.8 Principle of maximization of benefit whereby due care is taken to design and conduct the research in such a way
p.000004: as to directly or indirectly maximize the benefits to the research participants and/or to the society.
p.000004: 1.1.9 Principle of institutional arrangements whereby institutions where the research is being conducted, have
p.000004: policies for appropriate research governance and take the responsibility to facilitate research by providing required
p.000004: infrastructure, manpower, funds and training opportunities.
p.000004: 1.1.10 Principle of transparency and accountability whereby the research plan and outcomes emanating from the research
p.000004: are brought into the public domain through registries, reports and scientific and other publications while safeguarding
p.000004: the right to privacy of the participants. Stakeholders involved in research should disclose any existing conflict of
...
p.000007: 2.3 Privacy and confidentiality
p.000007: Privacy is the right of an individual to control or influence the information that can be collected and stored and by
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
p.000007: community.
p.000007: 2.3.2 Potential limitations to ensure strict confidentiality must be explained to the participant. Researchers must
p.000007: inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,
p.000007: it may not be possible to do so under certain circumstances.
p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
...
p.000031: MEDICAL RESEARCH
p.000031:
p.000031:
p.000031: Ethical Review Procedures
p.000031:
p.000031: 4.3.7 So as to maintain independence, the head of the institution should not be part of the EC but should act as an
p.000031: appellate authority to appoint the committee or to handle disputes.
p.000031: 4.3.8 The Chairperson and Member Secretary could have dual roles in the ethics committee. They could fulfil a role
p.000031: based on their qualifications (such as that of clinician, legal expert, basic scientist, social scientist, lay person
p.000031: etc.) in addition to taking on the role of Chairperson or Member Secretary.
p.000031: 4.3.9 The EC can also have a set of alternate members who can be invited as members with decision-making powers to
p.000031: meet the quorum requirements. These members have the same TORs as regular members and can attend meetings in
p.000031: the absence of regular members.
p.000031: 4.3.10 The EC can maintain a panel of subject experts who are consulted for their subject expertise, for
p.000031: instance, a paediatrician for research in children, a cardiologist for research on heart disorders, etc. They may be
p.000031: invited to attend the meeting to give an expert opinion on a specific proposal but will not have decision making
p.000031: power/voting rights.
p.000031: 4.3.11 The EC may invite subject experts as independent consultants or include a representative from a specific
p.000031: patient group as a member of the EC or special invitee, for opinion on a specific proposal, for example HIV, genetic
p.000031: disorders, or cancer, with appropriate decision making power.
p.000031: 4.3.12 As far as possible a separate scientific committee should priorly also review proposal before it is referred to
p.000031: EC. EC can raise scientific queries besides ethical ones as both good science and ethics are important to ensure
p.000031: quality of research and participant protection.
p.000031: 4.4 Terms of reference for EC members
p.000031: 4.4.1 The head of the institution should appoint all EC members, including the Chairperson.
p.000031: 4.4.2 The appointment letter issued to all members should specify the TORs. The letter issued by the head of the
p.000031: institution should include, at the minimum, the following:
p.000031: • Role and responsibility of the member in the committee
p.000031: • Duration of appointment
p.000031: • Conditions of appointment
p.000031: 4.4.3 Generally, the term of EC membership may be 2–3 years. The duration could be extended as specified in the SOPs.
p.000031: A defined percentage of EC members could be changed on a regular basis.
p.000031: 4.4.4 EC members may be given a reasonable honorarium for attendance at the meeting.
p.000031:
p.000031: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000031: 31
p.000032:
p.000032:
p.000032: Ethical Review Procedures
p.000032: 4.4.5 Members to be appointed on the EC should be willing to fulfil the EC requirements as given in Box 4.3.
p.000032: Box 4.3 Requirements for EC members
p.000032:
p.000032: Every EC member must:
p.000032: 1. provide a recent signed CV and training certificates on human research protection and good clinical practice (GCP)
p.000032: guidelines, if applicable;
...
p.000050: be enrolled, types of data collection and methods
p.000050: 4. Benefits to the participant, community or others that might reasonably be expected as an outcome of
p.000050: research
p.000050: 5. Any foreseeable risks, discomfort or inconvenience to the participant resulting from participation in
p.000050: the study
p.000050: 6. Extent to which confidentiality of records could be maintained, such as the limits to which the
p.000050: researcher would be able to safeguard confidentiality and the anticipated consequences of breach of confidentiality
p.000050: 7. Payment/reimbursement for participation and incidental expenses depending on the type of study
p.000050: 8. Free treatment and/or compensation of participants for research-related injury and/ or harm
p.000050: 9. Freedom of the individual to participate and/or withdraw from research at any time without penalty or loss
p.000050: of benefits to which the participant would otherwise be entitled
p.000050: 10. The identity of the research team and contact persons with addresses and phone numbers (for example, PI/Co PI
p.000050: for queries related to the research and Chairperson/Member Secretary/ or helpline for appeal against violations
p.000050: of ethical principles and human rights)
p.000050:
p.000050: In addition, the following elements may also be required, depending on the type of
p.000050: study:
p.000050: 1. Any alternative procedures or courses of treatment that might be as advantageous to the participant as
p.000050: the ones to which she/he is going to be subjected
p.000050: 2. If there is a possibility that the research could lead to any stigmatizing condition, for example HIV and genetic
p.000050: disorders, provision for pre- test- and post-test counselling
p.000050: 3. Insurance coverage if any, for research-related or other adverse events
p.000050: 4. Foreseeable extent of information on possible current and future uses of the biological material and of the
p.000050: data to be generated from the research. Other specifics are as follows:
p.000050: i period of storage of the sample/data and probability of the material being used for secondary purposes.
p.000050: ii whether material is to be shared with others, this should be clearly mentioned.
p.000050: iii right to prevent use of her/his biological sample, such as DNA, cell-line, etc., and related data at any
p.000050: time during or after the conduct of the research.
p.000050: iv risk of discovery of biologically sensitive information and provisions to safeguard confidentiality.
p.000050: v post research plan/benefit sharing, if research on biological material and/or data leads to
p.000050: commercialization.
p.000050: vi Publication plan, if any, including photographs and pedigree charts.
p.000050: See section 11 for further details.
p.000050:
p.000050: 50 INDIAN COUNCIL OF
p.000051: MEDICAL RESEARCH
p.000051:
p.000051:
p.000051: Informed Consent Process
p.000051:
p.000051: to participation, is included in the PIS. This is followed by the ICF in which the participant acknowledges that
p.000051: she/he has understood the information given in the PIS and is volunteering to be included in that research.
...
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
...
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
...
p.000079: disorder. Depending upon risks involved, devices (other than in vitro diagnostic devices) are classified as given in
p.000079: Table 7.1:
p.000079: Table 7.1 Classification of medical devices
p.000079: Class Level of risk Device examples
p.000079: A Low Thermometers/ bandages /tongue depressors
p.000079: B Low–moderate Hypodermic needles /suction equipment C Moderate–high Lung
p.000079: ventilator /bone fixation plate
p.000079: D High Heart valves/implantable defibrillator
p.000079:
p.000079: 7.7.3 Devices used for in vitro diagnosis could be a reagent, calibrator, control material, kit, instrument,
p.000079: apparatus, equipment, system, or specimen receptacle, whether used alone or in combination with any other such devices,
p.000079: that is intended by its manufacturer to be used in vitro for examination of any specimen, including any
p.000079: blood or tissue donation derived from the human body solely or principally for the purpose of providing information.
p.000079: The information could be related to:
p.000079: (i) a physiological or pathological state;
p.000079: (ii) congenital deformity;
p.000079: (iii) determining the safety and compatibility of any blood or tissue donation with a potential recipient thereof;
p.000079: or
p.000079: (iv) monitoring of therapeutic measures.
p.000079:
p.000079: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000079: 79
p.000080:
p.000080: Clinical Trials of Drugs and
p.000080: other Interventions
p.000080: • Diagnostics devices can be notified and non-notified. Notified are in vitro diagnostic devices for
p.000080: testing HIV, HBsAg, HCV and blood grouping. Non-notified are those for testing malaria, TB, dengue, chikungunya,
p.000080: typhoid, syphilis, cancer markers, etc.
p.000080: 7.8 Biologicals and biosimilars
p.000080: Biologics (biopharmaceutical drug) can be composed of sugars, proteins, nucleic acids or complex combinations of these
p.000080: substances, or may be living cells or tissues. This section applies to products that are produced by means of
p.000080: biological processes with or without recombinant DNA technology. All aspects that are described in section 7.1 are also
p.000080: applicable to biologics.
p.000080: 7.8.1 As these are biologic substances, special care must be taken to review all data generated. Special expertise
p.000080: may be sought for such reviews so that foreseeable risks are well identified.
p.000080: 7.8.2 A thorough benefit-risk assessment must be carried out with available data.
p.000080: 7.8.3 If the study involves biosimilars, the product quality (manufacturing and characterization), preclinical data
p.000080: and bioassay must demonstrate similarity with a reference biologic.
p.000080: 7.8.4 All applicable and current regulations must be followed.
p.000080: 7.9 Clinical trials with stem cells
p.000080: In recent years, stem cell research has undergone rapid developments promising new leads in the treatment of several
p.000080: incurable diseases. According to the source and degree of expected risk to human participants, stem cell research is
p.000080: categorized into permissible (adult and cord blood), restricted (embryonic) and prohibited (reproductive cloning) areas
...
p.000081: trial participant. The EC must determine the compensation amount after the investigator has described the relatedness.
p.000081: 7.10.6 Due to inherent ethical issues, sham surgery should not be included in the design of clinical trials, except
p.000081: in cases where there are strong scientific reasons. Under such circumstances, certain conditions must be met.
p.000081: See Box 7.6 for further details.
p.000081:
p.000081: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000081: 81
p.000082:
p.000082: Clinical Trials of Drugs and
p.000082: other Interventions
p.000082:
p.000082: Box 7.6 Conditions for sham surgery
p.000082: 1. There has to be a clear description of the justifications to include a sham surgery group in the protocol, which
p.000082: must be assessed by the EC.
p.000082: 2. There should be no serious harm caused by the sham surgery.
p.000082: 3. The participant must get access to appropriate, relevant intervention at the end of the trial.
p.000082:
p.000082: 7.11 Community trials (public health interventions)
p.000082: Community trials are studies involving whole communities and are conducted to evaluate preventive strategies like mass
p.000082: drug administration (MDA) trials, fortification of food, etc. Such studies typically involve the whole community. The
p.000082: study unit could be a group, area, institution, village, block, district, etc. and the whole population is expected to
p.000082: participate in the study. In such studies, different communities are randomized and allocated to different arms (see
p.000082: section 8 for further details).
p.000082: 7.12 Clinical trials of interventions in HIV/AIDS
p.000082: Clinical trials in HIV positive patients could be for the evaluation of new drugs, vaccines, other
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
p.000082: 7.12.1 Global studies in HIV/AIDS in specific communities should receive approval from the relevant national
p.000082: authority and any other relevant authority, such as the HMSC, where applicable, in addition to approval from the EC.
p.000082: 7.12.2 When testing for HIV is done, consent and pre-test- and post-test counselling should be done as per National
p.000082: AIDS Control Organization (NACO) guidelines.
p.000082: 7.12.3 Issues that may arise because of discordant couples should be addressed before initiating any
p.000082: study in people living with HIV/AIDS.
p.000082: 7.12.4 As HIV is a sexually transmitted disease and is potentially life-threatening, the right to life of the
p.000082: sexual partner must be respected over the right to privacy of the HIV positive individual.
p.000082: 7.12.5 Phase I studies are permissible in patients with HIV/AIDS if the drug under study cannot be tested in
p.000082: healthy participants due to expected toxicity of the IP.
p.000082:
p.000082: 82 INDIAN COUNCIL OF
p.000083: MEDICAL RESEARCH
p.000083:
p.000083: Clinical Trials of Drugs and
p.000083: other Interventions
p.000083:
p.000083: 7.12.6 A combined Phase I/II or Phase II study can be conducted in this population when other therapeutic options
p.000083: have been exhausted.
p.000083: 7.12.7 When a trial with a preventive HIV vaccine is conducted, it can result in positive serology. This does
p.000083: not indicate HIV infection but can create problems for travel and employment. Under such circumstances, the
p.000083: project investigator should issue a certificate stating that the person in question was a participant in a vaccine
p.000083: trial and provide clarification on the result.
p.000083: 7.12.8 Research that involves sexual minorities or IV drug users should have community engagement (community
p.000083: leaders) throughout the life of the project, until completion and dissemination of results.
p.000083: 7.12.9 The EC may also consider co-opting a member from this community, if relevant for initial and continuing
p.000083: review of proposals.
p.000083: 7.12.10 Where possible, for example, if the drug is found useful, standard of care is not available or regulatory
p.000083: permissions are in place, the EC should ensure post-trial access of the IP for the participants.
p.000083: 7.12.11 For HIV positive persons, any research may be misconstrued as research on anti-HIV treatment and make them
p.000083: willing to participate. Therefore, the full implications in simple terms should be explained to HIV positive
p.000083: participants about any other research being done on them, such as research on hepatitis B.
p.000083: 7.13 Clinical trials on traditional systems of medicine
p.000083: Although traditional systems of medicine (termed complementary and alternate systems in the west) are
p.000083: known for their long history of safe and effective use, validation of safety and efficacy using scientific and
p.000083: evidence-based methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners
p.000083: and satisfaction of end users in the products. Government of India has recognized Ayurveda, Siddha, Unani, Yoga,
p.000083: Naturopathy and Homeopathy as traditional Indian systems of medicine. In 2012, Sowa Rigpa (Amchi or Tibetan medicine)
p.000083: was also added to the list. Ministry of AYUSH (Ayurveda, Unani, Siddha and Homeopathy) governs and regulates these
p.000083: systems. Drugs under these systems come under the Drugs and Cosmetics Act, 1940, as ASU and H drugs. Drugs/formulations
p.000083: under these systems of medicine are classified into two groups. See Box 7.7 for further details:
p.000083: 7.13.1 Research on AYUSH and ASU interventions of traditional medicines (TM) including external
p.000083: medicines/therapeutic procedures, folk medicines, and patent and proprietary medicines of TM involving human
p.000083: participants should be conducted in accordance
p.000083: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000083: 83
p.000084:
p.000084: Clinical Trials of Drugs and
p.000084: other Interventions
p.000084: with all the ethical principles described in these guidelines including SAE reporting and compensation, AYUSH GCP
p.000084: guidelines32, as well as other applicable regulations of the country.
p.000084: Box 7.7 Classification of drugs/formulation under AYUSH
...
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
...
p.000093: is relational, since the interests of an individual as part of
p.000093:
p.000093: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000093: 93
p.000094:
p.000094:
p.000094: Public Health Research
p.000094:
p.000094: a community are relational in nature. Therefore, sometimes individual autonomy may not be appropriate as a stand-alone
p.000094: for application at the community level. While respect for the rights and dignity of all participants need to be
p.000094: considered and ensured, the same should be observed about the community. This can be facilitated by engaging the
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
...
p.000134: 11.5.1 Informed consent: If there is no written consent by the deceased person permitting use of organs or tissues, the
p.000134: family can be approached for consent for use of left-over organs or tissues.
p.000134: 11.5.2 No consent would be required if sample or data is anonymized.
p.000134: 11.5.3 If the deceased has no claimant then forensic officials will be authorized to give permission for
p.000134: use of material/data from its sources and be responsible for use of unclaimed cadavers.
p.000134: 11.5.4 The quantity of tissue taken should ideally be minimal, particularly if it is seen externally on the body in
p.000134: order to preserve the dignity of the dead and be culturally acceptable by
p.000134:
p.000134: 134 INDIAN COUNCIL OF MEDICAL
p.000135: RESEARCH
p.000135:
p.000135: Biological Materials,
p.000135: Biobanking and Datasets
p.000135:
p.000135: the next of kin or closest relative or friend.
p.000135: 11.5.5 The information in the informed consent document should state what tissue/organ will be retained, who will be
p.000135: the custodian, duration of storage of sample, what type of research would be conducted and method for disposal of the
p.000135: remains.
p.000135: 11.5.6 Genetic research or revelation of any other stigmatizing factors like HIV, etc. in the deceased may have
p.000135: implications for family members. In such instances, all ethical requirements as in the case of live
p.000135: participants should be followed.
p.000135: 11.5.7 The role of the EC is to review and approve the type of consent – broad, tiered with or without option to
p.000135: opt-out or specific and to assess from whom it would be taken – the family, closest relative or friend – or whether
p.000135: sample anonymization should be done.
p.000135: 11.6 Governance of biobank/biorepository
p.000135: Institutions where data are collected and archived must have an established governance structure with the following
p.000135: requirements for regulation.
p.000135: 11.6.1 Each biorepository should have its own technical authorization committee with representation of both
p.000135: science and ethics and external members. This committee should function in tandem with the EC.
p.000135: 11.6.2 A technical authorization committee, indigenous to the biorepository, should govern collection of specimens,
p.000135: disbursement of biospecimens and data to researchers. The same committee should also oversee regulatory aspects like
p.000135: execution of MTA or data transfer agreement (DTA) for transfer of biospecimens and/or data to other institutions.
p.000135: 11.6.3 Stand-alone huge repositories should have separate technical authorization committees and ECs to undertake the
p.000135: above-mentioned tasks.
p.000135: 11.6.4 The biobank should have well-structured SOPs and clear guidelines for collection, coding,
...
Searching for indicator hiv/aids:
(return to top)
Health / Healthy People
Searching for indicator healthy volunteers:
(return to top)
p.000073: • Phase I (for drugs and vaccines) studies
p.000073: m All Phase I trials require EC approval and applicable regulatory approvals. m A Phase I study is a
p.000073: non-therapeutic trial in which there is no anticipated direct clinical benefit to the participant. In general,
p.000073: therefore, it should be conducted
p.000073: in participants who can give voluntary informed consent themselves and who
p.000073: can sign and date the written informed consent forms themselves, unless the therapy under investigation is for diseases
p.000073: specific to those who cannot give consent, such as children, in which case consent of the LAR may be taken.
p.000073: m As Phase I studies are most often conducted in healthy volunteers, all safeguards to protect the
p.000073: participants must be established, especially recruitment methods, payment for participation, evidence of
p.000073: non-coercion and consent procedures.
p.000073: m When a Phase I study is conducted in participants with a disease such as cancer, due consideration should be given
p.000073: to the seriousness of the medical condition and the study procedures planned.
p.000073: m The study protocol should describe measures to minimize the risks of a Phase I clinical trial in healthy volunteers
p.000073: and patients. These include, but are not limited to, the measures given in Box 7.2.
p.000073: Box 7.2 Risks of Phase I clinical trials
p.000073:
p.000073: The measures to be taken to minimize risks in a Phase I clinical trial include:
p.000073: • exclusion of participants who may be at increased risk from the study;
p.000073: • careful review of investigational procedures posing high risk of physical harm or serious
p.000073: discomfort;
p.000073: • evaluation of available data to decide if the IP or procedures proposed in the protocol have been associated with
p.000073: SAEs and steps taken to prevent or minimize such risks; and
p.000073: • careful monitoring of the condition of participants and intervention to manage adverse
p.000073: events.
p.000073:
p.000073: m A Phase I study unit must have robust resources and tested procedures for immediate resuscitation and maintenance
p.000073: of life support and onward transfer to an intensive care unit, if necessary.
p.000073:
p.000073: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000073: 73
p.000074:
p.000074: Clinical Trials of Drugs and
p.000074: other Interventions
p.000074:
p.000074: m A Phase I study with a high-risk IP, such as first-in-human, biologic should be carried out in a hospital where
p.000074: experienced personnel and facilities are immediately available to manage medical emergencies.
p.000074: m Medical pharmacologist/physicians trained in clinical pharmacology should be involved in Phase I studies.
p.000074: • Phase II, III and IV studies
...
p.000075: drug that reaches the systemic circulation and is therefore available at the site of action.
p.000075: Bioequivalence (BE) is a term used in pharmacokinetics when there are two or more
p.000075:
p.000075: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000075: 75
p.000076:
p.000076: Clinical Trials of Drugs and
p.000076: other Interventions
p.000076:
p.000076: medicinal products (proprietary preparations of a drug), containing the same active substance that need to be compared
p.000076: in vivo for biological equivalence. These comparative studies are used to assess if the new version (generic) produces
p.000076: the same concentration in the systemic circulation when given to human participants. If two products are
p.000076: said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
p.000076: BE studies are used as surrogates for clinical effectiveness data for generic drugs where no clinical difference is
p.000076: anticipated between the two products.
p.000076: 7.3.1 Ethical issues
p.000076: • All BA/BE studies should be scientifically sound and conducted in compliance with principles of ethical
p.000076: conduct described earlier for a Phase I study.
p.000076: • Ethical conduct of BA/BE study requires evaluation of the benefit–risk profile of:
p.000076: a. the reference (comparator) and investigational (generic) product; and
p.000076: b. the study procedures such as indoor stay, fasting, screening, blood sampling.
p.000076: • BA/BE studies are usually conducted in healthy volunteers. Hence, they have no direct benefit to the
p.000076: participant but may pose risks due to the adverse effects of the drug. Therefore, all safeguards to protect
p.000076: participants must be in place.
p.000076: • The EC must carefully review the recruitment methods, payment for participation and consent procedures.
p.000076: Volunteers often regularly participate in such studies at the cost of their health and care should be taken that taking
p.000076: part in multiple trials is avoided by maintaining volunteer registries, biometry, follow up, etc. Care must be taken to
p.000076: maintain confidentiality of biometric data.
p.000076: • The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study
p.000076: design and the EC should take specific note on the amount of blood drawn depending on whether the individual is a
p.000076: healthy adult or a child or a patient.
p.000076: 7.4 Ethical implications of study designs
p.000076: Clinical trials have a wide range of methodological approaches. ECs need to look into the details of the ethical
p.000076: concerns involved.
p.000076: 7.4.1 If a SAE occurs in a blinded study, and it is imperative, in the interest of managing the event to know what
p.000076: the patient was receiving, unblinding mechanisms should be available to the researcher.
p.000076:
p.000076: 76 INDIAN COUNCIL OF
...
Searching for indicator volunteers:
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p.000017: back-up data saved in a secure place at a site that is different from the original data storage site.
p.000017: • Data sharing is important as research data is valuable and needs to be shared, but deciding when and with
p.000017: whom to share may raise difficult questions. Once a researcher has published the results of an experiment, it is
p.000017: generally expected that all the information about that experiment, including the final data, should be freely available
p.000017: for other researchers to check and use. Data should be shared or placed in a public domain in a
p.000017: de-identified/anonymized form, unless required otherwise, for which applicable permissions/re-consent should be sought
p.000017: unless obtained beforehand.
p.000017: 3.4 Reviewing and reporting research
p.000017: The public’s trust in published research is an essential component of ethical and responsible research.
p.000017:
p.000017: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000017: 17
p.000018:
p.000018:
p.000018: Responsible Conduct of Research
p.000018:
p.000018: 3.4.1 The basic premise of all reviewers and editors evaluating research is that the work has been performed
p.000018: honestly, its reporting is transparent and truthful and the researchers’ integrity is beyond doubt.
p.000018: 3.4.2 Transparency pertains to both the research site and the researcher(s). This would require disclosure of the
p.000018: location of the research as well as the collaborating sites/institutions and the authors of that research.
p.000018: 3.4.3 Research that is completed, irrespective of results, must be published, since it would be unethical to expose
p.000018: another set of participant/patients/volunteers to the same risks to obtain the same results.
p.000018: 3.4.4 Researchers should provide results of study in the public database of the Clinical Trial Registry-India (CTRI).
p.000018: 3.5 Responsible authorship and publication
p.000018: 3.5.1 Authorship – The researchers should follow the guidance of International Committee of Medical Journal Editors
p.000018: (ICMJE) on authorship23 which is largely accepted as a standard and is endorsed by the World Association of Medical
p.000018: Editors (WAME). See Box 3.3 for further details.
p.000018: Box 3.3 Criteria for authorship (ICMJE)
p.000018:
p.000018: According to the ICMJE, authorship entails the following criteria:
p.000018: 1. substantial contributions to the conception or design of the work, or the acquisition, analysis, or
p.000018: interpretation of data for the work;
p.000018: 2. drafting the work or revising it for important intellectual content;
p.000018: 3. final approval of the version to be published;
p.000018: 4. agreement to be accountable for all aspects of the work and ensuring that questions related to the accuracy or
p.000018: integrity of any part of the work are appropriately investigated and resolved.
p.000018:
p.000018: • Institutions and departments should have authorship policies. Editors of journals do not adjudicate on
p.000018: authorship disputes and would almost always refer these to the institution/researchers themselves to resolve.
p.000018: • Authorship should never be gifted and ‘ghost’ authors are not acceptable. The
p.000018: authorship of research should be considered at the time of its initiation.
p.000018: • The primary author should be the person who has done most of the research work
p.000018: related to the manuscript being submitted for publication. Research performed
p.000018:
...
p.000072: clinical trial is initiated, adequate data from preclinical investigations or previous clinical studies should
p.000072: be generated and be sufficient to indicate that the intervention is acceptably safe for the proposed investigation
p.000072: in humans.
p.000072: The investigator should make an assessment to determine if a clinical trial is under the regulatory ambit and if so, to
p.000072: ensure that all requirements as specified by CDSCO must
p.000072:
p.000072: 72 INDIAN COUNCIL OF
p.000073: MEDICAL RESEARCH
p.000073:
p.000073: Clinical Trials of Drugs and
p.000073: other Interventions
p.000073:
p.000073: also be followed. If required, the EC may provide relevant guidance to the members in deciding the same.
p.000073: • Phase I (for drugs and vaccines) studies
p.000073: m All Phase I trials require EC approval and applicable regulatory approvals. m A Phase I study is a
p.000073: non-therapeutic trial in which there is no anticipated direct clinical benefit to the participant. In general,
p.000073: therefore, it should be conducted
p.000073: in participants who can give voluntary informed consent themselves and who
p.000073: can sign and date the written informed consent forms themselves, unless the therapy under investigation is for diseases
p.000073: specific to those who cannot give consent, such as children, in which case consent of the LAR may be taken.
p.000073: m As Phase I studies are most often conducted in healthy volunteers, all safeguards to protect the
p.000073: participants must be established, especially recruitment methods, payment for participation, evidence of
p.000073: non-coercion and consent procedures.
p.000073: m When a Phase I study is conducted in participants with a disease such as cancer, due consideration should be given
p.000073: to the seriousness of the medical condition and the study procedures planned.
p.000073: m The study protocol should describe measures to minimize the risks of a Phase I clinical trial in healthy volunteers
p.000073: and patients. These include, but are not limited to, the measures given in Box 7.2.
p.000073: Box 7.2 Risks of Phase I clinical trials
p.000073:
p.000073: The measures to be taken to minimize risks in a Phase I clinical trial include:
p.000073: • exclusion of participants who may be at increased risk from the study;
p.000073: • careful review of investigational procedures posing high risk of physical harm or serious
p.000073: discomfort;
p.000073: • evaluation of available data to decide if the IP or procedures proposed in the protocol have been associated with
p.000073: SAEs and steps taken to prevent or minimize such risks; and
p.000073: • careful monitoring of the condition of participants and intervention to manage adverse
p.000073: events.
p.000073:
p.000073: m A Phase I study unit must have robust resources and tested procedures for immediate resuscitation and maintenance
...
p.000076: in vivo for biological equivalence. These comparative studies are used to assess if the new version (generic) produces
p.000076: the same concentration in the systemic circulation when given to human participants. If two products are
p.000076: said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
p.000076: BE studies are used as surrogates for clinical effectiveness data for generic drugs where no clinical difference is
p.000076: anticipated between the two products.
p.000076: 7.3.1 Ethical issues
p.000076: • All BA/BE studies should be scientifically sound and conducted in compliance with principles of ethical
p.000076: conduct described earlier for a Phase I study.
p.000076: • Ethical conduct of BA/BE study requires evaluation of the benefit–risk profile of:
p.000076: a. the reference (comparator) and investigational (generic) product; and
p.000076: b. the study procedures such as indoor stay, fasting, screening, blood sampling.
p.000076: • BA/BE studies are usually conducted in healthy volunteers. Hence, they have no direct benefit to the
p.000076: participant but may pose risks due to the adverse effects of the drug. Therefore, all safeguards to protect
p.000076: participants must be in place.
p.000076: • The EC must carefully review the recruitment methods, payment for participation and consent procedures.
p.000076: Volunteers often regularly participate in such studies at the cost of their health and care should be taken that taking
p.000076: part in multiple trials is avoided by maintaining volunteer registries, biometry, follow up, etc. Care must be taken to
p.000076: maintain confidentiality of biometric data.
p.000076: • The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study
p.000076: design and the EC should take specific note on the amount of blood drawn depending on whether the individual is a
p.000076: healthy adult or a child or a patient.
p.000076: 7.4 Ethical implications of study designs
p.000076: Clinical trials have a wide range of methodological approaches. ECs need to look into the details of the ethical
p.000076: concerns involved.
p.000076: 7.4.1 If a SAE occurs in a blinded study, and it is imperative, in the interest of managing the event to know what
p.000076: the patient was receiving, unblinding mechanisms should be available to the researcher.
p.000076:
p.000076: 76 INDIAN COUNCIL OF
p.000077: MEDICAL RESEARCH
p.000077:
p.000077: Clinical Trials of Drugs and
p.000077: other Interventions
p.000077:
p.000077: 7.4.2 When an available therapy is effective in preventing serious harm, such as death or irreversible morbidity in
p.000077: the clinical trial population, it is inappropriate to use a placebo control.
p.000077: 7.4.3 Placebo may be used as a comparator under the conditions given in Box 7.4.
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
...
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
...
Searching for indicator mentally:
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p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
...
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
...
Searching for indicator disability:
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p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
p.000008: is applicable to all participants, including those in comparator/control groups.
p.000008: 2.5.3 If there are provisions, participants may also receive additional medical services at no cost.
p.000008: 2.5.4 When the LAR is giving consent on behalf of a participant, payment should not become an undue inducement and to
p.000008: be reviewed carefully by the EC. Reimbursement may be offered for travel and other incidental expenses incurred due to
p.000008: participation of the child/ward in the research.
p.000008: 2.5.5 ECs must review and approve the payments (in cash or kind or both) and free services and the processes
p.000008: involved, and also determine that this does not amount to undue inducement.
p.000008: 2.6 Compensation for research-related harm
p.000008: Research participants who suffer direct physical, psychological, social, legal or economic harm as a result of their
p.000008: participation are entitled, after due assessment, to financial or other assistance to compensate them equitably
p.000008: for any temporary or permanent impairment or disability. In case of death, participant’s dependents are
p.000008: entitled to
p.000008:
p.000008: 8 INDIAN COUNCIL OF
p.000009: MEDICAL RESEARCH
p.000009:
p.000009:
p.000009: General Ethical Issues
p.000009:
p.000009: financial compensation. The research proposal should have an in-built provision for mitigating research related harm.
p.000009: 2.6.1 The researcher is responsible for reporting all SAEs to the EC within 24 hours of knowledge.
p.000009: Reporting of SAE may be done through email or fax communication (including on non-working days). A report on
p.000009: how the SAE was related to the research must also be submitted within 14 days.
p.000009: 2.6.2 The EC is responsible for reviewing the relatedness of the SAE to the research, as reported by the researcher,
p.000009: and determining the quantum and type of assistance to be provided to the participants.
p.000009: • For clinical trials under the purview of CDSCO, the timeline and procedures as
p.000009: notified from time to time may be followed.
p.000009: • All research participants who suffer harm, whether related or not, should be offered appropriate
p.000009: medical care, psycho-social support, referrals, clinical facilities, etc.
p.000009: • Medical management should be free if the harm is related to the research.
p.000009: • Compensation should be given to any participant when the injury is related to the research. This is
p.000009: applicable to participants in any of the arms of research, such as intervention, control and standard of care.
...
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
p.000051: so, then verbal/oral consent may be taken on approval by the EC, in the presence of an impartial witness who should
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
p.000051: the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be
p.000051: taken in exceptional circumstances and for specific, justifiable reasons with the approval of the EC. It should not to
p.000051: be practiced routinely.
p.000051: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000051: 51
p.000052:
p.000052:
p.000052: Informed Consent Process
p.000052:
p.000052: 5.3.9 Reconsent or fresh informed consent of each participant must be taken under circumstances
p.000052: described in section 5.8.
p.000052: 5.3.10 The researcher must assure prospective participants that their decision whether or not to participate in the
p.000052: research will not affect their rights, the patient–clinician relationship or any other benefits to which they are
p.000052: entitled.
p.000052: 5.3.11 Reimbursement may be given for travel and incidental expenses/participation in research after
p.000052: approval by the EC.
p.000052: 5.3.12 The researcher should ensure free treatment for research related injury (disability, chronic life-threatening
p.000052: disease and congenital anomaly or birth defect) and if required, payment of compensation over and above medical
p.000052: management by the investigator and/institution and sponsor(s), as the case may be.
p.000052: 5.3.13 The researcher should ensure that the participant can continue to access routine care even in the event of
p.000052: withdrawal of the participant.
p.000052: 5.4 Documentation of informed consent process
p.000052: Documentation of the informed consent process is an essential part of this exercise.
p.000052: 5.4.1 Each prospective participant should sign the informed consent form after going through the informed consent
p.000052: process of receiving information, understanding it and voluntarily agreeing to participate in the research.
p.000052: 5.4.2 In case the participant is incompetent (medically or legally) to give consent, the LAR’s consent must be
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
...
p.000055: Some types of research studies require deception due to nature of research design. A true informed consent may lead to
p.000055: modification and may defeat the purpose of research. Such research may be carefully reviewed by the EC before
p.000055: implementation.
p.000055: 5.11.1 True informed consent in studies involving deception is difficult due to the nature of research. A two-step
p.000055: procedure may be required comprising an initial consent and a debriefing after participation.
p.000055: 5.11.2 The possibility of unjustified deception, undue influence and intimidation should be avoided at all costs.
p.000055: Although deception is not permissible, approval may be taken from the EC in circumstances where some information
p.000055: requires to be withheld for validation until the completion of the research.
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
p.000056: • incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or
p.000056: permanently, for example people who are unconscious, differently abled;
p.000056: • able to give consent, but whose voluntariness or understanding is compromised due to
p.000056: their situational conditions; or
p.000056: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000056: refusal to participate which may lead them to give consent.
p.000056:
p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
...
p.000157: co-investigators.
p.000157: Research, particularly psychology studies, can put participants in
p.000157: situations that may make them feel uncomfortable while learning about their reaction to a situation. The result can be
p.000157: psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or
p.000157: depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.
p.000157: 51 Quorum Minimum number and/or kind of EC members required for
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
p.000157: related injury
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
p.000157: it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the
p.000157: intervention, whenever they occur, as well as any medical injury caused due to procedures.
p.000157: 53 Risk Probability of harm or discomfort to research participants.
p.000157: Acceptable risk differs depending on the conditions inherent in the conduct of research.
p.000157:
p.000157: 54 Serious adverse
p.000157: event (SAE)
p.000157: An adverse event is serious when the research outcome for
p.000157: the participant is death, life-threatening injury requiring hospitalization, prolongation of
p.000157: hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to
p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
...
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
p.000159: 66 Undue inducement
p.000159:
p.000159: 67 Unexpected ADR
p.000159: Offer of disproportionate benefit in cash or kind that compromises judgement which may lead to acceptance of
p.000159: serious risks that threaten fundamental interests.
p.000159: An adverse reaction, the nature or severity of which is not
p.000159: described in the informed consent/information sheet or the applicable product information, such as an
p.000159: investigator’s brochure for the unapproved IP or package insert/summary of product characteristics for an
p.000159: approved product.
p.000159: 68 Vulnerability Vulnerability in research pertains to individuals who are relatively
p.000159: or absolutely incapable of protecting their own interests because of personal disability, environmental burdens or
p.000159: social injustice, lack of power, understanding or ability to communicate or are in a situation that prevents them from
p.000159: doing so.
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000159: 159
p.000160:
p.000160: ANNEX 1
p.000160:
p.000160: STANDARD OPERATING PROCEDURES (SOPs)
p.000160:
p.000160: S. No. List of SOPs
p.000160: 1 Writing, Reviewing, Distributing and Amending Standard Operating Procedures for ECs
p.000160: 2 Constituting an Ethics Committee
p.000160: 3 Confidentiality Agreements
p.000160: 4 Conflict of Interest Agreements
p.000160: 5 Training Personnel and EC Members
p.000160: 6 Selection of Independent Consultants
p.000160: 7 Procedures for Allowing a Guest or Observer
p.000160: 8 Categorization of Submitted Protocols for Ethics Review
p.000160: a. Initial Full Committee Review of New Research Protocols
p.000160: b. Expedited Review of Research Protocols
p.000160: c. Exemption from Ethics Review of Research Protocols
p.000160: 9 Agenda Preparation, Meeting Procedures and Minutes
p.000160: 10 Review of New Medical Device Studies
p.000160: 11 Review of Resubmitted Protocols
p.000160: 12 Review of Protocol Amendments
p.000160: 13 Continuing Review of Protocols
p.000160: 14 Review of Final Reports
p.000160: 15 Review of Serious Adverse Events (SAE) Reports
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.000006: anonymous or non-identified data/samples, data available in the public domain, meta-analysis, etc.
p.000006: Minimal risk Probability of harm or discomfort anticipated in the research is not greater than that ordinarily
p.000006: encountered in routine daily life activities of an average healthy individual or general population or during the
p.000006: performance of routine tests where occurrence of serious harm or an adverse event (AE) is unlikely. Examples include
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
...
p.000010: inducement as determined by the EC.
p.000010: 2.8 Conflict of interest
p.000010: Conflict of interest (COI) is a set of conditions where professional judgement concerning a primary interest such as
p.000010: participants welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or
p.000010: non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or
p.000010: sponsors. If COI is inherent in the research, it is important to declare this at the outset and establish appropriate
p.000010: mechanisms to manage it.
p.000010: 2.8.1 Research institutions must develop and implement policies and procedures to identify, mitigate conflicts of
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
...
p.000055: 5.10.1 Gatekeepers
p.000055: Permission of the gatekeepers, that is, the head/leader of the group or culturally appropriate authorities,
p.000055: may be obtained in writing or audio/video recorded on behalf of the group and should be witnessed.
p.000055: 5.10.2 Community consent
p.000055: In certain populations, the community plays an important role in the consent process. Some participants may not
p.000055: participate in the research unless the community’s consent is available. There may be situations when individual
p.000055: consent cannot be obtained as it will change the behaviour of the individual (see section 8 for further details). In
p.000055: such situations community consent is required. When permission is obtained from an organization that represents the
p.000055: community, the quorum required for such a committee must be met. For example, in a village panchayat the number of
p.000055: members ordinarily required to conduct a meeting must be present while giving consent. Individual consent is important
p.000055: and required even if the community gives permission.
p.000055: 5.10.3 Consent from vulnerable groups
p.000055: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own interests
p.000055: and providing valid informed consent. The list of vulnerable populations/communities is given in Box 6.2.
p.000055: 5.11 Consent for studies using deception
p.000055: Some types of research studies require deception due to nature of research design. A true informed consent may lead to
p.000055: modification and may defeat the purpose of research. Such research may be carefully reviewed by the EC before
p.000055: implementation.
p.000055: 5.11.1 True informed consent in studies involving deception is difficult due to the nature of research. A two-step
p.000055: procedure may be required comprising an initial consent and a debriefing after participation.
p.000055: 5.11.2 The possibility of unjustified deception, undue influence and intimidation should be avoided at all costs.
p.000055: Although deception is not permissible, approval may be taken from the EC in circumstances where some information
p.000055: requires to be withheld for validation until the completion of the research.
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
p.000056: • incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or
p.000056: permanently, for example people who are unconscious, differently abled;
p.000056: • able to give consent, but whose voluntariness or understanding is compromised due to
p.000056: their situational conditions; or
p.000056: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000056: refusal to participate which may lead them to give consent.
p.000056:
p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
...
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
...
p.000158: are?”, “Do you know that you do not have to take part in this research study, if you do not wish to?”, “Do you have any
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
p.000159: 66 Undue inducement
p.000159:
p.000159: 67 Unexpected ADR
p.000159: Offer of disproportionate benefit in cash or kind that compromises judgement which may lead to acceptance of
p.000159: serious risks that threaten fundamental interests.
p.000159: An adverse reaction, the nature or severity of which is not
p.000159: described in the informed consent/information sheet or the applicable product information, such as an
p.000159: investigator’s brochure for the unapproved IP or package insert/summary of product characteristics for an
p.000159: approved product.
p.000159: 68 Vulnerability Vulnerability in research pertains to individuals who are relatively
p.000159: or absolutely incapable of protecting their own interests because of personal disability, environmental burdens or
p.000159: social injustice, lack of power, understanding or ability to communicate or are in a situation that prevents them from
p.000159: doing so.
p.000159:
p.000159:
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p.000159:
p.000159: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000159: 159
p.000160:
p.000160: ANNEX 1
p.000160:
p.000160: STANDARD OPERATING PROCEDURES (SOPs)
p.000160:
p.000160: S. No. List of SOPs
p.000160: 1 Writing, Reviewing, Distributing and Amending Standard Operating Procedures for ECs
p.000160: 2 Constituting an Ethics Committee
p.000160: 3 Confidentiality Agreements
p.000160: 4 Conflict of Interest Agreements
p.000160: 5 Training Personnel and EC Members
p.000160: 6 Selection of Independent Consultants
p.000160: 7 Procedures for Allowing a Guest or Observer
p.000160: 8 Categorization of Submitted Protocols for Ethics Review
p.000160: a. Initial Full Committee Review of New Research Protocols
p.000160: b. Expedited Review of Research Protocols
p.000160: c. Exemption from Ethics Review of Research Protocols
p.000160: 9 Agenda Preparation, Meeting Procedures and Minutes
p.000160: 10 Review of New Medical Device Studies
p.000160: 11 Review of Resubmitted Protocols
p.000160: 12 Review of Protocol Amendments
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p. ix: INDIAN COUNCIL OF MEDICAL RESEARCH 2017
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix: Compiled & Edited by:
p. ix: Dr. Roli Mathur
p. ix: Head, ICMR Bioethics Unit NCDIR, Bengaluru
p. ix:
p. ix: Published by:
p. ix: Director-General
p. ix: Indian Council of Medical Research New Delhi 110 029 www.icmr.nic.in
p. ix:
p. ix: ISBN: 978-81-910091-94
p. ix:
p. ix: October, 2017
p. ix: Price: ₹ 500.00
p. ix:
p. ix:
p. ix: © Copyright Indian Council of Medical Research
p. ix:
p. ix:
p. ix: The use of content from this book is permitted for all non-commercial purposes giving full acknowledgement to ICMR
p. ix: which shall not be held liable for any damages whatsoever as a result of the use or application of the contents of this
p. ix: document. ICMR reserves the right to update and change the contents without notice and accepts no liability
p. ix: for any errors or omissions in this regard. Care has been taken to present the information accurately, however the
p. ix: reader is urged to check latest notifications/rules/regulations by GOI from time to time.
p. ix:
p. ix: Design and layout:
p. ix: The cover page drawing depicts the sections of this document.
p. ix: Tejeswini Padma, Kalyani Thakur, Rajib K Hazam and Monesh B Vishwakarma
p. ix:
p. ix: TABLE OF CONTENTS
p. ix: Message from Hon’ble Union Minister for Health and Family Welfare, Government of India
p. ix: ix
p. x: Foreword by DG ICMR and Secretary DHR x
p. x: Message from President, Medical Council of India xi
p. x: Preface by Chairperson, Central Ethics Committee on Human Research xii
p. x: Message from Chairperson, Advisory Group xiii
p. x: Acknowledgement
p. xiv: xiv
p. xv: Introduction
p.000001: 1
p.000002: Scope
p.000002: 2
p.000003: Section 1 Statement of general principles 3
p.000003: 1.1 General principles 3
p.000003: Section 2 General ethical issues
p.000005: 5
p.000006: 2.1 Benefit-risk assessment 5
p.000006: 2.2 Informed consent process 5
p.000006: 2.3 Privacy and confidentiality 7
p.000006: 2.4 Distributive justice 8
p.000006: 2.5 Payment for participation 8
p.000006: 2.6 Compensation for research related harm 8
...
p.000038: the health problems of society. All stakeholders, including sponsors, researchers and ECs must ensure that the
p.000038: planned research has social value.
p.000038:
p.000038: 2 Scientific design and conduct of the study
p.000038: • Valid scientific methods are essential to make the research ethically viable as poor science can expose
p.000038: research participants or communities to risks without any possibility of benefit.
p.000038: (Contd.)
p.000038:
p.000038:
p.000038: 38 INDIAN COUNCIL OF
p.000039: MEDICAL RESEARCH
p.000039:
p.000039:
p.000039: Ethical Review Procedures
p.000039:
p.000039: • Although ECs may obtain documentation from a prior scientific review, they should also determine that
p.000039: the research methods are scientifically sound, and should examine the ethical implications of the chosen
p.000039: research design or strategy.
p.000039: • The EC can raise scientific concerns (even if the study has prior
p.000039: approval of a scientific committee) if it may affect quality of research and or safety of research participants.
p.000039: 3 Benefit-risk assessment • The benefits accruing from the planned research either to the
p.000039: participants or to the community or society in general must justify the risks inherent in the research.
p.000039: • Risks may be physical, psychological, economic, social or legal
p.000039: and harm may occur either at an individual level or at the family, community or societal level. It is
p.000039: necessary to first look at the intervention under investigation and assess its potential harm and benefits and then
p.000039: consider the aggregate of harm and benefits of the study as a whole.
p.000039: • The EC should review plans for risk management, including withdrawal criteria with rescue medication or procedures.
p.000039: • The EC should give advice regarding minimization of risk/
p.000039: discomfort wherever applicable.
p.000039: • Adequate provisions must be made for monitoring and auditing the conduct of the research, including
p.000039: the constitution of a Data and Safety Monitoring Board (DSMB) if applicable (for example in clinical trials)
p.000039:
p.000039: 4 Selection of the study population and
p.000039: recruitment of research participants
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: 5 Payment for participation
p.000039: • Recruitment should be voluntary and non-coercive. Participants should be fairly selected
p.000039: as per inclusion and exclusion criteria. However, selection of participants should be distributive such
p.000039: that a particular population or tribe or economic group is not coerced to participate or benefit.
p.000039: • Participants should be able to opt out at any time without their
p.000039: routine care being affected.
p.000039: • No individual or group of persons must bear the burden of participation in research without accruing
p.000039: any direct or indirect benefits.
...
p.000050: 4. Foreseeable extent of information on possible current and future uses of the biological material and of the
p.000050: data to be generated from the research. Other specifics are as follows:
p.000050: i period of storage of the sample/data and probability of the material being used for secondary purposes.
p.000050: ii whether material is to be shared with others, this should be clearly mentioned.
p.000050: iii right to prevent use of her/his biological sample, such as DNA, cell-line, etc., and related data at any
p.000050: time during or after the conduct of the research.
p.000050: iv risk of discovery of biologically sensitive information and provisions to safeguard confidentiality.
p.000050: v post research plan/benefit sharing, if research on biological material and/or data leads to
p.000050: commercialization.
p.000050: vi Publication plan, if any, including photographs and pedigree charts.
p.000050: See section 11 for further details.
p.000050:
p.000050: 50 INDIAN COUNCIL OF
p.000051: MEDICAL RESEARCH
p.000051:
p.000051:
p.000051: Informed Consent Process
p.000051:
p.000051: to participation, is included in the PIS. This is followed by the ICF in which the participant acknowledges that
p.000051: she/he has understood the information given in the PIS and is volunteering to be included in that research.
p.000051: 5.2.3 Adequate time should be given to the participant to read the consent form, if necessary discuss it with family
p.000051: and friends, and seek clarification of her/his doubts from the researchers/research team before deciding to enroll in
p.000051: the research.
p.000051: 5.2.4 Essential elements of an informed consent document are given in Box 5.1.
p.000051: 5.3 Responsibility of researchers
p.000051: 5.3.1 The researcher should only use the EC approved version of the consent form, including its local
p.000051: translations.
p.000051: 5.3.2 Adequate information necessary for informed consent should be communicated in a language and manner easily
p.000051: understood by prospective participants.
p.000051: 5.3.3 In case of differently abled participants, such as individuals with physical, neurological or mental
p.000051: disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for
p.000051: the visually impaired.
p.000051: 5.3.4 There should be no restriction on the participant’s right to ask questions related to the study or to
p.000051: discuss with family and friends or take time before coming to a decision.
p.000051: 5.3.5 The researcher should not give any unjustifiable assurances or influence or intimidate a prospective
p.000051: participant to enroll in the study.
p.000051: 5.3.6 The researcher must ensure that the participant is competent and has understood all aspects of the study and
p.000051: that the consent is given voluntarily. Where the participant and/or the LAR are illiterate, an impartial literate
p.000051: person, not connected to the research, should be present throughout the consent process as witness.
p.000051: 5.3.7 The researcher should administer a test of understanding whenever possible for sensitive studies.
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
p.000051: so, then verbal/oral consent may be taken on approval by the EC, in the presence of an impartial witness who should
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
p.000051: the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be
...
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
p.000052: should be a literate person who can read the participant information sheet and consent form and understand the language
p.000052: of the participant.
p.000052: 5.4.4 If the participant cannot sign then a thumb impression must be obtained.
p.000052: 5.4.5 The researcher who administers the consent must also sign and date the consent form.
p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
p.000053:
p.000053: Informed Consent Process
p.000053:
p.000053: participants if their details are recorded as a part of the family history. If information about the secondary
p.000053: participants is identifiable then their informed consent will also be required.
p.000053: 5.4.9 Online consent may be obtained, for example, in research involving sensitive data such as unsafe sex, high
p.000053: risk behaviour, use of contraceptives (condoms, oral pills), or emergency contraceptive pills among unmarried females
p.000053: in India etc. Investigators must ensure that privacy of the participant and confidentiality of related data is
p.000053: maintained.
p.000053: 5.5 Electronic consent
p.000053: Electronic media can be used to provide information as in the written informed consent document, which can be
p.000053: administered and documented using electronic informed consent systems. These are electronic processes that use
p.000053: various, and possibly multiple, electronic formats such as text, graphics, audio, video, podcasts or interactive
p.000053: websites to explain information related to a study and to document informed assent/consent from a participant or LAR.
p.000053: 5.5.1 The process, electronic materials, method of documentation (including electronic/ digital
p.000053: signatures), methods used to maintain privacy of participants, confidentiality, and security of the information as well
...
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
...
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
...
p.000085: radioactive substance is to be tested as a drug then all the ethical considerations described in previous sections will
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
...
p.000106:
p.000106: 1. Like any other research, the researchers must ensure that the proposed studies are scientifically sound, built
p.000106: on an adequate prior knowledge base, and are likely to generate valuable information.
p.000106: 2. In socially stratified groups and communities, researchers must spend time to become conversant with
p.000106: cultural norms and practices in order to develop strategies to build trust and negotiate power in ways that do not put
p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
p.000106: from some other nearby village so that her/his vulnerability and perceived threat from other participants can be
p.000106: mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested
p.000106: communication plan.
p.000106: 4. The information about these norms/practices should be collected from reliable and multiple sources including
p.000106: multiple persons/groups, which should be mentioned in detail. This knowledge should be considered while
p.000106: deciding the group of participants and style of interview/investigation. However, the final decision about
p.000106: recruiting the participant should be based on the participant’s and her/his family’s opinion about
p.000106: norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or
p.000106: restrictive communities.
p.000106: 5. Field work challenges for research team – Research team members may sometimes be subjected to unforeseen
p.000106: situations which may involve trauma, humiliation and threats of violence. Training should be given to the
p.000106: research team to meet such challenges.
p.000106: 9.2.2 Ethical review
p.000106: There are some unique features of social and behavioural sciences research which need to be considered by the EC on a
p.000106: case-by-case basis. See Box 9.3 for further details.
p.000106: Box 9.3 Considerations by the EC for ethical review
p.000106: 1. Social and behavioural sciences research approaches are not always positivist and, therefore,
p.000106: articulation of a hypothesis may not be possible at the beginning of the research. Instruments/documents are developed
p.000106: during the course of the research; are reflective; and may keep changing as the research progresses. The EC must be
p.000106: kept informed about these changes and appropriate re-consent taken from participants.
p.000106: 2. The researcher must take prior permission from the EC with justifiable reasons for audio/
p.000106: video recording of participants’ interviews.
p.000106:
p.000106:
p.000106: 106 INDIAN COUNCIL OF MEDICAL
p.000107: RESEARCH
p.000107:
p.000107: Social and Behavioural Sciences
p.000107: Research for Health
p.000107:
...
p.000107: cultural context and associated harm related to dignity as well as social and informational harm. This will avoid
p.000107: hurting or transgressing rights of the participants/community.
p.000107: • Harm to dignity is likely to occur when individuals are not treated as persons with their own values,
p.000107: preferences, and commitments, but rather as mere means not deserving of respect. This is also sometimes classified as
p.000107: another form of negligence. It may result in individuals feeling hurt, humiliated, excluded, dismissed or
p.000107: unfairly treated.
p.000107: • Psychological and emotional harm may result from participating in a study where memories of
p.000107: traumatic experiences such as disasters (natural or otherwise), violence, conflict, abuse, assault and other such
p.000107: conditions need to be revisited by the participants. This may also affect and compound the vulnerabilities of
p.000107: participants already experiencing post-traumatic stress disorder (PTSD).
p.000107: • Social harm is a non-medical adverse consequence of study participation, including difficulties in
p.000107: personal relationships and stigma or discrimination from family or community. Social harm can be related to
p.000107: personal relationships, travel, employment, education, health, housing, institutions (government/non- government) and
p.000107: others.
p.000107: • Informational risk is the potential for harm from disclosure of information about an identified research
p.000107: participant to others. For much of social and behavioural research, informational risk is one of the primary risks.
p.000107: 9.2.4 Risk mitigation
p.000107: Measures should be employed to minimize potential risks and their negative impact, such as short- and long-term adverse
p.000107: impacts on participants of studies on abortion, sexual abuse and other sensitive subjects. These measures should be
p.000107: incorporated into research methods, with special reference to hierarchies that exist in the social context where the
p.000107: research is undertaken.
p.000107: 9.2.5 Community engagement
p.000107: While devising methods and interpreting observations, researchers should engage potential participants and
p.000107: communities in a meaningful participatory process
p.000107:
p.000107: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000107: 107
p.000108:
p.000108: Social and Behavioural Sciences
p.000108: Research for Health
p.000108:
p.000108: that involves them in an early and sustained manner in the design, development, implementation and
p.000108: monitoring of research, and in the dissemination of its results.
...
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
p.000108: support and conditions for self-respect. Accordingly, concerns about social justice must be central to any
p.000108: adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the
p.000108: vulnerable status of prospective participants during review, for example, a woman asking her husband or family before
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
p.000108: practices. See section 5.7 for further details.
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p.000109: 9.2.7 Privacy and confidentiality
p.000109: Privacy and confidentiality of research participants should be considered while selecting sites for data collection,
p.000109: choosing sensitive research areas, specific contexts and settings. In some circumstances participants become more
p.000109: vulnerable in research because of heightened psychological, social, physical or legal risks. Breach of
p.000109: confidentiality in these types of research may cause serious harm to vulnerable participants. It is important to
p.000109: protect study participants from potential future risks and harm by establishing culturally sensitive and context
p.000109: specific safeguards.
p.000109: 9.2.8 Duty to disclose sensitive information
p.000109: As mentioned in Box 9.1, researcher(s) may come across certain facts detrimental to a participant’s self or others,
p.000109: such as suicidal tendency/ideation, notifiable diseases. In such a situation, researchers have a responsibility to
p.000109: disclose this information to relevant persons/authorities to save life or prevent damage contemplated by the
p.000109: participant. Measures to be taken in such instances are given below:
p.000109: • If there is a high likelihood of getting sensitive incidental findings during the research
p.000109: process, then the ways to handle these at individual, family and community levels should be discussed and mentioned in
p.000109: the protocol.
p.000109: • Researchers and the EC should have a basic understanding of the legal provisions in the related area. Persons
p.000109: with the necessary domain knowledge and experience can be special invitees to EC meetings.
p.000109: 9.2.9 Studies Using Deception
p.000109: Deception occurs when researchers provide false or incomplete information to participants for the purpose of
p.000109: misleading them so as to achieve the study objectives and for larger public good. Research employing any type of
p.000109: deception should undergo full committee review.
p.000109: Research involving any kind of deception should:
p.000109: • pose no more than minimal risk;
p.000109: • not adversely affect the welfare and safety of the participants;
p.000109: • be conducted only when the research cannot be carried out without deception;
p.000109: • have an adequate plan for debriefing the participants after completion of the
p.000109: study, if appropriate;
p.000109: • disseminate results of research to the participants, if applicable; and
p.000109: • be carefully reviewed by the EC.
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p.000110:
p.000110: Social and Behavioural Sciences
p.000110: Research for Health
p.000110: Box 9.5 Types of deception
p.000110:
p.000110: 1. Active deception: Selective withholding of the information/hypothesis of the study in the consent form along with
p.000110: giving incorrect information for achieving public good without influencing the outcome of the study, for example,
p.000110: psychology, neuro- behavioural, behaviour intervention study.
...
p.000111: in a user-friendly format with community leaders, gatekeepers and communities without disclosing individual identities.
p.000111: They must also share these findings and relevant information with the participants.
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
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p.000112: SECTION 10
p.000112: HUMAN GENETICS TESTING AND RESEARCH
p.000112:
p.000112: 10.0 In no other area of biomedical and health research has there been a greater concern for ethical issues
p.000112: than in the field of human genetics. In recent years this concern has grown even further because of direct
p.000112: to consumer testing and the possibilities of embryo manipulations. While the recent DNA technology has provided one of
p.000112: the most powerful tools in the hands of mankind to unravel the mysteries of the human genome and its manipulation, it
p.000112: has also led to a great deal of concern about scientists’ ability to handle such information. There is also a very
p.000112: narrow gap between routine genetic testing and research raising several ethical, legal and social issues (ELSI), which
p.000112: warrant continuous and prompt monitoring and judicious response to the emerging ethical issues.
p.000112: 10.1 General issues
p.000112: 10.1.1 The harm/risks associated with genetic testing may be psychosocial rather than physical in the form of
p.000112: anxiety, depression or disrupted family relationships.
p.000112: 10.1.2 Potential benefits and risks should be discussed thoroughly with prospective participants.
p.000112: Appropriate communication skills are required for genetic counselling which is akin to therapy.
p.000112: 10.1.3 There is a likelihood of social stigmatization and discrimination in schooling, employment, health
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
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p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
p.000113: confidentiality in certain circumstances and the anticipated consequences of breach of confidentiality.
p.000113: 10.3.2 The researcher can delink data to maintain confidentiality and safeguard the information for basic research.
p.000113: However, If the result of the research is of benefit to the health of the participant then, with approval of the EC,
p.000113: data could be re-linked for communication of the result. See Table 11.1 for further details.
p.000113: 10.3.3 Genetic research requires collection of family history and details about other members of the family, thus
p.000113: involving them as secondary participants. If identifiable information is being collected about the secondary
p.000113: participants, their informed consent will be required.
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p.000114: 10.3.4 An individual has the right to keep information generated by screening/testing confidential and not
p.000114: share it with family members to avoid the possibility of domestic disputes if the genetic information is damaging, such
p.000114: as results revealing non-paternity, disease carrier status or others.
p.000114: 10.3.5 The researcher cannot reveal the genetic information to family members without the participant’s permission.
p.000114: If family members are recruited/tested then their information should be kept confidential from each other by the
p.000114: physician/researcher.
p.000114: 10.3.6 If disclosure is absolutely warranted to provide treatment or counselling, the physician must first obtain
p.000114: informed consent from the family member concerned. If that family member does not consent, then the physician should
p.000114: balance the risks of non-disclosure against breach of confidentiality and take an appropriate decision.
p.000114: 10.3.7 Storage of samples collected as part of routine care with potential for future genetic research should be
p.000114: done with appropriate consent from individuals.
p.000114: 10.3.8 Transfer to, or sharing of biological material and/or data with other laboratories within or outside the
p.000114: country should be done as per relevant guidelines.
p.000114: 10.3.9 Handling IPRs related to gene patenting and development of newer technologies for commercial gains should
p.000114: follow the applicable national policy/regulations.
p.000114: 10.3.10 Newer genomic techniques for research like whole exome sequencing (WES) and whole genome sequencing
p.000114: (WGS) may create uncertain evidence at the present level of knowledge. Therefore, the confidentiality of data, and pre-
p.000114: and post-test counselling need to be revisited with an entirely new perspective.
p.000114: 10.4 Informed consent
p.000114: Stringent norms and caution should be followed in the consent process when done for research purposes.
p.000114: 10.4.1 For routine genetic diagnostic testing, written consent may or may not be needed as per institutional
p.000114: policies; however, for any research it is required.
p.000114: 10.4.2 Informed written consent is essential for procedures such as pre-symptomatic testing, next generation
p.000114: sequencing (NGS), prenatal testing, genomic studies, carrier status etc.
...
p.000114: to any specific treatment or termination of the pregnancy or for research.
p.000114: 10.4.4 If the research or testing involves a child, appropriate age-specific assent (verbal/
p.000114:
p.000114:
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p.000115: oral/written) should be obtained along with parental consent. See section 6 for further details.
p.000115: 10.4.5 In addition to the general contents specified in section 5, the consent form for genetic testing for research
p.000115: may have explanations/details on the following elements:
p.000115: • the nature and complexity of information that would be generated;
p.000115: • the nature and consequences of return of results and choice offered to the participant whether to
p.000115: receive that information or not and incidental findings, if any;
p.000115: • direct/indirect benefits and their implications including if there are no direct
p.000115: benefits to the participants;
p.000115: • how the data/samples will be stored, for how long, and procedures involved in
p.000115: anonymisation, sharing , etc. See section 11 for further details;
p.000115: • choice to opt out of testing/withdraw from research at any time;
p.000115: • whether the affected individual or the proband would like to share her/his genetic
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
p.000115: • In case of population or community based studies, it may be noted that the genetic research may generate
p.000115: information applicable to the community/populations from which the participants were drawn, and therefore, group
p.000115: consent must be taken from the community head and/or the culturally appropriate authority.
p.000115: • Even if group consent is taken, it will not be a replacement for individual consent
p.000115: as individual consent is important. See section 5 for further details.
p.000115: • Researchers should be aware of potential stigmatization of the entire group and must explain ways to
p.000115: avoid the same during the conduct of research and publication of research results.
p.000115: 10.5 Culturally sensitive issues
p.000115: 10.5.1 Transmission of a genetic abnormality from parents, especially the mother to the foetus, could be
p.000115: a very sensitive cultural issue. Such possibility arises when during routine testing or prenatal diagnosis it is
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
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p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
p.000116: information is revealed to the husband or other members of the family, it may cause marital discord despite the fact
p.000116: that the husband himself is a carrier of the autosomal recessive disorder. Appropriate counselling should be part of
p.000116: the testing process.
p.000116: 10.5.2 Consanguineous marriages are common in some communities. If there are inherited diseases detected in the
p.000116: family, it is the responsibility of the health professionals/ researchers to inform participants regarding the possible
p.000116: implications that may arise due to consanguinity. Appropriate pedigrees need to be prepared and stored, as these can
p.000116: reveal a lot regarding disease inheritance in affected families.
p.000116: 10.6 Storage of samples for future genetic research
p.000116: 10.6.1 Rapid advances in science and technology have necessitated the storage of biological materials for future
p.000116: genetic research.
p.000116: 10.6.2 The samples from patients with rare genetic conditions, ethnic groups/tribes/ populations on the
p.000116: verge of extinction, endogamous groups and others have great cultural and geographical value and need to be preserved
p.000116: for future research. See section 11 for further details.
p.000116: 10.7 Results of genetic testing
p.000116: 10.7.1 Results of the tests should be informed to the participants. Return of the results depends on
p.000116: the research findings. If results are anticipated to be actionable, leading to potential benefits of improving health
p.000116: outcomes through correction of diet as therapy or prevention (such as phenylketonuria) by delaying onset or reduction
p.000116: of disease burden, they need to be communicated to the participants. This should also be reported to the participants
p.000116: if they wish to know the results and must be specified in the ICD. For this, participants’ contact details should be
p.000116: available.
p.000116: 10.7.2 The researcher should work with the local EC to decide on the validity of the research finding and the
p.000116: severity of the potential disease in order to return the results which should be avoided if the logical outcome of the
...
p.000117: 10.11 Quality standards of the laboratory
p.000117: 10.11.1 There is a paucity of quality assurance programmes in the country and therefore valid and reliable testing is
p.000117: a constant concern for both clinical practice and research. Any
p.000117:
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p.000118:
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p.000118: Genetics Testing and Research
p.000118:
p.000118: misinterpretation of genetic results or misdiagnosis may lead to psychological harm, and unnecessary or inappropriate
p.000118: intervention.
p.000118: 10.11.2 It is important to set standards for laboratories to ensure that test results are reliable, manpower is
p.000118: competent and the care provider is updated on developments in genetics.
p.000118: 10.11.3 All laboratories offering genetic testing should consider undergoing quality accreditation standards which are
p.000118: specific to genetic testing laboratories.
p.000118: 10.12 Misuse of genetic technology
p.000118: Genetic information has potential for misuse as well as long-term implications.
p.000118: 10.12.1 Prenatal sex selection is not allowed and to prevent misuse of genetic tests, particularly pre-selection of
p.000118: sex, GOI has enacted the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994,
p.000118: amended in 2003.37 All researchers in this area shall follow the provisions of this Act. Prenatal sex determination is
p.000118: prohibited by law for sex selection of the foetus.
p.000118: 10.12.2 Misuse of genetic information by insurers, employers or schools: Knowledge of genetic information of an
p.000118: individual/family/community/population/child might be misused by insurers/employers leading to discrimination and
p.000118: psychosocial harm. Hence, the information about a patient’s disease and investigations may not be shared with anyone
p.000118: without the consent of the individual concerned.
p.000118: 10.12.3 Research involving genetic manipulations must be carefully reviewed and protections established for
p.000118: participants.
p.000118: 10.13 Genetic diagnosis/testing and screening
p.000118: 10.13.1 History and pedigree studies: These involve obtaining history of other members of the family of the proband
p.000118: under investigation. It may reveal information about the likelihood of individual members of the family being either
p.000118: carriers of genetic defects or being affected by the disease. Privacy and confidentiality issues involved in this
p.000118: process are given in section 10.3.
p.000118: 10.13.2 Predictive genetic testing: The results of genetic tests in diseases that are multifactorial in origin and
p.000118: have a polygenic basis involving multiple genes or gene–environment interaction or those that are late onset, must be
p.000118: communicated carefully to prevent unnecessary worry or fear in the minds of individuals.
p.000118: 10.13.3 Genetic screening: Genetic screening implies searching a population for those individuals who have,
p.000118: or are susceptible to a serious genetic disease; or who, though not at risk themselves, are carriers and thus at risk
p.000118: for having children with a particular
p.000118:
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p.000119: genetic disease.
p.000119: • It is essential for screening to be purposive. Besides validation of screening tests, it
p.000119: should also be ensured that a suitable intervention and counselling are available.
p.000119: • Those being screened are entitled to receive sufficient information about what is proposed to be done,
p.000119: reliability of the screening test, and what will be done with the collected samples.
p.000119: • Although screening may be permissible to allay anxiety, the response of different individuals might vary,
p.000119: which should be borne in mind by the health-care provider.
p.000119: • Confidentiality should be maintained in handling of results with emphasis on responsibility of individuals with
p.000119: an abnormal result to inform partners and family members. In case of refusal, the duty of confidentiality shall weigh
p.000119: higher than the duty for beneficence to family members unless sharing of information is vital to prevent serious harm
p.000119: to the beneficiary in the family. In such case, appropriate precautions may be taken to ensure that only the genetic
p.000119: information needed for diagnosis/treatment is shared.
p.000119: • Screening tests should be sensitive enough to identify a significant proportion of affected persons (the
p.000119: detection rate) with minimal misidentification of unaffected persons (the false positive rate). Screening tests do not
p.000119: aim to make a diagnosis, but rather rationalize the use of more accurate confirmatory tests.
p.000119: 10.13.4 Population screening: Genetic disorders can be population specific (for example,
p.000119: -thalassemia and sickle cell disease in some population groups in India).
p.000119: • Population screening should not be undertaken without prior education of the population to be
p.000119: screened and counselling should be integrated with the programme.
p.000119: • Screening tests should be robust with acceptable sensitivity and specificity.
p.000119: • Wherever applicable, community permission/group consent should be taken in
p.000119: addition to individual informed consent.
p.000119: • Researchers may conduct coded or reversible anonymized testing on general
p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
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p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
p.000120: embryos. This obviates the need for invasive testing for associated risks and also termination of the affected foetus,
p.000120: which is traumatic for the family.
p.000120: • Advanced techniques like chromosomal micro array (CMA) are being used for
p.000120:
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p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
p.000121: intervention for management.
p.000121: • The family should have a choice to decide if they would like to be part of newborn screening program with
p.000121: appropriate consent explaining the requirements and implications of the screening with provision to “optout”.
p.000121: • Community education and advocacy regarding NBS should precede the initiation
p.000121: of the programme.
p.000121: • Availability of facilities for confirmatory diagnosis and experts for management
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
p.000121: decision-making process, unless early intervention based on results of the test is likely to be of direct therapeutic
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
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p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
p.000122: linked), the individual should be tested after administering informed consent when she/he is able to comprehend the
p.000122: benefits and risks of screening. Stigmatization for carrier status is common and therefore, the information should be
p.000122: kept confidential.
p.000122: • Chromosomal: If there is a family history of balanced translocation in any individual, then
p.000122: immediate relatives may be at risk. The same principles as for carrier testing should be followed.
p.000122: 10.14 Gene therapy
p.000122: All gene therapies are considered as research and all protections for human research participants should be in place.
p.000122: 10.14.1 Somatic cell gene therapy is permissible for the purpose of preventing or treating a serious
p.000122: disease when it is the only therapeutic option. It should be restricted to alleviation of life
p.000122: threatening or seriously disabling genetic disease in individual patients and should not be permitted to change
p.000122: normal human traits.
p.000122: 10.14.2 Prior to obtaining approval for initiating a gene therapy trial, an approval from the local EC and DBT has to
p.000122: be obtained for the gene construct.
p.000122: 10.14.3 If the trial is for a product for commercial use or for marketing purposes, approval needs to be taken from
p.000122: CDSCO.
p.000122: 10.14.4 All gene therapy trials should have the provision for long-term surveillance.
p.000122: 10.14.5 Informed consent must be taken, especially regarding uncertainties about outcome.
p.000122: 10.14.6 Children could be candidates for therapy, if the therapy is meant for a childhood disorder.
p.000122: 10.14.7 Germ line therapy is prohibited under the present state of knowledge.
p.000122: 10.14.8 Eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called
p.000122: designer babies is prohibited. These should not be attempted, as we possess insufficient information at present to
...
p.000125: the embryonic stage is because of the formation of neural crest (future nervous system symbolizing moral being or
p.000125: personhood) by then. At 8 weeks, the rudiments of nearly all the main structures are developed giving a general
p.000125: appearance of a mammal-to-be with four limbs and a head. Research on human embryos raises a number of ethical issues.
p.000125: The concerns are more social, including questions about the rights of unborn babies and the roles of humans in making
p.000125: permanent genetic changes. If research is planned on embryos, consent of both parents should be taken.
p.000125: 10.16.1 The concerns are more social, including questions about the rights of unborn babies and the roles of humans
p.000125: in making permanent genetic changes.
p.000125: 10.16.2 If research is planned on embryos, consent of both parents should be taken.
p.000125:
p.000125:
p.000125:
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p.000126: 10.17 Foetal autopsy
p.000126: 10.17.2 Foetal autopsy should be done after informed consent, preferably from both parents/ LARs.
p.000126: 10.17.3 Relevant samples may be stored for possible future use following the guidelines of biological materials,
p.000126: biobanking and datasets given in section 11.
p.000126: 10.17.4 Adequate genetic counselling should be done to explain the requirements and benefits of autopsy to the family.
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126: 126 INDIAN COUNCIL OF MEDICAL
p.000127: RESEARCH
p.000127:
p.000127: SECTION 11
p.000127:
p.000127:
p.000127: BIOLOGICAL MATERIALS, BIOBANKING AND DATASETS
p.000127:
p.000127: 11.0 Biological materials or biospecimens or samples include biological fluids, such as blood, dried blood spots,
p.000127: body fluids, urine, tissues, organs, cord blood, oocytes, sperm, semen or embryos. These may be stored or prospectively
p.000127: collected.
p.000127: A repository or biobank is an organized collection of resources that can be accessed to retrieve human biological
p.000127: material and data for research purposes. The bio resources would therefore be protocol-based prospective
p.000127: collection of biospecimens, left-over samples after clinical investigations or research proposals, biopsy materials,
p.000127: surgical or autopsy specimens/tissues, embryos or foetuses, cell lines, or waste materials like abandoned
p.000127: organs/tissues. Repository activities involve three components: collection of biospecimens and/or data; storage of
p.000127: biospecimens and data including its management; and retrieval and disbursement to researchers.
p.000127: A dataset is an organized collection of data and information maintained in physical and/or electronic/digital form that
...
p.000134: non-financial benefits by having access to the products, tests, or discoveries resulting from the research.
p.000134: 2. The benefits accrued, if any, should be returned to the communities from where the donors were drawn in
p.000134: community-based studies.
p.000134: 3. To the maximum extent possible, benefits should be indirect or in kind.
p.000134:
p.000134: 11.4.6 Role of the EC
p.000134: ECs play a key role in oversight and use of the bio- and data repositories for research, scientific and public health
p.000134: programmes. Research proposals, which require biorepository services including material transfer and available data
p.000134: sets, should be reviewed by the EC, either an institutional one or that of the biorepository.
p.000134: 11.5 Biological material/data in forensic departments of laboratories
p.000134: Specimens collected for forensic purposes and related or unrelated data (DNA profiling) offer a good source for
p.000134: academic research after the initial purpose has been served. Data sharing with researchers across the globe is a common
p.000134: practice for refining techniques to develop biomarkers, which could identify missing persons in most difficult
p.000134: circumstances (for example, highly decomposed bodies, disaster situations). In academic institutions, there is a demand
p.000134: for organs and tissues for education, training and research purposes.
p.000134: 11.5.1 Informed consent: If there is no written consent by the deceased person permitting use of organs or tissues, the
p.000134: family can be approached for consent for use of left-over organs or tissues.
p.000134: 11.5.2 No consent would be required if sample or data is anonymized.
p.000134: 11.5.3 If the deceased has no claimant then forensic officials will be authorized to give permission for
p.000134: use of material/data from its sources and be responsible for use of unclaimed cadavers.
p.000134: 11.5.4 The quantity of tissue taken should ideally be minimal, particularly if it is seen externally on the body in
p.000134: order to preserve the dignity of the dead and be culturally acceptable by
p.000134:
p.000134: 134 INDIAN COUNCIL OF MEDICAL
p.000135: RESEARCH
p.000135:
p.000135: Biological Materials,
p.000135: Biobanking and Datasets
p.000135:
p.000135: the next of kin or closest relative or friend.
p.000135: 11.5.5 The information in the informed consent document should state what tissue/organ will be retained, who will be
p.000135: the custodian, duration of storage of sample, what type of research would be conducted and method for disposal of the
p.000135: remains.
p.000135: 11.5.6 Genetic research or revelation of any other stigmatizing factors like HIV, etc. in the deceased may have
p.000135: implications for family members. In such instances, all ethical requirements as in the case of live
p.000135: participants should be followed.
p.000135: 11.5.7 The role of the EC is to review and approve the type of consent – broad, tiered with or without option to
p.000135: opt-out or specific and to assess from whom it would be taken – the family, closest relative or friend – or whether
p.000135: sample anonymization should be done.
p.000135: 11.6 Governance of biobank/biorepository
p.000135: Institutions where data are collected and archived must have an established governance structure with the following
p.000135: requirements for regulation.
p.000135: 11.6.1 Each biorepository should have its own technical authorization committee with representation of both
p.000135: science and ethics and external members. This committee should function in tandem with the EC.
p.000135: 11.6.2 A technical authorization committee, indigenous to the biorepository, should govern collection of specimens,
p.000135: disbursement of biospecimens and data to researchers. The same committee should also oversee regulatory aspects like
p.000135: execution of MTA or data transfer agreement (DTA) for transfer of biospecimens and/or data to other institutions.
p.000135: 11.6.3 Stand-alone huge repositories should have separate technical authorization committees and ECs to undertake the
p.000135: above-mentioned tasks.
p.000135: 11.6.4 The biobank should have well-structured SOPs and clear guidelines for collection, coding,
p.000135: anonymization, storage, access, retrieval and sharing of biospecimens and data.
p.000135: 11.6.5 The technical authorization committee/governance committee could comprise members such as clinicians,
p.000135: geneticists, lawyers, basic scientists, sociologists, epidemiologists, statisticians and ethicists.
p.000135: 11.7 Special issues related to datasets
p.000135: 11.7.1 With increasing ease of establishing and maintaining large repositories the primary objective of data collection
...
p.000144: 25. Particularly vulnerable tribal groups [homepage on the Internet]. Ministry of Tribal Affairs. Available from:
p.000144: http://tribal.nic.in/pvtg.aspx (accessed 31 Aug 2017).
p.000144: 26. The Mental Healthcare Act, 2017, India [statute on the Internet]. Available from: http://
p.000144: www.prsindia.org/uploads/media/Mental%20Health/Mental%20Healthcare%20 Act,%202017.pdf (accessed 12 Sept 2017).
p.000144: 27. G.S.R. 313(E) dated 16th Mar 2016. New Delhi: Gazette of India. Available from: http://
p.000144: www.cdsco.nic.in/writereaddata/GSR%20313%20(E)%20dated%2016_03_2016.pdf (accessed 12 Sept 2017).
p.000144: 28. Clinical Trials Registry - India [homepage on the Internet]. Available from: http://
p.000144:
p.000144: 144 INDIAN COUNCIL OF MEDICAL
p.000145: RESEARCH
p.000145:
p.000145:
p.000145: List of references
p.000145:
p.000145: www.ctri.nic.in (accessed 12 Sept 2017).
p.000145: 29. GSR 918 (E) dated 30th Nov 2015. New Delhi : Gazette of India. Available from: http://
p.000145: www.cdsco.nic.in/writereaddata/GSR%20918-E-dated-30-11-2015.pdf (accessed 13th Sept 2017).
p.000145: 30. Guidelines for Good Clinical Laboratory Practices (GCLP).New Delhi. Indian Council of Medical Research.
p.000145: Available from: http://icmr.nic.in/guidelines/GCLP.pdf (accessed 18 May 2017).
p.000145: 31. Good Manufacturing Practices. New Delhi: Central Drugs Standard Control Organization. Available
p.000145: from:http://www.cdsco.nic.in/writereaddata/ schedulem(gmp)6.pdf (accessed 12 Sept 2017).
p.000145: 32. Good Clinical Practice Guidelines for clinical trials of ASU Medicine. New Delhi: Department of AYUSH,
p.000145: Ministry of Health and Family Welfare, Government of India; 2013. Available from:
p.000145: http://ayush.gov.in/acts-rules-and-notifications/good-clinical- practice-guidelines-clinical-trials-asu-medicine
p.000145: (accessed 31 Aug 2017).
p.000145: 33. Opinion on Synthetic Biology I [document on the Internet]. Scientific Committee on Health and
p.000145: Environmental Risks, Scientific Committee on Emerging and Newly Identified Health Risks, Scientific Committee on
p.000145: Consumer Safety. Available from: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_044. pdf
p.000145: (accessed 09 Sept 2017).
p.000145: 34. Atomic Energy Regulatory Board [homepage on the Internet]. Available from: http://
p.000145: www.aerb.gov.in/index.php/english/ (accessed 12 Sept 2017).
p.000145: 35. Biomedical Waste Management Rules [document on the Internet]. New Delhi: Ministry of Environment, Forest and
p.000145: Climate Change, Government of India. 2016. Available from: http://cpcbenvis.nic.in/pdf/bmw_rules_2016.pdf (accessed 31
p.000145: Aug 2017).
p.000145: 36. American Society for Testing and Materials [home page on the Internet]. Available from: https://www.astm.org/
p.000145: (accessed 31 Aug 2017).
p.000145: 37. The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, amended in
p.000145: 2003, India [statute on the Internet]. Available from: http:// pndt.gov.in/writereaddata/mainlinkfile/File22.pdf
p.000145: (accessed 31 Aug 2017).
p.000145: 38. Import/export policy for human biological samples for commercial purposes: amendment. Schedule–1
p.000145: (Import Policy) and Schedule–2 (Export Policy) of ITC (HS), 2012 (notification of 2016). Ministry of Commerce and
p.000145: Industry, Government of India. Available from: http://www.icmr.nic.in/IHD/DGFT%20notification%204-8-16.pdf (accessed 09
p.000145: Sept 2017).
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000145: 145
p.000146:
p.000146:
p.000146: SUGGESTED FURTHER READING
p.000146: A framework for the ethical conduct of public health initiatives. Toronto: Public Health Ontario; 2012. Available from:
p.000146: https://www.publichealthontario.ca/en/erepository/
p.000146: pho%20%20framework%20for%20ethical%20conduct%20of%20public%20health%20 initiatives%20april%202012.pdf (accessed 31 Aug
p.000146: 2017).
p.000146: Atomic Energy Act, 1962, India [statute on the Internet]. Available from: http://dae.nic. in/?q=node/153 (accessed 09
p.000146: Sept 2017).
p.000146: Department-related Standing Committee on Health and Family Welfare. Fifty-ninth report on the functioning of the
p.000146: Central Drugs Standard Control Organization. New Delhi: Rajya Sabha Secretariat; May 2012. Available from:
p.000146: http://164.100.47.5/newcommittee/ reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20 Welfare/59.pdf
p.000146: (accessed 07 Sept 2017).
p.000146: Distinguishing public health research and public health nonresearch policy. Atlanta: Centers for Disease Control and
p.000146: Prevention, US Department of Health and Human Services; 2010. Available from:
p.000146: https://www.cdc.gov/od/science/integrity/docs/cdc-policy- distinguishing-public-health-research-nonresearch.pdf
p.000146: (accessed 09 Sept 2017).
p.000146: Drugs and Cosmetics Act, 1940, and Rules, 1945, India [statute on the Internet]. Available from:
p.000146: http://www.cdsco.nic.in/writereaddata/drugs&cosmeticact.pdf (accessed 02 Sept 2017).
p.000146: Drugs and Cosmetics Rules, 8th Amendment, 2015, India [statute on the Internet]. Available from:
p.000146: http://drugscontrol.org/pdf/gsr%201011%20(e)%20dtd%2029.12.15_fee.pdf (accessed 09 Sept 2017).
p.000146: Ethical values and human rights. In: The forensic use of bioinformation. London: Nuffield Council on Bioethics;
p.000146: 2007. Available from: https://nuffieldbioethics.org/wp-
p.000146: content/uploads/The-forensic-use-of-bioinformation-ethical-issues.pdf (accessed 31 Aug 2017).
p.000146: Fokunang CN, Tembe-Fokunang EA, Awash P. et al. The role of ethics in public health clinical research. In: Dr Alfonso
p.000146: Rodriguez-Morales editor, Current topics in public health. InTech; 2013. Available from: Doi.org/10.5772/52478
...
p.000147: 2016. Available from: http://apps.who.int/iris/bitstre am/10665/250580/1/9789241549837-eng.pdf (accessed on 31 Aug
p.000147: 2017).
p.000147: Guide to active vaccine safety surveillance. Geneva: Council for International Organizations of Medical Sciences; 2017.
p.000147: Guidelines for establishing and licensing umbilical cord stem cell banks [homepage on the Internet].
p.000147: Available from: http://cdsco.nic.in/html/gsr%20899.pdf (accessed 02 Sept 2017).
p.000147: Guidelines for the care and use of animals in scientific research. New Delhi: Indian National Science Academy; 2000.
p.000147: Guidelines on code of conduct for research scientists engaged in field of life sciences. [document on the
p.000147: Internet]. New Delhi: Indian Council of Medical Research. Available from:
p.000147: http://www.icmr.nic.in/guidelines/coe%20of%20conduct%20for%20
p.000147: research%20scientists%20engaged%20in%20the%20field%20of%20life%20sciences. pdf (accessed 09 Sept 2017).
p.000147: Guidelines on good publication practice. In: The COPE report. UK: Committee on Publication Ethics. 1999 Available
p.000147: from: http://publicationethics.org/files/u7141/1999pdf13. pdf (accessed 09 Sept 2017).
p.000147: Health Risks, Scientific Committee on Consumer Safety. Available from: https://ec.europa.
p.000147: eu/health/scientific_committees/emerging/docs/scenihr_o_044.pdf (accessed 09
p.000147: Sept 2017).
p.000147: Joint statement on public disclosure of results from clinical trials [document on the Internet]. 2017. Available from:
p.000147: http://who.int/ictrp/results/ICTRP_JointStatement_2017.pdf (accessed 09 Sept 2017).
p.000147: Medical Device Rules, 2017, India. Ministry of Health and Family Welfare. Available from:
p.000147: http://www.cdsco.nic.in/writereaddata/grsoct17983.pdf (accessed 09 Sept 2017).
p.000147: Medical Termination of Pregnancy (Amendment) Act, 2002, India [statute on the Internet]. Available from:
p.000147: http://pbhealth.gov.in/Manuals/notify/4.pdf (accessed 09 Sept 2017)
p.000147: National Accreditation Board for Testing and Calibration Laboratories [homepage on the Internet]. Available from:
p.000147: http://www.nabl-india.org/ (accessed 09 Sept 2017).
p.000147: Operational guidelines for ethics committees that review biomedical research. Geneva: World Health Organization; 2000.
p.000147: Available from: http://www.who.int/tdr/publications/
p.000147:
p.000147: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000147: 147
p.000148:
p.000148:
p.000148: Suggested Further Reading
p.000148:
p.000148: documents/ethics.pdf (accessed 09 Sept 2017).
p.000148: Operational guidelines for the establishment and functioning of data and safety monitoring boards. Geneva: World Health
p.000148: Organization. Available from: http://www.who.int/ tdr/publications/documents/operational-guidelines.pdf?ua=1 (accessed
p.000148: 09 Sept 2017).
p.000148: Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995, India [statute
p.000148: on the Internet]. Available from: http://www.ccdisabilities. nic.in/page.php?s=&p=pwd_act&t=pb (accessed 31 Aug 2017).
p.000148: Policy statements. World Association of Medical Editors [homepage on the Internet]. Available from:
p.000148: http://www.wame.org/about/policy-statements (accessed 09 Sept 2017).
p.000148: Prevention of Cruelty to Animals Act, 1960, amended in 1982, India [statute on the Internet]. Available from:
p.000148: http://www.envfor.nic.in/legis/awbi/awbi01.pdf (accessed 31 Aug 2017).
p.000148: Principles of the ethical practice of public health. Public Health Leadership Society; 2002. Available from:
p.000148: https://www.apha.org/~/media/files/pdf/membergroups/ ethics_brochure.ashx (accessed 09 Sept 2017).
p.000148: Public health ethics [homepage on the Internet]. Center for Disease Control and Prevention. Available from:
p.000148: https://www.cdc.gov/od/science/integrity/phethics/index. htm(accessed 18 May 2017).
p.000148: Public health: ethical issues. London: Nuffield Council on Bioethics; 2007. Available from:
p.000148: https://nuffieldbioethics.org/wp-content/uploads/2014/07/Public-health-ethical- issues.pdf (accessed 09 Sept 2017).
p.000148: Report of the Prof. Ranjit Roy Chaudhury expert committee to formulate policy and guidelines for approval
p.000148: of new drugs, clinical trials and banning of drugs. Ministry of Health and Family Welfare; 2013. Available from:
p.000148: http://www.cdsco.nic.in/ writereaddata/report_of_dr_ranjit_roy.pdf (accessed 09 Sept 2017).
p.000148: Review Committee on Genetic Manipulation [homepage on the Internet]. Department of Biotechnology. Available from:
p.000148: http://dbtbiosafety.nic.in/committee/rcgm.htm (accessed 09 Sept 2017).
p.000148: Statement on behalf of The Government – on The Supreme Court Judgement on Right to Privacy. Available from:
p.000148: http://pib.nic.in/newsite/PrintRelease.aspx?relid=170206 (accessed 09 Sept 2017).
p.000148: Swasthya Adhikar Manch and Anr. v. Union of India and Ors. Supreme Court of India. 2012. [document on the Internet].
p.000148: Available from: http://cdsco.nic.in/writereaddata/
p.000148:
p.000148: 148 INDIAN COUNCIL OF MEDICAL
p.000149: RESEARCH
p.000149:
p.000149:
p.000149: Suggested Further Reading
p.000149:
p.000149: sc%20order%2030th%20sept%202013.pdf (accessed 09 Sept 2017).
p.000149: The ethics of research related to healthcare in developing countries.: The Nuffield Council on Bioethics; 2002.
p.000149: Available from: https://nuffieldbioethics.org/wp-content/
p.000149: uploads/2014/07/Ethics-of-research-related-to-healthcare-in-developing-countries-I. pdf (accessed 09 Sept 2017).
p.000149: Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical.
p.000149: International Committee of Medical Journal Editors; 2006. Available from:
...
p.000150: EC ethics committee
p.000150: ELSI ethical, legal and social issues
p.000150: GCP good clinical practice
p.000150: GLP good laboratory practices
p.000150: GMP good manufacturing practices
p.000150: GOI Government of India
p.000150: HMSC Health Ministry’s Screening Committee
p.000150: ICD informed consent document
p.000150: ICF informed consent form
p.000150: ICH International Conference on Harmonization
p.000150: ICJME International Committee of Medical Journal Editors
p.000150:
p.000150:
p.000150:
p.000150: 150 INDIAN COUNCIL OF MEDICAL
p.000151: RESEARCH
p.000151:
p.000151:
p.000151: Abbreviations and acronyms
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: ICMR Indian Council of Medical Research
p.000151: IC-SCR institutional committee for stem cell research
p.000151: IND investigational new drug
p.000151: Ind EC independent ethics committee
p.000151: IP investigational product
p.000151: IPR intellectual property rights
p.000151: LAR legally acceptable/authorized representative MoHFW Ministry of Health and Family
p.000151: Welfare MOU memorandum of understanding
p.000151: MTA material transfer agreement
p.000151: MTP medical termination of pregnancy
p.000151: NABH National Accreditation Board for Hospitals and Healthcare Providers NABL National
p.000151: Accreditation Board for Testing and Calibration Laboratories NACO National AIDS Control Organization
p.000151: NAC-SCRT National Apex Committee for Stem Cell Research and Therapy
p.000151: PGD/ PGS pre-implantation genetic diagnosis/screening
p.000151: PIS participant information sheet
p.000151: RCR responsible conduct of research
p.000151: SAE serious adverse events
p.000151: SIDCER Strategic Initiative for Developing Capacity in Ethical Review
p.000151: SOP standard operating procedure
p.000151: TM traditional medicines
p.000151: TOR terms of reference
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000151: 151
p.000152:
p.000152: GLOSSARY
p.000152: 1. Accountability The obligation of an individual or organization to account for its activities, accept
p.000152: responsibility for them and to disclose the results in a transparent manner.
p.000152: 2. Adverse event Any untoward medical occurrence in a patient or participant involved in a study
p.000152: which does not necessarily have a causal relationship with the intervention. The adverse event can therefore be
...
Health / Physically Disabled
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p.000011: 5.8 Re-consent or fresh consent 54
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
...
p.000035: 6. eligibility criteria and participant recruitment procedures;
p.000035: 7. detailed description of the methodology of the proposed research, including sample size (with
p.000035: justification), type of study design (observational, experimental, pilot, randomized, blinded, etc.), types of
p.000035: data collection, intended intervention, dosages of drugs, route of administration, duration of treatment and
p.000035: details of invasive procedures, if any;
p.000035: 8. duration of the study;
p.000035: 9. justification for placebo, benefit–risk assessment, plans to withdraw. If standard therapies are to be
p.000035: withheld,
p.000035: justification for the same;
p.000035: 10. procedure for seeking and obtaining informed consent with a sample of the patient/participant information
p.000035: sheet and informed consent forms in English and local languages. AV recording if applicable; informed consent for
p.000035: stored samples;
p.000035: 11. plan for statistical analysis of the study;
p.000035: 12. plan to maintain the privacy and confidentiality of the study participants;
p.000035: 13. for research involving more than minimal risk, an account of management of risk or injury;
p.000035: 14. proposed compensation, reimbursement of incidental expenses and management of research related injury/illness
p.000035: during and after research period;
p.000035: 15. provision of ancillary care for unrelated illness during the duration of research;
p.000035: 16. an account of storage and maintenance of all data collected during the trial; and
p.000035: 17. plans for publication of results – positive or negative – while maintaining confidentiality of personal
p.000035: information/ identity.
p.000035: 18. ethical considerations and safeguards for protection of participants.
p.000035:
p.000035: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000035: 35
p.000036:
p.000036:
p.000036: Ethical Review Procedures
p.000036:
p.000036: Table 4.2 Types of review
p.000036: S. No. Types of review
p.000036:
p.000036: 1 Exemption from review
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: 2 Expedited review
p.000036: Proposals with less than minimal risk where there are no linked identifiers, for example;
p.000036: • research conducted on data available in the public domain for systematic
p.000036: reviews or meta-analysis;
p.000036: • observation of public behaviour when information is recorded without any linked identifiers and disclosure
p.000036: would not harm the interests of the observed person;
p.000036: • quality control and quality assurance audits in the institution;
p.000036: • comparison of instructional techniques, curricula, or classroom management
p.000036: methods;
p.000036: • consumer acceptance studies related to taste and food quality; and
p.000036: • public health programmes by Govt agencies such as programme evaluation where the sole purpose of the exercise is
...
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
...
p.000059: to consent.
p.000059: • Respect dissent from the participant.
p.000059: • Seek permission of the appropriate authorities where relevant, such as
p.000059: for institutionalized individuals, tribal communities, etc.
p.000059: • Research should be conducted within the purview of existing relevant
p.000059: guidelines/regulations.
p.000059: Ethics Committees • During review, determine whether the prospective participants for a
p.000059: particular research are vulnerable.
p.000059: • Examine whether inclusion/exclusion of the vulnerable population is
p.000059: justified.
p.000059: • Ensure that COI do not increase harm or lessen benefits to the participants.
p.000059: • Carefully determine the benefits and risks to the participants and advise
p.000059: risk minimization strategies wherever possible.
p.000059: • Suggest additional safeguards, such as more frequent review and
p.000059: monitoring, including site visits.
p.000059: • Only the full committee should do initial and continuing review of such proposals. It is desirable to have
p.000059: empowered representatives from the specific populations during deliberations.
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
p.000059: as minimal as possible and are clearly spelt out in the ICD.
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
...
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
...
p.000077:
p.000077: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000077: 77
p.000078:
p.000078: Clinical Trials of Drugs and
p.000078: other Interventions
p.000078:
p.000078: 7.5.2 The ethical review procedure for common review of multicentric research is given in section 4.10. Not
p.000078: applicable for clinical trials under Drugs and Cosmetic Act.
p.000078: 7.6 Phytopharmaceutical drugs
p.000078: The Drugs and Cosmetics Rules, 8th Amendment, 2015,29 defines a new class of drugs called phytopharmaceutical drug as
p.000078: “purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and
p.000078: quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings
p.000078: or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include
p.000078: administration by parenteral route”. All details described in 7.2 also apply to this group of drugs.
p.000078: 7.7 Device trials
p.000078: 7.7.1 A medical device is defined as a medical tool which does not achieve its primary intended action in or on
p.000078: the human body by pharmacological, immunological, or metabolic means but which may be assisted in its intended
p.000078: function by such means. It may be an instrument, apparatus, appliance, implant, material or other article, whether used
p.000078: alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for
p.000078: human beings or animals for one or more of the specific purposes of:
p.000078: (i) detection, diagnosis, prevention, monitoring;
p.000078: (ii) treatment or alleviation of any physiological condition or state of health, or illness;
p.000078: (iii) replacement or modification or support of the anatomy or congenital deformity;
p.000078: (iv) supporting or sustaining life;
p.000078: (v) disinfection of medical devices; or
p.000078: (vi) control of conception.
p.000078: • Clinical trials should be conducted in accordance with the ethical principles described in these
p.000078: guidelines, Indian GCP as well as applicable regulations for medical and medicated devices, that is, GSR 78 (E)
p.000078: dated 31.1.2017 or as per amendments/modifications issued from time-to-time.
p.000078: • Safety data of the medical device in animals should be obtained and likely risks posed by the device should
p.000078: be considered in the same way as for a new drug under the Drugs and Cosmetics Rules, 1945.
p.000078: • Apart from safety considerations of the device, the procedures to introduce the
p.000078:
p.000078: 78 INDIAN COUNCIL OF
p.000079: MEDICAL RESEARCH
p.000079:
p.000079: Clinical Trials of Drugs and
p.000079: other Interventions
p.000079:
p.000079: medical device in the patient should also be evaluated for safety.
p.000079: • Devices should be provided free of cost or, if expensive, at feasible reduced rates.
p.000079: • Avoid therapeutic misconceptions.
p.000079: • Any AE/SAE should be reported within timelines as per the schedule for a new drug. Here user error could also
p.000079: be the cause of AE/SAE.
p.000079: • If the participant wants to withdraw from a trial, it may not be possible to remove the internal device. This
...
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
p.000113: confidentiality in certain circumstances and the anticipated consequences of breach of confidentiality.
...
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
p.000152: 152 INDIAN COUNCIL OF MEDICAL
p.000153: RESEARCH
p.000153:
p.000153:
p.000153: Glossary
p.000153:
p.000153:
p.000153: 8. Biomedical and health research
p.000153: Research including studies on basic, applied and operational research designed primarily to increase the
p.000153: scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and
p.000153: evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical
p.000153: research.
p.000153: 9. Beneficence To try to do good or an action which weighs the risks against
p.000153: benefits to prevent, reduce or remove harm for the welfare of the research participant(s) in any type of research.
p.000153: 10. Caregivers A caregiver or carer is an unpaid or paid person who helps another
p.000153: individual with illness or impairment with daily activities/ performance.
p.000153:
p.000153: 11. Case record/
p.000153: report form (CRF)
p.000153: 12. Clinical
p.000153: research
p.000153: Case record form orcase report form is a printed, opticalor electronic
p.000153: document designed to record all the required information in the protocol on each study participant for reporting to the
p.000153: sponsor.
p.000153: Research that directly involves a particular person or group of
p.000153: people to study the effect of interventions, or uses materials/data from humans indirectly, such as their
p.000153: behaviour or samples of their tissue for prevention, treatment and diagnosis of a disease condition/health disorder.
p.000153: 13. Clinical trial As per amended Schedule Y (2005) of the Drugs and Cosmetics
p.000153: Rules, 1945, a clinical trial refers to a systematic study of new drugs in human subjects to
p.000153: generate data for discovering and/or verifying the clinical, pharmacological (including
p.000153: pharmacodynamic and pharmacokinetic) and /or adverse effect with the objectives determining safety and/or
p.000153: efficacy of a new drug. The academic clinical trial as per GSR 313 (e) dated 16 March 2016 is a clinical trial
p.000153: intended for academic purposes in respect of approved drug formulations for any new indication or new route of
p.000153: administration or new dose or new dosage form.
p.000153:
p.000153: 14 Clinical trial
p.000153: registry
p.000153: An official platform for registering a clinical trial, such as Clinical
p.000153: Trial Registry-India
...
Searching for indicator physically:
(return to top)
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
...
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
...
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
...
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
...
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
p.000057: 7.12 Clinical trials of interventions in HIV/AIDS 82
p.000057:
...
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
...
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
...
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
p.000089: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000089: 89
p.000090:
p.000090: Clinical Trials of Drugs and
p.000090: other Interventions
p.000090:
p.000090: disadvantaged populations may participate in the research to gain free access to an intervention. It is important to
p.000090: ensure that the participant has understood that this is research and the benefits expected may be small or they may not
p.000090: occur at all.
p.000090: 7.19.3 Participants must be made to understand that they may be randomized to a placebo group and therefore receive
p.000090: an inert drug, in case of a placebo-controlled study.
p.000090: 7.19.4 If the trial is a placebo- or active-controlled trial, all the groups must be given the current standard of
p.000090: care to which the IP, placebo or active control is added.
p.000090: 7.19.5 Perceptions of benefits and risks may be different for patients, healthcare workers and EC members. All
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000053:
p.000053: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000053: 53
p.000054:
p.000054:
p.000054: Informed Consent Process
p.000054: Box 5.2 Conditions for granting waiver of consent
p.000054:
p.000054: The EC may grant consent waiver in the following situations:
p.000054: • research cannot practically be carried out without the waiver and the waiver is scientifically
p.000054: justified;
p.000054: • retrospective studies, where the participants are de-identified or cannot be contacted;
p.000054: • research on anonymized biological samples/data;
p.000054: • certain types of public health studies/surveillance programmes/programme evaluation studies;
p.000054: • research on data available in the public domain; or
p.000054: • research during humanitarian emergencies and disasters, when the participant may not be in a position to give
p.000054: consent. Attempt should be made to obtain the participant’s consent at the earliest.
p.000054:
p.000054: 5.8 Re-consent or fresh consent
p.000054: Re-consent is required in the following situations when:
p.000054: • new information pertaining to the study becomes available which has
p.000054: implications for participant or which changes the benefit and risk ratio;
p.000054: • a research participant who is unconscious regains consciousness or who had suffered loss of insight regains
p.000054: mental competence and is able to understand the implications of the research;
p.000054: • a child becomes an adult during the course of the study;
p.000054: • research requires a long-term follow-up or requires extension;
p.000054: • there is a change in treatment modality, procedures, site visits, data collection methods or tenure of
p.000054: participation which may impact the participant’s decision to continue in the research; and
p.000054: • there is possibility of disclosure of identity through data presentation or photographs (this
p.000054: should be camouflaged adequately) in an upcoming publication.
p.000054: • the partner/spouse may also be required to give additional re-consent in some
p.000054: of the above cases.
p.000054: 5.9 Procedures after the consent process
p.000054: 5.9.1 After consent is obtained, the participant should be given a copy of the PIS and signed ICF unless the
p.000054: participant is unwilling to take these documents. Such reluctance should be recorded.
p.000054: 5.9.2 The researcher has an obligation to convey details of how confidentiality will be maintained to
p.000054: the participant.
p.000054: 54 INDIAN COUNCIL OF
p.000055: MEDICAL RESEARCH
p.000055:
p.000055:
p.000055: Informed Consent Process
p.000055:
p.000055: 5.9.3 The original PIS and ICF should be archived as per the requirements given in the guidelines and regulations.
...
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
p.000056: • incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or
p.000056: permanently, for example people who are unconscious, differently abled;
p.000056: • able to give consent, but whose voluntariness or understanding is compromised due to
p.000056: their situational conditions; or
p.000056: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000056: refusal to participate which may lead them to give consent.
p.000056:
p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
...
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
...
Health / breastfeeding
Searching for indicator breastfeeding:
(return to top)
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
...
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
...
Health / ill
Searching for indicator ill:
(return to top)
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
p.000057: 7.12 Clinical trials of interventions in HIV/AIDS 82
p.000057:
...
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
...
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
p.000068: or populations in conflict zones, riot areas or disaster situations. Additional precautions should be taken to
...
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
p.000089: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000089: 89
p.000090:
p.000090: Clinical Trials of Drugs and
p.000090: other Interventions
p.000090:
p.000090: disadvantaged populations may participate in the research to gain free access to an intervention. It is important to
p.000090: ensure that the participant has understood that this is research and the benefits expected may be small or they may not
p.000090: occur at all.
p.000090: 7.19.3 Participants must be made to understand that they may be randomized to a placebo group and therefore receive
p.000090: an inert drug, in case of a placebo-controlled study.
p.000090: 7.19.4 If the trial is a placebo- or active-controlled trial, all the groups must be given the current standard of
p.000090: care to which the IP, placebo or active control is added.
p.000090: 7.19.5 Perceptions of benefits and risks may be different for patients, healthcare workers and EC members. All
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
...
p.000131: any research at any time in future without the need to revert to the individual for a re-consent. A consent model that
p.000131: allows for current and future access and use of samples or data for research without necessarily specifying what the
p.000131: focus of such studies might be.
p.000131: 2. Tiered consent: This model of consent offers several options from which participants can choose. It
p.000131: includes an opt-in option for future use specifying general permission, or use only related to some aspects of
p.000131: research, sharing of biospecimens/data benefit sharing, etc. It also takes into consideration return of results for
p.000131: which options are also provided for consent. See section 11.4.4 for further details.
p.000131: 3. Specific consent: Consent is obtained for a specific research purpose. Participants are re- contacted
p.000131: for every new use of their stored samples/data if the scope of research is outside that for which they had originally
p.000131: given consent.
p.000131: 4. Delayed consent: It may be administered in the post-medical procedure period when biospecimen or data
p.000131: may be collected for appropriate research from critically ill patients who may not have given prior consent for
p.000131: research. Consent may be taken from the participant or LAR when it is practical.
p.000131: 5. Dynamic consent: This consent is different from one of static, paper-based consent and involves an
p.000131: ongoing engagement and interactions over time with participants to re-contact in response to changing circumstances
p.000131: using technology based platforms. It incorporates a flexible, configurable, technology-based design accommodating both
p.000131: participant and researcher needs. Modern longitudinal biobanks equipped with advanced technology strive for this type
p.000131: of consent.
p.000131: 6. Withdrawal of consent or destruction of sample: The donor has the right to ask for destruction of her/his
p.000131: collected sample(s) and discontinuation/withdrawal from participation in the research. In longitudinal studies, a
p.000131: participant may withdraw from one component of the study, like continued follow-up/data collection when withdrawal may
p.000131: be referred to as partial.
p.000131: 7. Waiver of consent: While using anonymized (de-identified) samples/data, researchers should seek the approval of
p.000131: the EC of the institution or the repository for waiver of consent from donors.
p.000131: 8. Re-consent
...
Health / of childbearing age/fertile
Searching for indicator childbearing age:
(return to top)
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
p.000086: 86 INDIAN COUNCIL OF
p.000087: MEDICAL RESEARCH
p.000087:
p.000087: Clinical Trials of Drugs and
p.000087: other Interventions
p.000087:
...
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.000094: 10.12 Misuse of genetic technology 118
p.000094: 10.13 Genetic diagnosis/testing and screening 118
p.000094: 10.14 Gene therapy 122
p.000094: 10.15 Use of newer technologies 123
p.000094: 10.16 Research on human embryos 125
p.000094: 10.17 Foetal autopsy 126
p.000094: Section 11 Biological materials, biobanking and datasets 127
p.000094: 11.1 Biobanking 127
p.000094: 11.2 Storage of biospecimens and data
p.000094: with their personal identifiers 128
p.000094: 11.3 Ethical issues related to donors 130
p.000094: 11.4 Ethical issues related to research 132
p.000094: 11.5 Biological material/data in forensic
p.000094: departments of laboratories 134
p.000094: 11.6 Governance of biobank/biorepository 135
p.000094: 11.7 Special issues related to datasets 135
p.000094: 11.8 Contingency plan 136
p.000094: Section 12 Research during humanitarian emergencies and disasters 137
p.000094: 12.1 Pre-emptive research preparation for
p.000094: humanitarian emergency 138
p.000094: 12.2 Informed consent requirements 138
p.000094: 12.3 Risk-minimization and equitable
p.000094: distribution of benefits and risks 139
p.000094: 12.4 Privacy and confidentiality 139
p.000094: 12.5 Ethics review procedures 140
p.000094: 12.6 Post research benefit 140
p.000094: 12.7 Special considerations 140
p.000094:
p.000094: 12.8 Continuation of ongoing research when
p.000094: a humanitarian emergency occurs 141
p.000094: 12.9 International participation in research 141
p.000094: List of references
p.000143: 143
p.000144: Suggested further reading
p.000146: 146
p.000147: Abbreviations and acronyms
p.000150: 150
p.000151: Glossary
p.000152: 152
p.000153: Annex 1 Standard operating procedures 160
p.000153: Annex 2 List of members of committees involved
p.000153: in revision of guidelines (2015-2017) 161
...
p. xii: Medical profession is probably the oldest one to prescribe ethical guidelines. Such guidelines for practically all
p. xii: aspect of professional conduct were provided both in Caraksamhita and Susrutasamhita. Rapid advances in
p. xii: the whole field of biomedical sciences have added newer responsibilities and complex dilemmas for medical persons –
p. xii: both practitioner and researchers. It would be correct to say that every advance in medical science results in added
p. xii: moral responsibility. ICMR has always been on the forefront to set the standards for ethics in biomedical and health
p. xii: research. The Council brought out a policy document in 1980, which was revised in 2000 and further revised in 2006. The
p. xii: latest version of guidelines has addressed the newer emerging ethical issues keeping in view the social, cultural,
p. xii: economic, legal and religious aspects of our country. Ethics is a subject of discussions and debates and each and every
p. xii: word and line in the revised guidelines have been deliberated upon by a group of experts and have gone through a
p. xii: process of consultation and debate before it has been finalized. The new expanded document has separate sections on
p. xii: Responsible Conduct of Research, Informed Consent Process, Vulnerability, Public Health Research, Social and
p. xii: Behavioural Sciences Research for Health, Biological materials, Biobanking and Datasets, International Collaboration
p. xii: and Research during Humanitarian Emergencies and Disasters. The guidelines also highlight the need for capacity
p. xii: building in the area of ethics in order to improve the ethical conduct of research. These Guidelines are a result of
p. xii: in-depth discussions and debates, involving the diverse stake-holders and also the public. The ICMR ethical guidelines
p. xii: are well respected not only in India but a number of other countries. The new “National Ethical Guidelines for
p. xii: Biomedical and Health Research involving Human Participants, 2017” will serve as a guide to answer and meet the
p. xii: challenges and concerns raised by the emerging ethical issues.
p. xii: I wish that the society will be enormously benefitted by these revised guidelines in general and biomedical scientist
p. xii: in particular.
p. xii:
p. xii:
p. xii:
p. xii:
p. xii:
p. xii: New Delhi April 2017
p. xii: Dr. P N Tandon
p. xii: Chairperson
p. xii: Central Ethics Committee on Human Research
p. xii:
p. xii:
p. xii: xii
p. xiii:
p. xiii: MESSAGE FROM CHAIRPERSON ADVISORY GROUP
p. xiii: ICMR brought out the ‘Policy Statement on Ethical Considerations Involved in Research on Human Subjects’ in 1980 under
p. xiii: the chairmanship of Hon'ble Justice H R Khanna. These guidelines were revised in 2000 as the ‘Ethical Guidelines for
p. xiii: Biomedical Research on Human Subjects’ under the chairmanship of Hon'ble Justice M N Venkatachaliah. In view of the new
p. xiii: developments in the field of science and technology, another revision was carried out as Ethical Guidelines for
p. xiii: Biomedical Research on Human Participants in 2006. Bioethics is a dynamic area and over the last 10 years many new
p. xiii: concerns and issues have evolved internationally over the ethical dilemmas faced by the scientific and ethics
p. xiii: committees in the conduct and review of biomedical research; hence, an exercise was taken up over a period of one year
p. xiii: with national and international consultation to come up with this new set of state of art guidelines. It was a
p. xiii: challenging task to decide which of the best practices we should incorporate in this revised version. A wide range of
p. xiii: stakeholders in the country consult the ICMR ethical guidelines as gold standard and these are also looked upon by many
p. xiii: developing countries.
p. xiii: The new guidelines have many new sections added up and many changes incorporated in the existing sections. There are
p. xiii: now a total of 12 sections including Responsible Conduct of Research, Informed Consent Process, Vulnerability,
p. xiii: Public Health Research, Social and Behavioural Sciences Research for Health, Biological materials,
p. xiii: Biobanking and Datasets and Research during Humanitarian Emergencies and Disasters. Many new issues have been added
p. xiii: up as subsections e.g. sexual minorities (LGBT), multicentric studies, research using datasets etc. The section on
p. xiii: ethics review process has been elaborated to help the many ethics committees who have doubt about the various
p. xiii: procedures to be followed. The support given to the drafting committee by ICMR to complete the work within the
p. xiii: stipulated time needs appreciation.
p. xiii: With the emergence of new technologies and knowledge that can potentially transform society, it has become necessary to
p. xiii: constantly update the ethical guidelines to protect the rights and safety of the research participants involved in
p. xiii: clinical research. I hope the scientific community, the regulatory agencies and all the stakeholders at large involved
p. xiii: in biomedical research will be enormously benefitted by this revised new guidelines.
p. xiii:
p. xiii:
p. xiii:
p. xiii: Coimbatore September 2017
p. xiii: Dr Vasantha Muthuswamy
p. xiii: Chairperson, Advisory Group
p. xiii:
p. xiii:
p. xiii: xiii
p. xiv:
p. xiv: ACKNOWLEDGEMENT
p. xiv:
p. xiv: We acknowledge with gratitude the inspiration and patronage of Dr Soumya Swaminathan, Director General ICMR
p. xiv: and Secretary Department of Health Research, to update and revise the ICMR Ethical Guidelines for Biomedical Research
p. xiv: on Human Participants 2006. The dynamic efforts and contributions of the Advisory Group consisting of Dr
p. xiv: Vasantha Muthuswamy (Chairperson), Prof S D Seth, Dr Nandini K Kumar, Prof N K Arora and Prof Urmila Thatte are
...
p. xv: (2001),13 the Council for International Organizations of Medical Sciences (CIOMS), Geneva (2002 revised in 2016),14,15
p. xv: and the Nuffield Council of Bioethics, United Kingdom (2002)16 released recommendations/guidelines relevant
p. xv:
p. xv: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000001: 1
p.000002:
p.000002:
p.000002: Introduction
p.000002: to research in developing countries. UNESCO’s Universal Declaration on Bioethics and Human Rights (2005)17 and
p.000002: other international instruments on human rights further defined the Universal Codes of Ethics to be adopted by
p.000002: the member countries. The revised ICMR ethical guidelines have adapted important guidance points from these
p.000002: international guidelines keeping in mind the diverse socio-cultural milieu of our country.
p.000002: The socio-cultural ethos in India and its varying standards of healthcare pose unique challenges to the application of
p.000002: universal ethical principles to biomedical and health research. The last decade has seen emerging ethical issues
p.000002: necessitating further revision of the earlier guidelines and preparation of the current National Ethical Guidelines for
p.000002: Biomedical and Health Research Involving Human Participants, 2017. These guidelines have covered some newer areas like
p.000002: public health research, social and behavioural sciences research for health and responsible conduct of research, and
p.000002: research during humanitarian emergencies and disasters while a few other specialized areas like informed consent
p.000002: process, biological materials, biobanking and datasets and vulnerability have been expanded into separate sections.
p.000002: Scope
p.000002: These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in
p.000002: India involving human participants, their biological material and data. The purpose of such research should be:
p.000002: i. directed towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian
p.000002: cultural, social and natural environment;
p.000002: ii. conducted under conditions such that no person or persons become mere means for the betterment of others and
p.000002: that human beings who are participating in any biomedical and/ or health research or scientific experimentation are
p.000002: dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional
p.000002: fair treatment and transparency; and
p.000002: iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of
p.000002: the results thereof.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2 INDIAN COUNCIL OF
p.000003: MEDICAL RESEARCH
p.000003:
p.000003: SECTION 1
p.000003:
p.000003: STATEMENT OF GENERAL PRINCIPLES
p.000003: 1.0 Research on human participants pertains to a broad range of scientific enquiry aimed at developing
...
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
...
p.000036: refinement and improvement of the programme or monitoring (where there are no individual identifiers).
p.000036: Proposals that pose no more than minimal risk may undergo expedited review, for example;
p.000036: • research involving non-identifiable specimen and human tissue from
p.000036: sources like blood banks, tissue banks and left-over clinical samples;
p.000036: • research involving clinical documentation materials that are non-identifiable
p.000036: (data, documents, records);
p.000036: • modification or amendment to an approved protocol including administrative changes or
p.000036: correction of typographical errors and change in researcher(s);
p.000036: • revised proposals previously approved through expedited review, full
p.000036: review or continuing review of approved proposals;
p.000036: • minor deviations from originally approved research causing no risk or
p.000036: minimal risk;
p.000036: • progress/annual reports where there is no additional risk, for example activity limited to data analysis.
p.000036: Expedited review of SAEs/unexpected AEs will be conducted by SAE subcommittee; and
p.000036: • for multicentre research where a designated main EC among the participating sites has reviewed
p.000036: and approved the study, a local EC may conduct only an expedited review for site specific requirements in addition to
p.000036: the full committee common review.
p.000036: • research during emergencies and disasters (See Section 12 for further details).
p.000036: (Contd.)
p.000036: 36 INDIAN COUNCIL OF
p.000037: MEDICAL RESEARCH
p.000037:
p.000037:
p.000037: Ethical Review Procedures
p.000037:
p.000037:
p.000037: 3 Full committee review
p.000037: All research proposals presenting more than minimal risk that are not covered under exempt or expedited review
p.000037: should be subjected to full committee review, some examples are;
p.000037: • research involving vulnerable populations, even if the risk is minimal;
p.000037: • research with minor increase over minimal risk (see Table 2.1 for further
p.000037: details);
p.000037: • studies involving deception of participants (see section 5.11 for further
p.000037: details);
p.000037: • research proposals that have received exemption from review, or have undergone expedited review/undergone
p.000037: subcommittee review should be ratified by the full committee, which has the right to reverse/or modify any decision
p.000037: taken by the subcommittee or expedited committee;
p.000037: • amendments of proposals/related documents (including but not limited
p.000037: to informed consent documents, investigator’s brochure, advertisements, recruitment methods, etc.) involving an
p.000037: altered risk;
p.000037: • major deviations and violations in the protocol;
p.000037: • any new information that emerges during the course of the research for deciding whether or not to
p.000037: terminate the study in view of the altered benefit–risk assessment;
p.000037: • research during emergencies and disasters either through an expedited
p.000037: review/ scheduled or unscheduled full committee meetings. This may be decided by Member Secretary depending on the
p.000037: urgency and need;
p.000037: • prior approval of research on predictable emergencies or disasters before
p.000037: the actual crisis occurs for implementation later when the actual emergency or disaster occurs.
p.000037:
p.000037: 4.8.2 The Member Secretary/Secretariat shall screen the proposals for their completeness and depending on the risk
p.000037: involved categorize them into three types, namely, exemption from review, expedited review, and full committee
p.000037: review. See Tables 2.1 for risk categorization and 4.2 for further details regarding types of review.
p.000037: 4.8.3 A researcher cannot decide that her/his proposal falls in the exempted, expedited or full review category. All
p.000037: research proposals must be submitted to the EC. The decision on the type of review required rests with the EC and will
p.000037: be decided on a case-to-case basis. Researchers can approach the EC with appropriate justification for the proposal to
p.000037: be considered as exempt, expedited or if waiver of consent is requested.
p.000037: 4.8.4 Expedited review can be conducted by Chairperson, Member Secretary and one or two designated members or as
p.000037: specified in SOPs.
p.000037:
p.000037: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000037: 37
p.000038:
p.000038:
p.000038: Ethical Review Procedures
p.000038:
p.000038: 4.8.5 Approval granted through expedited review and the decisions of the SAE subcommittee must be ratified at the
p.000038: next full committee meeting.
p.000038: 4.8.6 EC members should be given enough time (at least 1 week) to review the proposal and related documents, except
p.000038: in the case of expedited review.
...
p.000040: • There is a need to determine that payments are not so large as to encourage prospective participants to participate
p.000040: in the research without due consideration of the risks or against their better judgement. No undue inducement must be
p.000040: offered.
p.000040: • ECs should examine the processes that are put in place to
p.000040: safeguard participants’ privacy and confidentiality.
p.000040: • Research records to be filed separately than routine clinical
p.000040: records such as in a hospital setting.
p.000040: • The EC should ensure that due respect is given to the community, their interests are
p.000040: protected and the research addresses the community’s needs.
p.000040: • The proposed research should not lead to any stigma or
p.000040: discrimination. Harm, if any, should be minimized.
p.000040: • Plans for communication of results to the community at the
p.000040: end of the study should be carefully reviewed.
p.000040: • It is important to examine how the benefits of the research will
p.000040: be disseminated to the community.
p.000040: • The EC should look at the suitability of qualifications and experience of the PI to conduct the proposed
p.000040: research along with adequacy of site facilities for participants.
p.000040: • The EC should review any declaration of COI by a researcher
p.000040: and suggest ways to manage these.
p.000040: • The EC should manage COI within the EC and members with COI should leave the room at the time of decision making in
p.000040: a particular study.
p.000040: • The proposed plan for tackling any medical injuries or
p.000040: emergencies should be reviewed.
p.000040: • Source and means for compensation for study related injury
p.000040: should be ascertained.
p.000040: The informed consent process must be reviewed keeping in mind the following:
p.000040: • the process used for obtaining informed consent, including the
p.000040: identification of those responsible for obtaining consent and the procedures adopted for vulnerable populations;
p.000040: • the adequacy, completeness and understandability of the
p.000040: information to be given to the research participants, and when appropriate, their LARs;
p.000040:
p.000040: (Contd.)
p.000040:
p.000040: 40 INDIAN COUNCIL OF
p.000041: MEDICAL RESEARCH
p.000041:
p.000041:
p.000041: Ethical Review Procedures
p.000041:
p.000041: • contents of the patient/participation information sheet including the local language
p.000041: translations (See section 5 for further details);
p.000041: • back translations of the informed consent document in English,
p.000041: wherever required;
p.000041: • provision for audio-visual recording of consent process, if
p.000041: applicable, as per relevant regulations; and
p.000041: • if consent waiver or verbal/oral consent request has been asked for, this should be reviewed by assessing
...
p.000053: electronic media.
p.000053: 5.5.7 Such tools may be reviewed and approved by EC before implementation.
p.000053: 5.6 Specific issues in Clinical trials
p.000053: There may be additional requirements for informed consent for clinical trials as specified by CDSCO. See section 7 for
p.000053: further details.
p.000053: 5.7 Waiver of consent
p.000053: The researcher can apply to the EC for a waiver of consent if the research involves less than minimal risk to
p.000053: participants and the waiver will not adversely affect the rights and welfare of the participants Box 5.2.
p.000053:
p.000053: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000053: 53
p.000054:
p.000054:
p.000054: Informed Consent Process
p.000054: Box 5.2 Conditions for granting waiver of consent
p.000054:
p.000054: The EC may grant consent waiver in the following situations:
p.000054: • research cannot practically be carried out without the waiver and the waiver is scientifically
p.000054: justified;
p.000054: • retrospective studies, where the participants are de-identified or cannot be contacted;
p.000054: • research on anonymized biological samples/data;
p.000054: • certain types of public health studies/surveillance programmes/programme evaluation studies;
p.000054: • research on data available in the public domain; or
p.000054: • research during humanitarian emergencies and disasters, when the participant may not be in a position to give
p.000054: consent. Attempt should be made to obtain the participant’s consent at the earliest.
p.000054:
p.000054: 5.8 Re-consent or fresh consent
p.000054: Re-consent is required in the following situations when:
p.000054: • new information pertaining to the study becomes available which has
p.000054: implications for participant or which changes the benefit and risk ratio;
p.000054: • a research participant who is unconscious regains consciousness or who had suffered loss of insight regains
p.000054: mental competence and is able to understand the implications of the research;
p.000054: • a child becomes an adult during the course of the study;
p.000054: • research requires a long-term follow-up or requires extension;
p.000054: • there is a change in treatment modality, procedures, site visits, data collection methods or tenure of
p.000054: participation which may impact the participant’s decision to continue in the research; and
p.000054: • there is possibility of disclosure of identity through data presentation or photographs (this
p.000054: should be camouflaged adequately) in an upcoming publication.
p.000054: • the partner/spouse may also be required to give additional re-consent in some
p.000054: of the above cases.
...
p.000073: to the seriousness of the medical condition and the study procedures planned.
p.000073: m The study protocol should describe measures to minimize the risks of a Phase I clinical trial in healthy volunteers
p.000073: and patients. These include, but are not limited to, the measures given in Box 7.2.
p.000073: Box 7.2 Risks of Phase I clinical trials
p.000073:
p.000073: The measures to be taken to minimize risks in a Phase I clinical trial include:
p.000073: • exclusion of participants who may be at increased risk from the study;
p.000073: • careful review of investigational procedures posing high risk of physical harm or serious
p.000073: discomfort;
p.000073: • evaluation of available data to decide if the IP or procedures proposed in the protocol have been associated with
p.000073: SAEs and steps taken to prevent or minimize such risks; and
p.000073: • careful monitoring of the condition of participants and intervention to manage adverse
p.000073: events.
p.000073:
p.000073: m A Phase I study unit must have robust resources and tested procedures for immediate resuscitation and maintenance
p.000073: of life support and onward transfer to an intensive care unit, if necessary.
p.000073:
p.000073: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000073: 73
p.000074:
p.000074: Clinical Trials of Drugs and
p.000074: other Interventions
p.000074:
p.000074: m A Phase I study with a high-risk IP, such as first-in-human, biologic should be carried out in a hospital where
p.000074: experienced personnel and facilities are immediately available to manage medical emergencies.
p.000074: m Medical pharmacologist/physicians trained in clinical pharmacology should be involved in Phase I studies.
p.000074: • Phase II, III and IV studies
p.000074: m All Phase II and III studies require EC approval and applicable regulatory approvals.
p.000074: m In the case of Phase IV studies, the following are some examples of studies that require EC approval:
p.000074: (i) Phase IV clinical trials
p.000074: (ii) Outcome research
p.000074: (iii) Registries
p.000074: (iv) Data that is used to answer any research question
p.000074: (v) New use/route/dose/dosage form/combination/regimen of a marketed drug for non-commercial purpose such as
p.000074: academic research
p.000074: m In addition to EC approval, a Phase IV clinical trial on drugs with a market authorization of less than 4 years
p.000074: requires regulatory approval (CDSCO).
p.000074: m Routine post-marketing surveillance (PMS) may not require EC approval. See Box 7.1 for further details.
p.000074: • Vaccine studies
p.000074: Vaccines can be prophylactic and/or therapeutic in nature. The guidelines for conducting clinical trials on
p.000074: investigational vaccines are similar to those governing a drug trial. However, the phases of these trials differ from
p.000074: drug trials as given below:
p.000074: m Phase I is for the study of dose and route of administration for determining its safety and biological effects,
p.000074: including immunogenicity, and should involve low risk.
p.000074: m Bridging studies in vaccine trials are conducted to support clinical comparability of efficacy, safety and
...
p.000136: computing technologies and those associated with big data initiatives, may pose additional risks to privacy and
p.000136: confidentiality than what is described under biobanks or traditional paper-based data repositories. Hence, in
p.000136: such situations all reasonable measures must be adopted to respect and protect privacy and confidentiality of
p.000136: individuals as given in Box 11.6.
p.000136: Box 11.6 Measures to ensure privacy and confidentiality of individuals
p.000136:
p.000136: 1. Ensure physical safety and security of the involved devices and computer servers
p.000136: 2. Take data security measures such as password protection
p.000136: 3. Provide differential and role-based controlled access to data elements for members of the research team
p.000136: 4. Ensure use of data encryption when data is transferred from one location/device to another
p.000136: 5. Ensure benefit sharing with owners and related legal issues since, unlike some other countries, India
p.000136: does not have a data protection act as yet
p.000136: 11.8 Contingency plan
p.000136: One of the important but often neglected ethical issues related to biorepository is the legacy or
p.000136: contingency plan. Institutions should develop the contingent plans for sustainability of the biobanks.
p.000136:
p.000136: 136 INDIAN COUNCIL OF MEDICAL
p.000137: RESEARCH
p.000137:
p.000137: SECTION 12
p.000137:
p.000137:
p.000137: RESEARCH DURING HUMANITARIAN EMERGENCIES AND DISASTERS
p.000137:
p.000137: 12.0 A humanitarian emergency or disaster is an event or series of events that represents a critical threat to the
p.000137: health, safety, security or well-being of a community or other large group of people, usually covering a wide
p.000137: land area. For the purpose of these guidelines, humanitarian emergencies and disasters include both man-made and
p.000137: natural ones, some of which occur at periodic frequency. Emergencies, such as an earthquake, flood, mass migration,
p.000137: conflict and outbreak of disease, leading to substantial material damage affecting persons, communities, society
p.000137: and state(s), create an imbalance between capacity and resources to meet the needs of the survivors or the people
p.000137: whose lives are threatened during that period. Research is necessary in such circumstances to enable provision of
p.000137: efficient and appropriate health and humanitarian response during the ongoing emergency and to be able to plan for
p.000137: future emergency situations. Local, national or international responses and preparedness, without interfering with
p.000137: measures to control the crisis or ecology, are the key to reducing morbidity and mortality in such events.
p.000137: Humanitarian emergencies raise complex issues. The health system, communications, research infrastructure, and research
p.000137: governance frameworks may be adversely affected during such situations, which create challenges for the feasibility and
p.000137: oversight of conduct of research. While there may be a need to undertake research quickly, this should not impact
p.000137: scientific validity and the need to uphold ethical requirements. Close attention should be paid to the effect of the
p.000137: emergency on perceptions of ethical questions, altered or increased vulnerabilities, provider–patient and
p.000137: researcher–participant relationships, issues related to integrity of studies and ethical review processes. A unique
p.000137: challenge would be the response to rapidly evolving health needs or priorities of those impacted by the humanitarian
p.000137: emergency when the research cannot be conducted outside the humanitarian emergency situation. Designing or adopting
p.000137: innovative relevant research, based on rapidly evolving scientific and ethical uncertainties, which is expected to
p.000137: yield scientifically valid results is another significant challenge. The other challenges are inadequate time
p.000137: to design a study and lack of infrastructure facilities and resources to
p.000137: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000137: 137
p.000138:
p.000138: Research during Humanitarian Emergencies and
p.000138: Disasters
p.000138:
p.000138: conduct it within a disrupted physical-socio-cultural environment. The role of ECs in such circumstances is very
p.000138: important in reviewing protocols prepared for such emergency situation(s). Responsiveness to the situation,
p.000138: supervision, training and prevention of heightened risk of violence are other factors to be considered and planned.
p.000138: 12.1 Pre-emptive research preparation for future humanitarian emergency
p.000138: A natural disaster of cyclical frequency is an expected phenomenon. The following will be acceptable if a research is
p.000138: planned to study various implications on humans and ecological effects on humans in these circumstances.
p.000138: 12.1.1 Researchers and sponsors could make arrangements about research questions to be addressed in the design,
p.000138: collection of samples and data, and sharing mechanisms much in advance of a future humanitarian emergency.
p.000138: 12.1.2 Researchers could screen available and/or relevant draft research protocols to expedite the review process.
p.000138: 12.1.3 The EC could review proposals prior to the occurrence of the emergency and determine who could be an
p.000138: acceptable LAR in the absence of intended LARs (authorized/ acceptable) in such situations.
p.000138: 12.2 Informed consent requirements
p.000138: 12.2.1 Obtaining valid informed consent in humanitarian emergencies is a challenge as the decisional capacity of the
p.000138: participants would be so low that they may not be able to differentiate between reliefs offered and research
p.000138: components. This should be very clearly distinguished during the informed consent process.
p.000138: 12.2.2 Additional safeguards are required for participants due to their vulnerability, for example,
p.000138: counselling, psychological help, medical advice and process of stakeholder consultation.
p.000138: 12.2.3 The potential research participants might be under duress and traumatized. Researchers should be sensitive to
p.000138: this situation and are obligated to ensure that the informed consent process is conducted in a respectful manner.
p.000138: 12.2.4 Researchers should strive to identify and address barriers to voluntary informed consent and not resort to
p.000138: inducements for research participation.
p.000138: 12.2.5 The different roles of researchers, caregivers and volunteer workers must always be clarified, and potential COI
p.000138: declared.
p.000138: 12.2.6 If research involves incompetent individuals (such as minors), then the LAR should give consent. Additional
p.000138: protections might be required in special cases, for example,
p.000138:
p.000138: 138 INDIAN COUNCIL OF MEDICAL
p.000139: RESEARCH
p.000139:
p.000139: Research during Humanitarian Emergencies and Disasters
p.000139:
p.000139: children with untraceable or deceased relatives. In these situations, the consent should be obtained from an individual
p.000139: who is not part of the research team who should be designated by the institution/agency conducting research.
p.000139: 12.2.7 For seeking waiver of consent, the researchers should give the rationale justifying the waiver. EC should
p.000139: approve such a waiver after careful discussion on the issue. See section 5 for further details.
p.000139: 12.2.8 When consent of the participant/LAR/assent is not possible due to the situation, informed consent
p.000139: must be administered to the participant/LAR at a later stage, when the situation allows. However, this should be done
p.000139: only with the prior approval of the EC.
p.000139: 12.3 Risk-minimization and equitable distribution of benefits and risks
p.000139: 12.3.1 Considerations for fair selection of participants are described in Box 12.1.
p.000139:
p.000139: Box 12.1 Considerations for fair selection of participants
p.000139:
p.000139: 1. The overall effort is not to over-sample, particularly vulnerable segments of the population.
p.000139: 2. Explicit selection criteria or prioritization of participants with proper justification should be provided in the
p.000139: protocol.
p.000139: 3. Efforts should be taken to ensure that research participants are not exploited during the research project by
p.000139: imposing additional burdens on them.
p.000139: 4. It is desirable to set up a DSMB to frequently review the data to check on risk quantum.
p.000139:
p.000139: 12.3.2 Efforts should be made to see that the positive results of a specific research are applicable to future similar
p.000139: disaster situations.
p.000139: 12.3.3 Whenever possible, a priori agreement could be reached between researcher(s) and disaster affected communities
p.000139: for benefit sharing, which could be extended to future disaster affected communities wherever applicable.
p.000139: 12.4 Privacy and confidentiality
p.000139: 12.4.1 Disruption of governance, infrastructure and communication networks and inflow of visitors during emergencies
p.000139: can lead to a breach of privacy and confidentiality. In some situations, there can be stigmatization and discrimination
p.000139: which should be minimized at all stages of research.
p.000139: 12.4.2 Special efforts (culturally appropriate and scientifically valid) are required to maintain dignity, privacy and
p.000139: confidentiality of individuals and the communities.
p.000139:
p.000139: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000139: 139
p.000140:
p.000140: Research during Humanitarian Emergencies and
p.000140: Disasters
p.000140:
p.000140: 12.4.3 Efforts should be made to protect the identifying information about individuals and communities, for example,
p.000140: from exploitation by the print and visual media.
p.000140: 12.5 Ethics review procedures
p.000140: 12.5.1 Research during humanitarian emergencies and disasters can be reviewed through an expedited
p.000140: review/scheduled/unscheduled full committee meetings and this may be decided by the Member Secretary on a case-to-case
p.000140: basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as
p.000140: possible.
p.000140: 12.5.2 Meticulous documentation and archiving are required to enable future application in similar situations.
p.000140: 12.5.3 Suggestions to expedite the review process are given below:
p.000140: • Measures such as virtual or tele-conferences should be attempted when face-to-
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
p.000140: data/sample collection that are likely to rapidly deteriorate or perish may be allowed while the review process is
p.000140: underway.
p.000140: • Available protocol templates could be reviewed to expedite the process.
p.000140: • Re-review should be done if the emergency situation changes.
p.000140: • In situations where members of local ECs are unavailable due to the emergency, the ethics review may be
p.000140: conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its
p.000140: meeting. ECs should develop procedures to ensure appropriate and timely review and monitoring of the approved research.
p.000140: On a case-by-case basis, some protocols may require re- review as the emergency situation may change with time and
p.000140: circumstances.
p.000140: 12.5.4 The EC should closely monitor the conduct and outcome of research.
p.000140: 12.6 Post-research benefit
p.000140: Sponsors and researchers should strive to continue to provide beneficial interventions, which were part of the research
p.000140: initiative even after the completion of research and till the local administrative and social support system is
p.000140: restored to provide regular services.
p.000140: 12.7 Special considerations
p.000140: Humanitarian emergencies lead to fragile political environments with disruption of health systems and social
p.000140: situations.
p.000140:
p.000140:
p.000140: 140 INDIAN COUNCIL OF MEDICAL
p.000141: RESEARCH
p.000141:
p.000141: Research during Humanitarian Emergencies and
p.000141: Disasters
p.000141:
p.000141: 12.7.1 The researchers should undertake steps to maintain participant and community trust.
p.000141: 12.7.2 Efforts should be made to engage the community in the conduct of research in a culturally sensitive manner to
p.000141: ensure public trust.
p.000141: • The research team should preferably describe a preliminary community mapping/
p.000141: scoping exercise.
p.000141: • Wherever possible, community representatives or advocates should be involved in conceptualization, review,
p.000141: research and dissemination of research results in such settings.
p.000141: 12.7.3 In case of an outbreak of infectious diseases, monitored emergency use of unregistered and experimental
p.000141: interventions (MEURI) may be approved with the following precautions:
p.000141: • A thorough scientific review should be conducted, followed by an ethics review
p.000141: by a national level EC constituted for this purpose.
p.000141: • Oversight by a local EC is necessary.
p.000141: • Only a product complying with GMP should be used.
p.000141: • Rescue medicines and supportive treatment should be accessible.
p.000141: • Sharing data on safety and efficacy would be beneficial to reduce delay for other
p.000141: researchers.
p.000141: • Consent process is important and must be carried out with care.
p.000141: • Planning should be done for community engagement.
p.000141: • Fair distribution should be ensured when faced with scarce supply.
p.000141: 12.8 Continuation of ongoing research when a humanitarian emergency occurs
p.000141: 12.8.1 The research may have to be suspended and the decision may be taken by researchers with information to EC.
p.000141: 12.8.2 The researchers can go back to the EC for guidance regarding continuation of research or not.
p.000141: 12.8.3 Amendments might be incorporated in the proposal(s) to align to the research needs arising from the emergency
p.000141: including issues related to re-consent from participants.
p.000141: 12.8.4 The EC may decide if more frequent monitoring is required.
p.000141: 12.9 International participation in research
p.000141: 12.9.1 Conduct of research in a humanitarian emergency situation, which involves a foreign researcher/institution, must
p.000141: involve local partner(s).
p.000141: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000141: 141
p.000142:
p.000142: Research during Humanitarian Emergencies and
p.000142: Disasters
p.000142:
p.000142: 12.9.2 Existing guidelines on international collaboration for biological samples, data and intellectual
p.000142: property including publication related issues will be applicable. See section
p.000142: 3.8.3 for further details.
p.000142: 12.9.3 The local EC will monitor the progress of the research and compliance to the various clauses of the
p.000142: international collaboration.
p.000142: 12.9.4 Permission should be obtained from relevant national and local authorities, wherever applicable.
p.000142: 12.9.5 The research should help in developing the capacity of local researchers and sites and provide key learning
p.000142: points to the policy makers and the community.
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: 142 INDIAN COUNCIL OF MEDICAL
p.000143: RESEARCH
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: LIST OF REFERENCES
p.000143: 1. Policy statement on ethical considerations involved in research on human subjects. New Delhi: Indian Council
p.000143: of Medical Research; 1980.
p.000143: 2. Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research;
p.000143: 2000.
...
Searching for indicator emergency situation:
(return to top)
p.000137: whose lives are threatened during that period. Research is necessary in such circumstances to enable provision of
p.000137: efficient and appropriate health and humanitarian response during the ongoing emergency and to be able to plan for
p.000137: future emergency situations. Local, national or international responses and preparedness, without interfering with
p.000137: measures to control the crisis or ecology, are the key to reducing morbidity and mortality in such events.
p.000137: Humanitarian emergencies raise complex issues. The health system, communications, research infrastructure, and research
p.000137: governance frameworks may be adversely affected during such situations, which create challenges for the feasibility and
p.000137: oversight of conduct of research. While there may be a need to undertake research quickly, this should not impact
p.000137: scientific validity and the need to uphold ethical requirements. Close attention should be paid to the effect of the
p.000137: emergency on perceptions of ethical questions, altered or increased vulnerabilities, provider–patient and
p.000137: researcher–participant relationships, issues related to integrity of studies and ethical review processes. A unique
p.000137: challenge would be the response to rapidly evolving health needs or priorities of those impacted by the humanitarian
p.000137: emergency when the research cannot be conducted outside the humanitarian emergency situation. Designing or adopting
p.000137: innovative relevant research, based on rapidly evolving scientific and ethical uncertainties, which is expected to
p.000137: yield scientifically valid results is another significant challenge. The other challenges are inadequate time
p.000137: to design a study and lack of infrastructure facilities and resources to
p.000137: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000137: 137
p.000138:
p.000138: Research during Humanitarian Emergencies and
p.000138: Disasters
p.000138:
p.000138: conduct it within a disrupted physical-socio-cultural environment. The role of ECs in such circumstances is very
p.000138: important in reviewing protocols prepared for such emergency situation(s). Responsiveness to the situation,
p.000138: supervision, training and prevention of heightened risk of violence are other factors to be considered and planned.
p.000138: 12.1 Pre-emptive research preparation for future humanitarian emergency
p.000138: A natural disaster of cyclical frequency is an expected phenomenon. The following will be acceptable if a research is
p.000138: planned to study various implications on humans and ecological effects on humans in these circumstances.
p.000138: 12.1.1 Researchers and sponsors could make arrangements about research questions to be addressed in the design,
p.000138: collection of samples and data, and sharing mechanisms much in advance of a future humanitarian emergency.
p.000138: 12.1.2 Researchers could screen available and/or relevant draft research protocols to expedite the review process.
p.000138: 12.1.3 The EC could review proposals prior to the occurrence of the emergency and determine who could be an
p.000138: acceptable LAR in the absence of intended LARs (authorized/ acceptable) in such situations.
p.000138: 12.2 Informed consent requirements
p.000138: 12.2.1 Obtaining valid informed consent in humanitarian emergencies is a challenge as the decisional capacity of the
p.000138: participants would be so low that they may not be able to differentiate between reliefs offered and research
...
p.000139: 139
p.000140:
p.000140: Research during Humanitarian Emergencies and
p.000140: Disasters
p.000140:
p.000140: 12.4.3 Efforts should be made to protect the identifying information about individuals and communities, for example,
p.000140: from exploitation by the print and visual media.
p.000140: 12.5 Ethics review procedures
p.000140: 12.5.1 Research during humanitarian emergencies and disasters can be reviewed through an expedited
p.000140: review/scheduled/unscheduled full committee meetings and this may be decided by the Member Secretary on a case-to-case
p.000140: basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as
p.000140: possible.
p.000140: 12.5.2 Meticulous documentation and archiving are required to enable future application in similar situations.
p.000140: 12.5.3 Suggestions to expedite the review process are given below:
p.000140: • Measures such as virtual or tele-conferences should be attempted when face-to-
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
p.000140: data/sample collection that are likely to rapidly deteriorate or perish may be allowed while the review process is
p.000140: underway.
p.000140: • Available protocol templates could be reviewed to expedite the process.
p.000140: • Re-review should be done if the emergency situation changes.
p.000140: • In situations where members of local ECs are unavailable due to the emergency, the ethics review may be
p.000140: conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its
p.000140: meeting. ECs should develop procedures to ensure appropriate and timely review and monitoring of the approved research.
p.000140: On a case-by-case basis, some protocols may require re- review as the emergency situation may change with time and
p.000140: circumstances.
p.000140: 12.5.4 The EC should closely monitor the conduct and outcome of research.
p.000140: 12.6 Post-research benefit
p.000140: Sponsors and researchers should strive to continue to provide beneficial interventions, which were part of the research
p.000140: initiative even after the completion of research and till the local administrative and social support system is
p.000140: restored to provide regular services.
p.000140: 12.7 Special considerations
p.000140: Humanitarian emergencies lead to fragile political environments with disruption of health systems and social
p.000140: situations.
p.000140:
p.000140:
p.000140: 140 INDIAN COUNCIL OF MEDICAL
p.000141: RESEARCH
p.000141:
p.000141: Research during Humanitarian Emergencies and
p.000141: Disasters
p.000141:
p.000141: 12.7.1 The researchers should undertake steps to maintain participant and community trust.
p.000141: 12.7.2 Efforts should be made to engage the community in the conduct of research in a culturally sensitive manner to
p.000141: ensure public trust.
p.000141: • The research team should preferably describe a preliminary community mapping/
p.000141: scoping exercise.
p.000141: • Wherever possible, community representatives or advocates should be involved in conceptualization, review,
p.000141: research and dissemination of research results in such settings.
...
p.000141: interventions (MEURI) may be approved with the following precautions:
p.000141: • A thorough scientific review should be conducted, followed by an ethics review
p.000141: by a national level EC constituted for this purpose.
p.000141: • Oversight by a local EC is necessary.
p.000141: • Only a product complying with GMP should be used.
p.000141: • Rescue medicines and supportive treatment should be accessible.
p.000141: • Sharing data on safety and efficacy would be beneficial to reduce delay for other
p.000141: researchers.
p.000141: • Consent process is important and must be carried out with care.
p.000141: • Planning should be done for community engagement.
p.000141: • Fair distribution should be ensured when faced with scarce supply.
p.000141: 12.8 Continuation of ongoing research when a humanitarian emergency occurs
p.000141: 12.8.1 The research may have to be suspended and the decision may be taken by researchers with information to EC.
p.000141: 12.8.2 The researchers can go back to the EC for guidance regarding continuation of research or not.
p.000141: 12.8.3 Amendments might be incorporated in the proposal(s) to align to the research needs arising from the emergency
p.000141: including issues related to re-consent from participants.
p.000141: 12.8.4 The EC may decide if more frequent monitoring is required.
p.000141: 12.9 International participation in research
p.000141: 12.9.1 Conduct of research in a humanitarian emergency situation, which involves a foreign researcher/institution, must
p.000141: involve local partner(s).
p.000141: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000141: 141
p.000142:
p.000142: Research during Humanitarian Emergencies and
p.000142: Disasters
p.000142:
p.000142: 12.9.2 Existing guidelines on international collaboration for biological samples, data and intellectual
p.000142: property including publication related issues will be applicable. See section
p.000142: 3.8.3 for further details.
p.000142: 12.9.3 The local EC will monitor the progress of the research and compliance to the various clauses of the
p.000142: international collaboration.
p.000142: 12.9.4 Permission should be obtained from relevant national and local authorities, wherever applicable.
p.000142: 12.9.5 The research should help in developing the capacity of local researchers and sites and provide key learning
p.000142: points to the policy makers and the community.
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: 142 INDIAN COUNCIL OF MEDICAL
p.000143: RESEARCH
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: LIST OF REFERENCES
...
Health / sexually transmitted disases
Searching for indicator sexually transmitted:
(return to top)
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
p.000082: 7.12.1 Global studies in HIV/AIDS in specific communities should receive approval from the relevant national
p.000082: authority and any other relevant authority, such as the HMSC, where applicable, in addition to approval from the EC.
p.000082: 7.12.2 When testing for HIV is done, consent and pre-test- and post-test counselling should be done as per National
p.000082: AIDS Control Organization (NACO) guidelines.
p.000082: 7.12.3 Issues that may arise because of discordant couples should be addressed before initiating any
p.000082: study in people living with HIV/AIDS.
p.000082: 7.12.4 As HIV is a sexually transmitted disease and is potentially life-threatening, the right to life of the
p.000082: sexual partner must be respected over the right to privacy of the HIV positive individual.
p.000082: 7.12.5 Phase I studies are permissible in patients with HIV/AIDS if the drug under study cannot be tested in
p.000082: healthy participants due to expected toxicity of the IP.
p.000082:
p.000082: 82 INDIAN COUNCIL OF
p.000083: MEDICAL RESEARCH
p.000083:
p.000083: Clinical Trials of Drugs and
p.000083: other Interventions
p.000083:
p.000083: 7.12.6 A combined Phase I/II or Phase II study can be conducted in this population when other therapeutic options
p.000083: have been exhausted.
p.000083: 7.12.7 When a trial with a preventive HIV vaccine is conducted, it can result in positive serology. This does
p.000083: not indicate HIV infection but can create problems for travel and employment. Under such circumstances, the
p.000083: project investigator should issue a certificate stating that the person in question was a participant in a vaccine
p.000083: trial and provide clarification on the result.
p.000083: 7.12.8 Research that involves sexual minorities or IV drug users should have community engagement (community
p.000083: leaders) throughout the life of the project, until completion and dissemination of results.
p.000083: 7.12.9 The EC may also consider co-opting a member from this community, if relevant for initial and continuing
p.000083: review of proposals.
...
Searching for indicator std:
(return to top)
p.000093: is relational, since the interests of an individual as part of
p.000093:
p.000093: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000093: 93
p.000094:
p.000094:
p.000094: Public Health Research
p.000094:
p.000094: a community are relational in nature. Therefore, sometimes individual autonomy may not be appropriate as a stand-alone
p.000094: for application at the community level. While respect for the rights and dignity of all participants need to be
p.000094: considered and ensured, the same should be observed about the community. This can be facilitated by engaging the
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
p.000057: 7.11 Community trials (public health interventions) 82
p.000057: 7.12 Clinical trials of interventions in HIV/AIDS 82
p.000057:
p.000057: 7.13 Clinical trials on traditional systems of medicine 83
p.000057: 7.14 Trials of diagnostic agents 84
p.000057: 7.15 Radioactive materials and X-rays 85
p.000057: 7.16 Investigator initiated clinical trials 86
p.000057: 7.17 Clinical trials on contraceptives 87
p.000057: 7.18 Pregnancy and clinical trials 88
p.000057: 7.19 Clinical trials in oncology 89
p.000057: 7.20 Clinical trials of products using any new technology 90
p.000057: 7.21 Synthetic biology 91
p.000057: Section 8 Public health research
p.000093: 93
p.000094: 8.1 Principles of public health research ethics 93
p.000094: 8.2 Ethical issues of epidemiological and
p.000094: public health research study designs 96
p.000094: 8.3 Use of administrative and other data sources for research 100
...
p.000079: or
p.000079: (iv) monitoring of therapeutic measures.
p.000079:
p.000079: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000079: 79
p.000080:
p.000080: Clinical Trials of Drugs and
p.000080: other Interventions
p.000080: • Diagnostics devices can be notified and non-notified. Notified are in vitro diagnostic devices for
p.000080: testing HIV, HBsAg, HCV and blood grouping. Non-notified are those for testing malaria, TB, dengue, chikungunya,
p.000080: typhoid, syphilis, cancer markers, etc.
p.000080: 7.8 Biologicals and biosimilars
p.000080: Biologics (biopharmaceutical drug) can be composed of sugars, proteins, nucleic acids or complex combinations of these
p.000080: substances, or may be living cells or tissues. This section applies to products that are produced by means of
p.000080: biological processes with or without recombinant DNA technology. All aspects that are described in section 7.1 are also
p.000080: applicable to biologics.
p.000080: 7.8.1 As these are biologic substances, special care must be taken to review all data generated. Special expertise
p.000080: may be sought for such reviews so that foreseeable risks are well identified.
p.000080: 7.8.2 A thorough benefit-risk assessment must be carried out with available data.
p.000080: 7.8.3 If the study involves biosimilars, the product quality (manufacturing and characterization), preclinical data
p.000080: and bioassay must demonstrate similarity with a reference biologic.
p.000080: 7.8.4 All applicable and current regulations must be followed.
p.000080: 7.9 Clinical trials with stem cells
p.000080: In recent years, stem cell research has undergone rapid developments promising new leads in the treatment of several
p.000080: incurable diseases. According to the source and degree of expected risk to human participants, stem cell research is
p.000080: categorized into permissible (adult and cord blood), restricted (embryonic) and prohibited (reproductive cloning) areas
p.000080: of research. In India, only permissible and restricted areas of research are permitted with appropriate approvals. It
p.000080: is necessary to ensure that donors are not exploited and commodified.
p.000080: To address issues related to stem cell research, ICMR and DBT published Guidelines for Stem Cell Research and Therapy
p.000080: in 2007, 2013 and revised as National Guidelines for Stem Cell Research in 2017. 6
p.000080: 7.9.1 Except haemopoietic stem cell transplantation for haematological disorders, any other uses of stem cells are
p.000080: categorized as research and must be conducted as clinical trials, needing the approval of the EC, IC-SCR (permissible
p.000080: research), National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) (restricted research) and CDSCO
p.000080: (IND products and drugs) as the case may be.29 Use of stem cells outside the domain of a clinical trial for any
p.000080: purpose is considered unethical and hence not permissible.
p.000080: 80 INDIAN COUNCIL OF
p.000081: MEDICAL RESEARCH
p.000081:
p.000081: Clinical Trials of Drugs and
p.000081: other Interventions
p.000081:
p.000081: 7.9.2 Clinical trials must be carried out with clinical grade cells processed as per applicable national Good
p.000081: Laboratory Practices (GLP)30, Good Manufacturing Practices (GMP)31, and GCP guidelines.12
p.000081: 7.9.3 Each institution should maintain a registry of researchers who are conducting stem cell research. Researcher
p.000081: must be kept updated in accordance with changes in guidelines and regulations regarding use of these cells. It is also
p.000081: the responsibility of the institution to ensure that all current standards are applied.
p.000081: 7.9.4 All clinical trials must be approved by IC-SCR, which in turn should be registered with NAC-SCRT. All such
p.000081: studies should also be registered with CTRI. The EC should give final approval before initiation of the clinical trial.
p.000081: 7.10 Surgical interventions
p.000081: Surgical interventions that are being studied systematically must be considered as research and follow all
p.000081: general principles described in these guidelines.
p.000081: 7.10.1 In any protocol where an established surgical intervention is to be studied, the researcher must provide
p.000081: references for the procedure and describe the most likely complications in the protocol for the EC to review and
p.000081: perform benefit-risk assessment. The frequency of each complication should also be mentioned.
...
p.000090: step-wise manner after clearance from the appropriate authority regarding environmental safety.
p.000090: 7.20.4 Differing process based technologies can result in similarly functioning biological products which can
p.000090: give rise to IPR issues.
p.000090: 7.20.5 The research on new technologies should have a well-established mechanism or system for assessing the risk,
p.000090: both in terms of severity and temporality. The unpredictable
p.000090:
p.000090: 90 INDIAN COUNCIL OF
p.000091: MEDICAL RESEARCH
p.000091:
p.000091: Clinical Trials of Drugs and
p.000091: other Interventions
p.000091:
p.000091: metabolic behaviour in a human system during clinical trial cannot exclude long-term side effects which may manifest
p.000091: later, leading to compensation issues.
p.000091: 7.20.6 Training of all stakeholders should address issues regarding safe research, handling of products,
p.000091: environmental safety and community misconceptions.
p.000091: 7.21 Synthetic biology
p.000091: Synthetic biology is the application of science, technology and engineering to “facilitate and accelerate the design,
p.000091: manufacture and/or modification of genetic material of living organisms”.33 The ethical, legal and social issues
p.000091: pertain to the impact of this science on society, biosafety, biosecurity, IPRs, governance of such research, and socio-
p.000091: economics. Creation of organisms, molecular compounds and biological systems by manipulating biology through
p.000091: standardized engineering techniques has led to the rise of the biotechnology industry which includes genetically
p.000091: modified organisms, stem cells, cloning, artificial life forms like biofuels, bioweapons, vaccines,
p.000091: diagnostics, etc. Software and bioinformatics as design tools, along with constructional and diagnostic
p.000091: tools, play a major role in the synthesis. EC review, pre-market approval and registration should be aimed at
p.000091: protection of human beings and the environment.
p.000091: 7.21.1 Special considerations
p.000091: • Precautionary principle: This applies to the prevention of harm to humans, environment and ecosystem because
p.000091: development of a new technology may emit hazardous elements like X-ray radiation, electro-magnetic currents and
p.000091: non-ionizing magnetic waves in the environment, which may manifest only later. Safety measures should be followed as
p.000091: per the Environmental Protection Act, 1986, Atomic Energy Act34, Biomedical Waste Management Rules35, and other
p.000091: relevant laws.
p.000091: • Biosecurity: Sometimes, the product can have dual use, that is, one beneficial use for a particular
p.000091: purpose and the other for harmful use which could be unintentional or intentional, for example, use as a
p.000091: biological weapon. Therefore, to maintain security, the ICMR code of conduct for researchers involved in life sciences
p.000091: should be followed along with creation of a system for reporting and maintaining vigilance to prevent misuse. There
p.000091: should be effective partnership between researchers and policy makers to create a secure system.
p.000091: • GLP, GMP and GCP should be observed when conducting clinical trials.
p.000091: • Products should be contained and released into the environment in a step-wise
...
Health / visual impairment
Searching for indicator blind:
(return to top)
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
p.000157: uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of
p.000157: adequate size, and whenever possible, double-blind.
p.000157:
p.000157: 47 Post-marketing
p.000157: surveillance
p.000157:
p.000157: 48 Professional competence
p.000157: 49 Principal
p.000157: investigator
p.000157:
p.000157:
p.000157: 50 Psychosocial harm
p.000157: The practice of monitoring the safety of a pharmaceutical drug or
p.000157: medical device after it has been released on the market. This is an important part of the science of pharmacovigilance.
p.000157: The broad professional knowledge, attitude and skills required in
p.000157: order to work in a specialized area or profession.
p.000157: An individual or the leader of a group of individuals who initiates and takes full responsibility for the conduct of
p.000157: biomedical health research; if there is more than one such individual, they may be called co-principal investigators/
p.000157: co-investigators.
p.000157: Research, particularly psychology studies, can put participants in
p.000157: situations that may make them feel uncomfortable while learning about their reaction to a situation. The result can be
p.000157: psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or
p.000157: depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.
p.000157: 51 Quorum Minimum number and/or kind of EC members required for
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
p.000157: related injury
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
...
Searching for indicator blinded:
(return to top)
p.000035: MEDICAL RESEARCH
p.000035:
p.000035:
p.000035: Ethical Review Procedures
p.000035:
p.000035:
p.000035: 21. Documentation of clinical trial registration (preferable)
p.000035: 22. Insurance policy (it is preferable to have the policy and not only the insurance certificate)for study
p.000035: participants indicating conditions of coverage, date of commencement and date of expiry of coverage of risk (if
p.000035: applicable)
p.000035: 23. Indemnity policy, clearly indicating the conditions of coverage, date of commencement and date of
p.000035: expiry of coverage of risk (if applicable)
p.000035: 24. Any additional document(s), as required by EC (such as other EC clearances for multicentric studies)
p.000035: 25. Protocol
p.000035:
p.000035: Box 4.4 (b) Details of documents to be included in the protocol
p.000035:
p.000035: The protocol should including the following:
p.000035: 1. the face page carrying the title of the proposal with signatures of the investigators;
p.000035: 2. brief summary/ lay summary;
p.000035: 3. background with rationale of why a human study is needed to answer the research question;
p.000035: 4. justification of inclusion/exclusion of vulnerable populations;
p.000035: 5. clear research objectives and end points (if applicable);
p.000035: 6. eligibility criteria and participant recruitment procedures;
p.000035: 7. detailed description of the methodology of the proposed research, including sample size (with
p.000035: justification), type of study design (observational, experimental, pilot, randomized, blinded, etc.), types of
p.000035: data collection, intended intervention, dosages of drugs, route of administration, duration of treatment and
p.000035: details of invasive procedures, if any;
p.000035: 8. duration of the study;
p.000035: 9. justification for placebo, benefit–risk assessment, plans to withdraw. If standard therapies are to be
p.000035: withheld,
p.000035: justification for the same;
p.000035: 10. procedure for seeking and obtaining informed consent with a sample of the patient/participant information
p.000035: sheet and informed consent forms in English and local languages. AV recording if applicable; informed consent for
p.000035: stored samples;
p.000035: 11. plan for statistical analysis of the study;
p.000035: 12. plan to maintain the privacy and confidentiality of the study participants;
p.000035: 13. for research involving more than minimal risk, an account of management of risk or injury;
p.000035: 14. proposed compensation, reimbursement of incidental expenses and management of research related injury/illness
p.000035: during and after research period;
p.000035: 15. provision of ancillary care for unrelated illness during the duration of research;
p.000035: 16. an account of storage and maintenance of all data collected during the trial; and
p.000035: 17. plans for publication of results – positive or negative – while maintaining confidentiality of personal
...
p.000076: a. the reference (comparator) and investigational (generic) product; and
p.000076: b. the study procedures such as indoor stay, fasting, screening, blood sampling.
p.000076: • BA/BE studies are usually conducted in healthy volunteers. Hence, they have no direct benefit to the
p.000076: participant but may pose risks due to the adverse effects of the drug. Therefore, all safeguards to protect
p.000076: participants must be in place.
p.000076: • The EC must carefully review the recruitment methods, payment for participation and consent procedures.
p.000076: Volunteers often regularly participate in such studies at the cost of their health and care should be taken that taking
p.000076: part in multiple trials is avoided by maintaining volunteer registries, biometry, follow up, etc. Care must be taken to
p.000076: maintain confidentiality of biometric data.
p.000076: • The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study
p.000076: design and the EC should take specific note on the amount of blood drawn depending on whether the individual is a
p.000076: healthy adult or a child or a patient.
p.000076: 7.4 Ethical implications of study designs
p.000076: Clinical trials have a wide range of methodological approaches. ECs need to look into the details of the ethical
p.000076: concerns involved.
p.000076: 7.4.1 If a SAE occurs in a blinded study, and it is imperative, in the interest of managing the event to know what
p.000076: the patient was receiving, unblinding mechanisms should be available to the researcher.
p.000076:
p.000076: 76 INDIAN COUNCIL OF
p.000077: MEDICAL RESEARCH
p.000077:
p.000077: Clinical Trials of Drugs and
p.000077: other Interventions
p.000077:
p.000077: 7.4.2 When an available therapy is effective in preventing serious harm, such as death or irreversible morbidity in
p.000077: the clinical trial population, it is inappropriate to use a placebo control.
p.000077: 7.4.3 Placebo may be used as a comparator under the conditions given in Box 7.4.
p.000077: Box 7.4 Conditions where a placebo may be used
p.000077: A placebo may be used when:
p.000077: • there is no established effective therapy available;
p.000077: • withholding an established effective therapy would not expose participants to serious
p.000077: harm, but may cause temporary discomfort or delay in relief of symptoms;
p.000077: • if the disease is self-limited; or
p.000077: • the use of an established effective therapy as a comparator would not yield scientifically reliable
p.000077: results and the use of placebo would not add any additional risk of serious or irreversible harm to the participants.
...
Searching for indicator visually impaired:
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p.000050:
p.000050: 50 INDIAN COUNCIL OF
p.000051: MEDICAL RESEARCH
p.000051:
p.000051:
p.000051: Informed Consent Process
p.000051:
p.000051: to participation, is included in the PIS. This is followed by the ICF in which the participant acknowledges that
p.000051: she/he has understood the information given in the PIS and is volunteering to be included in that research.
p.000051: 5.2.3 Adequate time should be given to the participant to read the consent form, if necessary discuss it with family
p.000051: and friends, and seek clarification of her/his doubts from the researchers/research team before deciding to enroll in
p.000051: the research.
p.000051: 5.2.4 Essential elements of an informed consent document are given in Box 5.1.
p.000051: 5.3 Responsibility of researchers
p.000051: 5.3.1 The researcher should only use the EC approved version of the consent form, including its local
p.000051: translations.
p.000051: 5.3.2 Adequate information necessary for informed consent should be communicated in a language and manner easily
p.000051: understood by prospective participants.
p.000051: 5.3.3 In case of differently abled participants, such as individuals with physical, neurological or mental
p.000051: disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for
p.000051: the visually impaired.
p.000051: 5.3.4 There should be no restriction on the participant’s right to ask questions related to the study or to
p.000051: discuss with family and friends or take time before coming to a decision.
p.000051: 5.3.5 The researcher should not give any unjustifiable assurances or influence or intimidate a prospective
p.000051: participant to enroll in the study.
p.000051: 5.3.6 The researcher must ensure that the participant is competent and has understood all aspects of the study and
p.000051: that the consent is given voluntarily. Where the participant and/or the LAR are illiterate, an impartial literate
p.000051: person, not connected to the research, should be present throughout the consent process as witness.
p.000051: 5.3.7 The researcher should administer a test of understanding whenever possible for sensitive studies.
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
p.000051: so, then verbal/oral consent may be taken on approval by the EC, in the presence of an impartial witness who should
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p. x: Acknowledgement
p. xiv: xiv
p. xv: Introduction
p.000001: 1
p.000002: Scope
p.000002: 2
p.000003: Section 1 Statement of general principles 3
p.000003: 1.1 General principles 3
p.000003: Section 2 General ethical issues
p.000005: 5
p.000006: 2.1 Benefit-risk assessment 5
p.000006: 2.2 Informed consent process 5
p.000006: 2.3 Privacy and confidentiality 7
p.000006: 2.4 Distributive justice 8
p.000006: 2.5 Payment for participation 8
p.000006: 2.6 Compensation for research related harm 8
p.000006: 2.7 Ancillary care 10
p.000006: 2.8 Conflict of interest 10
p.000006: 2.9 Selection of vulnerable and special groups as research participants
p.000010: 10
p.000011: 2.10 Community engagement 11
p.000011: 2.11 Post research access and benefit sharing 12
p.000011: Section 3 Responsible conduct of research 13
p.000011: 3.1 Values of research 13
p.000011: 3.2 Policies 14
p.000011: 3.3 Planning and conducting research - specific issues 15
p.000011:
p.000011: 3.4 Reviewing and reporting research 17
p.000011: 3.5 Responsible authorship and publication 18
p.000011: 3.6 Research misconduct and policies for handling misconduct 19
p.000011: 3.7 Registration with Clinical Trials Registry- India 20
p.000011: 3.8 Collaborative research 21
p.000011: Section 4 Ethical review procedures 25
p.000011: 4.1 Terms of reference for ethics committees (EC) 25
p.000011: 4.2 Special situations 26
p.000011: 4.3 Composition of an EC 27
p.000011: 4.4 Terms of reference for EC members 31
p.000011: 4.5 Criteria for selection of EC members 32
p.000011: 4.6 Training 32
...
p.000003: principles described below, and are to be applied to all biomedical, social and behavioural science research for
p.000003: health involving human participants, their biological material and data.
p.000003: 1.1 General Principles
p.000003: 1.1.1 Principle of essentiality whereby after due consideration of all alternatives in the light of existing
p.000003: knowledge, the use of human participants is considered to be essential for the proposed research. This should be duly
p.000003: vetted by an ethics committee (EC) independent of the proposed research.
p.000003: 1.1.2 Principle of voluntariness whereby respect for the right of the participant to agree or not to agree to
p.000003: participate in research, or to withdraw from research at any time, is paramount. The informed consent process
p.000003: ensures that participants’ rights are safeguarded.
p.000003: 1.1.3 Principle of non-exploitation whereby research participants are equitably selected so that the benefits and
p.000003: burdens of the research are distributed fairly and without arbitrariness or discrimination. Sufficient safeguards to
p.000003: protect vulnerable groups should be ensured.
p.000003: 1.1.4 Principle of social responsibility whereby the research is planned and conducted so as to avoid creation or
p.000003: deepening of social and historic divisions or in any way disturb social harmony in community relationships.
p.000003: 1.1.5 Principle of ensuring privacy and confidentiality whereby to maintain privacy of the potential
p.000003: participant, her/his identity and records are kept confidential and access
p.000003: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000003: 3
p.000004:
p.000004:
p.000004: Statement of General Principles
p.000004:
p.000004: is limited to only those authorized. However, under certain circumstances (suicidal ideation, homicidal tendency, HIV
p.000004: positive status, when required by court of law etc.) privacy of the information can be breached in consultation with
p.000004: the EC for valid scientific or legal reasons as the right to life of an individual supersedes the right to privacy of
p.000004: the research participant.
p.000004: 1.1.6 Principle of risk minimization whereby due care is taken by all stakeholders (including but not limited to
p.000004: researchers, ECs, sponsors, regulators) at all stages of the research to ensure that the risks are minimized and
p.000004: appropriate care and compensation is given if any harm occurs.
p.000004: 1.1.7 Principle of professional competence whereby the research is planned, conducted, evaluated and monitored
p.000004: throughout by persons who are competent and have the appropriate and relevant qualification, experience and/or
p.000004: training.
p.000004: 1.1.8 Principle of maximization of benefit whereby due care is taken to design and conduct the research in such a way
p.000004: as to directly or indirectly maximize the benefits to the research participants and/or to the society.
p.000004: 1.1.9 Principle of institutional arrangements whereby institutions where the research is being conducted, have
p.000004: policies for appropriate research governance and take the responsibility to facilitate research by providing required
p.000004: infrastructure, manpower, funds and training opportunities.
...
p.000006: obtained. If a participant or LAR is illiterate, a literate impartial witness should also be present during the
p.000006: informed consent process.
p.000006:
p.000006: 6 INDIAN COUNCIL OF
p.000007: MEDICAL RESEARCH
p.000007:
p.000007:
p.000007: General Ethical Issues
p.000007:
p.000007: 2.2.2 In certain circumstances audio/audio-visual recording of the informed consent process may be required, for
p.000007: example in certain clinical trials as notified by CDSCO.
p.000007: 2.2.3 Verbal/oral consent/waiver of consent/re-consent may be obtained under certain conditions after due
p.000007: consideration and approval by the EC. See section 5 for further details.
p.000007: 2.3 Privacy and confidentiality
p.000007: Privacy is the right of an individual to control or influence the information that can be collected and stored and by
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
p.000007: community.
p.000007: 2.3.2 Potential limitations to ensure strict confidentiality must be explained to the participant. Researchers must
p.000007: inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,
p.000007: it may not be possible to do so under certain circumstances.
p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
...
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
p.000012: General Ethical Issues
p.000012:
p.000012: representative, local institution or the government department from where the data was collected to help in
p.000012: dissemination of the results to the entire community.
p.000012: See sections 8 and 9 for further details.
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
p.000012: 2.11.1 Efforts should be made to communicate the findings of the research study to the
p.000012: individuals/communities wherever relevant.
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
p.000013: RESPONSIBLE CONDUCT OF RESEARCH
p.000013:
p.000013: 3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a
p.000013: significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide
p.000013: by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members
p.000013: of a research team are expected to maintain high standards and to uphold the fundamental values of research. The
...
p.000013: components of RCR as outlined in the following sections.
p.000013: 3.1 Values of research
p.000013: RCR is guided by shared values including honesty, accuracy, efficiency, fairness, objectivity, reliability,
p.000013: accountability, transparency, personal integrity, and knowledge of current best practices, and these should be
p.000013: reflected in the policies related to RCR.
p.000013: 3.1.1 The scientist as a responsible member of society
p.000013: Scientific research is vital to improving our understanding of various health related problems and their solutions.
p.000013: All research components depend on cooperation and shared expectations as part of inter-professional ethics.
p.000013: Unethical behaviour in scientific research can destroy the public’s trust in science and have a negative impact on the
p.000013: research team. Without trust between scientists and the public, or within research teams, meaningful research is
p.000013: compromised. Researchers should be aware that the resources of biomedical research are precious and to be used
p.000013: judiciously. Whereever possible they should also seek oppurtunities to plan translation of research findings into
p.000013: public health outcomes.
p.000013: 3.1.2 Contemporary ethical issues in biomedical and health research
p.000013: Emerging new areas of research give rise to new ethical issues. Among the contemporary
p.000013: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000013: 13
p.000014:
p.000014:
p.000014: Responsible Conduct of Research
p.000014:
p.000014: issues recently under debate are the use of underprivileged and vulnerable groups as participants, post-trial access of
p.000014: research benefits to participants and their communities, research on emerging technologies, etc. Continuing
p.000014: education is necessary to keep researchers apprised of contemporary issues.
p.000014: 3.1.3 Sensitivity to societal and cultural impact of biomedical and health research
p.000014: To understand the social and cultural impact of research, one must analyse how the health sector and general public
p.000014: engage with the results of biomedical and health research. It is essential that researchers bear this in mind
p.000014: while planning, conducting and evaluating research as it will improve public accountability and enhance public, private
p.000014: and political advocacy.
p.000014: 3.1.4 Mentoring
p.000014: Mentoring is one of the primary means for one generation of scientists to pass on their knowledge, values and
p.000014: principles to succeeding generations. Mentors, through their experience, can guide researchers in ways above and beyond
p.000014: what can be gathered from reading textbooks. The relationship between mentors and trainees should enable trainees to
p.000014: become responsible researchers. Mentors should ensure their trainees conduct research honestly, do not interfere
p.000014: with the work of other researchers and use resources judiciously. A mentor should be knowledgeable, teach and lead by
p.000014: example and understand that trainees differ in their abilities. She/he should devote sufficient time and be
p.000014: available to discuss, debate and guide trainees ably. A mentor should encourage decision making by the
...
p.000021: all aspects including local, national and international requirements for research collaboration including necessary
p.000021: approvals, memorandums of understanding (MoUs) and material transfer agreements (MTA) and EC approval of collaborating
p.000021: institutes.
p.000021: 3.8.1 Ethical considerations in collaborative research
p.000021: Collaborative studies should take into account the values/benefits expected from the research as compared to the risks
p.000021: involving the persons/population being studied.
p.000021: • The participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of
p.000021: ownership of samples and data, analysis, dissemination, publication and IPR as appropriate. There must be free flow of
p.000021: knowledge and capacity at bilateral/multilateral levels.
p.000021: • Careful consideration should be given to protecting the dignity, rights, safety and well-being of the
p.000021: participants in cases where the social contexts of the proposed research can create foreseeable conditions for their
p.000021: exploitation or increase their vulnerability to harm.
p.000021: • The nature, magnitude and probability of all foreseeable harm resulting from participation in a collaborative
p.000021: research programme should be specified in the research protocol and well explained to the participants.
p.000021: • The benefits and burdens should be equally distributed amongst participants
p.000021: recruited by all collaborating institutions.
p.000021: • All participants in collaborative research should have access to the best nationally
p.000021: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000021: 21
p.000022:
p.000022:
p.000022: Responsible Conduct of Research
p.000022:
p.000022: available standard of care.
p.000022: • If there is exchange of biological material involved between collaborating sites, the EC may require
p.000022: appropriate MoU and/or MTA to safeguard the interests of participants and ensure compliance while addressing
p.000022: issues related to confidentiality, sharing of data, joint publications, benefit sharing, etc.
p.000022: 3.8.2 Responsibilities of ethics committees, researchers and institutions
p.000022: The review, conduct and monitoring of collaborative research should be overseen and stakeholders must be aware of
p.000022: the requirements of various regulatory and funding agencies.
p.000022: • An EC should review the protocols in the local social and cultural context and ensure respect for
p.000022: sensitivities and values of participants and communities at collaborative sites.
p.000022: • A mechanism for communication between the ECs of different participating centres should be
p.000022: established. In case of any conflict, the decision of the local EC based on relevant facts/guidelines/law of the land
p.000022: shall prevail.
p.000022: • An EC should examine whether the researcher has the required expertise and
p.000022: training in the area of collaboration.
p.000022: • An EC should protect the interests and rights of the collaborating researcher(s)
p.000022: and ensure that they are not treated as mere collectors of samples or data.
p.000022: • Participating researchers from collaborating sites should be adequately represented
...
p.000025: trained on the SOPs. The SOPs must be available in the secretariat of the EC as both hard and soft copies.
p.000025: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000025: 25
p.000026:
p.000026:
p.000026: Ethical Review Procedures
p.000026:
p.000026: 4.1.3 The scope, tenure and renewal policy of the EC should be stated.
p.000026: 4.1.4 Members of the EC should not have any known record of misconduct.
p.000026: 4.1.5 The EC should be registered with the relevant regulatory authorities, for example, ECs approving clinical
p.000026: trials under the ambit of Drugs and Cosmetics Act should be registered with CDSCO.
p.000026: 4.2 Special situations
p.000026: 4.2.1 Institutions can have one or more than one EC. They can have multiple ECs to review large numbers of research
p.000026: proposals. Each EC can function as a stand-alone committee which should follow all the SOPs and TORs of that
p.000026: institution.
p.000026: 4.2.2 An institution that does not have its own EC (user institution) may utilize the services of the EC of another
p.000026: institution (host institution) preferably in the adjoining/nearby area. Relevant requirements must be fulfilled before
p.000026: they do so. See Box 4.1 for further details.
p.000026: Box 4.1 Utilizing the services of an EC of another institution
p.000026:
p.000026: The following requirements must be fulfilled by institutions that use the services of an EC from another institution:
p.000026: • The two institutions (host and user) should enter into an MoU for utilizing the services of the EC of the host
p.000026: institution or the user institution should provide a ‘No Objection Certificate’ and agree to be overseen by the EC of
p.000026: the host institution.
p.000026: • The EC of the host institution should have access to all research records including the source documents and
p.000026: research participants for continuing review of the implemented project, including site visits.
p.000026: • The EC of the host institution can undertake site monitoring and will have all the rights and
p.000026: responsibilities related to ethical review of the projects submitted by the user institutions.
p.000026:
p.000026: 4.2.3 For multicentric biomedical and health research, all participating sites may decide to utilize the services of
p.000026: one common EC from a participating site identified as designated main EC for the purpose of primary review. This EC
p.000026: should be located in India and registered with the relevant authority. However, the local site requirements, such as
p.000026: informed consent process, research implementation and its monitoring, etc. may be performed by the local EC. This would
p.000026: require good communication and coordination between the researchers and EC secretariats of participating sites. For
p.000026: clinical trials under the Drugs and Cosmetics Act, the requirements as stated by CDSCO must be followed. See section
p.000026: 4.10 for further details.
p.000026: 4.2.4 Stem cell proposals should be reviewed and approved by the institutional committee
p.000026: 26 INDIAN COUNCIL OF
p.000027: MEDICAL RESEARCH
p.000027:
p.000027:
p.000027: Ethical Review Procedures
p.000027:
p.000027: for stem cell research (IC-SCR) before being submitted to the EC for consideration, in accordance with the National
p.000027: Guidelines for Stem Cell Research (2017).
p.000027: 4.2.5 Independent ECs (Ind EC) that function outside institutions can be used by researchers who have no
p.000027: institutional attachments. For these committees, the following essential conditions should be met:
p.000027: • The Ind EC must be established as a registered legal entity, governed by individuals who are not
p.000027: members of the proposed EC and who will oversee and monitor the functioning of the Ind EC.
p.000027: • It should function according to SOPs that follow the national guidelines for
p.000027: functioning of ECs.
p.000027: • It should not accept research proposals from investigators affiliated to institutions
p.000027: that have their own ECs unless there is an MoU.
p.000027: • It will have rights and responsibilities related to the projects submitted to it.
p.000027: • It should have access to all research records, including the source documents and
p.000027: research participants.
p.000027: • It should undertake continuing review of the implemented project including site
p.000027: visits.
p.000027: • It should familiarize itself with local socio-cultural norms that may help to ensure
p.000027: protection of rights and well-being of research participants.
p.000027: 4.2.6 Institutions could have subcommittees such as the SAE subcommittee or expedited review committee. These should
p.000027: be part of the main committee and comprise Chairperson/ Member Secretary and one to two appropriate designated members
p.000027: of the main EC as defined in the SOPs. These subcommittees can report to the concerned main EC.
p.000027: 4.2.7 Institutions could have separate committee for SAE in which one or two members of EC could be included to
p.000027: facilitate continuity of EC activity and its report should be reviewed by main EC.
p.000027: 4.3 Composition of an EC
p.000027: 4.3.1 ECs should be multi-disciplinary and multi-sectoral.
p.000027: 4.3.2 There should be adequate representation of age and gender.
p.000027: 4.3.3 Preferably 50% of the members should be non-affiliated or from outside the institution.
p.000027: 4.3.4 The number of members in an EC should preferably be between seven and 15 and a minimum of five members should
p.000027: be present to meet the quorum requirements.
p.000027: 4.3.5 The EC should have a balance between medical and non-medical members/technical and non-technical members,
p.000027: depending upon the needs of the institution.
p.000027: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000027: 27
p.000028:
p.000028:
...
p.000045: until completion of the research to check for compliance or improve the function.
p.000045:
p.000045: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000045: 45
p.000046:
p.000046:
p.000046: Ethical Review Procedures
p.000046:
p.000046: 4.12.2 Monitoring can be routine or “for cause” and must be decided at a full committee meeting. For research that
p.000046: involves higher risk or vulnerable participants or if there is any other reason for concern, the EC at the time of
p.000046: initial review or continuing review can suggest that routine monitoring may be conducted at more frequent intervals.
p.000046: Some causes for monitoring are given in Box 4.6.
p.000046: Box 4.6 Examples of “for cause” monitoring
p.000046:
p.000046: The following situations may justify “for cause” monitoring:
p.000046:
p.000046: • high number of protocol violations/
p.000046: deviations;
p.000046: • large number of proposals carried out at
p.000046: the study site or by the same researcher;
p.000046: • large number of SAE reports;
p.000046: • high recruitment rate;
p.000046: • complaints received from participants;
p.000046: • any adverse media report;
p.000046: • adverse information received from any
p.000046: other source;
p.000046: • non-compliance with EC directions;
p.000046: • misconduct by the researcher; and
p.000046: • any other cause as decided by the EC.
p.000046:
p.000046: 4.13 Record keeping and archiving
p.000046: 4.13.1 All documentation and communication of an EC should be dated, filed and preserved according to written
p.000046: procedures.
p.000046: 4.13.2 Confidentiality should be maintained during access and retrieval procedures by designated persons.
p.000046: 4.13.3 All active and inactive (closed) files should be appropriately labelled and archived separately in
p.000046: designated areas.
p.000046: 4.13.4 Records can be maintained in hard copies as well as soft copies.
p.000046: 4.13.5 All records must be archived for a period of at least 3 years after the completion/ termination of the
p.000046: study.
p.000046: 4.13.6 Documents related to regulatory clinical trials must be archived for 5 years after the
p.000046: completion/termination of the study or as per regulations.
p.000046: 4.13.7 Records may be archived for a longer period, if required by the sponsors/regulatory bodies.
p.000046: 4.13.8 EC should describe archival and retrieval mechanisms in SOPs.
p.000046: 4.13.9 EC records should be accessible for inspection by authorized representatives of regulatory
p.000046: agencies.
p.000046:
p.000046: 46 INDIAN COUNCIL OF
p.000047: MEDICAL RESEARCH
p.000047:
p.000047:
p.000047: Ethical Review Procedures
p.000047:
p.000047: 4.13.10 ECs may adopt methods for electronic storage of records wherever feasible. Table 4.4 gives examples of
p.000047: records that can be maintained.
p.000047: Table 4.4 Documents to be maintained by EC for record
p.000047: Type of document Document specifics
p.000047:
p.000047: Administrative documents
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Proposal-related documents
p.000047: • Constitution and composition of the EC
p.000047: • Appointment letters
p.000047: • Signed and dated copies of the most recent curriculum vitae of all EC
...
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
p.000051: the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be
p.000051: taken in exceptional circumstances and for specific, justifiable reasons with the approval of the EC. It should not to
p.000051: be practiced routinely.
p.000051: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000051: 51
p.000052:
p.000052:
p.000052: Informed Consent Process
p.000052:
p.000052: 5.3.9 Reconsent or fresh informed consent of each participant must be taken under circumstances
p.000052: described in section 5.8.
p.000052: 5.3.10 The researcher must assure prospective participants that their decision whether or not to participate in the
p.000052: research will not affect their rights, the patient–clinician relationship or any other benefits to which they are
p.000052: entitled.
p.000052: 5.3.11 Reimbursement may be given for travel and incidental expenses/participation in research after
p.000052: approval by the EC.
p.000052: 5.3.12 The researcher should ensure free treatment for research related injury (disability, chronic life-threatening
p.000052: disease and congenital anomaly or birth defect) and if required, payment of compensation over and above medical
p.000052: management by the investigator and/institution and sponsor(s), as the case may be.
p.000052: 5.3.13 The researcher should ensure that the participant can continue to access routine care even in the event of
p.000052: withdrawal of the participant.
p.000052: 5.4 Documentation of informed consent process
p.000052: Documentation of the informed consent process is an essential part of this exercise.
p.000052: 5.4.1 Each prospective participant should sign the informed consent form after going through the informed consent
p.000052: process of receiving information, understanding it and voluntarily agreeing to participate in the research.
p.000052: 5.4.2 In case the participant is incompetent (medically or legally) to give consent, the LAR’s consent must be
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
p.000052: should be a literate person who can read the participant information sheet and consent form and understand the language
p.000052: of the participant.
p.000052: 5.4.4 If the participant cannot sign then a thumb impression must be obtained.
...
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
p.000068: or populations in conflict zones, riot areas or disaster situations. Additional precautions should be taken to
p.000068: avoid exploitation/retaliation/ reward/credits and other inducements when such individuals are to be recruited as
p.000068: research participants.
p.000068: 6.11.1 Autonomy of such individuals is already compromised and researchers have to justify their inclusion.
p.000068: 6.11.2 ECs have to satisfy themselves with the justification provided to include these participants and record the same
p.000068: in the proceedings of the EC meeting.
p.000068: 6.11.3 Additional safety measures suggested earlier in the guidelines should be strictly followed by the ECs.
p.000068: 6.11.4 The informed consent process should be well documented. There should not be any undue coercion or incentive for
p.000068: participation. A person’s refusal to participate should be respected and there should be no penalization.
p.000068: 6.11.5 The EC should also carefully determine the benefits and risks of the study and examine risk minimization
p.000068: strategies.
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
...
p.000081: comparative study be conducted where the conventional method is compared to the test surgical intervention.
p.000081: 7.10.3 In trials where an entirely new surgical intervention is being tested, the EC may insist on some animal
p.000081: data/modeling data which establishes the efficacy and safety of the technique or case reports/case series that indicate
p.000081: benefits and describe risks.
p.000081: 7.10.4 During the conduct of a surgical interventional trial all adverse events must be reported to the EC and sponsor
p.000081: as applicable, within the specified timelines as described for drug trials.
p.000081: 7.10.5 Provision of free treatment and compensation for any study-related injury must be ensured for the
p.000081: trial participant. The EC must determine the compensation amount after the investigator has described the relatedness.
p.000081: 7.10.6 Due to inherent ethical issues, sham surgery should not be included in the design of clinical trials, except
p.000081: in cases where there are strong scientific reasons. Under such circumstances, certain conditions must be met.
p.000081: See Box 7.6 for further details.
p.000081:
p.000081: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000081: 81
p.000082:
p.000082: Clinical Trials of Drugs and
p.000082: other Interventions
p.000082:
p.000082: Box 7.6 Conditions for sham surgery
p.000082: 1. There has to be a clear description of the justifications to include a sham surgery group in the protocol, which
p.000082: must be assessed by the EC.
p.000082: 2. There should be no serious harm caused by the sham surgery.
p.000082: 3. The participant must get access to appropriate, relevant intervention at the end of the trial.
p.000082:
p.000082: 7.11 Community trials (public health interventions)
p.000082: Community trials are studies involving whole communities and are conducted to evaluate preventive strategies like mass
p.000082: drug administration (MDA) trials, fortification of food, etc. Such studies typically involve the whole community. The
p.000082: study unit could be a group, area, institution, village, block, district, etc. and the whole population is expected to
p.000082: participate in the study. In such studies, different communities are randomized and allocated to different arms (see
p.000082: section 8 for further details).
p.000082: 7.12 Clinical trials of interventions in HIV/AIDS
p.000082: Clinical trials in HIV positive patients could be for the evaluation of new drugs, vaccines, other
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
...
p.000082: healthy participants due to expected toxicity of the IP.
p.000082:
p.000082: 82 INDIAN COUNCIL OF
p.000083: MEDICAL RESEARCH
p.000083:
p.000083: Clinical Trials of Drugs and
p.000083: other Interventions
p.000083:
p.000083: 7.12.6 A combined Phase I/II or Phase II study can be conducted in this population when other therapeutic options
p.000083: have been exhausted.
p.000083: 7.12.7 When a trial with a preventive HIV vaccine is conducted, it can result in positive serology. This does
p.000083: not indicate HIV infection but can create problems for travel and employment. Under such circumstances, the
p.000083: project investigator should issue a certificate stating that the person in question was a participant in a vaccine
p.000083: trial and provide clarification on the result.
p.000083: 7.12.8 Research that involves sexual minorities or IV drug users should have community engagement (community
p.000083: leaders) throughout the life of the project, until completion and dissemination of results.
p.000083: 7.12.9 The EC may also consider co-opting a member from this community, if relevant for initial and continuing
p.000083: review of proposals.
p.000083: 7.12.10 Where possible, for example, if the drug is found useful, standard of care is not available or regulatory
p.000083: permissions are in place, the EC should ensure post-trial access of the IP for the participants.
p.000083: 7.12.11 For HIV positive persons, any research may be misconstrued as research on anti-HIV treatment and make them
p.000083: willing to participate. Therefore, the full implications in simple terms should be explained to HIV positive
p.000083: participants about any other research being done on them, such as research on hepatitis B.
p.000083: 7.13 Clinical trials on traditional systems of medicine
p.000083: Although traditional systems of medicine (termed complementary and alternate systems in the west) are
p.000083: known for their long history of safe and effective use, validation of safety and efficacy using scientific and
p.000083: evidence-based methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners
p.000083: and satisfaction of end users in the products. Government of India has recognized Ayurveda, Siddha, Unani, Yoga,
p.000083: Naturopathy and Homeopathy as traditional Indian systems of medicine. In 2012, Sowa Rigpa (Amchi or Tibetan medicine)
p.000083: was also added to the list. Ministry of AYUSH (Ayurveda, Unani, Siddha and Homeopathy) governs and regulates these
p.000083: systems. Drugs under these systems come under the Drugs and Cosmetics Act, 1940, as ASU and H drugs. Drugs/formulations
p.000083: under these systems of medicine are classified into two groups. See Box 7.7 for further details:
p.000083: 7.13.1 Research on AYUSH and ASU interventions of traditional medicines (TM) including external
p.000083: medicines/therapeutic procedures, folk medicines, and patent and proprietary medicines of TM involving human
p.000083: participants should be conducted in accordance
p.000083: INDIAN COUNCIL OF MEDICAL RESEARCH
...
p.000085: regulations of the country.
p.000085: 7.14.1 Benefit-risk assessment involving diagnostic agents additionally includes the assessment of benefits,
p.000085: such as technical performance, diagnostic performance, impact on diagnostic thinking and impact on patient
p.000085: management/outcome, and the risks related to the agent itself, such as immunogenicity, allergic reactions, but also
p.000085: risks related to incorrect handling of test procedures or incorrect diagnosis induced by its use.
p.000085: 7.14.2 The EC must review the pharmacology, toxicology, pharmacokinetics and safety data (preclinical and clinical
p.000085: data as applicable) especially for diagnostic agents which come in contact with skin or mucosal surfaces in the human
p.000085: body (in vivo use). Special expertise may be co-opted in the EC for review of such products.
p.000085: 7.14.3 These trials are usually comparative, the comparator being the reference/gold standard test to diagnose the
p.000085: disease. Hence, the protocol must state clearly the choice of the reference with justification. Likewise, omission of a
p.000085: reference standard as comparator must also be justified.
p.000085: 7.14.4 A placebo may be used as comparator when the response to a diagnostic test is being assessed using
p.000085: subjective evaluation criteria, for example, skin changes in a skin prick test or for the assessment of
p.000085: tolerability. There have to be clear justifications in the protocol for the use of a placebo and no irreversible harm
p.000085: should occur to the participant. Post-trial access to the standard of care diagnostic test must be assured.
p.000085: 7.14.5 Safety follow-up of patients in these trials should not be limited to the duration of the diagnostic
p.000085: procedure but may be extended for a longer period according to the pharmacokinetic and pharmacodynamic properties of
p.000085: the diagnostic agent.
p.000085: 7.14.6 Long-term safety (when appropriate) should be assessed especially for agents accumulating in the
p.000085: body, such as deposits of gadolinium in bones and skin.
p.000085: 7.15 Radioactive materials and X-rays
p.000085: Radioactive substances contain a radioactive isotope, and may be used for therapeutic or diagnostic purposes. If the
p.000085: radioactive substance is to be tested as a drug then all the ethical considerations described in previous sections will
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
...
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
p.000089: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000089: 89
p.000090:
p.000090: Clinical Trials of Drugs and
p.000090: other Interventions
p.000090:
p.000090: disadvantaged populations may participate in the research to gain free access to an intervention. It is important to
p.000090: ensure that the participant has understood that this is research and the benefits expected may be small or they may not
p.000090: occur at all.
p.000090: 7.19.3 Participants must be made to understand that they may be randomized to a placebo group and therefore receive
p.000090: an inert drug, in case of a placebo-controlled study.
p.000090: 7.19.4 If the trial is a placebo- or active-controlled trial, all the groups must be given the current standard of
p.000090: care to which the IP, placebo or active control is added.
p.000090: 7.19.5 Perceptions of benefits and risks may be different for patients, healthcare workers and EC members. All
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
p.000090: 7.19.8 A post-trial access plan must be in place for patients who show benefit from an IP. In case it is a placebo
p.000090: controlled trial, those participants who have been in the placebo group may be offered post-trial access to the IP if
p.000090: found effective in other patients.
p.000090: 7.20 Clinical trials of products using any new technology
p.000090: If any product using new technologies (such as nanotechnology) is developed for human use and is to be evaluated in
p.000090: human beings, the following ethical issues have to be taken into consideration in addition to all the general ethical
p.000090: guidelines for clinical trials as elaborated in the guidelines.
p.000090: 7.20.1 Compliance with GLP, GMP, and GCP norms should be observed in research using new technology products.
p.000090: 7.20.2 Before the use of a new technology product in a human being, preclinical studies should be carried out and
p.000090: all applicable regulatory requirements fulfilled.
p.000090: 7.20.3 The new technology-based products should be contained and released into the environment in a
p.000090: step-wise manner after clearance from the appropriate authority regarding environmental safety.
p.000090: 7.20.4 Differing process based technologies can result in similarly functioning biological products which can
p.000090: give rise to IPR issues.
p.000090: 7.20.5 The research on new technologies should have a well-established mechanism or system for assessing the risk,
p.000090: both in terms of severity and temporality. The unpredictable
p.000090:
p.000090: 90 INDIAN COUNCIL OF
p.000091: MEDICAL RESEARCH
p.000091:
p.000091: Clinical Trials of Drugs and
p.000091: other Interventions
p.000091:
p.000091: metabolic behaviour in a human system during clinical trial cannot exclude long-term side effects which may manifest
p.000091: later, leading to compensation issues.
...
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
p.000095: • Principle of reciprocity – This principle requires that individuals or communities, who have borne a
p.000095: disproportionate share of burden or risks for the benefit of others be given some form of benefit. The benefit should
p.000095: be context specific such as protection from further exposure, access to food, healthcare, clothing and
p.000095: shelter, communication or compensation for lost income.
p.000095: • Principle of solidarity – Public health research should respect the intra- and inter- dependence among
p.000095: members of communities leading to solidarity for collective welfare or the common good.
p.000095: • Principle of accountability and transparency – The conduct of research must be fair, honest and transparent.
p.000095: The results should be made available in the public domain.
p.000095: In order to undertake a review of public health research, an EC must carefully consider the points given in Box 8.1.
p.000095: Box 8.1 Public health research proposal review
p.000095:
p.000095: When reviewing public health research proposals, ECs should consider the followings aspects:
p.000095: 1. Are the objectives of the study scientifically sound and linked to the achievement of public health goals?
p.000095: 2. Is individual written informed consent required?
p.000095: • If not, is gatekeeper consent/permission sufficient? Who is a gatekeeper and how is this
p.000095: decided?
p.000095: • Is it a two-stage process – initially a gatekeeper consent/permission followed by individual
p.000095: consent?
p.000095: 3. If applicable, is respect for the community applied through community engagement? If so, is the methodology
p.000095: appropriate?
p.000095: 4. Which segments of the population are likely beneficiaries and what are the expected benefits?
...
p.000095: • What, if any, measures can be taken to mitigate/minimize this?
p.000095: • Is the harm fairly distributed?
p.000095: • How do societal benefits outweigh individual harm?
p.000095: 6. Is social justice considered while designing, implementing and assessing outcomes of the study?
p.000095:
p.000095: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000095: 95
p.000096:
p.000096:
p.000096: Public Health Research
p.000096:
p.000096: 8.2 Ethical issues of epidemiological and public health research study designs
p.000096: 8.2.1 Epidemiological and public health research studies
p.000096: These involve use of different study methods and tools on a large number of research participants in single or multiple
p.000096: settings. These include observational studies (such as cross-sectional studies), case control studies, cohort studies,
p.000096: case reports, case series and other descriptive studies and experimental studies (such as field trials and cluster
p.000096: randomized controlled trials, stepped-wedge and quasi-experimental study designs involving groups, geographic
p.000096: areas, institutions or systems collectively rather than individually).
p.000096: • Specific ethical issues emerge from the scientific merit and design of the research
p.000096: and its implementation and should be considered by EC.
p.000096: 8.2.2 Surveillance, programme monitoring data and programme evaluations
p.000096: A fundamental public health activity is to measure and monitor changes in health status, risk factors and
p.000096: health service access and utilization. Surveillance is an ongoing, systematic collection, analysis, and interpretation
p.000096: of outcome-specific data, with the timely dissemination of these data to those responsible for preventing and
p.000096: controlling disease or injury. These data may be used by researchers for generating new evidence to improve programme
p.000096: performance, and for more generalizable application at other sites and contexts. Programme evaluation refers to
p.000096: the systematic application of scientific and statistical procedures for measuring programme conceptualization,
p.000096: design, implementation and utility; the comparison of these measurements; and the use of the resulting information to
p.000096: optimize programme outcomes. Evaluation research may or may not involve human participants such as health personnel,
p.000096: patients, community members and other stakeholders. It will also involve screening the documents and observations of
p.000096: various activities at different levels.
p.000096: • These studies may be placed under the exempt from review category in specific situations where the sole
p.000096: purpose of the exercise is refinement and improvement of the programme or where an unspecified but large number of
p.000096: stakeholders are to be interviewed who are spread across large geographic areas.
p.000096: • Proper ethical review must be carried out for programme evaluation research activities if it is clearly for
p.000096: generalizable knowledge, to ensure scientific soundness, examine the public health value and potential harm inherent in
p.000096: the protocol, and the need to have permission from relevant public health authorities.
p.000096:
p.000096:
p.000096: 96 INDIAN COUNCIL OF
...
p.000099: a case- by-case basis?
p.000099:
p.000099:
p.000099: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000099: 99
p.000100:
p.000100:
p.000100: Public Health Research
p.000100:
p.000100: 8.2.6 Community Trials
p.000100: These are trials carried out at the community level or on groups and the treatment or intervention is allocated to
p.000100: communities rather than individuals. These could both be interventional or observational studies. Such studies may be
p.000100: carried out for conditions that are influenced due to social reasons and the interventions may be directed at group
p.000100: behaviour as well. These studies target the community as a whole and the randomization is also at community level and
p.000100: usually the method is useful in order to study public health interventions or disease prevention models.
p.000100: • The studies require review and monitoring by EC as for other research.
p.000100: • Informed consent issues are complex and details in section 8.4 may be seen.
p.000100: 8.3 Use of administrative and other data sources for research
p.000100: Administrative data refer to systematically collected or compiled information designed to assist in programmatic and
p.000100: organizational operations. There is a shift in use of these data sets, from primarily managing and monitoring
p.000100: programmes and performing audits, to conducting research and informing policy. Large volume of data may be accessible
p.000100: from state health departments, national surveys, commercial sources and other data repositories and big data sources.
p.000100: In recent years, administrative data have been more widely used for research and the increase is attributed to
p.000100: technology improvements that permit easier data compilation and access and time- and cost-effectiveness. Data files are
p.000100: often population based, providing information on large numbers of persons and permitting longitudinal analysis over
p.000100: multiple years.
p.000100: • While such data can provide quick and easy access to information for secondary analysis, there are
p.000100: possibilities of misinterpretation of the data, violations of terms and conditions for which data was allowed
p.000100: access thus compromising data security, confidentiality of information, disclosure permissions, unauthorized and
p.000100: inappropriate use of the data, and unethical publication.
p.000100: • Partnership between the researcher(s) and the representation from the department or the organization from
p.000100: where data is sourced is considered an important strategy to take care of some of these concerns.
p.000100: • ECs should ensure that research using administrative data does not violate any
p.000100: principles of public health research ethics.
p.000100: 8.4 Informed consent
p.000100: 8.4.1 Obtaining informed consent – Several public health research studies, such as cluster
p.000100:
p.000100: 100 INDIAN COUNCIL OF MEDICAL
p.000101: RESEARCH
p.000101:
p.000101:
p.000101: Public Health Research
p.000101:
p.000101: randomized field trials or IR, have participants who cannot avoid interventions. This implies that
p.000101: participant’s informed consent refers only to data collection, not administration of an intervention.
p.000101: Occasionally, complete participant information may be a source of selection bias, which then raises methodological
p.000101: concerns. Participant informed consent in such types of research protocols should therefore be differently reviewed by
p.000101: an EC than in individually randomized trials because of methodological consequences.
...
p.000105: public health research.
p.000105: 9.1.4. There are, however, specific ethical issues involved in social and behavioural sciences studies as given in Box
p.000105: 9.1.
p.000105:
p.000105: Box 9.1 Ethical issues in social and behaviour sciences studies
p.000105:
p.000105: 1. Risks are non-measurable and dynamic in nature and therefore might be misconstrued as no/minimum risk research.
p.000105: 2. PI’s obligations related to data sharing, incidental findings and post-research benefits to the study population
p.000105: would need to be reviewed by the EC on a case-by-case basis, and prior approval from the EC should be obtained for any
p.000105: exemptions.
p.000105: 3. What would constitute ancillary care during such research needs to be carefully considered on a case-by-case basis
p.000105: by the EC.
p.000105: 4. As part of the research protocols, socially, legally, medically and technically unacceptable practices and
p.000105: behaviour may be discovered, documented, or observed. While researchers are not required to interrupt such behaviours
p.000105: to determine the truth, they must document these in the research findings and appropriately disseminate the findings
p.000105: for the larger social good.
p.000105: 5. While maintaining the privacy and confidentiality of the respondent’s identity, researchers have an obligation
p.000105: to report the extent or the patterns of behaviour, such as suicidal tendency or infanticide, to the
p.000105: concerned authorities.
p.000105:
p.000105: 9.1.5 Ethical challenges are more pronounced in collaborative research (national or international) due to
p.000105: possible inequity of expertise and knowledge access between partnering institutions and researchers, and funding
p.000105: relationships. See section 3.8.3 for further details.
p.000105: 9.1.6 Appropriate experts/expertise of EC members in the social and behavioural sciences domain are an essential
p.000105: aspect to address the above challenges.
p.000105: 9.2 Addressing the ethical challenges
p.000105: 9.2.1 Design and conduct of the study is important for a meaningful outcome in social and behavioural research. See
p.000105: Box 9.2 for further details.
p.000105:
p.000105: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000105: 105
p.000106:
p.000106: Social and Behavioural Sciences
p.000106: Research for Health
p.000106: Box 9.2 Consideration for appropriate design and conduct of study
p.000106:
p.000106: 1. Like any other research, the researchers must ensure that the proposed studies are scientifically sound, built
p.000106: on an adequate prior knowledge base, and are likely to generate valuable information.
p.000106: 2. In socially stratified groups and communities, researchers must spend time to become conversant with
p.000106: cultural norms and practices in order to develop strategies to build trust and negotiate power in ways that do not put
p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
...
p.000109: Research involving any kind of deception should:
p.000109: • pose no more than minimal risk;
p.000109: • not adversely affect the welfare and safety of the participants;
p.000109: • be conducted only when the research cannot be carried out without deception;
p.000109: • have an adequate plan for debriefing the participants after completion of the
p.000109: study, if appropriate;
p.000109: • disseminate results of research to the participants, if applicable; and
p.000109: • be carefully reviewed by the EC.
p.000109: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000109: 109
p.000110:
p.000110: Social and Behavioural Sciences
p.000110: Research for Health
p.000110: Box 9.5 Types of deception
p.000110:
p.000110: 1. Active deception: Selective withholding of the information/hypothesis of the study in the consent form along with
p.000110: giving incorrect information for achieving public good without influencing the outcome of the study, for example,
p.000110: psychology, neuro- behavioural, behaviour intervention study.
p.000110: 2. Incomplete disclosure: If research involves incomplete disclosure but no deception.
p.000110: 3. Authorized deception: Unlike in active deception, participants are informed that they would be deceived prior to
p.000110: the research but the nature of the deception will not be disclosed or research will not be described accurately or some
p.000110: procedures will be deceptive. Such revelation provides the participants an opportunity to decide whether or not to
p.000110: participate on these terms.
p.000110:
p.000110: 9.2.10 Safety of participants
p.000110: Support systems, such as access to counselling centres, rehabilitation centres, police protection, etc., should be in
p.000110: place when research is on a sensitive issue, such as mental health, gender based violence and social exclusion and
p.000110: discrimination.
p.000110: 9.2.11 Safety of research teams in the field
p.000110: The safety of the research team is the responsibility of the institution, sponsors and local authorities, particularly
p.000110: in research on sensitive topics or in sensitive research settings since there would be a possibility of the researcher
p.000110: or research team being subjected to disturbing instances while conducting the research. Besides providing safety,
p.000110: including insurance coverage, and giving training to the researcher or research team to meet such challenges, setting
p.000110: up community advisory boards could be helpful to ease the situation.
p.000110: 9.2.12 Qualitative research
p.000110: The knowledge gathered through qualitative research is interpretative based on the observation and its
p.000110: analysis by the researcher or research team which is socially constructed at individual and socio-cultural levels.
p.000110: • Informed consent is very often dynamic in nature and negotiable. When written
p.000110: consent may not be possible, other means could be used and documented.
...
p.000124: technology.
p.000124: • The risks are irreversible changes in germline, risks of inaccurate genome editing, implications for future
p.000124: generations, interactions with other genetic variations and environment, and the fear that once the genetic change is
p.000124: introduced it may be permanent which would have long-term effects.
p.000124: • Despite the promise of the technique, there is a possibility of encountering error in genetic engineering which
p.000124: has unforeseen implications. Cas9 will sometimes identify a wrong target even when up to five of the guide RNAs do not
p.000124: match the DNA – hence the off-target mutations may cause disease or alter germline or DNA of future generations of
p.000124: humans.
p.000124: • It could be used to change harmless genes, as for eye colour, leading to designer possibilities. There are also
p.000124: possibilities of creating interspecies organogenesis or chimerism. There are possibilities of making gene correction in
p.000124: zygotes using CRISPR-Cas9 which has ethical implications.
p.000124: • The application of this technology in plants and animals can lead to possible lateral transfer and emergence of
p.000124: irreversible damage to biodiversity and environment which can be a risk to not only human and animal life but also the
p.000124: environment due to its long-term consequences. It could also possibly be used for bioterrorism.
p.000124: • CRISPR-Cas9 needs to be judged for the good of future generations. This needs
p.000124: time and thus, at present, there is a ban on germline manipulations.
p.000124: • There is a need to consider the possibility of commercialization, patenting or rightful access, therefore, a
p.000124: vigorous benefit-risk evaluation is required to address the expectations and concerns of the public. There is need for
p.000124: an initial cautious approach before this technology can be widely used for various applications.
p.000124: • An open and transparent discussion, advocacy and public engagement should be
p.000124:
p.000124: 124 INDIAN COUNCIL OF MEDICAL
p.000125: RESEARCH
p.000125:
p.000125: Human
p.000125: Genetics Testing and Research
p.000125:
p.000125: encouraged with various stakeholders to understand, build trust and be involved in decision making. Capacity building
p.000125: is required not only of researchers but also regulators and policy makers to carefully consider social and ethical
p.000125: aspects and put systems in place to ensure safety.
p.000125: • At the moment, there is a need for initiatives to increase knowledge base, infrastructure, funding,
p.000125: guidelines, inter agency communications and interactions, engagement with public and other stakeholders, and
p.000125: establish science communication. In addition, attempts should be made to foster research to assess the feasibility,
p.000125: efficacy and safety of CRISPR technology.
p.000125: 10.15.4 Genome-wide association study (GWAS)
p.000125: Genetic epidemiology, also known as whole genome-wide association study, involves an examination of many common genetic
p.000125: variants in different individuals to see if any variant is associated with a trait. A GWAS typically focuses on
p.000125: associations between single-nucleotide polymorphisms (SNPs) and traits like major diseases, particularly multifactorial
...
p.000128: with other researchers and overarching ethical oversight. The biological materials could be kept for research, assisted
p.000128: reproductive technology (ART) purposes or for forensic purposes. The stored samples in these biobanks can range
p.000128: from small numbers in researcher’s refrigerator to departments, research institutions including universities and
p.000128: non-profit organizations, judiciary custody, pharmaceutical companies and may extend into large warehouse like
p.000128: facilities at a single site or a chain of facilities with central coordination which provide medical, genetic and
p.000128: life-style related data. Thus biobank may be very large with public or private funding, for commercial or non
p.000128: commercial use and on other hand may be small limited to a researcher who stores samples in the laboratory or at
p.000128: institutional level where common facility is available for storing samples. Biobanks can also store non-human
p.000128: materials, such as plant, animal, microbes and parasites, but for the purpose of these guidelines this section will
p.000128: only pertain to human biomaterials and/or related data.
p.000128: There is a need to comply with all the safety requirements and sets of universal standards, testing of biomaterials and
p.000128: biocompatibility as per relevant regulatory standards. The testing of such standards could be done in a NABL certified
p.000128: laboratory.
p.000128: As biobanking concerns storage and research at a later time, the ethical issues pertaining to consent requirements for
p.000128: the collection and banking and further uses of tissue and DNA samples and/or data are the same but with greater
p.000128: responsibilities concerning their ownership, access and benefit sharing to the individual or community. Therefore, to
p.000128: prevent any exploitation and protect the rights of donors, the main requirements are individual informed consent,
p.000128: clarity on custodianship, approval of the EC and the repository governance committee and post-research benefit sharing,
p.000128: wherever applicable.
p.000128: 11.1.1 Samples can be classified in a variety of manner. Samples classified on the basis of availability of attached
p.000128: identifying information are provided in Table 11.1.
p.000128: 11.1.2 Privacy of donor and confidentiality related to biological materials and/or data
p.000128: This pertains to both personal identifiers and the related data of the participant. Some key points for maintaining
p.000128: privacy and confidentiality related to donors are listed in Box 11.1.
p.000128: 11.2 Storage of biospecimens and data with personal identifiers
p.000128: 11.2.1 Informed consent, confidentiality, privacy and re-consent are largely influenced by the degree of
p.000128: identifiability, whether the biospecimens and data are anonymized or not. As a general principle, research must be
p.000128: conducted on least identifiable data.
p.000128:
p.000128:
p.000128: 128 INDIAN COUNCIL OF MEDICAL
p.000129: RESEARCH
p.000129:
p.000129: Biological Materials,
p.000129: Biobanking and Datasets
p.000129:
p.000129:
p.000129: Table 11.1 Types of samples
p.000129:
p.000129:
p.000129: Anonymous or unidentified
p.000129: No identifiers are present from the start or if collected, are not maintained. Such samples are received by
p.000129: biobanks without any identifiers and supplied to researchers.
p.000129: Anonymized This involves systematic de-identification, reversible or irreversible: link of samples/data
p.000129: to personal identity is reversibly or irreversibly cut.
p.000129:
p.000129:
p.000129: Coded or reversibly anonymized: There is an indirect link of sample/ data to the participant’s
p.000129: identity with restricted access. This link could be re-linked if required; therefore, it may also be
p.000129: termed reversible anonymization.
p.000129: Irreversibly anonymized:
p.000129: Link to the participant’s identity is removed and cannot be re-linked.
p.000129: Identifiable A direct link of sample/data to the participant’s identity exists.
p.000129:
p.000129:
p.000129: Box 11.1 Confidentiality and privacy of donors related to biological materials and/or data
p.000129:
p.000129: Some key aspects related to maintaining confidentiality and privacy of donors of biological materials and/or data:
p.000129: 1. The procedure of anonymization minimizes the connection between the identifiers and the stored sample or medical
p.000129: data by delinking the person from her/his biological material.
p.000129: 2. Maintaining confidentiality of data and respecting ethnic identity is of prime importance, especially
p.000129: in population based genetic studies.
p.000129: 3. More precautions should be sought when the research pertains to stigmatizing diseases.
p.000129: 4. When data pertains to epidemiological and public health practice or research, it may be dealt with in the manner
p.000129: described in section 8.
p.000129:
p.000129: 11.2.2 Under certain circumstances, some degree of identifiability may have to be retained for reasons related to the
p.000129: research. For example, anonymized data or specimens will not allow later withdrawal of consent by an individual, while
p.000129: in the coded category, this will be possible. In the latter scenario, the custodians of the respective biorepository or
p.000129: biobank have a greater responsibility to take adequate measures to safeguard the
p.000129:
p.000129: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000129: 129
p.000130:
p.000130: Biological Materials,
p.000130: Biobanking and Datasets
p.000130:
p.000130: codes and the data so as to respect the privacy and confidentiality of individual research participants.
p.000130: 11.2.3 Permissibility of a certain research design, acceptability of benefits versus risks, and adequacy of the
p.000130: informed consent, will thus have to be assessed by the EC on a case- by-case basis, taking into account specific
p.000130: contextual and potential vulnerability factors of the participants and the sensitive nature of the proposed research.
p.000130: 11.3 Ethical issues related to donors
p.000130: 11.3.1 Informed consent for biobanking poses specific ethical issues as the aims of scientific study based on which
p.000130: biospecimens are collected and stored in a biorepository are not defined clearly at the time of collection when there
p.000130: are no specific end points and there is a time lag between the collection of the sample and its use in research.
p.000130: 11.3.2 The issues involve multiple stages at which consent needs to be administered – storage, analysis of the
p.000130: biospecimens/samples, use of data linked to the sample, incidental findings, return of results to the
p.000130: participant, sharing of the sample/data with other researchers/national or international institutions, multicentre
p.000130: and multinational collaborations and potential commercialization. These raise issues of access and benefit sharing.
p.000130:
p.000130: Box 11. 2 Example of multiple options in a multi-layered consent
p.000130:
p.000130: Please pick one of the choices below:
p.000130: a. I agree to allow my sample/biospecimen to be stored for future use for any biomedical research.
p.000130: b. I agree to allow my sample/biospecimen to be stored for future use for specific disease such as cancer
p.000130: research.
p.000130: c. I agree to allow my sample/biospecimen to be stored for future use for other pre- specified health problems, such
p.000130: as diabetes, heart disease.
p.000130: d. I do not wish to allow my sample/biospecimen to be used in future research which is beyond the scope I have
p.000130: already consented for, unless researchers re-contact me to seek my permission.
p.000130: e. I do not wish to allow my sample/biospecimen to be used in future research. I do not want researchers to contact
p.000130: me about future studies.
p.000130: f. I wish to be informed/not to be informed about the results of my investigation.
p.000130:
p.000130: Examples of different types of consent processes and their implications are given in Box 11.3.
p.000130: 130 INDIAN COUNCIL OF MEDICAL
p.000131: RESEARCH
p.000131:
p.000131: Biological Materials,
p.000131: Biobanking and Datasets
p.000131:
p.000131: Box 11. 3 Types of consent processes and their implications
p.000131: 1. Blanket or broad consent: This is an open consent given only once to collect the sample, store it and use it for
p.000131: any research at any time in future without the need to revert to the individual for a re-consent. A consent model that
p.000131: allows for current and future access and use of samples or data for research without necessarily specifying what the
p.000131: focus of such studies might be.
p.000131: 2. Tiered consent: This model of consent offers several options from which participants can choose. It
p.000131: includes an opt-in option for future use specifying general permission, or use only related to some aspects of
p.000131: research, sharing of biospecimens/data benefit sharing, etc. It also takes into consideration return of results for
p.000131: which options are also provided for consent. See section 11.4.4 for further details.
p.000131: 3. Specific consent: Consent is obtained for a specific research purpose. Participants are re- contacted
p.000131: for every new use of their stored samples/data if the scope of research is outside that for which they had originally
p.000131: given consent.
p.000131: 4. Delayed consent: It may be administered in the post-medical procedure period when biospecimen or data
p.000131: may be collected for appropriate research from critically ill patients who may not have given prior consent for
p.000131: research. Consent may be taken from the participant or LAR when it is practical.
...
p.000133: • In the absence of an appropriate mechanism to deal with informational harm that can occur if participants are
p.000133: provided feedback when they are not prepared to face it or if it is not actionable or when such information is
p.000133: unrelated, a lot of distress could be caused to participants concerned.
p.000133: • At the time of sample collection, it may be a good approach to offer donors the choice of receiving the
p.000133: results of the research whether they are beneficial or not. Participants may also choose not to be contacted about
p.000133: their results. Another alternative is to give participants the option of receiving an aggregate report of all the
p.000133: results of the study which could become a shared benefit for the community. The aforementioned options may be
p.000133: incorporated in a tiered consent.
p.000133:
p.000133: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000133: 133
p.000134:
p.000134: Biological Materials,
p.000134: Biobanking and Datasets
p.000134:
p.000134: 11.4.5 Benefit sharing
p.000134: Biological materials and/or data have potential commercial value but the participants’ contribution and their share in
p.000134: this benefit is very often not known to them. The informed consent document should emphasize this aspect with necessary
p.000134: clauses for clarity about benefit sharing. See Box 11.5 for further details.
p.000134: Box 11.5 Considerations for benefit sharing
p.000134:
p.000134: 1. The document should describe whether donors, their families, or communities would receive any financial or
p.000134: non-financial benefits by having access to the products, tests, or discoveries resulting from the research.
p.000134: 2. The benefits accrued, if any, should be returned to the communities from where the donors were drawn in
p.000134: community-based studies.
p.000134: 3. To the maximum extent possible, benefits should be indirect or in kind.
p.000134:
p.000134: 11.4.6 Role of the EC
p.000134: ECs play a key role in oversight and use of the bio- and data repositories for research, scientific and public health
p.000134: programmes. Research proposals, which require biorepository services including material transfer and available data
p.000134: sets, should be reviewed by the EC, either an institutional one or that of the biorepository.
p.000134: 11.5 Biological material/data in forensic departments of laboratories
p.000134: Specimens collected for forensic purposes and related or unrelated data (DNA profiling) offer a good source for
p.000134: academic research after the initial purpose has been served. Data sharing with researchers across the globe is a common
p.000134: practice for refining techniques to develop biomarkers, which could identify missing persons in most difficult
p.000134: circumstances (for example, highly decomposed bodies, disaster situations). In academic institutions, there is a demand
p.000134: for organs and tissues for education, training and research purposes.
p.000134: 11.5.1 Informed consent: If there is no written consent by the deceased person permitting use of organs or tissues, the
p.000134: family can be approached for consent for use of left-over organs or tissues.
...
p.000135: implications for family members. In such instances, all ethical requirements as in the case of live
p.000135: participants should be followed.
p.000135: 11.5.7 The role of the EC is to review and approve the type of consent – broad, tiered with or without option to
p.000135: opt-out or specific and to assess from whom it would be taken – the family, closest relative or friend – or whether
p.000135: sample anonymization should be done.
p.000135: 11.6 Governance of biobank/biorepository
p.000135: Institutions where data are collected and archived must have an established governance structure with the following
p.000135: requirements for regulation.
p.000135: 11.6.1 Each biorepository should have its own technical authorization committee with representation of both
p.000135: science and ethics and external members. This committee should function in tandem with the EC.
p.000135: 11.6.2 A technical authorization committee, indigenous to the biorepository, should govern collection of specimens,
p.000135: disbursement of biospecimens and data to researchers. The same committee should also oversee regulatory aspects like
p.000135: execution of MTA or data transfer agreement (DTA) for transfer of biospecimens and/or data to other institutions.
p.000135: 11.6.3 Stand-alone huge repositories should have separate technical authorization committees and ECs to undertake the
p.000135: above-mentioned tasks.
p.000135: 11.6.4 The biobank should have well-structured SOPs and clear guidelines for collection, coding,
p.000135: anonymization, storage, access, retrieval and sharing of biospecimens and data.
p.000135: 11.6.5 The technical authorization committee/governance committee could comprise members such as clinicians,
p.000135: geneticists, lawyers, basic scientists, sociologists, epidemiologists, statisticians and ethicists.
p.000135: 11.7 Special issues related to datasets
p.000135: 11.7.1 With increasing ease of establishing and maintaining large repositories the primary objective of data collection
p.000135: and storage in some of these databases may not be research but with advances in information technology (IT) and
p.000135: decreasing costs, they offer a huge potential for subsequent research as well as commercialization. Whenever such
p.000135: repositories are used for purposes of research or for subsequent commercialization, it must follow the expected
p.000135: requirements of any other health-related research with due
p.000135: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000135: 135
p.000136:
p.000136: Biological Materials,
p.000136: Biobanking and Datasets
p.000136:
p.000136: diligence, including review by an EC.
p.000136: 11.7.2 There is also a proliferation of data mining and other data science tools that can be employed on existing
p.000136: databases for research purposes to reduce costs and health related processes. EC approval is required to establish
p.000136: legitimacy of the purpose for data mining, access control and about the usefulness of information for particular groups
p.000136: (such as rare disease group). Data privacy, data accuracy, data security, and possibility of legal liability should be
p.000136: ensured when the data is outsourced or sold. Auditing could be done to detect misuse.
p.000136: 11.7.3 Health data is increasingly being collected outside of traditional healthcare settings. Data is shared with
p.000136: third parties not only for research, but also for commercial gain. Big data in health research raise a wide spectrum of
p.000136: ethical issues, ranging from risks to individual rights, such as privacy and concerns about autonomy to individuals.
p.000136: There are unique aspects, such as its data sources, scale, and open access provisions. Ethical issues related to data
p.000136: security, sharing, rights, benefit sharing and others surrounding big data need to be closely examined.
p.000136: 11.7.4 Databases maintained in electronic/digital formats, linked by internet or other networks, using cloud
p.000136: computing technologies and those associated with big data initiatives, may pose additional risks to privacy and
p.000136: confidentiality than what is described under biobanks or traditional paper-based data repositories. Hence, in
p.000136: such situations all reasonable measures must be adopted to respect and protect privacy and confidentiality of
p.000136: individuals as given in Box 11.6.
p.000136: Box 11.6 Measures to ensure privacy and confidentiality of individuals
p.000136:
p.000136: 1. Ensure physical safety and security of the involved devices and computer servers
p.000136: 2. Take data security measures such as password protection
p.000136: 3. Provide differential and role-based controlled access to data elements for members of the research team
p.000136: 4. Ensure use of data encryption when data is transferred from one location/device to another
p.000136: 5. Ensure benefit sharing with owners and related legal issues since, unlike some other countries, India
p.000136: does not have a data protection act as yet
p.000136: 11.8 Contingency plan
p.000136: One of the important but often neglected ethical issues related to biorepository is the legacy or
p.000136: contingency plan. Institutions should develop the contingent plans for sustainability of the biobanks.
p.000136:
p.000136: 136 INDIAN COUNCIL OF MEDICAL
p.000137: RESEARCH
p.000137:
p.000137: SECTION 12
p.000137:
p.000137:
p.000137: RESEARCH DURING HUMANITARIAN EMERGENCIES AND DISASTERS
p.000137:
p.000137: 12.0 A humanitarian emergency or disaster is an event or series of events that represents a critical threat to the
p.000137: health, safety, security or well-being of a community or other large group of people, usually covering a wide
p.000137: land area. For the purpose of these guidelines, humanitarian emergencies and disasters include both man-made and
p.000137: natural ones, some of which occur at periodic frequency. Emergencies, such as an earthquake, flood, mass migration,
p.000137: conflict and outbreak of disease, leading to substantial material damage affecting persons, communities, society
...
Searching for indicator access to information:
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p.000100: communities rather than individuals. These could both be interventional or observational studies. Such studies may be
p.000100: carried out for conditions that are influenced due to social reasons and the interventions may be directed at group
p.000100: behaviour as well. These studies target the community as a whole and the randomization is also at community level and
p.000100: usually the method is useful in order to study public health interventions or disease prevention models.
p.000100: • The studies require review and monitoring by EC as for other research.
p.000100: • Informed consent issues are complex and details in section 8.4 may be seen.
p.000100: 8.3 Use of administrative and other data sources for research
p.000100: Administrative data refer to systematically collected or compiled information designed to assist in programmatic and
p.000100: organizational operations. There is a shift in use of these data sets, from primarily managing and monitoring
p.000100: programmes and performing audits, to conducting research and informing policy. Large volume of data may be accessible
p.000100: from state health departments, national surveys, commercial sources and other data repositories and big data sources.
p.000100: In recent years, administrative data have been more widely used for research and the increase is attributed to
p.000100: technology improvements that permit easier data compilation and access and time- and cost-effectiveness. Data files are
p.000100: often population based, providing information on large numbers of persons and permitting longitudinal analysis over
p.000100: multiple years.
p.000100: • While such data can provide quick and easy access to information for secondary analysis, there are
p.000100: possibilities of misinterpretation of the data, violations of terms and conditions for which data was allowed
p.000100: access thus compromising data security, confidentiality of information, disclosure permissions, unauthorized and
p.000100: inappropriate use of the data, and unethical publication.
p.000100: • Partnership between the researcher(s) and the representation from the department or the organization from
p.000100: where data is sourced is considered an important strategy to take care of some of these concerns.
p.000100: • ECs should ensure that research using administrative data does not violate any
p.000100: principles of public health research ethics.
p.000100: 8.4 Informed consent
p.000100: 8.4.1 Obtaining informed consent – Several public health research studies, such as cluster
p.000100:
p.000100: 100 INDIAN COUNCIL OF MEDICAL
p.000101: RESEARCH
p.000101:
p.000101:
p.000101: Public Health Research
p.000101:
p.000101: randomized field trials or IR, have participants who cannot avoid interventions. This implies that
p.000101: participant’s informed consent refers only to data collection, not administration of an intervention.
p.000101: Occasionally, complete participant information may be a source of selection bias, which then raises methodological
p.000101: concerns. Participant informed consent in such types of research protocols should therefore be differently reviewed by
...
Social / Age
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p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
...
p.000027: members of the proposed EC and who will oversee and monitor the functioning of the Ind EC.
p.000027: • It should function according to SOPs that follow the national guidelines for
p.000027: functioning of ECs.
p.000027: • It should not accept research proposals from investigators affiliated to institutions
p.000027: that have their own ECs unless there is an MoU.
p.000027: • It will have rights and responsibilities related to the projects submitted to it.
p.000027: • It should have access to all research records, including the source documents and
p.000027: research participants.
p.000027: • It should undertake continuing review of the implemented project including site
p.000027: visits.
p.000027: • It should familiarize itself with local socio-cultural norms that may help to ensure
p.000027: protection of rights and well-being of research participants.
p.000027: 4.2.6 Institutions could have subcommittees such as the SAE subcommittee or expedited review committee. These should
p.000027: be part of the main committee and comprise Chairperson/ Member Secretary and one to two appropriate designated members
p.000027: of the main EC as defined in the SOPs. These subcommittees can report to the concerned main EC.
p.000027: 4.2.7 Institutions could have separate committee for SAE in which one or two members of EC could be included to
p.000027: facilitate continuity of EC activity and its report should be reviewed by main EC.
p.000027: 4.3 Composition of an EC
p.000027: 4.3.1 ECs should be multi-disciplinary and multi-sectoral.
p.000027: 4.3.2 There should be adequate representation of age and gender.
p.000027: 4.3.3 Preferably 50% of the members should be non-affiliated or from outside the institution.
p.000027: 4.3.4 The number of members in an EC should preferably be between seven and 15 and a minimum of five members should
p.000027: be present to meet the quorum requirements.
p.000027: 4.3.5 The EC should have a balance between medical and non-medical members/technical and non-technical members,
p.000027: depending upon the needs of the institution.
p.000027: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000027: 27
p.000028:
p.000028:
p.000028: Ethical Review Procedures
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: S.
p.000028: No.
p.000028:
p.000028: The composition, affiliations, qualifications, member specific roles and responsibilities are given in Table 4.1.
p.000028: Table 4.1 Composition, affiliations, qualifications, member specific roles and responsibilities of an EC
p.000028:
p.000028: Members of EC Definition/description
p.000028:
p.000028: 1. Chairperson/
p.000028: Vice Chairperson (optional) Non-affiliated
p.000028: Qualifications -
p.000028: A well-respected person from any background with prior experience of having served/ serving in an EC
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 2. Member Secretary/ Alternate Member Secretary (optional)
p.000028: Affiliated
p.000028:
p.000028: Qualifications -
p.000028: • Should be a staff member of
p.000028: the institution
p.000028: • Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills
p.000028: • Conduct EC meetings and be accountable for independent
...
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
p.000062: 7. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is
p.000062: age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
...
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
p.000064: definitely benefit the child but would be available only if the child participates in the study, waiver of assent could
p.000064: be allowed. However, this situation should be accepted only in exceptional cases where all forms of assent/consent have
p.000064: failed. In such cases, approval of the EC should be obtained.
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
...
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
...
p.000114: country should be done as per relevant guidelines.
p.000114: 10.3.9 Handling IPRs related to gene patenting and development of newer technologies for commercial gains should
p.000114: follow the applicable national policy/regulations.
p.000114: 10.3.10 Newer genomic techniques for research like whole exome sequencing (WES) and whole genome sequencing
p.000114: (WGS) may create uncertain evidence at the present level of knowledge. Therefore, the confidentiality of data, and pre-
p.000114: and post-test counselling need to be revisited with an entirely new perspective.
p.000114: 10.4 Informed consent
p.000114: Stringent norms and caution should be followed in the consent process when done for research purposes.
p.000114: 10.4.1 For routine genetic diagnostic testing, written consent may or may not be needed as per institutional
p.000114: policies; however, for any research it is required.
p.000114: 10.4.2 Informed written consent is essential for procedures such as pre-symptomatic testing, next generation
p.000114: sequencing (NGS), prenatal testing, genomic studies, carrier status etc.
p.000114: 10.4.3 It needs to be emphasized that consent for screening or a subsequent confirmatory test does not imply consent
p.000114: to any specific treatment or termination of the pregnancy or for research.
p.000114: 10.4.4 If the research or testing involves a child, appropriate age-specific assent (verbal/
p.000114:
p.000114:
p.000114: 114 INDIAN COUNCIL OF MEDICAL
p.000115: RESEARCH
p.000115:
p.000115: Human
p.000115: Genetics Testing and Research
p.000115:
p.000115: oral/written) should be obtained along with parental consent. See section 6 for further details.
p.000115: 10.4.5 In addition to the general contents specified in section 5, the consent form for genetic testing for research
p.000115: may have explanations/details on the following elements:
p.000115: • the nature and complexity of information that would be generated;
p.000115: • the nature and consequences of return of results and choice offered to the participant whether to
p.000115: receive that information or not and incidental findings, if any;
p.000115: • direct/indirect benefits and their implications including if there are no direct
p.000115: benefits to the participants;
p.000115: • how the data/samples will be stored, for how long, and procedures involved in
p.000115: anonymisation, sharing , etc. See section 11 for further details;
p.000115: • choice to opt out of testing/withdraw from research at any time;
p.000115: • whether the affected individual or the proband would like to share her/his genetic
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
...
p.000131: be referred to as partial.
p.000131: 7. Waiver of consent: While using anonymized (de-identified) samples/data, researchers should seek the approval of
p.000131: the EC of the institution or the repository for waiver of consent from donors.
p.000131: 8. Re-consent
p.000131: • Secondary or extended uses of stored samples/dataset: In such an instance, one of the preliminary considerations
p.000131: for ECs must be to identify the circumstances under which the research requires re-use of collected identifiable
p.000131: biological material to generate the data or utilize the pre-existing identifiable dataset. This must also include
p.000131: review of the informed consent obtained originally to see if re-consent is warranted. There may be situations where
p.000131: consent would be impossible or impracticable to obtain for such research, in which case the research may be done only
p.000131: after independent evaluation by an EC (Declaration of Helsinki, October 2013).
p.000131:
p.000131:
p.000131: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000131: (Contd.)
p.000131: 131
p.000132:
p.000132: Biological Materials,
p.000132: Biobanking and Datasets
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: • Paediatric donors: In longitudinal studies once the child donor attains the legal age of consent a re-consent
p.000132: should be sought for the storage and use of her/his tissue or sample. In paediatric biobanks or biobanks with
p.000132: paediatric samples it is important to address the issue of children reaching legal age of consent. Sometimes re-contact
p.000132: may lead to withdrawal, resulting in limited data analysis. This may lead to bias or it could evoke emotional distress
p.000132: about past research. On the other hand, re-consent may give the participant the power to agree. A biobank should decide
p.000132: the policy it would like to adopt for re-contact.
p.000132:
p.000132: 11.4 Ethical issues related to research
p.000132: Biobanks can use the stored material/data for doing research themselves or they can outsource or supply such
p.000132: material/data to other researchers or institutions on a non- profit basis.
p.000132: 11.4.1 Ownership of the biological samples and data: The participant owns the biological sample and data collected
p.000132: from her/him and therefore, could withdraw both the biological material donated to the biobank and the
p.000132: related data unless the latter is required for outcome measurement and is so mentioned in the initial informed
p.000132: consent document. Complete anonymization would practically make the original donor lose the right of ownership.
p.000132: Biobanks/institutes are the custodians or trustees of the samples and data through their ECs as their present and
p.000132: future use would be done under supervision of the respective ECs. Researchers have no claim for either ownership or
p.000132: custodianship.
p.000132: 11.4.2 Transfer of biospecimens: An MTA should be executed if the biospecimens are likely to be shipped from the host
p.000132: institution to collaborating institutions within the country or abroad. The EC should oversee the process of
p.000132: the in-country and international material transfer. Mandatory regulatory clearances with appropriate MoU are
...
p.000151: RCR responsible conduct of research
p.000151: SAE serious adverse events
p.000151: SIDCER Strategic Initiative for Developing Capacity in Ethical Review
p.000151: SOP standard operating procedure
p.000151: TM traditional medicines
p.000151: TOR terms of reference
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000151: 151
p.000152:
p.000152: GLOSSARY
p.000152: 1. Accountability The obligation of an individual or organization to account for its activities, accept
p.000152: responsibility for them and to disclose the results in a transparent manner.
p.000152: 2. Adverse event Any untoward medical occurrence in a patient or participant involved in a study
p.000152: which does not necessarily have a causal relationship with the intervention. The adverse event can therefore be
p.000152: any unfavourable or unintended sign or experience, whether or not related to the product under investigation.
p.000152:
p.000152: 3. Appellate
p.000152: authority
p.000152: It decides on the appeal filed against a decision of the lower authority. Its mandate is to ensure
p.000152: that due process of law is followed.
p.000152: 4. Assent To agree or approve after thoughtful consideration an idea or suggestion to
p.000152: participate in research by a young person below the age of 18 years who is old enough to understand the implications of
p.000152: any proposed research but not legally eligible to give consent. The assent has to be corroborated with informed consent
p.000152: of parent/ LAR.
p.000152: 5. Audit A systematic and independent examination of research activities and documents to
p.000152: determine whether the review and approval activities were conducted, data recorded and accurately reported as per
p.000152: applicable guidelines and regulatory requirements.
p.000152: 6. Autonomy The ability and capacity of a rational individual to make an independently
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
p.000152: 152 INDIAN COUNCIL OF MEDICAL
p.000153: RESEARCH
p.000153:
p.000153:
p.000153: Glossary
p.000153:
p.000153:
p.000153: 8. Biomedical and health research
p.000153: Research including studies on basic, applied and operational research designed primarily to increase the
...
Social / Child
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p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
p.000008: 2.5.1 If applicable, participants may be reimbursed for expenses incurred relating to their participation in
p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
p.000008: is applicable to all participants, including those in comparator/control groups.
p.000008: 2.5.3 If there are provisions, participants may also receive additional medical services at no cost.
p.000008: 2.5.4 When the LAR is giving consent on behalf of a participant, payment should not become an undue inducement and to
p.000008: be reviewed carefully by the EC. Reimbursement may be offered for travel and other incidental expenses incurred due to
p.000008: participation of the child/ward in the research.
p.000008: 2.5.5 ECs must review and approve the payments (in cash or kind or both) and free services and the processes
p.000008: involved, and also determine that this does not amount to undue inducement.
p.000008: 2.6 Compensation for research-related harm
p.000008: Research participants who suffer direct physical, psychological, social, legal or economic harm as a result of their
p.000008: participation are entitled, after due assessment, to financial or other assistance to compensate them equitably
p.000008: for any temporary or permanent impairment or disability. In case of death, participant’s dependents are
p.000008: entitled to
p.000008:
p.000008: 8 INDIAN COUNCIL OF
p.000009: MEDICAL RESEARCH
p.000009:
p.000009:
p.000009: General Ethical Issues
p.000009:
p.000009: financial compensation. The research proposal should have an in-built provision for mitigating research related harm.
p.000009: 2.6.1 The researcher is responsible for reporting all SAEs to the EC within 24 hours of knowledge.
p.000009: Reporting of SAE may be done through email or fax communication (including on non-working days). A report on
p.000009: how the SAE was related to the research must also be submitted within 14 days.
p.000009: 2.6.2 The EC is responsible for reviewing the relatedness of the SAE to the research, as reported by the researcher,
p.000009: and determining the quantum and type of assistance to be provided to the participants.
...
p.000054:
p.000054: The EC may grant consent waiver in the following situations:
p.000054: • research cannot practically be carried out without the waiver and the waiver is scientifically
p.000054: justified;
p.000054: • retrospective studies, where the participants are de-identified or cannot be contacted;
p.000054: • research on anonymized biological samples/data;
p.000054: • certain types of public health studies/surveillance programmes/programme evaluation studies;
p.000054: • research on data available in the public domain; or
p.000054: • research during humanitarian emergencies and disasters, when the participant may not be in a position to give
p.000054: consent. Attempt should be made to obtain the participant’s consent at the earliest.
p.000054:
p.000054: 5.8 Re-consent or fresh consent
p.000054: Re-consent is required in the following situations when:
p.000054: • new information pertaining to the study becomes available which has
p.000054: implications for participant or which changes the benefit and risk ratio;
p.000054: • a research participant who is unconscious regains consciousness or who had suffered loss of insight regains
p.000054: mental competence and is able to understand the implications of the research;
p.000054: • a child becomes an adult during the course of the study;
p.000054: • research requires a long-term follow-up or requires extension;
p.000054: • there is a change in treatment modality, procedures, site visits, data collection methods or tenure of
p.000054: participation which may impact the participant’s decision to continue in the research; and
p.000054: • there is possibility of disclosure of identity through data presentation or photographs (this
p.000054: should be camouflaged adequately) in an upcoming publication.
p.000054: • the partner/spouse may also be required to give additional re-consent in some
p.000054: of the above cases.
p.000054: 5.9 Procedures after the consent process
p.000054: 5.9.1 After consent is obtained, the participant should be given a copy of the PIS and signed ICF unless the
p.000054: participant is unwilling to take these documents. Such reluctance should be recorded.
p.000054: 5.9.2 The researcher has an obligation to convey details of how confidentiality will be maintained to
p.000054: the participant.
p.000054: 54 INDIAN COUNCIL OF
p.000055: MEDICAL RESEARCH
p.000055:
p.000055:
p.000055: Informed Consent Process
p.000055:
p.000055: 5.9.3 The original PIS and ICF should be archived as per the requirements given in the guidelines and regulations.
p.000055: 5.10 Special situations
p.000055: 5.10.1 Gatekeepers
...
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
...
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
p.000062: 7. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is
p.000062: age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
p.000063: Box 6.5 Consent of parent/LAR
p.000063:
p.000063: 1. The EC should determine if consent of one or both parents would be required before a child could be enrolled.
p.000063: 2. Generally, consent from one parent/LAR may be considered sufficient for research involving no more than
p.000063: minimal risk and/or that offers direct benefit to the child. Consent from both parents may have to be obtained when the
p.000063: research involves more than minimal risk and/or offers no benefit to the child.
p.000063: 3. Only one parent’s consent is acceptable if the other parent is deceased, unknown, incompetent, not
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
p.000064: definitely benefit the child but would be available only if the child participates in the study, waiver of assent could
p.000064: be allowed. However, this situation should be accepted only in exceptional cases where all forms of assent/consent have
p.000064: failed. In such cases, approval of the EC should be obtained.
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
...
p.000076: • All BA/BE studies should be scientifically sound and conducted in compliance with principles of ethical
p.000076: conduct described earlier for a Phase I study.
p.000076: • Ethical conduct of BA/BE study requires evaluation of the benefit–risk profile of:
p.000076: a. the reference (comparator) and investigational (generic) product; and
p.000076: b. the study procedures such as indoor stay, fasting, screening, blood sampling.
p.000076: • BA/BE studies are usually conducted in healthy volunteers. Hence, they have no direct benefit to the
p.000076: participant but may pose risks due to the adverse effects of the drug. Therefore, all safeguards to protect
p.000076: participants must be in place.
p.000076: • The EC must carefully review the recruitment methods, payment for participation and consent procedures.
p.000076: Volunteers often regularly participate in such studies at the cost of their health and care should be taken that taking
p.000076: part in multiple trials is avoided by maintaining volunteer registries, biometry, follow up, etc. Care must be taken to
p.000076: maintain confidentiality of biometric data.
p.000076: • The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study
p.000076: design and the EC should take specific note on the amount of blood drawn depending on whether the individual is a
p.000076: healthy adult or a child or a patient.
p.000076: 7.4 Ethical implications of study designs
p.000076: Clinical trials have a wide range of methodological approaches. ECs need to look into the details of the ethical
p.000076: concerns involved.
p.000076: 7.4.1 If a SAE occurs in a blinded study, and it is imperative, in the interest of managing the event to know what
p.000076: the patient was receiving, unblinding mechanisms should be available to the researcher.
p.000076:
p.000076: 76 INDIAN COUNCIL OF
p.000077: MEDICAL RESEARCH
p.000077:
p.000077: Clinical Trials of Drugs and
p.000077: other Interventions
p.000077:
p.000077: 7.4.2 When an available therapy is effective in preventing serious harm, such as death or irreversible morbidity in
p.000077: the clinical trial population, it is inappropriate to use a placebo control.
p.000077: 7.4.3 Placebo may be used as a comparator under the conditions given in Box 7.4.
p.000077: Box 7.4 Conditions where a placebo may be used
p.000077: A placebo may be used when:
p.000077: • there is no established effective therapy available;
p.000077: • withholding an established effective therapy would not expose participants to serious
p.000077: harm, but may cause temporary discomfort or delay in relief of symptoms;
p.000077: • if the disease is self-limited; or
p.000077: • the use of an established effective therapy as a comparator would not yield scientifically reliable
...
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
...
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
...
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
p.000113: confidentiality in certain circumstances and the anticipated consequences of breach of confidentiality.
p.000113: 10.3.2 The researcher can delink data to maintain confidentiality and safeguard the information for basic research.
p.000113: However, If the result of the research is of benefit to the health of the participant then, with approval of the EC,
p.000113: data could be re-linked for communication of the result. See Table 11.1 for further details.
p.000113: 10.3.3 Genetic research requires collection of family history and details about other members of the family, thus
p.000113: involving them as secondary participants. If identifiable information is being collected about the secondary
...
p.000114: 10.3.8 Transfer to, or sharing of biological material and/or data with other laboratories within or outside the
p.000114: country should be done as per relevant guidelines.
p.000114: 10.3.9 Handling IPRs related to gene patenting and development of newer technologies for commercial gains should
p.000114: follow the applicable national policy/regulations.
p.000114: 10.3.10 Newer genomic techniques for research like whole exome sequencing (WES) and whole genome sequencing
p.000114: (WGS) may create uncertain evidence at the present level of knowledge. Therefore, the confidentiality of data, and pre-
p.000114: and post-test counselling need to be revisited with an entirely new perspective.
p.000114: 10.4 Informed consent
p.000114: Stringent norms and caution should be followed in the consent process when done for research purposes.
p.000114: 10.4.1 For routine genetic diagnostic testing, written consent may or may not be needed as per institutional
p.000114: policies; however, for any research it is required.
p.000114: 10.4.2 Informed written consent is essential for procedures such as pre-symptomatic testing, next generation
p.000114: sequencing (NGS), prenatal testing, genomic studies, carrier status etc.
p.000114: 10.4.3 It needs to be emphasized that consent for screening or a subsequent confirmatory test does not imply consent
p.000114: to any specific treatment or termination of the pregnancy or for research.
p.000114: 10.4.4 If the research or testing involves a child, appropriate age-specific assent (verbal/
p.000114:
p.000114:
p.000114: 114 INDIAN COUNCIL OF MEDICAL
p.000115: RESEARCH
p.000115:
p.000115: Human
p.000115: Genetics Testing and Research
p.000115:
p.000115: oral/written) should be obtained along with parental consent. See section 6 for further details.
p.000115: 10.4.5 In addition to the general contents specified in section 5, the consent form for genetic testing for research
p.000115: may have explanations/details on the following elements:
p.000115: • the nature and complexity of information that would be generated;
p.000115: • the nature and consequences of return of results and choice offered to the participant whether to
p.000115: receive that information or not and incidental findings, if any;
p.000115: • direct/indirect benefits and their implications including if there are no direct
p.000115: benefits to the participants;
p.000115: • how the data/samples will be stored, for how long, and procedures involved in
p.000115: anonymisation, sharing , etc. See section 11 for further details;
p.000115: • choice to opt out of testing/withdraw from research at any time;
p.000115: • whether the affected individual or the proband would like to share her/his genetic
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
...
p.000117: 10.11 Quality standards of the laboratory
p.000117: 10.11.1 There is a paucity of quality assurance programmes in the country and therefore valid and reliable testing is
p.000117: a constant concern for both clinical practice and research. Any
p.000117:
p.000117: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000117: 117
p.000118:
p.000118: Human
p.000118: Genetics Testing and Research
p.000118:
p.000118: misinterpretation of genetic results or misdiagnosis may lead to psychological harm, and unnecessary or inappropriate
p.000118: intervention.
p.000118: 10.11.2 It is important to set standards for laboratories to ensure that test results are reliable, manpower is
p.000118: competent and the care provider is updated on developments in genetics.
p.000118: 10.11.3 All laboratories offering genetic testing should consider undergoing quality accreditation standards which are
p.000118: specific to genetic testing laboratories.
p.000118: 10.12 Misuse of genetic technology
p.000118: Genetic information has potential for misuse as well as long-term implications.
p.000118: 10.12.1 Prenatal sex selection is not allowed and to prevent misuse of genetic tests, particularly pre-selection of
p.000118: sex, GOI has enacted the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994,
p.000118: amended in 2003.37 All researchers in this area shall follow the provisions of this Act. Prenatal sex determination is
p.000118: prohibited by law for sex selection of the foetus.
p.000118: 10.12.2 Misuse of genetic information by insurers, employers or schools: Knowledge of genetic information of an
p.000118: individual/family/community/population/child might be misused by insurers/employers leading to discrimination and
p.000118: psychosocial harm. Hence, the information about a patient’s disease and investigations may not be shared with anyone
p.000118: without the consent of the individual concerned.
p.000118: 10.12.3 Research involving genetic manipulations must be carefully reviewed and protections established for
p.000118: participants.
p.000118: 10.13 Genetic diagnosis/testing and screening
p.000118: 10.13.1 History and pedigree studies: These involve obtaining history of other members of the family of the proband
p.000118: under investigation. It may reveal information about the likelihood of individual members of the family being either
p.000118: carriers of genetic defects or being affected by the disease. Privacy and confidentiality issues involved in this
p.000118: process are given in section 10.3.
p.000118: 10.13.2 Predictive genetic testing: The results of genetic tests in diseases that are multifactorial in origin and
p.000118: have a polygenic basis involving multiple genes or gene–environment interaction or those that are late onset, must be
p.000118: communicated carefully to prevent unnecessary worry or fear in the minds of individuals.
p.000118: 10.13.3 Genetic screening: Genetic screening implies searching a population for those individuals who have,
p.000118: or are susceptible to a serious genetic disease; or who, though not at risk themselves, are carriers and thus at risk
...
p.000131: participant may withdraw from one component of the study, like continued follow-up/data collection when withdrawal may
p.000131: be referred to as partial.
p.000131: 7. Waiver of consent: While using anonymized (de-identified) samples/data, researchers should seek the approval of
p.000131: the EC of the institution or the repository for waiver of consent from donors.
p.000131: 8. Re-consent
p.000131: • Secondary or extended uses of stored samples/dataset: In such an instance, one of the preliminary considerations
p.000131: for ECs must be to identify the circumstances under which the research requires re-use of collected identifiable
p.000131: biological material to generate the data or utilize the pre-existing identifiable dataset. This must also include
p.000131: review of the informed consent obtained originally to see if re-consent is warranted. There may be situations where
p.000131: consent would be impossible or impracticable to obtain for such research, in which case the research may be done only
p.000131: after independent evaluation by an EC (Declaration of Helsinki, October 2013).
p.000131:
p.000131:
p.000131: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000131: (Contd.)
p.000131: 131
p.000132:
p.000132: Biological Materials,
p.000132: Biobanking and Datasets
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: • Paediatric donors: In longitudinal studies once the child donor attains the legal age of consent a re-consent
p.000132: should be sought for the storage and use of her/his tissue or sample. In paediatric biobanks or biobanks with
p.000132: paediatric samples it is important to address the issue of children reaching legal age of consent. Sometimes re-contact
p.000132: may lead to withdrawal, resulting in limited data analysis. This may lead to bias or it could evoke emotional distress
p.000132: about past research. On the other hand, re-consent may give the participant the power to agree. A biobank should decide
p.000132: the policy it would like to adopt for re-contact.
p.000132:
p.000132: 11.4 Ethical issues related to research
p.000132: Biobanks can use the stored material/data for doing research themselves or they can outsource or supply such
p.000132: material/data to other researchers or institutions on a non- profit basis.
p.000132: 11.4.1 Ownership of the biological samples and data: The participant owns the biological sample and data collected
p.000132: from her/him and therefore, could withdraw both the biological material donated to the biobank and the
p.000132: related data unless the latter is required for outcome measurement and is so mentioned in the initial informed
p.000132: consent document. Complete anonymization would practically make the original donor lose the right of ownership.
...
Searching for indicator children:
(return to top)
p.000011: 5.5 Electronic consent 53
p.000011: 5.6 Specific issues in clinical trials 53
p.000011: 5.7 Waiver of consent 53
p.000011: 5.8 Re-consent or fresh consent 54
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
...
p.000006: Probability of harm or discomfort anticipated in the research is nil or not expected. For example, research on
p.000006: anonymous or non-identified data/samples, data available in the public domain, meta-analysis, etc.
p.000006: Minimal risk Probability of harm or discomfort anticipated in the research is not greater than that ordinarily
p.000006: encountered in routine daily life activities of an average healthy individual or general population or during the
p.000006: performance of routine tests where occurrence of serious harm or an adverse event (AE) is unlikely. Examples include
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
...
p.000010: participants welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or
p.000010: non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or
p.000010: sponsors. If COI is inherent in the research, it is important to declare this at the outset and establish appropriate
p.000010: mechanisms to manage it.
p.000010: 2.8.1 Research institutions must develop and implement policies and procedures to identify, mitigate conflicts of
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
...
p.000030: 4. Preferably the lay person should be part of the quorum.
p.000030: 5. The quorum for reviewing regulatory clinical trials should be in accordance with current CDSCO requirements.
p.000030: 6. No decision is valid without fulfilment of the quorum.
p.000030:
p.000030: *Medical members are clinicians with appropriate medical qualifications. Technical members are persons with
p.000030: qualifications related to a particular branch in which the study is conducted, for example social sciences.
p.000030: 30 INDIAN COUNCIL OF
p.000031: MEDICAL RESEARCH
p.000031:
p.000031:
p.000031: Ethical Review Procedures
p.000031:
p.000031: 4.3.7 So as to maintain independence, the head of the institution should not be part of the EC but should act as an
p.000031: appellate authority to appoint the committee or to handle disputes.
p.000031: 4.3.8 The Chairperson and Member Secretary could have dual roles in the ethics committee. They could fulfil a role
p.000031: based on their qualifications (such as that of clinician, legal expert, basic scientist, social scientist, lay person
p.000031: etc.) in addition to taking on the role of Chairperson or Member Secretary.
p.000031: 4.3.9 The EC can also have a set of alternate members who can be invited as members with decision-making powers to
p.000031: meet the quorum requirements. These members have the same TORs as regular members and can attend meetings in
p.000031: the absence of regular members.
p.000031: 4.3.10 The EC can maintain a panel of subject experts who are consulted for their subject expertise, for
p.000031: instance, a paediatrician for research in children, a cardiologist for research on heart disorders, etc. They may be
p.000031: invited to attend the meeting to give an expert opinion on a specific proposal but will not have decision making
p.000031: power/voting rights.
p.000031: 4.3.11 The EC may invite subject experts as independent consultants or include a representative from a specific
p.000031: patient group as a member of the EC or special invitee, for opinion on a specific proposal, for example HIV, genetic
p.000031: disorders, or cancer, with appropriate decision making power.
p.000031: 4.3.12 As far as possible a separate scientific committee should priorly also review proposal before it is referred to
p.000031: EC. EC can raise scientific queries besides ethical ones as both good science and ethics are important to ensure
p.000031: quality of research and participant protection.
p.000031: 4.4 Terms of reference for EC members
p.000031: 4.4.1 The head of the institution should appoint all EC members, including the Chairperson.
p.000031: 4.4.2 The appointment letter issued to all members should specify the TORs. The letter issued by the head of the
p.000031: institution should include, at the minimum, the following:
p.000031: • Role and responsibility of the member in the committee
p.000031: • Duration of appointment
p.000031: • Conditions of appointment
p.000031: 4.4.3 Generally, the term of EC membership may be 2–3 years. The duration could be extended as specified in the SOPs.
p.000031: A defined percentage of EC members could be changed on a regular basis.
...
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
...
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
p.000059: Researchers • Recognize the vulnerability of the participant and ensure additional
p.000059: safeguards are in place for their protection.
p.000059: • Justify inclusion/exclusion of vulnerable populations in the study.
p.000059: • COI issues must be addressed.
p.000059: • Have well defined procedures (SOPs) to ensure a balanced benefit-risk
p.000059: ratio.
p.000059: • Ensure that prospective participants are competent to give informed
p.000059: consent.
p.000059: • Take consent of the LAR when a prospective participant lacks the capacity
p.000059: to consent.
p.000059: • Respect dissent from the participant.
...
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
p.000062: 7. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is
p.000062: age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
...
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
p.000064: definitely benefit the child but would be available only if the child participates in the study, waiver of assent could
p.000064: be allowed. However, this situation should be accepted only in exceptional cases where all forms of assent/consent have
p.000064: failed. In such cases, approval of the EC should be obtained.
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
...
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
...
p.000072: institution, EC, and regulatory authority (if applicable) are responsible for ethical conduct of a study. Before any
p.000072: clinical trial is initiated, adequate data from preclinical investigations or previous clinical studies should
p.000072: be generated and be sufficient to indicate that the intervention is acceptably safe for the proposed investigation
p.000072: in humans.
p.000072: The investigator should make an assessment to determine if a clinical trial is under the regulatory ambit and if so, to
p.000072: ensure that all requirements as specified by CDSCO must
p.000072:
p.000072: 72 INDIAN COUNCIL OF
p.000073: MEDICAL RESEARCH
p.000073:
p.000073: Clinical Trials of Drugs and
p.000073: other Interventions
p.000073:
p.000073: also be followed. If required, the EC may provide relevant guidance to the members in deciding the same.
p.000073: • Phase I (for drugs and vaccines) studies
p.000073: m All Phase I trials require EC approval and applicable regulatory approvals. m A Phase I study is a
p.000073: non-therapeutic trial in which there is no anticipated direct clinical benefit to the participant. In general,
p.000073: therefore, it should be conducted
p.000073: in participants who can give voluntary informed consent themselves and who
p.000073: can sign and date the written informed consent forms themselves, unless the therapy under investigation is for diseases
p.000073: specific to those who cannot give consent, such as children, in which case consent of the LAR may be taken.
p.000073: m As Phase I studies are most often conducted in healthy volunteers, all safeguards to protect the
p.000073: participants must be established, especially recruitment methods, payment for participation, evidence of
p.000073: non-coercion and consent procedures.
p.000073: m When a Phase I study is conducted in participants with a disease such as cancer, due consideration should be given
p.000073: to the seriousness of the medical condition and the study procedures planned.
p.000073: m The study protocol should describe measures to minimize the risks of a Phase I clinical trial in healthy volunteers
p.000073: and patients. These include, but are not limited to, the measures given in Box 7.2.
p.000073: Box 7.2 Risks of Phase I clinical trials
p.000073:
p.000073: The measures to be taken to minimize risks in a Phase I clinical trial include:
p.000073: • exclusion of participants who may be at increased risk from the study;
p.000073: • careful review of investigational procedures posing high risk of physical harm or serious
p.000073: discomfort;
p.000073: • evaluation of available data to decide if the IP or procedures proposed in the protocol have been associated with
p.000073: SAEs and steps taken to prevent or minimize such risks; and
p.000073: • careful monitoring of the condition of participants and intervention to manage adverse
...
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
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p.000087: MEDICAL RESEARCH
p.000087:
p.000087: Clinical Trials of Drugs and
p.000087: other Interventions
p.000087:
p.000087: auditing, DSMB, etc.
...
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
...
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
...
p.000118: psychosocial harm. Hence, the information about a patient’s disease and investigations may not be shared with anyone
p.000118: without the consent of the individual concerned.
p.000118: 10.12.3 Research involving genetic manipulations must be carefully reviewed and protections established for
p.000118: participants.
p.000118: 10.13 Genetic diagnosis/testing and screening
p.000118: 10.13.1 History and pedigree studies: These involve obtaining history of other members of the family of the proband
p.000118: under investigation. It may reveal information about the likelihood of individual members of the family being either
p.000118: carriers of genetic defects or being affected by the disease. Privacy and confidentiality issues involved in this
p.000118: process are given in section 10.3.
p.000118: 10.13.2 Predictive genetic testing: The results of genetic tests in diseases that are multifactorial in origin and
p.000118: have a polygenic basis involving multiple genes or gene–environment interaction or those that are late onset, must be
p.000118: communicated carefully to prevent unnecessary worry or fear in the minds of individuals.
p.000118: 10.13.3 Genetic screening: Genetic screening implies searching a population for those individuals who have,
p.000118: or are susceptible to a serious genetic disease; or who, though not at risk themselves, are carriers and thus at risk
p.000118: for having children with a particular
p.000118:
p.000118: 118 INDIAN COUNCIL OF MEDICAL
p.000119: RESEARCH
p.000119:
p.000119: Human
p.000119: Genetics Testing and Research
p.000119:
p.000119: genetic disease.
p.000119: • It is essential for screening to be purposive. Besides validation of screening tests, it
p.000119: should also be ensured that a suitable intervention and counselling are available.
p.000119: • Those being screened are entitled to receive sufficient information about what is proposed to be done,
p.000119: reliability of the screening test, and what will be done with the collected samples.
p.000119: • Although screening may be permissible to allay anxiety, the response of different individuals might vary,
p.000119: which should be borne in mind by the health-care provider.
p.000119: • Confidentiality should be maintained in handling of results with emphasis on responsibility of individuals with
p.000119: an abnormal result to inform partners and family members. In case of refusal, the duty of confidentiality shall weigh
p.000119: higher than the duty for beneficence to family members unless sharing of information is vital to prevent serious harm
p.000119: to the beneficiary in the family. In such case, appropriate precautions may be taken to ensure that only the genetic
p.000119: information needed for diagnosis/treatment is shared.
p.000119: • Screening tests should be sensitive enough to identify a significant proportion of affected persons (the
...
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
p.000121: intervention for management.
p.000121: • The family should have a choice to decide if they would like to be part of newborn screening program with
p.000121: appropriate consent explaining the requirements and implications of the screening with provision to “optout”.
p.000121: • Community education and advocacy regarding NBS should precede the initiation
p.000121: of the programme.
p.000121: • Availability of facilities for confirmatory diagnosis and experts for management
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
p.000121: decision-making process, unless early intervention based on results of the test is likely to be of direct therapeutic
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
p.000121: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000121: 121
p.000122:
p.000122: Human
p.000122: Genetics Testing and Research
p.000122:
p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
p.000122: linked), the individual should be tested after administering informed consent when she/he is able to comprehend the
p.000122: benefits and risks of screening. Stigmatization for carrier status is common and therefore, the information should be
p.000122: kept confidential.
p.000122: • Chromosomal: If there is a family history of balanced translocation in any individual, then
p.000122: immediate relatives may be at risk. The same principles as for carrier testing should be followed.
p.000122: 10.14 Gene therapy
p.000122: All gene therapies are considered as research and all protections for human research participants should be in place.
p.000122: 10.14.1 Somatic cell gene therapy is permissible for the purpose of preventing or treating a serious
p.000122: disease when it is the only therapeutic option. It should be restricted to alleviation of life
p.000122: threatening or seriously disabling genetic disease in individual patients and should not be permitted to change
p.000122: normal human traits.
p.000122: 10.14.2 Prior to obtaining approval for initiating a gene therapy trial, an approval from the local EC and DBT has to
p.000122: be obtained for the gene construct.
p.000122: 10.14.3 If the trial is for a product for commercial use or for marketing purposes, approval needs to be taken from
p.000122: CDSCO.
p.000122: 10.14.4 All gene therapy trials should have the provision for long-term surveillance.
p.000122: 10.14.5 Informed consent must be taken, especially regarding uncertainties about outcome.
p.000122: 10.14.6 Children could be candidates for therapy, if the therapy is meant for a childhood disorder.
p.000122: 10.14.7 Germ line therapy is prohibited under the present state of knowledge.
p.000122: 10.14.8 Eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called
p.000122: designer babies is prohibited. These should not be attempted, as we possess insufficient information at present to
p.000122: understand the effects of attempts to alter/enhance the genetic machinery of humans. It would be unethical to use
p.000122: genetic engineering for improvement of intelligence, memory, formation of body organs, fertility, physical,
p.000122: mental and emotional characteristics, etc. even if specific gene/genes are identified in future.
p.000122:
p.000122:
p.000122: 122 INDIAN COUNCIL OF MEDICAL
p.000123: RESEARCH
p.000123:
p.000123: Human
p.000123: Genetics Testing and Research
p.000123:
p.000123: 10.15 Use of newer technologies
p.000123: New technologies like CMA, WES and WGS and clustered regularly interspaced short palindromic repeat (CRISPR) technology
p.000123: have unmasked new knowledge that could find solutions to diseases or inherited disorders but could also create ethical
p.000123: debates due to uncertain future. These techniques have made it possible to study genomes. Each individual’s genome is a
p.000123: unique and definite identity, which in spite of anonymization of such data will always be associated with individual’s
p.000123: identity, and this would be in conflict with the principle of privacy. With the advent of digitized medical records of
p.000123: such sophisticated data, additional efforts should be made to maintain confidentiality.
...
p.000131: 8. Re-consent
p.000131: • Secondary or extended uses of stored samples/dataset: In such an instance, one of the preliminary considerations
p.000131: for ECs must be to identify the circumstances under which the research requires re-use of collected identifiable
p.000131: biological material to generate the data or utilize the pre-existing identifiable dataset. This must also include
p.000131: review of the informed consent obtained originally to see if re-consent is warranted. There may be situations where
p.000131: consent would be impossible or impracticable to obtain for such research, in which case the research may be done only
p.000131: after independent evaluation by an EC (Declaration of Helsinki, October 2013).
p.000131:
p.000131:
p.000131: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000131: (Contd.)
p.000131: 131
p.000132:
p.000132: Biological Materials,
p.000132: Biobanking and Datasets
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: • Paediatric donors: In longitudinal studies once the child donor attains the legal age of consent a re-consent
p.000132: should be sought for the storage and use of her/his tissue or sample. In paediatric biobanks or biobanks with
p.000132: paediatric samples it is important to address the issue of children reaching legal age of consent. Sometimes re-contact
p.000132: may lead to withdrawal, resulting in limited data analysis. This may lead to bias or it could evoke emotional distress
p.000132: about past research. On the other hand, re-consent may give the participant the power to agree. A biobank should decide
p.000132: the policy it would like to adopt for re-contact.
p.000132:
p.000132: 11.4 Ethical issues related to research
p.000132: Biobanks can use the stored material/data for doing research themselves or they can outsource or supply such
p.000132: material/data to other researchers or institutions on a non- profit basis.
p.000132: 11.4.1 Ownership of the biological samples and data: The participant owns the biological sample and data collected
p.000132: from her/him and therefore, could withdraw both the biological material donated to the biobank and the
p.000132: related data unless the latter is required for outcome measurement and is so mentioned in the initial informed
p.000132: consent document. Complete anonymization would practically make the original donor lose the right of ownership.
p.000132: Biobanks/institutes are the custodians or trustees of the samples and data through their ECs as their present and
p.000132: future use would be done under supervision of the respective ECs. Researchers have no claim for either ownership or
p.000132: custodianship.
p.000132: 11.4.2 Transfer of biospecimens: An MTA should be executed if the biospecimens are likely to be shipped from the host
p.000132: institution to collaborating institutions within the country or abroad. The EC should oversee the process of
...
p.000138: components. This should be very clearly distinguished during the informed consent process.
p.000138: 12.2.2 Additional safeguards are required for participants due to their vulnerability, for example,
p.000138: counselling, psychological help, medical advice and process of stakeholder consultation.
p.000138: 12.2.3 The potential research participants might be under duress and traumatized. Researchers should be sensitive to
p.000138: this situation and are obligated to ensure that the informed consent process is conducted in a respectful manner.
p.000138: 12.2.4 Researchers should strive to identify and address barriers to voluntary informed consent and not resort to
p.000138: inducements for research participation.
p.000138: 12.2.5 The different roles of researchers, caregivers and volunteer workers must always be clarified, and potential COI
p.000138: declared.
p.000138: 12.2.6 If research involves incompetent individuals (such as minors), then the LAR should give consent. Additional
p.000138: protections might be required in special cases, for example,
p.000138:
p.000138: 138 INDIAN COUNCIL OF MEDICAL
p.000139: RESEARCH
p.000139:
p.000139: Research during Humanitarian Emergencies and Disasters
p.000139:
p.000139: children with untraceable or deceased relatives. In these situations, the consent should be obtained from an individual
p.000139: who is not part of the research team who should be designated by the institution/agency conducting research.
p.000139: 12.2.7 For seeking waiver of consent, the researchers should give the rationale justifying the waiver. EC should
p.000139: approve such a waiver after careful discussion on the issue. See section 5 for further details.
p.000139: 12.2.8 When consent of the participant/LAR/assent is not possible due to the situation, informed consent
p.000139: must be administered to the participant/LAR at a later stage, when the situation allows. However, this should be done
p.000139: only with the prior approval of the EC.
p.000139: 12.3 Risk-minimization and equitable distribution of benefits and risks
p.000139: 12.3.1 Considerations for fair selection of participants are described in Box 12.1.
p.000139:
p.000139: Box 12.1 Considerations for fair selection of participants
p.000139:
p.000139: 1. The overall effort is not to over-sample, particularly vulnerable segments of the population.
p.000139: 2. Explicit selection criteria or prioritization of participants with proper justification should be provided in the
p.000139: protocol.
p.000139: 3. Efforts should be taken to ensure that research participants are not exploited during the research project by
p.000139: imposing additional burdens on them.
...
p.000144: and Cultural Organization’s General Conference; 2005.
p.000144: 18. Guidelines for laboratory animal facilities. Committee for the Purpose of Control and Supervision of
p.000144: Experiments on Animals; 2003.
p.000144: 19. Guidelines for international collaboration/research projects in health research [homepage on the
p.000144: Internet]. Indian Council of Medical Research. Available from: http://www.icmr.nic.in/guide.htm (accessed 31 Aug 2017).
p.000144: 20. Environmental Protection Act, 1986, India [statute of the Internet]. Available from:
p.000144: http://envfor.nic.in/legis/env/env1.html (accessed 31 Aug 2017).
p.000144: 21. The Biological Diversity Act, 2002, India [statute on the Internet]. Available from:
p.000144: http://www.bamu.ac.in/Portals/0/3_%20The%20biological%20Diversity%20 act%2C%202002.pdf (accessed 31 Aug 2017).
p.000144: 22. Foreign Contribution (Regulation) Act, 2010, India [statute on the Internet]. Available from:
p.000144: http://lawmin.nic.in/ld/regionallanguages/THE%20FOREIGN%20
p.000144: CONTRIBUTION%20(REGULATION)%20ACT,2010.%20(42%20OF%202010).pdf (accessed 13 Sept 2017).
p.000144: 23. Defining the role of authors and contributors [homepage on the Internet]. International Committee of Medical
p.000144: Journal Editors. Available from: http://www.icmje.org/
p.000144: recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors- and-contributors.html (accessed 02 Sept
p.000144: 2017).
p.000144: 24. National ethical guidelines for bio-medical research involving children, 2017.
p.000144: 25. Particularly vulnerable tribal groups [homepage on the Internet]. Ministry of Tribal Affairs. Available from:
p.000144: http://tribal.nic.in/pvtg.aspx (accessed 31 Aug 2017).
p.000144: 26. The Mental Healthcare Act, 2017, India [statute on the Internet]. Available from: http://
p.000144: www.prsindia.org/uploads/media/Mental%20Health/Mental%20Healthcare%20 Act,%202017.pdf (accessed 12 Sept 2017).
p.000144: 27. G.S.R. 313(E) dated 16th Mar 2016. New Delhi: Gazette of India. Available from: http://
p.000144: www.cdsco.nic.in/writereaddata/GSR%20313%20(E)%20dated%2016_03_2016.pdf (accessed 12 Sept 2017).
p.000144: 28. Clinical Trials Registry - India [homepage on the Internet]. Available from: http://
p.000144:
p.000144: 144 INDIAN COUNCIL OF MEDICAL
p.000145: RESEARCH
p.000145:
p.000145:
p.000145: List of references
p.000145:
p.000145: www.ctri.nic.in (accessed 12 Sept 2017).
p.000145: 29. GSR 918 (E) dated 30th Nov 2015. New Delhi : Gazette of India. Available from: http://
p.000145: www.cdsco.nic.in/writereaddata/GSR%20918-E-dated-30-11-2015.pdf (accessed 13th Sept 2017).
p.000145: 30. Guidelines for Good Clinical Laboratory Practices (GCLP).New Delhi. Indian Council of Medical Research.
p.000145: Available from: http://icmr.nic.in/guidelines/GCLP.pdf (accessed 18 May 2017).
p.000145: 31. Good Manufacturing Practices. New Delhi: Central Drugs Standard Control Organization. Available
p.000145: from:http://www.cdsco.nic.in/writereaddata/ schedulem(gmp)6.pdf (accessed 12 Sept 2017).
p.000145: 32. Good Clinical Practice Guidelines for clinical trials of ASU Medicine. New Delhi: Department of AYUSH,
...
Social / Elderly
Searching for indicator elderly:
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p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
...
Social / Ethnicity
Searching for indicator ethnic:
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p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
p.000008: 2.5.1 If applicable, participants may be reimbursed for expenses incurred relating to their participation in
p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
p.000008: is applicable to all participants, including those in comparator/control groups.
p.000008: 2.5.3 If there are provisions, participants may also receive additional medical services at no cost.
p.000008: 2.5.4 When the LAR is giving consent on behalf of a participant, payment should not become an undue inducement and to
p.000008: be reviewed carefully by the EC. Reimbursement may be offered for travel and other incidental expenses incurred due to
p.000008: participation of the child/ward in the research.
p.000008: 2.5.5 ECs must review and approve the payments (in cash or kind or both) and free services and the processes
p.000008: involved, and also determine that this does not amount to undue inducement.
...
p.000010: interest and educate their staff about such conflicts.
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
...
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
...
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
p.000104: evident due to multi-religious, caste, class, endogamic, gender and geo-ethnic variations which are important
p.000104: characteristics of society that need to be considered in socio-behavioural research proposals. In view of the above,
p.000104: ECs should be aware of the challenges that may be encountered in the process of conducting such studies.
p.000104: 9.1 Some key features
p.000104: 9.1.1. Conventional social science research on health underscores the importance of bringing contemporary contexts to
p.000104: biomedical and health research.
p.000104: 9.1.2. It has now emerged as a cross-cutting area of enquiry relevant to almost every type of
p.000104:
p.000104: 104 INDIAN COUNCIL OF MEDICAL
p.000105: RESEARCH
p.000105:
p.000105: Social and Behavioural Sciences
p.000105: Research for Health
p.000105:
p.000105: medical, biomedical, clinical and health research such as clinical trials, epidemiological research, programme
p.000105: evaluations, implementation research, genetics, research on disaster and conflict contexts.
p.000105: 9.1.3. The principles of social science research ethics, with rights and responsibilities of the different
p.000105: stakeholders including participants, researchers, reviewers, publishers, etc., are similar to those for biomedical and
p.000105: public health research.
p.000105: 9.1.4. There are, however, specific ethical issues involved in social and behavioural sciences studies as given in Box
p.000105: 9.1.
p.000105:
p.000105: Box 9.1 Ethical issues in social and behaviour sciences studies
p.000105:
p.000105: 1. Risks are non-measurable and dynamic in nature and therefore might be misconstrued as no/minimum risk research.
...
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
p.000115: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000115: 115
p.000116:
p.000116: Human
p.000116: Genetics Testing and Research
p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
p.000116: information is revealed to the husband or other members of the family, it may cause marital discord despite the fact
p.000116: that the husband himself is a carrier of the autosomal recessive disorder. Appropriate counselling should be part of
p.000116: the testing process.
p.000116: 10.5.2 Consanguineous marriages are common in some communities. If there are inherited diseases detected in the
p.000116: family, it is the responsibility of the health professionals/ researchers to inform participants regarding the possible
p.000116: implications that may arise due to consanguinity. Appropriate pedigrees need to be prepared and stored, as these can
p.000116: reveal a lot regarding disease inheritance in affected families.
p.000116: 10.6 Storage of samples for future genetic research
p.000116: 10.6.1 Rapid advances in science and technology have necessitated the storage of biological materials for future
p.000116: genetic research.
p.000116: 10.6.2 The samples from patients with rare genetic conditions, ethnic groups/tribes/ populations on the
p.000116: verge of extinction, endogamous groups and others have great cultural and geographical value and need to be preserved
p.000116: for future research. See section 11 for further details.
p.000116: 10.7 Results of genetic testing
p.000116: 10.7.1 Results of the tests should be informed to the participants. Return of the results depends on
p.000116: the research findings. If results are anticipated to be actionable, leading to potential benefits of improving health
p.000116: outcomes through correction of diet as therapy or prevention (such as phenylketonuria) by delaying onset or reduction
p.000116: of disease burden, they need to be communicated to the participants. This should also be reported to the participants
p.000116: if they wish to know the results and must be specified in the ICD. For this, participants’ contact details should be
p.000116: available.
p.000116: 10.7.2 The researcher should work with the local EC to decide on the validity of the research finding and the
p.000116: severity of the potential disease in order to return the results which should be avoided if the logical outcome of the
p.000116: research is expected to be inconclusive and the participants were informed of this in the ICD.
p.000116: 10.7.3 Results cannot be returned for the advantage of participants when the research is done using irreversibly
p.000116: anonymized samples or data, as identifying the individuals is not possible.
p.000116: 10.8 Publication aspects
p.000116:
p.000116:
p.000116: 116 INDIAN COUNCIL OF MEDICAL
p.000117: RESEARCH
p.000117:
p.000117: Human
p.000117: Genetics Testing and Research
p.000117:
...
p.000129: RESEARCH
p.000129:
p.000129: Biological Materials,
p.000129: Biobanking and Datasets
p.000129:
p.000129:
p.000129: Table 11.1 Types of samples
p.000129:
p.000129:
p.000129: Anonymous or unidentified
p.000129: No identifiers are present from the start or if collected, are not maintained. Such samples are received by
p.000129: biobanks without any identifiers and supplied to researchers.
p.000129: Anonymized This involves systematic de-identification, reversible or irreversible: link of samples/data
p.000129: to personal identity is reversibly or irreversibly cut.
p.000129:
p.000129:
p.000129: Coded or reversibly anonymized: There is an indirect link of sample/ data to the participant’s
p.000129: identity with restricted access. This link could be re-linked if required; therefore, it may also be
p.000129: termed reversible anonymization.
p.000129: Irreversibly anonymized:
p.000129: Link to the participant’s identity is removed and cannot be re-linked.
p.000129: Identifiable A direct link of sample/data to the participant’s identity exists.
p.000129:
p.000129:
p.000129: Box 11.1 Confidentiality and privacy of donors related to biological materials and/or data
p.000129:
p.000129: Some key aspects related to maintaining confidentiality and privacy of donors of biological materials and/or data:
p.000129: 1. The procedure of anonymization minimizes the connection between the identifiers and the stored sample or medical
p.000129: data by delinking the person from her/his biological material.
p.000129: 2. Maintaining confidentiality of data and respecting ethnic identity is of prime importance, especially
p.000129: in population based genetic studies.
p.000129: 3. More precautions should be sought when the research pertains to stigmatizing diseases.
p.000129: 4. When data pertains to epidemiological and public health practice or research, it may be dealt with in the manner
p.000129: described in section 8.
p.000129:
p.000129: 11.2.2 Under certain circumstances, some degree of identifiability may have to be retained for reasons related to the
p.000129: research. For example, anonymized data or specimens will not allow later withdrawal of consent by an individual, while
p.000129: in the coded category, this will be possible. In the latter scenario, the custodians of the respective biorepository or
p.000129: biobank have a greater responsibility to take adequate measures to safeguard the
p.000129:
p.000129: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000129: 129
p.000130:
p.000130: Biological Materials,
p.000130: Biobanking and Datasets
p.000130:
p.000130: codes and the data so as to respect the privacy and confidentiality of individual research participants.
p.000130: 11.2.3 Permissibility of a certain research design, acceptability of benefits versus risks, and adequacy of the
p.000130: informed consent, will thus have to be assessed by the EC on a case- by-case basis, taking into account specific
p.000130: contextual and potential vulnerability factors of the participants and the sensitive nature of the proposed research.
p.000130: 11.3 Ethical issues related to donors
...
p.000133: validity of the objectives of the new research;
p.000133: 2. whether provisions for ensuring anonymity of the samples for secondary use are stated;
p.000133: 3. whether the permission of LAR is obtained for post-mortem uses of samples;
p.000133: 4. whether the consent form mentions retention and various possible future uses of tissues in the form of a tiered
p.000133: consent; and
p.000133: 5. Whether provisions have been made for allowance of waiver of consent if the donor is not traceable or the
p.000133: sample/data is anonymized or it is impractical to conduct the research.
p.000133:
p.000133: 11.4.4 Return of research results to individual/groups
p.000133: There are several possibilities which may be appropriate for a particular research and, according to the suitability,
p.000133: could be included in the participant information sheet/ informed consent document for biobanking.
p.000133: • Results of the study should be communicated back to the providers of samples/
p.000133: data.
p.000133: • If the findings are in an aggregate form, the participant will not be able to receive
p.000133: any feedback on individual data.
p.000133: • Wherever applicable, research findings in aggregate form (which does not reveal individual results) must
p.000133: be discussed with the community, especially when research involves populations who are more vulnerable, such as
p.000133: tribal populations, ethnic groups and people living with certain diseases.
p.000133: • In the absence of an appropriate mechanism to deal with informational harm that can occur if participants are
p.000133: provided feedback when they are not prepared to face it or if it is not actionable or when such information is
p.000133: unrelated, a lot of distress could be caused to participants concerned.
p.000133: • At the time of sample collection, it may be a good approach to offer donors the choice of receiving the
p.000133: results of the research whether they are beneficial or not. Participants may also choose not to be contacted about
p.000133: their results. Another alternative is to give participants the option of receiving an aggregate report of all the
p.000133: results of the study which could become a shared benefit for the community. The aforementioned options may be
p.000133: incorporated in a tiered consent.
p.000133:
p.000133: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000133: 133
p.000134:
p.000134: Biological Materials,
p.000134: Biobanking and Datasets
p.000134:
p.000134: 11.4.5 Benefit sharing
p.000134: Biological materials and/or data have potential commercial value but the participants’ contribution and their share in
p.000134: this benefit is very often not known to them. The informed consent document should emphasize this aspect with necessary
p.000134: clauses for clarity about benefit sharing. See Box 11.5 for further details.
p.000134: Box 11.5 Considerations for benefit sharing
p.000134:
p.000134: 1. The document should describe whether donors, their families, or communities would receive any financial or
...
Searching for indicator ethnicity:
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p.000108: individual consent unless a waiver has been granted.
p.000108: 2. Participant consent: Researchers must develop culturally appropriate ways to communicate information
p.000108: necessary for adherence to the standard required in the informed consent process.
p.000108: 3. Selective withholding of study information: ECs may permit selective withholding of
p.000108: information/hypothesis of the study in the consent form for achieving overall social and public good, without
p.000108: influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
p.000108: support and conditions for self-respect. Accordingly, concerns about social justice must be central to any
p.000108: adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the
p.000108: vulnerable status of prospective participants during review, for example, a woman asking her husband or family before
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
p.000108: practices. See section 5.7 for further details.
p.000108: 108 INDIAN COUNCIL OF MEDICAL
p.000109: RESEARCH
p.000109:
p.000109: Social and Behavioural Sciences
p.000109: Research for Health
p.000109:
p.000109: 9.2.7 Privacy and confidentiality
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
p.000119: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000119: 119
p.000120:
p.000120: Human
p.000120: Genetics Testing and Research
p.000120:
p.000120: the approval of the EC.
p.000120: 10.13.5 Prenatal screening: Prenatal screening is aimed to screen mothers and foetuses that are at high risk of having
p.000120: functional or structural defects including chromosomal and single gene disorders. There are many screening tests
p.000120: which are recommended in routine practice.
p.000120: • Biochemical and ultrasound screening: Various combinations of serum screening and ultrasound screening tests
p.000120: are done either during first (dual marker) or second trimester (triple or quadruple screening) for aneuploidy
p.000120: screening. It is important to discuss detection rates, false positive and negative results with participants.
p.000120: • Invasive testing for prenatal diagnosis: Preliminary genetic counselling of women for invasive prenatal
p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
...
Searching for indicator foetus:
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p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
...
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
...
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
p.000113: safety and may be vulnerable, such as children, individuals with mental illness, cognitively impaired individuals,
p.000113: people with rare diseases and others. See section 6 for further details.
p.000113: 10.2 Genetic Counselling
p.000113: 10.2.1 Pre- and post-test non-directive counselling should be given by persons who are qualified and
p.000113: experienced in communicating the meaning of genetic information as some conditions may require termination of pregnancy
p.000113: or selection of embryos to avert birth of a genetically abnormal child/foetus. While disclosing the result, appropriate
p.000113: options should be provided to the family to enable them to come to a decision.
p.000113: 10.2.2 While general principles of counselling require the presence of both spouses, necessary care and caution must
p.000113: be taken so as not to break families. Truthful counselling with extreme caution and patience is essential to explain
p.000113: the situation in a proper perspective in order to minimize psychosocial harm.
p.000113: 10.3 Privacy and confidentiality
p.000113: The researcher should explain the specific nature of the confidentiality of data generated through genetic
p.000113: testing/research to the patient/participant. Disclosure may cause psychosocial harm and needs careful handling.
p.000113: 10.3.1 Participants should be told of the limits of the researcher’s ability to safeguard
p.000113: confidentiality in certain circumstances and the anticipated consequences of breach of confidentiality.
p.000113: 10.3.2 The researcher can delink data to maintain confidentiality and safeguard the information for basic research.
p.000113: However, If the result of the research is of benefit to the health of the participant then, with approval of the EC,
p.000113: data could be re-linked for communication of the result. See Table 11.1 for further details.
p.000113: 10.3.3 Genetic research requires collection of family history and details about other members of the family, thus
p.000113: involving them as secondary participants. If identifiable information is being collected about the secondary
...
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
p.000115: • In case of population or community based studies, it may be noted that the genetic research may generate
p.000115: information applicable to the community/populations from which the participants were drawn, and therefore, group
p.000115: consent must be taken from the community head and/or the culturally appropriate authority.
p.000115: • Even if group consent is taken, it will not be a replacement for individual consent
p.000115: as individual consent is important. See section 5 for further details.
p.000115: • Researchers should be aware of potential stigmatization of the entire group and must explain ways to
p.000115: avoid the same during the conduct of research and publication of research results.
p.000115: 10.5 Culturally sensitive issues
p.000115: 10.5.1 Transmission of a genetic abnormality from parents, especially the mother to the foetus, could be
p.000115: a very sensitive cultural issue. Such possibility arises when during routine testing or prenatal diagnosis it is
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
p.000115: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000115: 115
p.000116:
p.000116: Human
p.000116: Genetics Testing and Research
p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
p.000116: information is revealed to the husband or other members of the family, it may cause marital discord despite the fact
p.000116: that the husband himself is a carrier of the autosomal recessive disorder. Appropriate counselling should be part of
p.000116: the testing process.
p.000116: 10.5.2 Consanguineous marriages are common in some communities. If there are inherited diseases detected in the
p.000116: family, it is the responsibility of the health professionals/ researchers to inform participants regarding the possible
p.000116: implications that may arise due to consanguinity. Appropriate pedigrees need to be prepared and stored, as these can
p.000116: reveal a lot regarding disease inheritance in affected families.
p.000116: 10.6 Storage of samples for future genetic research
p.000116: 10.6.1 Rapid advances in science and technology have necessitated the storage of biological materials for future
p.000116: genetic research.
p.000116: 10.6.2 The samples from patients with rare genetic conditions, ethnic groups/tribes/ populations on the
p.000116: verge of extinction, endogamous groups and others have great cultural and geographical value and need to be preserved
p.000116: for future research. See section 11 for further details.
p.000116: 10.7 Results of genetic testing
p.000116: 10.7.1 Results of the tests should be informed to the participants. Return of the results depends on
p.000116: the research findings. If results are anticipated to be actionable, leading to potential benefits of improving health
...
p.000117: experience in genetics.
p.000117: 10.10.3 The concerned specialists dealing with genetic disorders should ideally undergo training in genetic
p.000117: counselling and be able to devote time to handle sensitive issues appropriately.
p.000117: 10.11 Quality standards of the laboratory
p.000117: 10.11.1 There is a paucity of quality assurance programmes in the country and therefore valid and reliable testing is
p.000117: a constant concern for both clinical practice and research. Any
p.000117:
p.000117: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000117: 117
p.000118:
p.000118: Human
p.000118: Genetics Testing and Research
p.000118:
p.000118: misinterpretation of genetic results or misdiagnosis may lead to psychological harm, and unnecessary or inappropriate
p.000118: intervention.
p.000118: 10.11.2 It is important to set standards for laboratories to ensure that test results are reliable, manpower is
p.000118: competent and the care provider is updated on developments in genetics.
p.000118: 10.11.3 All laboratories offering genetic testing should consider undergoing quality accreditation standards which are
p.000118: specific to genetic testing laboratories.
p.000118: 10.12 Misuse of genetic technology
p.000118: Genetic information has potential for misuse as well as long-term implications.
p.000118: 10.12.1 Prenatal sex selection is not allowed and to prevent misuse of genetic tests, particularly pre-selection of
p.000118: sex, GOI has enacted the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994,
p.000118: amended in 2003.37 All researchers in this area shall follow the provisions of this Act. Prenatal sex determination is
p.000118: prohibited by law for sex selection of the foetus.
p.000118: 10.12.2 Misuse of genetic information by insurers, employers or schools: Knowledge of genetic information of an
p.000118: individual/family/community/population/child might be misused by insurers/employers leading to discrimination and
p.000118: psychosocial harm. Hence, the information about a patient’s disease and investigations may not be shared with anyone
p.000118: without the consent of the individual concerned.
p.000118: 10.12.3 Research involving genetic manipulations must be carefully reviewed and protections established for
p.000118: participants.
p.000118: 10.13 Genetic diagnosis/testing and screening
p.000118: 10.13.1 History and pedigree studies: These involve obtaining history of other members of the family of the proband
p.000118: under investigation. It may reveal information about the likelihood of individual members of the family being either
p.000118: carriers of genetic defects or being affected by the disease. Privacy and confidentiality issues involved in this
p.000118: process are given in section 10.3.
p.000118: 10.13.2 Predictive genetic testing: The results of genetic tests in diseases that are multifactorial in origin and
p.000118: have a polygenic basis involving multiple genes or gene–environment interaction or those that are late onset, must be
p.000118: communicated carefully to prevent unnecessary worry or fear in the minds of individuals.
p.000118: 10.13.3 Genetic screening: Genetic screening implies searching a population for those individuals who have,
...
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
p.000120: embryos. This obviates the need for invasive testing for associated risks and also termination of the affected foetus,
p.000120: which is traumatic for the family.
p.000120: • Advanced techniques like chromosomal micro array (CMA) are being used for
p.000120:
p.000120: 120 INDIAN COUNCIL OF MEDICAL
p.000121: RESEARCH
p.000121:
p.000121: Human
p.000121: Genetics Testing and Research
p.000121:
p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
p.000121: intervention for management.
...
Searching for indicator foetuses:
(return to top)
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
...
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
...
p.000119: detection rate) with minimal misidentification of unaffected persons (the false positive rate). Screening tests do not
p.000119: aim to make a diagnosis, but rather rationalize the use of more accurate confirmatory tests.
p.000119: 10.13.4 Population screening: Genetic disorders can be population specific (for example,
p.000119: -thalassemia and sickle cell disease in some population groups in India).
p.000119: • Population screening should not be undertaken without prior education of the population to be
p.000119: screened and counselling should be integrated with the programme.
p.000119: • Screening tests should be robust with acceptable sensitivity and specificity.
p.000119: • Wherever applicable, community permission/group consent should be taken in
p.000119: addition to individual informed consent.
p.000119: • Researchers may conduct coded or reversible anonymized testing on general
p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
p.000119: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000119: 119
p.000120:
p.000120: Human
p.000120: Genetics Testing and Research
p.000120:
p.000120: the approval of the EC.
p.000120: 10.13.5 Prenatal screening: Prenatal screening is aimed to screen mothers and foetuses that are at high risk of having
p.000120: functional or structural defects including chromosomal and single gene disorders. There are many screening tests
p.000120: which are recommended in routine practice.
p.000120: • Biochemical and ultrasound screening: Various combinations of serum screening and ultrasound screening tests
p.000120: are done either during first (dual marker) or second trimester (triple or quadruple screening) for aneuploidy
p.000120: screening. It is important to discuss detection rates, false positive and negative results with participants.
p.000120: • Invasive testing for prenatal diagnosis: Preliminary genetic counselling of women for invasive prenatal
p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
p.000120: embryos. This obviates the need for invasive testing for associated risks and also termination of the affected foetus,
p.000120: which is traumatic for the family.
p.000120: • Advanced techniques like chromosomal micro array (CMA) are being used for
p.000120:
p.000120: 120 INDIAN COUNCIL OF MEDICAL
p.000121: RESEARCH
p.000121:
p.000121: Human
p.000121: Genetics Testing and Research
p.000121:
p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
...
p.000126: 10.17.3 Relevant samples may be stored for possible future use following the guidelines of biological materials,
p.000126: biobanking and datasets given in section 11.
p.000126: 10.17.4 Adequate genetic counselling should be done to explain the requirements and benefits of autopsy to the family.
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126: 126 INDIAN COUNCIL OF MEDICAL
p.000127: RESEARCH
p.000127:
p.000127: SECTION 11
p.000127:
p.000127:
p.000127: BIOLOGICAL MATERIALS, BIOBANKING AND DATASETS
p.000127:
p.000127: 11.0 Biological materials or biospecimens or samples include biological fluids, such as blood, dried blood spots,
p.000127: body fluids, urine, tissues, organs, cord blood, oocytes, sperm, semen or embryos. These may be stored or prospectively
p.000127: collected.
p.000127: A repository or biobank is an organized collection of resources that can be accessed to retrieve human biological
p.000127: material and data for research purposes. The bio resources would therefore be protocol-based prospective
p.000127: collection of biospecimens, left-over samples after clinical investigations or research proposals, biopsy materials,
p.000127: surgical or autopsy specimens/tissues, embryos or foetuses, cell lines, or waste materials like abandoned
p.000127: organs/tissues. Repository activities involve three components: collection of biospecimens and/or data; storage of
p.000127: biospecimens and data including its management; and retrieval and disbursement to researchers.
p.000127: A dataset is an organized collection of data and information maintained in physical and/or electronic/digital form that
p.000127: can be used for biomedical and health research. Besides data related to biospecimens as in biobanks, there are other
p.000127: repositories like disease registries, health surveys, disease surveillance, census data and even personal health
p.000127: records in health-care institutions which may have huge potential for subsequent research. The data may be from small
p.000127: numbers to large numbers or whole population. Examples of biobanks and datasets are Iceland’s deCODE biobank, National
p.000127: Institute of Mental Health and Neurosciences (NIMHANS) Brain Bank, Tumour Tissue Bank at Tata Memorial Hospital (TMH),
p.000127: Census data, NFHS data, Cancer Registry of India, CTRI, etc.
p.000127: 11.1 Biobanking
p.000127: A biobank is an organized collection of human biological materials with usually associated dataset stored
p.000127: for years in appropriate facilities for research and potential commercial purposes with inbuilt policies for
p.000127: transparency. The space occupied by organized collection of these materials and data is termed biorepository.
p.000127: Research on such biospecimens or samples and/or related datasets may not directly involve the individuals. Biobanks
p.000127: involve governance of collection of biological material, processing, storage with associated data, and dissemination of
p.000127: samples and/or data through sharing
p.000127:
p.000127: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000127: 127
p.000128:
p.000128: Biological Materials,
...
Social / Homeless Persons
Searching for indicator homeless:
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p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
...
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
p.000068: or populations in conflict zones, riot areas or disaster situations. Additional precautions should be taken to
p.000068: avoid exploitation/retaliation/ reward/credits and other inducements when such individuals are to be recruited as
p.000068: research participants.
p.000068: 6.11.1 Autonomy of such individuals is already compromised and researchers have to justify their inclusion.
p.000068: 6.11.2 ECs have to satisfy themselves with the justification provided to include these participants and record the same
p.000068: in the proceedings of the EC meeting.
p.000068: 6.11.3 Additional safety measures suggested earlier in the guidelines should be strictly followed by the ECs.
p.000068: 6.11.4 The informed consent process should be well documented. There should not be any undue coercion or incentive for
p.000068: participation. A person’s refusal to participate should be respected and there should be no penalization.
p.000068: 6.11.5 The EC should also carefully determine the benefits and risks of the study and examine risk minimization
p.000068: strategies.
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: 68 INDIAN COUNCIL OF
p.000069: MEDICAL RESEARCH
p.000069:
p.000069: SECTION 7
p.000069:
p.000069: CLINICAL TRIALS OF DRUGS AND OTHER INTERVENTIONS
p.000069:
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000094: for application at the community level. While respect for the rights and dignity of all participants need to be
p.000094: considered and ensured, the same should be observed about the community. This can be facilitated by engaging the
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
p.000095: • Principle of reciprocity – This principle requires that individuals or communities, who have borne a
p.000095: disproportionate share of burden or risks for the benefit of others be given some form of benefit. The benefit should
p.000095: be context specific such as protection from further exposure, access to food, healthcare, clothing and
...
Searching for indicator restricted:
(return to top)
p.000012: dissemination of the results to the entire community.
p.000012: See sections 8 and 9 for further details.
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
p.000012: 2.11.1 Efforts should be made to communicate the findings of the research study to the
p.000012: individuals/communities wherever relevant.
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
p.000013: RESPONSIBLE CONDUCT OF RESEARCH
p.000013:
p.000013: 3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a
p.000013: significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide
p.000013: by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members
p.000013: of a research team are expected to maintain high standards and to uphold the fundamental values of research. The
p.000013: responsible conduct of research (RCR) involves the following major components: values; policies; planning and
p.000013: conducting research; reviewing and reporting research; and responsible authorship and publication.
p.000013: Institutions conducting research must establish a research office within their institution to facilitate research,
p.000013: manage grants, and oversee all aspects of RCR. The research office must work closely with the EC and with all
p.000013: stakeholders, including undergraduate and postgraduate students. SOPs should be in place to address all the major
...
p.000077: the clinical trial population, it is inappropriate to use a placebo control.
p.000077: 7.4.3 Placebo may be used as a comparator under the conditions given in Box 7.4.
p.000077: Box 7.4 Conditions where a placebo may be used
p.000077: A placebo may be used when:
p.000077: • there is no established effective therapy available;
p.000077: • withholding an established effective therapy would not expose participants to serious
p.000077: harm, but may cause temporary discomfort or delay in relief of symptoms;
p.000077: • if the disease is self-limited; or
p.000077: • the use of an established effective therapy as a comparator would not yield scientifically reliable
p.000077: results and the use of placebo would not add any additional risk of serious or irreversible harm to the participants.
p.000077: 7.4.4 If a placebo must be used for scientific reasons, then certain precautions must be exercised. These should be
p.000077: reviewed and approved by the EC. See Box 7.5 for further details.
p.000077: Box 7.5 Precautions to be taken when a placebo is used
p.000077: 1. The protocol must have added safeguards to protect participants from harm, such as but not restricted to
p.000077: having clear-cut withdrawal criteria, intensive monitoring and rescue medications.
p.000077: 2. Use an add-on trial design where the IP or placebo are added to standard of care.
p.000077: 3. Expose fewer patients to placebo groups, for example by having 2:1 randomization with 2 participants
p.000077: receiving IP against 1 getting placebo (unbalanced randomization).
p.000077: 4. An active comparator as an additional arm may also be included in such trials where randomization can be,
p.000077: for example, 2:2:1 (IP: active comparator: placebo).
p.000077: 5. Ensure transition to standard of care/active medicine for study participants after research is completed,
p.000077: including post-trial arrangements for implementing any positive trial results.
p.000077:
p.000077: 7.5 Multicentric trials
p.000077: Multicentric trials are carried out with a primary aim of providing a sound basis for the subsequent generalization of
p.000077: its results.
p.000077: 7.5.1 ECs of all sites should follow all applicable regulatory guidelines, including registration with regulating
p.000077: bodies.
p.000077:
p.000077: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000077: 77
p.000078:
p.000078: Clinical Trials of Drugs and
p.000078: other Interventions
p.000078:
p.000078: 7.5.2 The ethical review procedure for common review of multicentric research is given in section 4.10. Not
p.000078: applicable for clinical trials under Drugs and Cosmetic Act.
p.000078: 7.6 Phytopharmaceutical drugs
...
p.000080: testing HIV, HBsAg, HCV and blood grouping. Non-notified are those for testing malaria, TB, dengue, chikungunya,
p.000080: typhoid, syphilis, cancer markers, etc.
p.000080: 7.8 Biologicals and biosimilars
p.000080: Biologics (biopharmaceutical drug) can be composed of sugars, proteins, nucleic acids or complex combinations of these
p.000080: substances, or may be living cells or tissues. This section applies to products that are produced by means of
p.000080: biological processes with or without recombinant DNA technology. All aspects that are described in section 7.1 are also
p.000080: applicable to biologics.
p.000080: 7.8.1 As these are biologic substances, special care must be taken to review all data generated. Special expertise
p.000080: may be sought for such reviews so that foreseeable risks are well identified.
p.000080: 7.8.2 A thorough benefit-risk assessment must be carried out with available data.
p.000080: 7.8.3 If the study involves biosimilars, the product quality (manufacturing and characterization), preclinical data
p.000080: and bioassay must demonstrate similarity with a reference biologic.
p.000080: 7.8.4 All applicable and current regulations must be followed.
p.000080: 7.9 Clinical trials with stem cells
p.000080: In recent years, stem cell research has undergone rapid developments promising new leads in the treatment of several
p.000080: incurable diseases. According to the source and degree of expected risk to human participants, stem cell research is
p.000080: categorized into permissible (adult and cord blood), restricted (embryonic) and prohibited (reproductive cloning) areas
p.000080: of research. In India, only permissible and restricted areas of research are permitted with appropriate approvals. It
p.000080: is necessary to ensure that donors are not exploited and commodified.
p.000080: To address issues related to stem cell research, ICMR and DBT published Guidelines for Stem Cell Research and Therapy
p.000080: in 2007, 2013 and revised as National Guidelines for Stem Cell Research in 2017. 6
p.000080: 7.9.1 Except haemopoietic stem cell transplantation for haematological disorders, any other uses of stem cells are
p.000080: categorized as research and must be conducted as clinical trials, needing the approval of the EC, IC-SCR (permissible
p.000080: research), National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) (restricted research) and CDSCO
p.000080: (IND products and drugs) as the case may be.29 Use of stem cells outside the domain of a clinical trial for any
p.000080: purpose is considered unethical and hence not permissible.
p.000080: 80 INDIAN COUNCIL OF
p.000081: MEDICAL RESEARCH
p.000081:
p.000081: Clinical Trials of Drugs and
p.000081: other Interventions
p.000081:
p.000081: 7.9.2 Clinical trials must be carried out with clinical grade cells processed as per applicable national Good
p.000081: Laboratory Practices (GLP)30, Good Manufacturing Practices (GMP)31, and GCP guidelines.12
p.000081: 7.9.3 Each institution should maintain a registry of researchers who are conducting stem cell research. Researcher
p.000081: must be kept updated in accordance with changes in guidelines and regulations regarding use of these cells. It is also
p.000081: the responsibility of the institution to ensure that all current standards are applied.
p.000081: 7.9.4 All clinical trials must be approved by IC-SCR, which in turn should be registered with NAC-SCRT. All such
p.000081: studies should also be registered with CTRI. The EC should give final approval before initiation of the clinical trial.
p.000081: 7.10 Surgical interventions
p.000081: Surgical interventions that are being studied systematically must be considered as research and follow all
p.000081: general principles described in these guidelines.
p.000081: 7.10.1 In any protocol where an established surgical intervention is to be studied, the researcher must provide
p.000081: references for the procedure and describe the most likely complications in the protocol for the EC to review and
...
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
...
p.000097: A demographic surveillance site is a geographically defined population with continuous demographic monitoring and
p.000097: regular production of data and reports on all births, deaths and migrations. This monitoring system should provide a
p.000097: platform for assessing a wide range of health-systems and social and economic interventions. In addition, these sites
p.000097: can also be used to monitor developmental and environmental parameters and determine their interaction with, and impact
p.000097: on, human health. The sites are used as platforms for the testing of new health and non-health interventions and can
p.000097: provide feedback on programme effectiveness. The aim of a surveillance site is to provide an evidence base for
p.000097: improving the lives of people living in developing countries by informing and influencing existing as well as future
p.000097: health-related policy and practice. They can also help define a relevant research and development agenda.
p.000097: • Prior approval from competent state/national authorities and from the community leadership is required to
p.000097: set-up the demographic surveillance sites, with or without the use of geographic information system (GIS) facilities.
p.000097: Setting-up such sites need not be subject to prior review and approval by an EC.
p.000097: • Strategies for research studies to be undertaken at these sites including data-set collection and its
p.000097: storage, with plans to maintain confidentiality, will have to undergo appropriate EC review. To safeguard the
p.000097: confidentiality of personally identifiable records, the collected data at demographic sites must be stored in an
p.000097: encrypted format with primary identifiers accessible only to restricted designated individuals who are bound by a
p.000097: confidentiality agreement.
p.000097: • Spatial epidemiology, including use of GIS technology, in health is an evolving area and the related
p.000097: ethical issues that may emerge need to be addressed as experience grows.
p.000097: • Registries are a systematic collection of data concerning a particular diseases and/ or health conditions at
p.000097: one or more places. For registries that are established as part of research projects or if the data emerging from these
p.000097: registries is proposed to be used for research, prior approval of the EC is required.
p.000097: • On the other hand, registries that are set-up as part of public health programmes by a national authority may
p.000097: be exempted from the ethical review process if the data is de-identified, but are subject to governance processes and a
p.000097: certificate
p.000097:
p.000097: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000097: 97
p.000098:
p.000098:
p.000098: Public Health Research
p.000098:
p.000098: from an EC for exemption for ethics review and if required for waiver of informed consent.
p.000098: • The ethical concerns for EC approval are similar to those mentioned in section
p.000098: 8.3.
p.000098: 8.2.4 Implementation research
p.000098: At local, national and global levels, a persistent challenge is to effectively implement and scale-up policies,
p.000098: programmes and interventions that can save lives and improve health. A new approach to achieving these goals is through
p.000098: implementation research (IR), which facilitates informed decisions about health policies, programmes and clinical
...
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
p.000121: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000121: 121
p.000122:
p.000122: Human
p.000122: Genetics Testing and Research
p.000122:
p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
p.000122: linked), the individual should be tested after administering informed consent when she/he is able to comprehend the
p.000122: benefits and risks of screening. Stigmatization for carrier status is common and therefore, the information should be
p.000122: kept confidential.
p.000122: • Chromosomal: If there is a family history of balanced translocation in any individual, then
p.000122: immediate relatives may be at risk. The same principles as for carrier testing should be followed.
p.000122: 10.14 Gene therapy
p.000122: All gene therapies are considered as research and all protections for human research participants should be in place.
p.000122: 10.14.1 Somatic cell gene therapy is permissible for the purpose of preventing or treating a serious
p.000122: disease when it is the only therapeutic option. It should be restricted to alleviation of life
p.000122: threatening or seriously disabling genetic disease in individual patients and should not be permitted to change
p.000122: normal human traits.
p.000122: 10.14.2 Prior to obtaining approval for initiating a gene therapy trial, an approval from the local EC and DBT has to
p.000122: be obtained for the gene construct.
p.000122: 10.14.3 If the trial is for a product for commercial use or for marketing purposes, approval needs to be taken from
p.000122: CDSCO.
p.000122: 10.14.4 All gene therapy trials should have the provision for long-term surveillance.
p.000122: 10.14.5 Informed consent must be taken, especially regarding uncertainties about outcome.
p.000122: 10.14.6 Children could be candidates for therapy, if the therapy is meant for a childhood disorder.
p.000122: 10.14.7 Germ line therapy is prohibited under the present state of knowledge.
p.000122: 10.14.8 Eugenic genetic engineering for changing/selecting/altering genetic characteristics and creating so called
p.000122: designer babies is prohibited. These should not be attempted, as we possess insufficient information at present to
p.000122: understand the effects of attempts to alter/enhance the genetic machinery of humans. It would be unethical to use
p.000122: genetic engineering for improvement of intelligence, memory, formation of body organs, fertility, physical,
p.000122: mental and emotional characteristics, etc. even if specific gene/genes are identified in future.
p.000122:
p.000122:
p.000122: 122 INDIAN COUNCIL OF MEDICAL
p.000123: RESEARCH
p.000123:
p.000123: Human
p.000123: Genetics Testing and Research
p.000123:
p.000123: 10.15 Use of newer technologies
...
p.000128: identifying information are provided in Table 11.1.
p.000128: 11.1.2 Privacy of donor and confidentiality related to biological materials and/or data
p.000128: This pertains to both personal identifiers and the related data of the participant. Some key points for maintaining
p.000128: privacy and confidentiality related to donors are listed in Box 11.1.
p.000128: 11.2 Storage of biospecimens and data with personal identifiers
p.000128: 11.2.1 Informed consent, confidentiality, privacy and re-consent are largely influenced by the degree of
p.000128: identifiability, whether the biospecimens and data are anonymized or not. As a general principle, research must be
p.000128: conducted on least identifiable data.
p.000128:
p.000128:
p.000128: 128 INDIAN COUNCIL OF MEDICAL
p.000129: RESEARCH
p.000129:
p.000129: Biological Materials,
p.000129: Biobanking and Datasets
p.000129:
p.000129:
p.000129: Table 11.1 Types of samples
p.000129:
p.000129:
p.000129: Anonymous or unidentified
p.000129: No identifiers are present from the start or if collected, are not maintained. Such samples are received by
p.000129: biobanks without any identifiers and supplied to researchers.
p.000129: Anonymized This involves systematic de-identification, reversible or irreversible: link of samples/data
p.000129: to personal identity is reversibly or irreversibly cut.
p.000129:
p.000129:
p.000129: Coded or reversibly anonymized: There is an indirect link of sample/ data to the participant’s
p.000129: identity with restricted access. This link could be re-linked if required; therefore, it may also be
p.000129: termed reversible anonymization.
p.000129: Irreversibly anonymized:
p.000129: Link to the participant’s identity is removed and cannot be re-linked.
p.000129: Identifiable A direct link of sample/data to the participant’s identity exists.
p.000129:
p.000129:
p.000129: Box 11.1 Confidentiality and privacy of donors related to biological materials and/or data
p.000129:
p.000129: Some key aspects related to maintaining confidentiality and privacy of donors of biological materials and/or data:
p.000129: 1. The procedure of anonymization minimizes the connection between the identifiers and the stored sample or medical
p.000129: data by delinking the person from her/his biological material.
p.000129: 2. Maintaining confidentiality of data and respecting ethnic identity is of prime importance, especially
p.000129: in population based genetic studies.
p.000129: 3. More precautions should be sought when the research pertains to stigmatizing diseases.
p.000129: 4. When data pertains to epidemiological and public health practice or research, it may be dealt with in the manner
p.000129: described in section 8.
p.000129:
p.000129: 11.2.2 Under certain circumstances, some degree of identifiability may have to be retained for reasons related to the
p.000129: research. For example, anonymized data or specimens will not allow later withdrawal of consent by an individual, while
p.000129: in the coded category, this will be possible. In the latter scenario, the custodians of the respective biorepository or
p.000129: biobank have a greater responsibility to take adequate measures to safeguard the
p.000129:
...
p.000139: which should be minimized at all stages of research.
p.000139: 12.4.2 Special efforts (culturally appropriate and scientifically valid) are required to maintain dignity, privacy and
p.000139: confidentiality of individuals and the communities.
p.000139:
p.000139: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000139: 139
p.000140:
p.000140: Research during Humanitarian Emergencies and
p.000140: Disasters
p.000140:
p.000140: 12.4.3 Efforts should be made to protect the identifying information about individuals and communities, for example,
p.000140: from exploitation by the print and visual media.
p.000140: 12.5 Ethics review procedures
p.000140: 12.5.1 Research during humanitarian emergencies and disasters can be reviewed through an expedited
p.000140: review/scheduled/unscheduled full committee meetings and this may be decided by the Member Secretary on a case-to-case
p.000140: basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as
p.000140: possible.
p.000140: 12.5.2 Meticulous documentation and archiving are required to enable future application in similar situations.
p.000140: 12.5.3 Suggestions to expedite the review process are given below:
p.000140: • Measures such as virtual or tele-conferences should be attempted when face-to-
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
p.000140: data/sample collection that are likely to rapidly deteriorate or perish may be allowed while the review process is
p.000140: underway.
p.000140: • Available protocol templates could be reviewed to expedite the process.
p.000140: • Re-review should be done if the emergency situation changes.
p.000140: • In situations where members of local ECs are unavailable due to the emergency, the ethics review may be
p.000140: conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its
p.000140: meeting. ECs should develop procedures to ensure appropriate and timely review and monitoring of the approved research.
p.000140: On a case-by-case basis, some protocols may require re- review as the emergency situation may change with time and
p.000140: circumstances.
p.000140: 12.5.4 The EC should closely monitor the conduct and outcome of research.
p.000140: 12.6 Post-research benefit
p.000140: Sponsors and researchers should strive to continue to provide beneficial interventions, which were part of the research
p.000140: initiative even after the completion of research and till the local administrative and social support system is
p.000140: restored to provide regular services.
p.000140: 12.7 Special considerations
p.000140: Humanitarian emergencies lead to fragile political environments with disruption of health systems and social
p.000140: situations.
p.000140:
p.000140:
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
...
Social / Institutionalized
Searching for indicator institutionalized:
(return to top)
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
...
p.000052: 5.4.1 Each prospective participant should sign the informed consent form after going through the informed consent
p.000052: process of receiving information, understanding it and voluntarily agreeing to participate in the research.
p.000052: 5.4.2 In case the participant is incompetent (medically or legally) to give consent, the LAR’s consent must be
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
p.000052: should be a literate person who can read the participant information sheet and consent form and understand the language
p.000052: of the participant.
p.000052: 5.4.4 If the participant cannot sign then a thumb impression must be obtained.
p.000052: 5.4.5 The researcher who administers the consent must also sign and date the consent form.
p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
p.000053:
p.000053: Informed Consent Process
p.000053:
p.000053: participants if their details are recorded as a part of the family history. If information about the secondary
p.000053: participants is identifiable then their informed consent will also be required.
p.000053: 5.4.9 Online consent may be obtained, for example, in research involving sensitive data such as unsafe sex, high
p.000053: risk behaviour, use of contraceptives (condoms, oral pills), or emergency contraceptive pills among unmarried females
p.000053: in India etc. Investigators must ensure that privacy of the participant and confidentiality of related data is
p.000053: maintained.
p.000053: 5.5 Electronic consent
...
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
...
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
p.000059: Researchers • Recognize the vulnerability of the participant and ensure additional
p.000059: safeguards are in place for their protection.
p.000059: • Justify inclusion/exclusion of vulnerable populations in the study.
p.000059: • COI issues must be addressed.
p.000059: • Have well defined procedures (SOPs) to ensure a balanced benefit-risk
p.000059: ratio.
p.000059: • Ensure that prospective participants are competent to give informed
p.000059: consent.
p.000059: • Take consent of the LAR when a prospective participant lacks the capacity
p.000059: to consent.
p.000059: • Respect dissent from the participant.
p.000059: • Seek permission of the appropriate authorities where relevant, such as
p.000059: for institutionalized individuals, tribal communities, etc.
p.000059: • Research should be conducted within the purview of existing relevant
p.000059: guidelines/regulations.
p.000059: Ethics Committees • During review, determine whether the prospective participants for a
p.000059: particular research are vulnerable.
p.000059: • Examine whether inclusion/exclusion of the vulnerable population is
p.000059: justified.
p.000059: • Ensure that COI do not increase harm or lessen benefits to the participants.
p.000059: • Carefully determine the benefits and risks to the participants and advise
p.000059: risk minimization strategies wherever possible.
p.000059: • Suggest additional safeguards, such as more frequent review and
p.000059: monitoring, including site visits.
p.000059: • Only the full committee should do initial and continuing review of such proposals. It is desirable to have
p.000059: empowered representatives from the specific populations during deliberations.
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
...
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
...
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
...
Social / LGBTQ+ Status
Searching for indicator LGBT:
(return to top)
p. xiii: developments in the field of science and technology, another revision was carried out as Ethical Guidelines for
p. xiii: Biomedical Research on Human Participants in 2006. Bioethics is a dynamic area and over the last 10 years many new
p. xiii: concerns and issues have evolved internationally over the ethical dilemmas faced by the scientific and ethics
p. xiii: committees in the conduct and review of biomedical research; hence, an exercise was taken up over a period of one year
p. xiii: with national and international consultation to come up with this new set of state of art guidelines. It was a
p. xiii: challenging task to decide which of the best practices we should incorporate in this revised version. A wide range of
p. xiii: stakeholders in the country consult the ICMR ethical guidelines as gold standard and these are also looked upon by many
p. xiii: developing countries.
p. xiii: The new guidelines have many new sections added up and many changes incorporated in the existing sections. There are
p. xiii: now a total of 12 sections including Responsible Conduct of Research, Informed Consent Process, Vulnerability,
p. xiii: Public Health Research, Social and Behavioural Sciences Research for Health, Biological materials,
p. xiii: Biobanking and Datasets and Research during Humanitarian Emergencies and Disasters. Many new issues have been added
p. xiii: up as subsections e.g. sexual minorities (LGBT), multicentric studies, research using datasets etc. The section on
p. xiii: ethics review process has been elaborated to help the many ethics committees who have doubt about the various
p. xiii: procedures to be followed. The support given to the drafting committee by ICMR to complete the work within the
p. xiii: stipulated time needs appreciation.
p. xiii: With the emergence of new technologies and knowledge that can potentially transform society, it has become necessary to
p. xiii: constantly update the ethical guidelines to protect the rights and safety of the research participants involved in
p. xiii: clinical research. I hope the scientific community, the regulatory agencies and all the stakeholders at large involved
p. xiii: in biomedical research will be enormously benefitted by this revised new guidelines.
p. xiii:
p. xiii:
p. xiii:
p. xiii: Coimbatore September 2017
p. xiii: Dr Vasantha Muthuswamy
p. xiii: Chairperson, Advisory Group
p. xiii:
p. xiii:
p. xiii: xiii
p. xiv:
p. xiv: ACKNOWLEDGEMENT
p. xiv:
p. xiv: We acknowledge with gratitude the inspiration and patronage of Dr Soumya Swaminathan, Director General ICMR
p. xiv: and Secretary Department of Health Research, to update and revise the ICMR Ethical Guidelines for Biomedical Research
p. xiv: on Human Participants 2006. The dynamic efforts and contributions of the Advisory Group consisting of Dr
p. xiv: Vasantha Muthuswamy (Chairperson), Prof S D Seth, Dr Nandini K Kumar, Prof N K Arora and Prof Urmila Thatte are
p. xiv: gratefully acknowledged. Special thanks are due to all the members of the 14 subcommittees who drafted the initial
...
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
p.000007: community.
p.000007: 2.3.2 Potential limitations to ensure strict confidentiality must be explained to the participant. Researchers must
p.000007: inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,
p.000007: it may not be possible to do so under certain circumstances.
p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
...
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
...
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
...
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
p.000157: related injury
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
p.000157: it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the
p.000157: intervention, whenever they occur, as well as any medical injury caused due to procedures.
p.000157: 53 Risk Probability of harm or discomfort to research participants.
p.000157: Acceptable risk differs depending on the conditions inherent in the conduct of research.
p.000157:
p.000157: 54 Serious adverse
p.000157: event (SAE)
p.000157: An adverse event is serious when the research outcome for
p.000157: the participant is death, life-threatening injury requiring hospitalization, prolongation of
p.000157: hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to
p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
p.000158: 62 Theologian A person who is an expert in the study of religious faith(s), including the
p.000158: system of spirituality, practice and experience about the nature of the divine.
p.000158:
p.000158: 63 Test of
p.000158: understanding
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000005: causing discomfort or harm anticipated as physical, psychological, social, economic or legal.
p.000005: 2.1.1 The researcher, sponsor and EC should attempt to maximize benefits and minimize risks to participants so that
p.000005: risks are balanced to lead to potential benefits at individual, societal and/or community levels.
p.000005: 2.1.2 The EC should assess the inherent benefits and risks, ensure a favourable balance of benefits and risks,
p.000005: evaluate plans for minimizing the risk and discomfort and decide on the merit of the research before approving it.
p.000005: 2.1.3 The EC should also assess any altered risks in the study at the time of continuing review.
p.000005: 2.1.4 The type of EC review based on risk involved in the research, is categorized as given in Table 2.1. Also see
p.000005: Table 4.2 for further details.
p.000005: 2.2 Informed consent process
p.000005: Informed consent protects the individual’s autonomy to freely choose whether or not to participate in the research. The
p.000005: process involves three components – providing relevant information to potential participants, ensuring the information
p.000005: is comprehended by them and assuring voluntariness of participation. Informed consent should explain medical
p.000005: terminology in simple terms and be in a language that the participant understands.
p.000005: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000005: 5
p.000006:
p.000006:
p.000006: General Ethical Issues
p.000006: Table 2.1 Categories of Risk
p.000006: Type of risk Definition/description
p.000006:
p.000006: Less than minimal risk
p.000006: Probability of harm or discomfort anticipated in the research is nil or not expected. For example, research on
p.000006: anonymous or non-identified data/samples, data available in the public domain, meta-analysis, etc.
p.000006: Minimal risk Probability of harm or discomfort anticipated in the research is not greater than that ordinarily
p.000006: encountered in routine daily life activities of an average healthy individual or general population or during the
p.000006: performance of routine tests where occurrence of serious harm or an adverse event (AE) is unlikely. Examples include
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
...
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
...
p.000019: 3.6 Research misconduct and policies for handling misconduct
p.000019: Research misconduct involves fabrication, falsification and plagiarism of data, which are serious issues both
p.000019: nationally and internationally. See Box 3.4 for further details.
p.000019: 3.6.1 Institutions should develop policies to address scientific/research misconduct.
p.000019: 3.6.2 Research misconduct, if suspected, needs to be investigated. An institution must investigate all
p.000019: allegations of misconduct as present or future participants’ lives may be endangered if facts are not presented
p.000019: accurately. Such investigations must be done in a timely, fair and transparent manner and the results should be made
p.000019: available in the public domain.
p.000019: 3.6.3 It is important to establish institutional mechanisms for protection of both the whistle- blower and the person
p.000019: accused of research misconduct. This information must be kept
p.000019:
p.000019: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000019: 19
p.000020:
p.000020:
p.000020: Responsible Conduct of Research
p.000020: Box 3.4 Types of research misconduct
p.000020:
p.000020: Research misconduct includes the following:
p.000020: • Fabrication is the intentional act of making-up data or results and recording or reporting
p.000020: them.
p.000020: • Falsification is manipulating research materials, equipment or processes, or changing or omitting/suppressing data
p.000020: or results without scientific or statistical justification, such that the research is not accurately represented in the
p.000020: research record.
p.000020: • Plagiarism is the “wrongful appropriation” and “stealing and publication” of another paper or another author’s
p.000020: “language, thoughts, ideas, or expressions” and the representation of them as one’s own original work or
p.000020: duplicating one’s own publication (self plagiarism).
p.000020:
p.000020: confidential until the enquiry is complete.
p.000020: 3.6.4 Simultaneous submission of the same grant application to different funding agencies or submitting
p.000020: papers/overlapping publications to journals is not acceptable, as this could lead to unnecessary duplication in review
p.000020: process or in meta analysis. .
p.000020: 3.7 Registration with Clinical Trials Registry–India
p.000020: The Clinical Trials Registry–India, linked to WHO registry, was launched on 20 July 2007 by ICMR, as a free and online
p.000020: public record system for registration of clinical trials, PG thesis and other biomedical research being conducted in
p.000020: the country. Trial registration in the CTRI was made mandatory by CDSCO on 15 June 2009 for clinical trials that are
p.000020: registered under the Drugs and Cosmetics Act and its Rules. Registration with CTRI is voluntary for other
p.000020: biomedical and health research. In addition, editors of major biomedical journals of India declared that only
p.000020: trials on any of the public databases would be considered for publication in journals. According to 64th WMA
p.000020: General Assembly, held at Fortaleza, Brazil, in October 2013, the Declaration of Helsinki clearly states that “Every
p.000020: research study involving human subjects must be registered in a publicly accessible database before recruitment of the
p.000020: first subject.” Under the aegis of WHO, a joint statement on public disclosure of results from all international trials
p.000020: was signed by ICMR and others in May 2017.
...
p.000029: submitted documents.
p.000029: • Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial
p.000029: Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s
p.000029: undertaking, protocol specific other permissions, such as, stem cell committee for stem cell research, HMSC
p.000029: for international collaboration, compliance with guidelines etc.
p.000029: • Interpret and inform EC members about new regulations
p.000029: if any
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000029: (Contd.)
p.000029:
p.000029: 29
p.000030:
p.000030:
p.000030: Ethical Review Procedures
p.000030:
p.000030:
p.000030: 6. Social scientist/ philosopher/ ethicist/theologian
p.000030: Affiliated/ non-affiliated
p.000030:
p.000030: Qualifications -
p.000030: • Should be an individual with social/ behavioural science/ philosophy/ religious qualification and training and/or
p.000030: expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities
p.000030: 7. Lay person(s)
p.000030: Non-affiliated Qualifications -
p.000030: • Literate person from the public or
p.000030: community
p.000030: • Has not pursued a medical science/ health-
p.000030: related career in the last 5 years
p.000030: • May be a representative of the community
p.000030: from which the participants are to be drawn
p.000030: • Is aware of the local language, cultural and
p.000030: moral values of the community
p.000030: • Desirable: involved in social and
p.000030: community welfare activities
p.000030: • Ethical review of the proposal, ICD along
p.000030: with the translations.
p.000030: • Assess impact on community involvement, socio–cultural context, religious or philosophical context, if
p.000030: any
p.000030: • Serve as a patient/participant/ societal / community representative and bring in ethical and societal
p.000030: concerns.
p.000030:
p.000030:
p.000030:
p.000030: • Ethical review of the proposal, ICD along
p.000030: with translation(s).
p.000030: • Evaluate benefits and risks from the participant’s perspective and opine whether
p.000030: benefits justify the risks.
p.000030: • Serve as a patient/participant/ community representative and bring in ethical and societal concerns.
p.000030: • Assess on societal aspects if any.
p.000030:
p.000030: 4.3.6 The quorum should be as specified in Box 4.2.
p.000030: Box 4.2 Quorum requirements for EC meetings
p.000030: 1. A minimum of five members present in the meeting room.
p.000030: 2. The quorum should include both medical, non medical or technical or/and non-technical members.*
p.000030: 3. Minimum one non-affiliated member should be part of the quorum.
p.000030: 4. Preferably the lay person should be part of the quorum.
p.000030: 5. The quorum for reviewing regulatory clinical trials should be in accordance with current CDSCO requirements.
p.000030: 6. No decision is valid without fulfilment of the quorum.
p.000030:
...
p.000033: 4.7.11 The EC should recommend appropriate compensation for research related injury, wherever required.
p.000033: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000033: 33
p.000034:
p.000034:
p.000034: Ethical Review Procedures
p.000034: 4.7.12 The EC should carry out monitoring visits at study sites as and when needed.
p.000034: 4.7.13 The EC should participate in continuing education activities in research ethics and get updated on relevant
p.000034: guidelines and regulations.
p.000034: 4.7.14 The EC may see that conduct of same/similar research by different investigators from same institution
p.000034: is harmonized. ‘Me too’ research (replicative) should not to be encouraged and submission of same research to different
p.000034: funding agencies should not be accepted.
p.000034: 4.8 Submission and review procedures
p.000034: 4.8.1 Researchers should submit research proposals as soft or hard copies to the Secretariat for review in the
p.000034: prescribed format and required documents as per EC SOPs. The EC should prepare a checklist for the required documents
p.000034: as given in Box 4.4 (a) and 4.4 (b). This list is subject to modifications, depending on the type of research, EC SOPs
p.000034: and institutional policies.
p.000034: Box 4.4 (a) Details of documents to be submitted for EC review
p.000034:
p.000034: 1. Cover letter to the Member Secretary
p.000034: 2. Type of review requested
p.000034: 3. Application form for initial review
p.000034: 4. The correct version of the informed consent document (ICD) in English and the local language(s).
p.000034: Translation and back translation certificates (if applicable)
p.000034: 5. Case record form/questionnaire
p.000034: 6. Recruitment procedures: advertisement, notices (if applicable)
p.000034: 7. Patient instruction card, diary, etc. (if applicable)
p.000034: 8. Investigator’s brochure (as applicable for drug/biologicals/device trials)
p.000034: 9. Details of funding agency/sponsor and fund allocation (if applicable)
p.000034: 10. Brief curriculum vitae of all the study researchers
p.000034: 11. A statement on COI, if any
p.000034: 12. GCP training certificate (preferably
p.000034: within 5 years) of investigators (clinical trials)
p.000034: 13. Any other research ethics/other training evidence, if applicable as per EC SOP
p.000034: 14. List of ongoing research studies undertaken by the principal investigator (if applicable)
p.000034: 15. Undertaking with signatures of investigators
p.000034: 16. Regulatory permissions (as applicable)
p.000034: 17. Relevant administrative approvals (such as HMSC approval for International trials)
p.000034: 18. Institutional Committee for Stem Cell Research (IC-SCR) approval (if applicable)
p.000034: 19. MoU in case of studies involving collaboration with other institutions (if applicable)
p.000034: 20.Clinical trial agreement between the sponsors, investigator and the head of the institution(s) (if
p.000034: applicable)
p.000034: (Contd.)
p.000034: 34 INDIAN COUNCIL OF
p.000035: MEDICAL RESEARCH
p.000035:
p.000035:
p.000035: Ethical Review Procedures
p.000035:
p.000035:
p.000035: 21. Documentation of clinical trial registration (preferable)
...
p.000040: be disseminated to the community.
p.000040: • The EC should look at the suitability of qualifications and experience of the PI to conduct the proposed
p.000040: research along with adequacy of site facilities for participants.
p.000040: • The EC should review any declaration of COI by a researcher
p.000040: and suggest ways to manage these.
p.000040: • The EC should manage COI within the EC and members with COI should leave the room at the time of decision making in
p.000040: a particular study.
p.000040: • The proposed plan for tackling any medical injuries or
p.000040: emergencies should be reviewed.
p.000040: • Source and means for compensation for study related injury
p.000040: should be ascertained.
p.000040: The informed consent process must be reviewed keeping in mind the following:
p.000040: • the process used for obtaining informed consent, including the
p.000040: identification of those responsible for obtaining consent and the procedures adopted for vulnerable populations;
p.000040: • the adequacy, completeness and understandability of the
p.000040: information to be given to the research participants, and when appropriate, their LARs;
p.000040:
p.000040: (Contd.)
p.000040:
p.000040: 40 INDIAN COUNCIL OF
p.000041: MEDICAL RESEARCH
p.000041:
p.000041:
p.000041: Ethical Review Procedures
p.000041:
p.000041: • contents of the patient/participation information sheet including the local language
p.000041: translations (See section 5 for further details);
p.000041: • back translations of the informed consent document in English,
p.000041: wherever required;
p.000041: • provision for audio-visual recording of consent process, if
p.000041: applicable, as per relevant regulations; and
p.000041: • if consent waiver or verbal/oral consent request has been asked for, this should be reviewed by assessing
p.000041: whether the protocol meets the criteria. See section 5 for further details.
p.000041: 4.9 Full committee meeting
p.000041: 4.9.1 All proposals that are determined to undergo full committee review must be deliberated and the
p.000041: decision about the proposal taken at a full committee meeting.
p.000041: 4.9.2 ECs should conduct regular full committee meetings to deliberate proposals in accordance with a
p.000041: pre-decided schedule, as described in the SOPs.
p.000041: 4.9.3 A meeting will be considered valid only if the quorum is fulfilled. This should be maintained throughout
p.000041: the meeting and at the time of decision making.
p.000041: 4.9.4 If a member has declared a COI for a proposal then this should be submitted in writing to the Chairperson
p.000041: before beginning the meeting and should be recorded in the minutes.
p.000041: 4.9.5 The member who has declared COI should withdraw from the EC meeting (leave the room) while the research
p.000041: proposal is being discussed upon. This should be minuted and the quorum rechecked.
p.000041: 4.9.6 A list of absentee members as well as members leaving or entering in-between the meeting should be
p.000041: recorded.
...
p.000049: of choice and respects the individual’s autonomy.
p.000049: 5.1 Requisites
p.000049: 5.1.1 The participant must have the capacity to understand the proposed research, be able to make an informed
p.000049: decision on whether or not to be enrolled and convey her/his decision to the researcher in order to give consent.
p.000049: 5.1.2 The consent should be given voluntarily and not be obtained under duress or coercion of any sort or by offering
p.000049: any undue inducements.
p.000049: 5.1.3 In the case of an individual who is not capable of giving voluntary informed consent, the consent of LAR must
p.000049: be obtained. See section 6 for further details.
p.000049: 5.1.4 It is mandatory for a researcher to administer consent before initiating any study related procedures involving
p.000049: the participant.
p.000049: 5.1.5 It is necessary to maintain privacy and confidentiality of participants at all stages.
p.000049: 5.2 Essential information for prospective research participants
p.000049: 5.2.1 Before requesting an individual’s consent to participate in research, the researcher must provide the
p.000049: individual with detailed information and discuss her/his queries about the research in the language she/he is able to
p.000049: understand. The language should not only be scientifically accurate and simple, but should also be sensitive to the
p.000049: social and cultural context of the participant.
p.000049: 5.2.2 The ICD has two parts – patient/participant information sheet (PIS) and the informed consent form (ICF).
p.000049: Information on known facts about the research, which has relevance
p.000049:
p.000049: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000049: 49
p.000050:
p.000050:
p.000050: Informed Consent Process
p.000050: Box 5.1 Essential and additional elements of an informed consent document
p.000050:
p.000050:
p.000050: An informed consent form must include the
p.000050: following:
p.000050: 1. Statement mentioning that it is research
p.000050: 2. Purpose and methods of the research in simple language
p.000050: 3. Expected duration of the participation and frequency of contact with estimated number of participants to
p.000050: be enrolled, types of data collection and methods
p.000050: 4. Benefits to the participant, community or others that might reasonably be expected as an outcome of
p.000050: research
p.000050: 5. Any foreseeable risks, discomfort or inconvenience to the participant resulting from participation in
p.000050: the study
p.000050: 6. Extent to which confidentiality of records could be maintained, such as the limits to which the
p.000050: researcher would be able to safeguard confidentiality and the anticipated consequences of breach of confidentiality
p.000050: 7. Payment/reimbursement for participation and incidental expenses depending on the type of study
p.000050: 8. Free treatment and/or compensation of participants for research-related injury and/ or harm
p.000050: 9. Freedom of the individual to participate and/or withdraw from research at any time without penalty or loss
p.000050: of benefits to which the participant would otherwise be entitled
p.000050: 10. The identity of the research team and contact persons with addresses and phone numbers (for example, PI/Co PI
p.000050: for queries related to the research and Chairperson/Member Secretary/ or helpline for appeal against violations
p.000050: of ethical principles and human rights)
p.000050:
p.000050: In addition, the following elements may also be required, depending on the type of
p.000050: study:
p.000050: 1. Any alternative procedures or courses of treatment that might be as advantageous to the participant as
p.000050: the ones to which she/he is going to be subjected
...
p.000050: v post research plan/benefit sharing, if research on biological material and/or data leads to
p.000050: commercialization.
p.000050: vi Publication plan, if any, including photographs and pedigree charts.
p.000050: See section 11 for further details.
p.000050:
p.000050: 50 INDIAN COUNCIL OF
p.000051: MEDICAL RESEARCH
p.000051:
p.000051:
p.000051: Informed Consent Process
p.000051:
p.000051: to participation, is included in the PIS. This is followed by the ICF in which the participant acknowledges that
p.000051: she/he has understood the information given in the PIS and is volunteering to be included in that research.
p.000051: 5.2.3 Adequate time should be given to the participant to read the consent form, if necessary discuss it with family
p.000051: and friends, and seek clarification of her/his doubts from the researchers/research team before deciding to enroll in
p.000051: the research.
p.000051: 5.2.4 Essential elements of an informed consent document are given in Box 5.1.
p.000051: 5.3 Responsibility of researchers
p.000051: 5.3.1 The researcher should only use the EC approved version of the consent form, including its local
p.000051: translations.
p.000051: 5.3.2 Adequate information necessary for informed consent should be communicated in a language and manner easily
p.000051: understood by prospective participants.
p.000051: 5.3.3 In case of differently abled participants, such as individuals with physical, neurological or mental
p.000051: disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for
p.000051: the visually impaired.
p.000051: 5.3.4 There should be no restriction on the participant’s right to ask questions related to the study or to
p.000051: discuss with family and friends or take time before coming to a decision.
p.000051: 5.3.5 The researcher should not give any unjustifiable assurances or influence or intimidate a prospective
p.000051: participant to enroll in the study.
p.000051: 5.3.6 The researcher must ensure that the participant is competent and has understood all aspects of the study and
p.000051: that the consent is given voluntarily. Where the participant and/or the LAR are illiterate, an impartial literate
p.000051: person, not connected to the research, should be present throughout the consent process as witness.
p.000051: 5.3.7 The researcher should administer a test of understanding whenever possible for sensitive studies.
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
...
p.000052: 5.3.13 The researcher should ensure that the participant can continue to access routine care even in the event of
p.000052: withdrawal of the participant.
p.000052: 5.4 Documentation of informed consent process
p.000052: Documentation of the informed consent process is an essential part of this exercise.
p.000052: 5.4.1 Each prospective participant should sign the informed consent form after going through the informed consent
p.000052: process of receiving information, understanding it and voluntarily agreeing to participate in the research.
p.000052: 5.4.2 In case the participant is incompetent (medically or legally) to give consent, the LAR’s consent must be
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
p.000052: should be a literate person who can read the participant information sheet and consent form and understand the language
p.000052: of the participant.
p.000052: 5.4.4 If the participant cannot sign then a thumb impression must be obtained.
p.000052: 5.4.5 The researcher who administers the consent must also sign and date the consent form.
p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
p.000053:
p.000053: Informed Consent Process
p.000053:
p.000053: participants if their details are recorded as a part of the family history. If information about the secondary
p.000053: participants is identifiable then their informed consent will also be required.
p.000053: 5.4.9 Online consent may be obtained, for example, in research involving sensitive data such as unsafe sex, high
p.000053: risk behaviour, use of contraceptives (condoms, oral pills), or emergency contraceptive pills among unmarried females
p.000053: in India etc. Investigators must ensure that privacy of the participant and confidentiality of related data is
p.000053: maintained.
p.000053: 5.5 Electronic consent
p.000053: Electronic media can be used to provide information as in the written informed consent document, which can be
p.000053: administered and documented using electronic informed consent systems. These are electronic processes that use
p.000053: various, and possibly multiple, electronic formats such as text, graphics, audio, video, podcasts or interactive
p.000053: websites to explain information related to a study and to document informed assent/consent from a participant or LAR.
p.000053: 5.5.1 The process, electronic materials, method of documentation (including electronic/ digital
p.000053: signatures), methods used to maintain privacy of participants, confidentiality, and security of the information as well
p.000053: as data use policies at the research site must be reviewed and approved by the EC a priori.
p.000053: 5.5.2 The electronic consent must contain all elements of informed consent in a language understandable by the
p.000053: participant. See Box 5.1 for further details.
p.000053: 5.5.3 The PI or her/his designee must supervise the process.
p.000053: 5.5.4 In addition to electronic consent, if required a paper/soft copy of the document is needed for archiving and
p.000053: a paper/soft copy is also given to the participant.
p.000053: 5.5.5 Interactive formats, if used, should be simple to navigate.
p.000053: 5.5.6 Electronic methods should not be used if participants, for any reason, indicate a lack of comfort with
p.000053: electronic media.
p.000053: 5.5.7 Such tools may be reviewed and approved by EC before implementation.
p.000053: 5.6 Specific issues in Clinical trials
p.000053: There may be additional requirements for informed consent for clinical trials as specified by CDSCO. See section 7 for
p.000053: further details.
p.000053: 5.7 Waiver of consent
p.000053: The researcher can apply to the EC for a waiver of consent if the research involves less than minimal risk to
p.000053: participants and the waiver will not adversely affect the rights and welfare of the participants Box 5.2.
p.000053:
p.000053: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000053: 53
p.000054:
p.000054:
p.000054: Informed Consent Process
p.000054: Box 5.2 Conditions for granting waiver of consent
p.000054:
p.000054: The EC may grant consent waiver in the following situations:
...
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
p.000063: Box 6.5 Consent of parent/LAR
p.000063:
p.000063: 1. The EC should determine if consent of one or both parents would be required before a child could be enrolled.
p.000063: 2. Generally, consent from one parent/LAR may be considered sufficient for research involving no more than
...
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
...
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
...
p.000108: authorities/healthcare providers/institutions or organizations responsible for community welfare or their appointed
p.000108: advocates. Consent procedures must respect local cultural customs, however, community traditions do not substitute for
p.000108: individual consent unless a waiver has been granted.
p.000108: 2. Participant consent: Researchers must develop culturally appropriate ways to communicate information
p.000108: necessary for adherence to the standard required in the informed consent process.
p.000108: 3. Selective withholding of study information: ECs may permit selective withholding of
p.000108: information/hypothesis of the study in the consent form for achieving overall social and public good, without
p.000108: influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
p.000108: support and conditions for self-respect. Accordingly, concerns about social justice must be central to any
p.000108: adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the
p.000108: vulnerable status of prospective participants during review, for example, a woman asking her husband or family before
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
...
p.000155: not be unfairly influenced by people involved with the study, who attends the informed consent process if the
p.000155: participant and/or their LAR cannot read, and understand the informed consent form and any other written information
p.000155: supplied to the participant.
p.000155: An expert who gives advice, comments and suggestions to the
p.000155: EC and has no affiliation to the institute or researchers proposing the research protocols. This individual has
p.000155: no voting power for decision making.
p.000155: 32 Inducement A motive or consideration that leads one to action or to additional
p.000155: or more effective actions without considering the harm that may occur.
p.000155:
p.000155: 33 Informed
p.000155: consent document (ICD)
p.000155: Written signed and dated paper confirming a participant’s
p.000155: willingness to voluntarily participate in a particular research, after having been informed of all aspects of
p.000155: the research that are relevant for the participant’s decision to participate.
p.000155: 34 Justice Pertains to fairness in the way people are dealt with, indicating fair
p.000155: selection and distribution of benefits and risks to participants who should be fully apprised about them.
p.000155: 35 Lay person A literate person who has not pursued a medical science/health-
p.000155: related career in the last 5 years and is aware of the local language, cultural and moral values of the community.
p.000155: 36 Legal expert A person with a basic degree in law from a recognized university,
p.000155: with experience.
p.000155:
p.000155: 37 Legally acceptable representative (LAR)
p.000155:
p.000155: 38 Legally authorized representative (LAR)
p.000155: A person who will give consent on behalf of a prospective participant who, for either legal or medical
p.000155: reasons, is unable to give consent herself/himself to participate in research or to undergo a diagnostic,
p.000155: therapeutic or preventive procedure as per research protocol, duly approved by the EC.
p.000155: A person who, under applicable law or judicial authority, can give
p.000155: consent on behalf of a prospective participant who, for either legal or medical reasons, is unable to give
p.000155: consent herself/himself to participate in research or to undergo a diagnostic, therapeutic or preventive procedure as
p.000155: per research protocol, duly approved by the ethics committee.
p.000155: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000155: 155
p.000156:
p.000156:
p.000156: Glossary
p.000156: 39 Maleficence The act of committing harm or a harmful act.
p.000156:
p.000156: 40 Marginalized communities
p.000156: A group of people actively separated or excluded from the rest of society.
...
p.000156: cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but
p.000156: this may be within the range of minimal risk for the research participant since it would be undertaken as
p.000156: part of current everyday life.
p.000156:
p.000156: 42 Non-
p.000156: therapeutic trial
p.000156: A trial which is unlikely to produce any direct benefit to the
p.000156: participants involved. The aim of a non-therapeutic trial is to obtain knowledge which may contribute
p.000156: towards the future development of new forms of treatment or procedures.
p.000156: 43 Ostracization To exclude, by general consent, from society, friendship,
p.000156: conversation, privileges, etc.
p.000156:
p.000156: 44 Particularly vulnerable tribal group (PVTG)
p.000156: These are a special class of tribal groups, classified as such by the Government of India, due to their
p.000156: especially low development indices when compared to other local tribes. These were classified under the Dhebar
p.000156: Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
p.000157: uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of
p.000157: adequate size, and whenever possible, double-blind.
p.000157:
p.000157: 47 Post-marketing
p.000157: surveillance
p.000157:
p.000157: 48 Professional competence
p.000157: 49 Principal
p.000157: investigator
p.000157:
p.000157:
p.000157: 50 Psychosocial harm
p.000157: The practice of monitoring the safety of a pharmaceutical drug or
p.000157: medical device after it has been released on the market. This is an important part of the science of pharmacovigilance.
...
Social / Literacy
Searching for indicator illiterate:
(return to top)
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
p.000006: obtained. If a participant or LAR is illiterate, a literate impartial witness should also be present during the
p.000006: informed consent process.
p.000006:
p.000006: 6 INDIAN COUNCIL OF
p.000007: MEDICAL RESEARCH
p.000007:
p.000007:
p.000007: General Ethical Issues
p.000007:
p.000007: 2.2.2 In certain circumstances audio/audio-visual recording of the informed consent process may be required, for
p.000007: example in certain clinical trials as notified by CDSCO.
p.000007: 2.2.3 Verbal/oral consent/waiver of consent/re-consent may be obtained under certain conditions after due
p.000007: consideration and approval by the EC. See section 5 for further details.
p.000007: 2.3 Privacy and confidentiality
p.000007: Privacy is the right of an individual to control or influence the information that can be collected and stored and by
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
...
p.000051: the research.
p.000051: 5.2.4 Essential elements of an informed consent document are given in Box 5.1.
p.000051: 5.3 Responsibility of researchers
p.000051: 5.3.1 The researcher should only use the EC approved version of the consent form, including its local
p.000051: translations.
p.000051: 5.3.2 Adequate information necessary for informed consent should be communicated in a language and manner easily
p.000051: understood by prospective participants.
p.000051: 5.3.3 In case of differently abled participants, such as individuals with physical, neurological or mental
p.000051: disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for
p.000051: the visually impaired.
p.000051: 5.3.4 There should be no restriction on the participant’s right to ask questions related to the study or to
p.000051: discuss with family and friends or take time before coming to a decision.
p.000051: 5.3.5 The researcher should not give any unjustifiable assurances or influence or intimidate a prospective
p.000051: participant to enroll in the study.
p.000051: 5.3.6 The researcher must ensure that the participant is competent and has understood all aspects of the study and
p.000051: that the consent is given voluntarily. Where the participant and/or the LAR are illiterate, an impartial literate
p.000051: person, not connected to the research, should be present throughout the consent process as witness.
p.000051: 5.3.7 The researcher should administer a test of understanding whenever possible for sensitive studies.
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
p.000051: so, then verbal/oral consent may be taken on approval by the EC, in the presence of an impartial witness who should
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
p.000051: the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be
p.000051: taken in exceptional circumstances and for specific, justifiable reasons with the approval of the EC. It should not to
p.000051: be practiced routinely.
p.000051: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000051: 51
p.000052:
p.000052:
p.000052: Informed Consent Process
p.000052:
p.000052: 5.3.9 Reconsent or fresh informed consent of each participant must be taken under circumstances
p.000052: described in section 5.8.
...
p.000052: entitled.
p.000052: 5.3.11 Reimbursement may be given for travel and incidental expenses/participation in research after
p.000052: approval by the EC.
p.000052: 5.3.12 The researcher should ensure free treatment for research related injury (disability, chronic life-threatening
p.000052: disease and congenital anomaly or birth defect) and if required, payment of compensation over and above medical
p.000052: management by the investigator and/institution and sponsor(s), as the case may be.
p.000052: 5.3.13 The researcher should ensure that the participant can continue to access routine care even in the event of
p.000052: withdrawal of the participant.
p.000052: 5.4 Documentation of informed consent process
p.000052: Documentation of the informed consent process is an essential part of this exercise.
p.000052: 5.4.1 Each prospective participant should sign the informed consent form after going through the informed consent
p.000052: process of receiving information, understanding it and voluntarily agreeing to participate in the research.
p.000052: 5.4.2 In case the participant is incompetent (medically or legally) to give consent, the LAR’s consent must be
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
p.000052: should be a literate person who can read the participant information sheet and consent form and understand the language
p.000052: of the participant.
p.000052: 5.4.4 If the participant cannot sign then a thumb impression must be obtained.
p.000052: 5.4.5 The researcher who administers the consent must also sign and date the consent form.
p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
...
Searching for indicator literacy:
(return to top)
p.000156: cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but
p.000156: this may be within the range of minimal risk for the research participant since it would be undertaken as
p.000156: part of current everyday life.
p.000156:
p.000156: 42 Non-
p.000156: therapeutic trial
p.000156: A trial which is unlikely to produce any direct benefit to the
p.000156: participants involved. The aim of a non-therapeutic trial is to obtain knowledge which may contribute
p.000156: towards the future development of new forms of treatment or procedures.
p.000156: 43 Ostracization To exclude, by general consent, from society, friendship,
p.000156: conversation, privileges, etc.
p.000156:
p.000156: 44 Particularly vulnerable tribal group (PVTG)
p.000156: These are a special class of tribal groups, classified as such by the Government of India, due to their
p.000156: especially low development indices when compared to other local tribes. These were classified under the Dhebar
p.000156: Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
p.000157: uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of
p.000157: adequate size, and whenever possible, double-blind.
p.000157:
p.000157: 47 Post-marketing
p.000157: surveillance
p.000157:
p.000157: 48 Professional competence
p.000157: 49 Principal
p.000157: investigator
p.000157:
p.000157:
p.000157: 50 Psychosocial harm
p.000157: The practice of monitoring the safety of a pharmaceutical drug or
...
Searching for indicator literate:
(return to top)
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
p.000006: obtained. If a participant or LAR is illiterate, a literate impartial witness should also be present during the
p.000006: informed consent process.
p.000006:
p.000006: 6 INDIAN COUNCIL OF
p.000007: MEDICAL RESEARCH
p.000007:
p.000007:
p.000007: General Ethical Issues
p.000007:
p.000007: 2.2.2 In certain circumstances audio/audio-visual recording of the informed consent process may be required, for
p.000007: example in certain clinical trials as notified by CDSCO.
p.000007: 2.2.3 Verbal/oral consent/waiver of consent/re-consent may be obtained under certain conditions after due
p.000007: consideration and approval by the EC. See section 5 for further details.
p.000007: 2.3 Privacy and confidentiality
p.000007: Privacy is the right of an individual to control or influence the information that can be collected and stored and by
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
p.000007: community.
...
p.000029: or violation, progress and completion report)
p.000029: • Review medical care, facility and appropriateness of the principal investigator, provision for
p.000029: medical car, management and compensation.
p.000029: • Thorough review of protocol, investigators brochure (if applicable) and all other protocol details and
p.000029: submitted documents.
p.000029: • Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial
p.000029: Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s
p.000029: undertaking, protocol specific other permissions, such as, stem cell committee for stem cell research, HMSC
p.000029: for international collaboration, compliance with guidelines etc.
p.000029: • Interpret and inform EC members about new regulations
p.000029: if any
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000029: (Contd.)
p.000029:
p.000029: 29
p.000030:
p.000030:
p.000030: Ethical Review Procedures
p.000030:
p.000030:
p.000030: 6. Social scientist/ philosopher/ ethicist/theologian
p.000030: Affiliated/ non-affiliated
p.000030:
p.000030: Qualifications -
p.000030: • Should be an individual with social/ behavioural science/ philosophy/ religious qualification and training and/or
p.000030: expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities
p.000030: 7. Lay person(s)
p.000030: Non-affiliated Qualifications -
p.000030: • Literate person from the public or
p.000030: community
p.000030: • Has not pursued a medical science/ health-
p.000030: related career in the last 5 years
p.000030: • May be a representative of the community
p.000030: from which the participants are to be drawn
p.000030: • Is aware of the local language, cultural and
p.000030: moral values of the community
p.000030: • Desirable: involved in social and
p.000030: community welfare activities
p.000030: • Ethical review of the proposal, ICD along
p.000030: with the translations.
p.000030: • Assess impact on community involvement, socio–cultural context, religious or philosophical context, if
p.000030: any
p.000030: • Serve as a patient/participant/ societal / community representative and bring in ethical and societal
p.000030: concerns.
p.000030:
p.000030:
p.000030:
p.000030: • Ethical review of the proposal, ICD along
p.000030: with translation(s).
p.000030: • Evaluate benefits and risks from the participant’s perspective and opine whether
p.000030: benefits justify the risks.
p.000030: • Serve as a patient/participant/ community representative and bring in ethical and societal concerns.
p.000030: • Assess on societal aspects if any.
p.000030:
p.000030: 4.3.6 The quorum should be as specified in Box 4.2.
p.000030: Box 4.2 Quorum requirements for EC meetings
p.000030: 1. A minimum of five members present in the meeting room.
p.000030: 2. The quorum should include both medical, non medical or technical or/and non-technical members.*
...
p.000051: 5.3 Responsibility of researchers
p.000051: 5.3.1 The researcher should only use the EC approved version of the consent form, including its local
p.000051: translations.
p.000051: 5.3.2 Adequate information necessary for informed consent should be communicated in a language and manner easily
p.000051: understood by prospective participants.
p.000051: 5.3.3 In case of differently abled participants, such as individuals with physical, neurological or mental
p.000051: disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for
p.000051: the visually impaired.
p.000051: 5.3.4 There should be no restriction on the participant’s right to ask questions related to the study or to
p.000051: discuss with family and friends or take time before coming to a decision.
p.000051: 5.3.5 The researcher should not give any unjustifiable assurances or influence or intimidate a prospective
p.000051: participant to enroll in the study.
p.000051: 5.3.6 The researcher must ensure that the participant is competent and has understood all aspects of the study and
p.000051: that the consent is given voluntarily. Where the participant and/or the LAR are illiterate, an impartial literate
p.000051: person, not connected to the research, should be present throughout the consent process as witness.
p.000051: 5.3.7 The researcher should administer a test of understanding whenever possible for sensitive studies.
p.000051: If need be, the test may be repeated until the participant has really understood the contents.
p.000051: 5.3.8 When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do
p.000051: so, then verbal/oral consent may be taken on approval by the EC, in the presence of an impartial witness who should
p.000051: sign and date the consent document. This process can be documented through audio or video recording of the participant,
p.000051: the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be
p.000051: taken in exceptional circumstances and for specific, justifiable reasons with the approval of the EC. It should not to
p.000051: be practiced routinely.
p.000051: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000051: 51
p.000052:
p.000052:
p.000052: Informed Consent Process
p.000052:
p.000052: 5.3.9 Reconsent or fresh informed consent of each participant must be taken under circumstances
p.000052: described in section 5.8.
p.000052: 5.3.10 The researcher must assure prospective participants that their decision whether or not to participate in the
...
p.000052: approval by the EC.
p.000052: 5.3.12 The researcher should ensure free treatment for research related injury (disability, chronic life-threatening
p.000052: disease and congenital anomaly or birth defect) and if required, payment of compensation over and above medical
p.000052: management by the investigator and/institution and sponsor(s), as the case may be.
p.000052: 5.3.13 The researcher should ensure that the participant can continue to access routine care even in the event of
p.000052: withdrawal of the participant.
p.000052: 5.4 Documentation of informed consent process
p.000052: Documentation of the informed consent process is an essential part of this exercise.
p.000052: 5.4.1 Each prospective participant should sign the informed consent form after going through the informed consent
p.000052: process of receiving information, understanding it and voluntarily agreeing to participate in the research.
p.000052: 5.4.2 In case the participant is incompetent (medically or legally) to give consent, the LAR’s consent must be
p.000052: documented.
p.000052: 5.4.3 The process of consent for an illiterate participant/LAR should be witnessed by an impartial literate
p.000052: witness who is not a relative of the participant and is in no way connected to the conduct of research, such as other
p.000052: patients in the ward who are not in the study, staff from the social service department and counsellors. The witness
p.000052: should be a literate person who can read the participant information sheet and consent form and understand the language
p.000052: of the participant.
p.000052: 5.4.4 If the participant cannot sign then a thumb impression must be obtained.
p.000052: 5.4.5 The researcher who administers the consent must also sign and date the consent form.
p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
p.000053:
p.000053: Informed Consent Process
p.000053:
p.000053: participants if their details are recorded as a part of the family history. If information about the secondary
p.000053: participants is identifiable then their informed consent will also be required.
...
p.000154: affected or concerned parties. It is an important ethical consideration in studies involving deception.
p.000154: Such post- experimental follow-up is considered beneficial even if no deception is used or there is only
p.000154: minimal risk to participants.
p.000154: 25 Deception Deception occurs when investigators provide false or incomplete
p.000154: information to participants to misleading them to achieve the study objectives and for larger public good. Research
p.000154: employing any type of deception should undergo full committee review.
p.000154:
p.000154: 26 Distributive
p.000154: justice
p.000154: Fair distribution of burden, resources and benefits. In research, it
p.000154: means fair selection of participants.
p.000154: 27 Ethicist One whose judgement on ethics and ethical codes is based on
p.000154: knowledge/experience through qualification or training.
p.000154: 28 Exploitation The action or fact of treating someone unfairly in order to benefit
p.000154: from their participation.
p.000154:
p.000154:
p.000154:
p.000154: 154 INDIAN COUNCIL OF MEDICAL
p.000155: RESEARCH
p.000155:
p.000155: Glossary
p.000155:
p.000155:
p.000155: 29 Exploratory research
p.000155: 30 Impartial
p.000155: witness
p.000155:
p.000155:
p.000155:
p.000155: 31 Independent consultant
p.000155: Preliminary research conducted to gain insights for a problem that has not yet been clearly defined.
p.000155: A literate person, who is independent of the research and would
p.000155: not be unfairly influenced by people involved with the study, who attends the informed consent process if the
p.000155: participant and/or their LAR cannot read, and understand the informed consent form and any other written information
p.000155: supplied to the participant.
p.000155: An expert who gives advice, comments and suggestions to the
p.000155: EC and has no affiliation to the institute or researchers proposing the research protocols. This individual has
p.000155: no voting power for decision making.
p.000155: 32 Inducement A motive or consideration that leads one to action or to additional
p.000155: or more effective actions without considering the harm that may occur.
p.000155:
p.000155: 33 Informed
p.000155: consent document (ICD)
p.000155: Written signed and dated paper confirming a participant’s
p.000155: willingness to voluntarily participate in a particular research, after having been informed of all aspects of
p.000155: the research that are relevant for the participant’s decision to participate.
p.000155: 34 Justice Pertains to fairness in the way people are dealt with, indicating fair
p.000155: selection and distribution of benefits and risks to participants who should be fully apprised about them.
p.000155: 35 Lay person A literate person who has not pursued a medical science/health-
p.000155: related career in the last 5 years and is aware of the local language, cultural and moral values of the community.
p.000155: 36 Legal expert A person with a basic degree in law from a recognized university,
p.000155: with experience.
p.000155:
p.000155: 37 Legally acceptable representative (LAR)
p.000155:
p.000155: 38 Legally authorized representative (LAR)
p.000155: A person who will give consent on behalf of a prospective participant who, for either legal or medical
p.000155: reasons, is unable to give consent herself/himself to participate in research or to undergo a diagnostic,
p.000155: therapeutic or preventive procedure as per research protocol, duly approved by the EC.
p.000155: A person who, under applicable law or judicial authority, can give
p.000155: consent on behalf of a prospective participant who, for either legal or medical reasons, is unable to give
p.000155: consent herself/himself to participate in research or to undergo a diagnostic, therapeutic or preventive procedure as
p.000155: per research protocol, duly approved by the ethics committee.
p.000155: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000155: 155
p.000156:
p.000156:
p.000156: Glossary
p.000156: 39 Maleficence The act of committing harm or a harmful act.
p.000156:
p.000156: 40 Marginalized communities
...
Social / Marital Status
Searching for indicator single:
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p.000015: 1. Research institutions must:
p.000015: • develop policies and SOPs to address COI issues that are dynamic, transparent and actively
p.000015: communicated;
p.000015: • implement policies and procedures to address COI and conflicts of commitment, and
p.000015: educate their staff about such policies;
p.000015: • monitor the research or check research results for accuracy and objectivity; and
p.000015: • not interfere in the functioning and decision making of the EC.
p.000015: 2. Researchers must:
p.000015: • ensure that documents submitted to the EC include disclosure of COI (financial or non-
p.000015: financial) that may affect their research;
p.000015: • guard against conflicts of commitment that may arise from situations that place competing
p.000015: demands on researchers’ time and loyalties; and
p.000015: • prevent intellectual and personal conflicts by ensuring they do not serve as reviewers for
p.000015: grants and publications submitted by close colleagues, relatives and/or students.
p.000015:
p.000015:
p.000015: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000015: (Contd.)
p.000015: 15
p.000016:
p.000016:
p.000016: Responsible Conduct of Research
p.000016:
p.000016: 3. ECs must:
p.000016: • evaluate each study in light of any disclosed COI and ensure appropriate action is taken
p.000016: to mitigate this; and
p.000016: • require their members to disclose their own COI and take appropriate measures to recuse
p.000016: themselves from reviewing or decision making on protocols related to their COI; and
p.000016: • make appropriate suggestions for management, if COI is detected at the institutional or
p.000016: researchers level.
p.000016:
p.000016: 3.3.2 Data acquisition, management, sharing and ownership
p.000016: • There is no single best way to collect data. Different collection techniques are needed for
p.000016: different types of research. Researchers should be sensitive to participants and use best practices for data
p.000016: collection.
p.000016: • Data collection involves physical process of recording data in hard copy, soft or electronic copy, or other
p.000016: permanent forms. The physical formats for recording data vary considerably, from measurements or observations to
p.000016: photographs or interview recordings. To be valuable, research data must be properly recorded.
p.000016: • Institutes receiving research funds have responsibilities for budgets, regulatory compliance and management
p.000016: of collected data with funded research. This means that researchers should obtain appropriate permissions/approvals to
p.000016: take their data and funding with them if they move to another institution.
p.000016: • Ownership issues and responsibilities need to be carefully worked out well before data are collected and
p.000016: researchers should ensure clarity about data ownership, publication rights and obligations following data collection.
p.000016: MoUs vetted by the institution and/or EC should be in place.
p.000016: • For biological samples, donors (participants) maintain the ownership of the sample. She/he could
p.000016: withdraw both the biological material and the related data unless the latter is required for outcome measurement and is
p.000016: so mentioned in the initial informed consent document.
p.000016: • Institutes hosting/implementing the research are the custodians of the data/
p.000016: samples.
p.000016: • Research must be conducted using appropriate and reliable methods to provide reliable data. The use of
...
p.000022: benefit sharing and avoiding unauthorized use of their expertise, biological samples and data) to safeguard the
p.000022: interests of participants, researchers and institutions.
p.000022: • Institutions should provide opportunities for collaboration to build capacity and
p.000022: engage in research which is mutually beneficial.
p.000022: 3.8.3 International collaboration
p.000022: The scope of international collaboration in biomedical and health research has gained such momentum in recent years
p.000022: that it could have potentially exploitative commercial and human dimensions. While on one hand collaboration in medical
p.000022: research could be seen as a humane interest in the health of civil society, on the other hand it could create the
p.000022: impression of exploitation by one country experimenting on the population of another
p.000022:
p.000022: 22 INDIAN COUNCIL OF
p.000023: MEDICAL RESEARCH
p.000023:
p.000023:
p.000023: Responsible Conduct of Research
p.000023:
p.000023: poorer one. Due to different levels of development in terms of infrastructure, expertise, social and cultural
p.000023: perceptions, laws relating to IPR, ethical review procedures, etc., an ethical framework based on equality and equity
p.000023: is required to guide such collaborations. The same is applicable to research undertaken with assistance and/or
p.000023: collaboration from international organizations (public or private). The collaboration may involve either implementation
p.000023: of multiple components of the research or even a single component like laboratory testing. To undertake a collaborative
p.000023: research in India, our country’s ethical guidelines and relevant regulatory requirements should be followed and
p.000023: understood before the sponsor agency/country initiates collaboration.
p.000023: • Indian participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of
p.000023: ownership of samples and data, analysis, dissemination, publication and IPR related to research in India, as may be
p.000023: considered appropriate.
p.000023: • There should be good communication between international participating centres and in case of any conflict,
p.000023: the decision of the EC of the Indian participating centre(s), based on relevant facts/guidelines/law of the land, shall
p.000023: prevail.
p.000023: • The institution should protect against imposition of moral or ethical standards of the sponsoring country
p.000023: (ethical imperialism) which may not be in agreement with India’s ethical and regulatory requirements.
p.000023: • The institution/EC should not accept international proposals which cannot be
p.000023: conducted in the country of origin.
p.000023: • Researchers and EC members should be trained to understand and recognize
p.000023: ethical perspectives that reflect India’s best interests.
p.000023: The types of international collaborations are mentioned in Box 3.5
p.000023:
p.000023: Box 3.5 Types of international collaboration
p.000023:
p.000023: International collaboration can include all or any of the following elements:
p.000023: • funding by international agencies, such as UN Agencies, NIH, WHO, Wellcome Trust,
p.000023: World Bank and others;
p.000023: • academic collaborations with foreign institutions, universities, organizations,
...
p.000095: decided?
p.000095: • Is it a two-stage process – initially a gatekeeper consent/permission followed by individual
p.000095: consent?
p.000095: 3. If applicable, is respect for the community applied through community engagement? If so, is the methodology
p.000095: appropriate?
p.000095: 4. Which segments of the population are likely beneficiaries and what are the expected benefits?
p.000095: 5. Is individual harm overriding the potentially larger societal benefit?
p.000095: • If so, is it justified?
p.000095: • What are the different types of potential harm?
p.000095: • Who would be harmed?
p.000095: • What, if any, measures can be taken to mitigate/minimize this?
p.000095: • Is the harm fairly distributed?
p.000095: • How do societal benefits outweigh individual harm?
p.000095: 6. Is social justice considered while designing, implementing and assessing outcomes of the study?
p.000095:
p.000095: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000095: 95
p.000096:
p.000096:
p.000096: Public Health Research
p.000096:
p.000096: 8.2 Ethical issues of epidemiological and public health research study designs
p.000096: 8.2.1 Epidemiological and public health research studies
p.000096: These involve use of different study methods and tools on a large number of research participants in single or multiple
p.000096: settings. These include observational studies (such as cross-sectional studies), case control studies, cohort studies,
p.000096: case reports, case series and other descriptive studies and experimental studies (such as field trials and cluster
p.000096: randomized controlled trials, stepped-wedge and quasi-experimental study designs involving groups, geographic
p.000096: areas, institutions or systems collectively rather than individually).
p.000096: • Specific ethical issues emerge from the scientific merit and design of the research
p.000096: and its implementation and should be considered by EC.
p.000096: 8.2.2 Surveillance, programme monitoring data and programme evaluations
p.000096: A fundamental public health activity is to measure and monitor changes in health status, risk factors and
p.000096: health service access and utilization. Surveillance is an ongoing, systematic collection, analysis, and interpretation
p.000096: of outcome-specific data, with the timely dissemination of these data to those responsible for preventing and
p.000096: controlling disease or injury. These data may be used by researchers for generating new evidence to improve programme
p.000096: performance, and for more generalizable application at other sites and contexts. Programme evaluation refers to
p.000096: the systematic application of scientific and statistical procedures for measuring programme conceptualization,
p.000096: design, implementation and utility; the comparison of these measurements; and the use of the resulting information to
p.000096: optimize programme outcomes. Evaluation research may or may not involve human participants such as health personnel,
...
p.000119: 10.13.4 Population screening: Genetic disorders can be population specific (for example,
p.000119: -thalassemia and sickle cell disease in some population groups in India).
p.000119: • Population screening should not be undertaken without prior education of the population to be
p.000119: screened and counselling should be integrated with the programme.
p.000119: • Screening tests should be robust with acceptable sensitivity and specificity.
p.000119: • Wherever applicable, community permission/group consent should be taken in
p.000119: addition to individual informed consent.
p.000119: • Researchers may conduct coded or reversible anonymized testing on general
p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
p.000119: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000119: 119
p.000120:
p.000120: Human
p.000120: Genetics Testing and Research
p.000120:
p.000120: the approval of the EC.
p.000120: 10.13.5 Prenatal screening: Prenatal screening is aimed to screen mothers and foetuses that are at high risk of having
p.000120: functional or structural defects including chromosomal and single gene disorders. There are many screening tests
p.000120: which are recommended in routine practice.
p.000120: • Biochemical and ultrasound screening: Various combinations of serum screening and ultrasound screening tests
p.000120: are done either during first (dual marker) or second trimester (triple or quadruple screening) for aneuploidy
p.000120: screening. It is important to discuss detection rates, false positive and negative results with participants.
p.000120: • Invasive testing for prenatal diagnosis: Preliminary genetic counselling of women for invasive prenatal
p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
...
p.000121: appropriate consent explaining the requirements and implications of the screening with provision to “optout”.
p.000121: • Community education and advocacy regarding NBS should precede the initiation
p.000121: of the programme.
p.000121: • Availability of facilities for confirmatory diagnosis and experts for management
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
p.000121: decision-making process, unless early intervention based on results of the test is likely to be of direct therapeutic
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
p.000121: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000121: 121
p.000122:
p.000122: Human
p.000122: Genetics Testing and Research
p.000122:
p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
p.000122: linked), the individual should be tested after administering informed consent when she/he is able to comprehend the
p.000122: benefits and risks of screening. Stigmatization for carrier status is common and therefore, the information should be
p.000122: kept confidential.
p.000122: • Chromosomal: If there is a family history of balanced translocation in any individual, then
p.000122: immediate relatives may be at risk. The same principles as for carrier testing should be followed.
p.000122: 10.14 Gene therapy
p.000122: All gene therapies are considered as research and all protections for human research participants should be in place.
p.000122: 10.14.1 Somatic cell gene therapy is permissible for the purpose of preventing or treating a serious
p.000122: disease when it is the only therapeutic option. It should be restricted to alleviation of life
p.000122: threatening or seriously disabling genetic disease in individual patients and should not be permitted to change
p.000122: normal human traits.
p.000122: 10.14.2 Prior to obtaining approval for initiating a gene therapy trial, an approval from the local EC and DBT has to
p.000122: be obtained for the gene construct.
p.000122: 10.14.3 If the trial is for a product for commercial use or for marketing purposes, approval needs to be taken from
p.000122: CDSCO.
p.000122: 10.14.4 All gene therapy trials should have the provision for long-term surveillance.
...
p.000124: vigorous benefit-risk evaluation is required to address the expectations and concerns of the public. There is need for
p.000124: an initial cautious approach before this technology can be widely used for various applications.
p.000124: • An open and transparent discussion, advocacy and public engagement should be
p.000124:
p.000124: 124 INDIAN COUNCIL OF MEDICAL
p.000125: RESEARCH
p.000125:
p.000125: Human
p.000125: Genetics Testing and Research
p.000125:
p.000125: encouraged with various stakeholders to understand, build trust and be involved in decision making. Capacity building
p.000125: is required not only of researchers but also regulators and policy makers to carefully consider social and ethical
p.000125: aspects and put systems in place to ensure safety.
p.000125: • At the moment, there is a need for initiatives to increase knowledge base, infrastructure, funding,
p.000125: guidelines, inter agency communications and interactions, engagement with public and other stakeholders, and
p.000125: establish science communication. In addition, attempts should be made to foster research to assess the feasibility,
p.000125: efficacy and safety of CRISPR technology.
p.000125: 10.15.4 Genome-wide association study (GWAS)
p.000125: Genetic epidemiology, also known as whole genome-wide association study, involves an examination of many common genetic
p.000125: variants in different individuals to see if any variant is associated with a trait. A GWAS typically focuses on
p.000125: associations between single-nucleotide polymorphisms (SNPs) and traits like major diseases, particularly multifactorial
p.000125: disorders.
p.000125: 10.15.5 As in other techniques there is a possibility of getting variations of known or unknown significance and
p.000125: participants should be aware of these facts.
p.000125: 10.16 Research on human embryos
p.000125: Embryonic state is the period between 15 days and 8 weeks post-conception of a pregnancy and in the
p.000125: absence of more precise information (such as menstrual cycle length), conception is presumed to have taken place 2
p.000125: weeks after the beginning of the woman’s last menstrual period. The distinction of the 15-day stage as the beginning of
p.000125: the embryonic stage is because of the formation of neural crest (future nervous system symbolizing moral being or
p.000125: personhood) by then. At 8 weeks, the rudiments of nearly all the main structures are developed giving a general
p.000125: appearance of a mammal-to-be with four limbs and a head. Research on human embryos raises a number of ethical issues.
p.000125: The concerns are more social, including questions about the rights of unborn babies and the roles of humans in making
p.000125: permanent genetic changes. If research is planned on embryos, consent of both parents should be taken.
p.000125: 10.16.1 The concerns are more social, including questions about the rights of unborn babies and the roles of humans
p.000125: in making permanent genetic changes.
p.000125: 10.16.2 If research is planned on embryos, consent of both parents should be taken.
p.000125:
p.000125:
p.000125:
p.000125: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000125: 125
p.000126:
p.000126: Human
...
p.000127: records in health-care institutions which may have huge potential for subsequent research. The data may be from small
p.000127: numbers to large numbers or whole population. Examples of biobanks and datasets are Iceland’s deCODE biobank, National
p.000127: Institute of Mental Health and Neurosciences (NIMHANS) Brain Bank, Tumour Tissue Bank at Tata Memorial Hospital (TMH),
p.000127: Census data, NFHS data, Cancer Registry of India, CTRI, etc.
p.000127: 11.1 Biobanking
p.000127: A biobank is an organized collection of human biological materials with usually associated dataset stored
p.000127: for years in appropriate facilities for research and potential commercial purposes with inbuilt policies for
p.000127: transparency. The space occupied by organized collection of these materials and data is termed biorepository.
p.000127: Research on such biospecimens or samples and/or related datasets may not directly involve the individuals. Biobanks
p.000127: involve governance of collection of biological material, processing, storage with associated data, and dissemination of
p.000127: samples and/or data through sharing
p.000127:
p.000127: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000127: 127
p.000128:
p.000128: Biological Materials,
p.000128: Biobanking and Datasets
p.000128:
p.000128: with other researchers and overarching ethical oversight. The biological materials could be kept for research, assisted
p.000128: reproductive technology (ART) purposes or for forensic purposes. The stored samples in these biobanks can range
p.000128: from small numbers in researcher’s refrigerator to departments, research institutions including universities and
p.000128: non-profit organizations, judiciary custody, pharmaceutical companies and may extend into large warehouse like
p.000128: facilities at a single site or a chain of facilities with central coordination which provide medical, genetic and
p.000128: life-style related data. Thus biobank may be very large with public or private funding, for commercial or non
p.000128: commercial use and on other hand may be small limited to a researcher who stores samples in the laboratory or at
p.000128: institutional level where common facility is available for storing samples. Biobanks can also store non-human
p.000128: materials, such as plant, animal, microbes and parasites, but for the purpose of these guidelines this section will
p.000128: only pertain to human biomaterials and/or related data.
p.000128: There is a need to comply with all the safety requirements and sets of universal standards, testing of biomaterials and
p.000128: biocompatibility as per relevant regulatory standards. The testing of such standards could be done in a NABL certified
p.000128: laboratory.
p.000128: As biobanking concerns storage and research at a later time, the ethical issues pertaining to consent requirements for
p.000128: the collection and banking and further uses of tissue and DNA samples and/or data are the same but with greater
p.000128: responsibilities concerning their ownership, access and benefit sharing to the individual or community. Therefore, to
p.000128: prevent any exploitation and protect the rights of donors, the main requirements are individual informed consent,
p.000128: clarity on custodianship, approval of the EC and the repository governance committee and post-research benefit sharing,
p.000128: wherever applicable.
p.000128: 11.1.1 Samples can be classified in a variety of manner. Samples classified on the basis of availability of attached
...
Searching for indicator unmarried:
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p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
p.000053:
p.000053: Informed Consent Process
p.000053:
p.000053: participants if their details are recorded as a part of the family history. If information about the secondary
p.000053: participants is identifiable then their informed consent will also be required.
p.000053: 5.4.9 Online consent may be obtained, for example, in research involving sensitive data such as unsafe sex, high
p.000053: risk behaviour, use of contraceptives (condoms, oral pills), or emergency contraceptive pills among unmarried females
p.000053: in India etc. Investigators must ensure that privacy of the participant and confidentiality of related data is
p.000053: maintained.
p.000053: 5.5 Electronic consent
p.000053: Electronic media can be used to provide information as in the written informed consent document, which can be
p.000053: administered and documented using electronic informed consent systems. These are electronic processes that use
p.000053: various, and possibly multiple, electronic formats such as text, graphics, audio, video, podcasts or interactive
p.000053: websites to explain information related to a study and to document informed assent/consent from a participant or LAR.
p.000053: 5.5.1 The process, electronic materials, method of documentation (including electronic/ digital
p.000053: signatures), methods used to maintain privacy of participants, confidentiality, and security of the information as well
p.000053: as data use policies at the research site must be reviewed and approved by the EC a priori.
p.000053: 5.5.2 The electronic consent must contain all elements of informed consent in a language understandable by the
p.000053: participant. See Box 5.1 for further details.
p.000053: 5.5.3 The PI or her/his designee must supervise the process.
p.000053: 5.5.4 In addition to electronic consent, if required a paper/soft copy of the document is needed for archiving and
p.000053: a paper/soft copy is also given to the participant.
...
Social / Mothers
Searching for indicator mothers:
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p.000119: detection rate) with minimal misidentification of unaffected persons (the false positive rate). Screening tests do not
p.000119: aim to make a diagnosis, but rather rationalize the use of more accurate confirmatory tests.
p.000119: 10.13.4 Population screening: Genetic disorders can be population specific (for example,
p.000119: -thalassemia and sickle cell disease in some population groups in India).
p.000119: • Population screening should not be undertaken without prior education of the population to be
p.000119: screened and counselling should be integrated with the programme.
p.000119: • Screening tests should be robust with acceptable sensitivity and specificity.
p.000119: • Wherever applicable, community permission/group consent should be taken in
p.000119: addition to individual informed consent.
p.000119: • Researchers may conduct coded or reversible anonymized testing on general
p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
p.000119: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000119: 119
p.000120:
p.000120: Human
p.000120: Genetics Testing and Research
p.000120:
p.000120: the approval of the EC.
p.000120: 10.13.5 Prenatal screening: Prenatal screening is aimed to screen mothers and foetuses that are at high risk of having
p.000120: functional or structural defects including chromosomal and single gene disorders. There are many screening tests
p.000120: which are recommended in routine practice.
p.000120: • Biochemical and ultrasound screening: Various combinations of serum screening and ultrasound screening tests
p.000120: are done either during first (dual marker) or second trimester (triple or quadruple screening) for aneuploidy
p.000120: screening. It is important to discuss detection rates, false positive and negative results with participants.
p.000120: • Invasive testing for prenatal diagnosis: Preliminary genetic counselling of women for invasive prenatal
p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
p.000120: embryos. This obviates the need for invasive testing for associated risks and also termination of the affected foetus,
p.000120: which is traumatic for the family.
p.000120: • Advanced techniques like chromosomal micro array (CMA) are being used for
p.000120:
p.000120: 120 INDIAN COUNCIL OF MEDICAL
p.000121: RESEARCH
p.000121:
p.000121: Human
p.000121: Genetics Testing and Research
p.000121:
p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
...
Social / Occupation
Searching for indicator job:
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p. xiii: in biomedical research will be enormously benefitted by this revised new guidelines.
p. xiii:
p. xiii:
p. xiii:
p. xiii: Coimbatore September 2017
p. xiii: Dr Vasantha Muthuswamy
p. xiii: Chairperson, Advisory Group
p. xiii:
p. xiii:
p. xiii: xiii
p. xiv:
p. xiv: ACKNOWLEDGEMENT
p. xiv:
p. xiv: We acknowledge with gratitude the inspiration and patronage of Dr Soumya Swaminathan, Director General ICMR
p. xiv: and Secretary Department of Health Research, to update and revise the ICMR Ethical Guidelines for Biomedical Research
p. xiv: on Human Participants 2006. The dynamic efforts and contributions of the Advisory Group consisting of Dr
p. xiv: Vasantha Muthuswamy (Chairperson), Prof S D Seth, Dr Nandini K Kumar, Prof N K Arora and Prof Urmila Thatte are
p. xiv: gratefully acknowledged. Special thanks are due to all the members of the 14 subcommittees who drafted the initial
p. xiv: write up as well as all contributors who devoted their time and efforts towards these guidelines. The team of experts
p. xiv: that was chosen provided a perfect blend of knowledge, experience and skill to prepare different sections
p. xiv: of these guidelines. The inputs of stakeholders from all parts of the country in providing their valuable comments
p. xiv: and suggestions in the Regional and National Consultation meetings and web based Public Consultation are duly
p. xiv: acknowledged. The support from WHO – country office for India in their technical inputs and jointly hosting the
p. xiv: consultation meetings in Bangalore and New Delhi is deeply appreciated and acknowledged. Special thanks are due to a
p. xiv: team of very motivated persons especially Dr Rajib Hazam and Dr Kalyani Thakur who knew their job and provided
p. xiv: technical and secretarial support and also assisted in coordination and communications involved in undertaking
p. xiv: this exercise. This involved a very large number of consultations with experts and stakeholders who provided comments
p. xiv: during face to face as well as online consultations. We are thankful to Dr Prashant Mathur, Director, National Center
p. xiv: for Disease Informatics & Research (NCDIR), Bengaluru for guiding and facilitating the process. The administrative
p. xiv: support extended by Mr Shyam Singh and Mr Santosh Saini from ICMR Headquarters and Mr N M Ramesha and Mr C Somasekhar
p. xiv: from NCDIR, Bengaluru along with many others is duly recognised.
p. xiv: It is hoped that this document is able to address the ethical challenges involved in a variety of
p. xiv: biomedical and health research areas and will be a useful document for the researchers, ethics committees,
p. xiv: institution and sponsors engaged in the conduct of biomedical and health research involving human participants across
p. xiv: the country.
p. xiv:
p. xiv:
p. xiv:
p. xiv:
p. xiv:
p. xiv: Dr Vijay Kumar Scientist G & Head
p. xiv: Division of BMS, ICMR, New Delhi
p. xiv: Dr Roli Mathur Scientist E & Head
p. xiv: ICMR Bioethics Unit, NCDIR, Bangalore
p. xiv:
p. xiv: xiv
p. xv:
p. xv:
p. xv:
p. xv: INTRODUCTION
p. xv:
p. xv: The code of conduct for physicians was well laid out in traditional Indian systems of medicine and do no harm was the
p. xv: underlying universal principle besides other principles applicable to the prevalent culture and the class systems of
...
Social / Police Officer
Searching for indicator police:
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p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
...
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
p.000066: of medication, illicit drugs or alcohol; mental retardation; and traumatic brain injury (that causes unconsciousness or
p.000066: cognitive impairment while conscious).
p.000066: 6.8.1 There are some psychiatric conditions that may lead people to cause risk or harm to themselves or others.
p.000066: • During the informed consent process, prospective participants must be informed about how the researcher will
p.000066: address a participant’s suicidal ideation or other risks of harm to themselves or others.
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
...
p.000109: • not adversely affect the welfare and safety of the participants;
p.000109: • be conducted only when the research cannot be carried out without deception;
p.000109: • have an adequate plan for debriefing the participants after completion of the
p.000109: study, if appropriate;
p.000109: • disseminate results of research to the participants, if applicable; and
p.000109: • be carefully reviewed by the EC.
p.000109: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000109: 109
p.000110:
p.000110: Social and Behavioural Sciences
p.000110: Research for Health
p.000110: Box 9.5 Types of deception
p.000110:
p.000110: 1. Active deception: Selective withholding of the information/hypothesis of the study in the consent form along with
p.000110: giving incorrect information for achieving public good without influencing the outcome of the study, for example,
p.000110: psychology, neuro- behavioural, behaviour intervention study.
p.000110: 2. Incomplete disclosure: If research involves incomplete disclosure but no deception.
p.000110: 3. Authorized deception: Unlike in active deception, participants are informed that they would be deceived prior to
p.000110: the research but the nature of the deception will not be disclosed or research will not be described accurately or some
p.000110: procedures will be deceptive. Such revelation provides the participants an opportunity to decide whether or not to
p.000110: participate on these terms.
p.000110:
p.000110: 9.2.10 Safety of participants
p.000110: Support systems, such as access to counselling centres, rehabilitation centres, police protection, etc., should be in
p.000110: place when research is on a sensitive issue, such as mental health, gender based violence and social exclusion and
p.000110: discrimination.
p.000110: 9.2.11 Safety of research teams in the field
p.000110: The safety of the research team is the responsibility of the institution, sponsors and local authorities, particularly
p.000110: in research on sensitive topics or in sensitive research settings since there would be a possibility of the researcher
p.000110: or research team being subjected to disturbing instances while conducting the research. Besides providing safety,
p.000110: including insurance coverage, and giving training to the researcher or research team to meet such challenges, setting
p.000110: up community advisory boards could be helpful to ease the situation.
p.000110: 9.2.12 Qualitative research
p.000110: The knowledge gathered through qualitative research is interpretative based on the observation and its
p.000110: analysis by the researcher or research team which is socially constructed at individual and socio-cultural levels.
p.000110: • Informed consent is very often dynamic in nature and negotiable. When written
p.000110: consent may not be possible, other means could be used and documented.
p.000110: • The EC may look at issues that pertain to the design involving researcher–
...
Social / Presence of Coercion
Searching for indicator coerce:
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p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
p.000012: General Ethical Issues
p.000012:
p.000012: representative, local institution or the government department from where the data was collected to help in
p.000012: dissemination of the results to the entire community.
p.000012: See sections 8 and 9 for further details.
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
...
Searching for indicator coerced:
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p.000039: • Risks may be physical, psychological, economic, social or legal
p.000039: and harm may occur either at an individual level or at the family, community or societal level. It is
p.000039: necessary to first look at the intervention under investigation and assess its potential harm and benefits and then
p.000039: consider the aggregate of harm and benefits of the study as a whole.
p.000039: • The EC should review plans for risk management, including withdrawal criteria with rescue medication or procedures.
p.000039: • The EC should give advice regarding minimization of risk/
p.000039: discomfort wherever applicable.
p.000039: • Adequate provisions must be made for monitoring and auditing the conduct of the research, including
p.000039: the constitution of a Data and Safety Monitoring Board (DSMB) if applicable (for example in clinical trials)
p.000039:
p.000039: 4 Selection of the study population and
p.000039: recruitment of research participants
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: 5 Payment for participation
p.000039: • Recruitment should be voluntary and non-coercive. Participants should be fairly selected
p.000039: as per inclusion and exclusion criteria. However, selection of participants should be distributive such
p.000039: that a particular population or tribe or economic group is not coerced to participate or benefit.
p.000039: • Participants should be able to opt out at any time without their
p.000039: routine care being affected.
p.000039: • No individual or group of persons must bear the burden of participation in research without accruing
p.000039: any direct or indirect benefits.
p.000039: • Vulnerable groups may be recruited after proper justification
p.000039: is provided.
p.000039: • Plans for payment for participation, reimbursement of incurred costs, such as travel or lost wages,
p.000039: incidental expenses and other inconveniences should be reviewed.
p.000039:
p.000039:
p.000039: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000039: (Contd.)
p.000039: 39
p.000040:
p.000040:
p.000040: Ethical Review Procedures
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 6 Protection of research participants’ privacy and confidentiality
p.000040:
p.000040: 7 Community considerations
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 8 Qualifications of researchers and adequacy assessment of study sites
p.000040: 9 Disclosure or declaration of potential COI
p.000040:
p.000040:
p.000040:
p.000040: 10 Plans for medical management and compensation for study related injury
p.000040: 11 Review of the informed consent process
p.000040: • There is a need to determine that payments are not so large as to encourage prospective participants to participate
p.000040: in the research without due consideration of the risks or against their better judgement. No undue inducement must be
p.000040: offered.
p.000040: • ECs should examine the processes that are put in place to
...
Social / Property Ownership
Searching for indicator home:
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p.000145: Available from: http://icmr.nic.in/guidelines/GCLP.pdf (accessed 18 May 2017).
p.000145: 31. Good Manufacturing Practices. New Delhi: Central Drugs Standard Control Organization. Available
p.000145: from:http://www.cdsco.nic.in/writereaddata/ schedulem(gmp)6.pdf (accessed 12 Sept 2017).
p.000145: 32. Good Clinical Practice Guidelines for clinical trials of ASU Medicine. New Delhi: Department of AYUSH,
p.000145: Ministry of Health and Family Welfare, Government of India; 2013. Available from:
p.000145: http://ayush.gov.in/acts-rules-and-notifications/good-clinical- practice-guidelines-clinical-trials-asu-medicine
p.000145: (accessed 31 Aug 2017).
p.000145: 33. Opinion on Synthetic Biology I [document on the Internet]. Scientific Committee on Health and
p.000145: Environmental Risks, Scientific Committee on Emerging and Newly Identified Health Risks, Scientific Committee on
p.000145: Consumer Safety. Available from: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_044. pdf
p.000145: (accessed 09 Sept 2017).
p.000145: 34. Atomic Energy Regulatory Board [homepage on the Internet]. Available from: http://
p.000145: www.aerb.gov.in/index.php/english/ (accessed 12 Sept 2017).
p.000145: 35. Biomedical Waste Management Rules [document on the Internet]. New Delhi: Ministry of Environment, Forest and
p.000145: Climate Change, Government of India. 2016. Available from: http://cpcbenvis.nic.in/pdf/bmw_rules_2016.pdf (accessed 31
p.000145: Aug 2017).
p.000145: 36. American Society for Testing and Materials [home page on the Internet]. Available from: https://www.astm.org/
p.000145: (accessed 31 Aug 2017).
p.000145: 37. The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, amended in
p.000145: 2003, India [statute on the Internet]. Available from: http:// pndt.gov.in/writereaddata/mainlinkfile/File22.pdf
p.000145: (accessed 31 Aug 2017).
p.000145: 38. Import/export policy for human biological samples for commercial purposes: amendment. Schedule–1
p.000145: (Import Policy) and Schedule–2 (Export Policy) of ITC (HS), 2012 (notification of 2016). Ministry of Commerce and
p.000145: Industry, Government of India. Available from: http://www.icmr.nic.in/IHD/DGFT%20notification%204-8-16.pdf (accessed 09
p.000145: Sept 2017).
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000145: 145
p.000146:
p.000146:
p.000146: SUGGESTED FURTHER READING
p.000146: A framework for the ethical conduct of public health initiatives. Toronto: Public Health Ontario; 2012. Available from:
p.000146: https://www.publichealthontario.ca/en/erepository/
p.000146: pho%20%20framework%20for%20ethical%20conduct%20of%20public%20health%20 initiatives%20april%202012.pdf (accessed 31 Aug
p.000146: 2017).
p.000146: Atomic Energy Act, 1962, India [statute on the Internet]. Available from: http://dae.nic. in/?q=node/153 (accessed 09
p.000146: Sept 2017).
p.000146: Department-related Standing Committee on Health and Family Welfare. Fifty-ninth report on the functioning of the
p.000146: Central Drugs Standard Control Organization. New Delhi: Rajya Sabha Secretariat; May 2012. Available from:
...
Searching for indicator property:
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p.000141: • Sharing data on safety and efficacy would be beneficial to reduce delay for other
p.000141: researchers.
p.000141: • Consent process is important and must be carried out with care.
p.000141: • Planning should be done for community engagement.
p.000141: • Fair distribution should be ensured when faced with scarce supply.
p.000141: 12.8 Continuation of ongoing research when a humanitarian emergency occurs
p.000141: 12.8.1 The research may have to be suspended and the decision may be taken by researchers with information to EC.
p.000141: 12.8.2 The researchers can go back to the EC for guidance regarding continuation of research or not.
p.000141: 12.8.3 Amendments might be incorporated in the proposal(s) to align to the research needs arising from the emergency
p.000141: including issues related to re-consent from participants.
p.000141: 12.8.4 The EC may decide if more frequent monitoring is required.
p.000141: 12.9 International participation in research
p.000141: 12.9.1 Conduct of research in a humanitarian emergency situation, which involves a foreign researcher/institution, must
p.000141: involve local partner(s).
p.000141: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000141: 141
p.000142:
p.000142: Research during Humanitarian Emergencies and
p.000142: Disasters
p.000142:
p.000142: 12.9.2 Existing guidelines on international collaboration for biological samples, data and intellectual
p.000142: property including publication related issues will be applicable. See section
p.000142: 3.8.3 for further details.
p.000142: 12.9.3 The local EC will monitor the progress of the research and compliance to the various clauses of the
p.000142: international collaboration.
p.000142: 12.9.4 Permission should be obtained from relevant national and local authorities, wherever applicable.
p.000142: 12.9.5 The research should help in developing the capacity of local researchers and sites and provide key learning
p.000142: points to the policy makers and the community.
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
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p.000142:
p.000142: 142 INDIAN COUNCIL OF MEDICAL
p.000143: RESEARCH
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: LIST OF REFERENCES
p.000143: 1. Policy statement on ethical considerations involved in research on human subjects. New Delhi: Indian Council
p.000143: of Medical Research; 1980.
p.000143: 2. Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research;
p.000143: 2000.
p.000143: 3. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical
p.000143: Research; 2006.
p.000143: 4. Good clinical practice. New Delhi: Central Drugs Standard Control Organization; 2004. Available from:
p.000143: http://www.cdsco.nic.in/html/gcp1.html (accessed 31 Aug 2017).
...
p.000150: Directorate General of Health Services DSMB Data and Safety Monitoring Board DTA
p.000150: data transfer agreement
p.000150: EC ethics committee
p.000150: ELSI ethical, legal and social issues
p.000150: GCP good clinical practice
p.000150: GLP good laboratory practices
p.000150: GMP good manufacturing practices
p.000150: GOI Government of India
p.000150: HMSC Health Ministry’s Screening Committee
p.000150: ICD informed consent document
p.000150: ICF informed consent form
p.000150: ICH International Conference on Harmonization
p.000150: ICJME International Committee of Medical Journal Editors
p.000150:
p.000150:
p.000150:
p.000150: 150 INDIAN COUNCIL OF MEDICAL
p.000151: RESEARCH
p.000151:
p.000151:
p.000151: Abbreviations and acronyms
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: ICMR Indian Council of Medical Research
p.000151: IC-SCR institutional committee for stem cell research
p.000151: IND investigational new drug
p.000151: Ind EC independent ethics committee
p.000151: IP investigational product
p.000151: IPR intellectual property rights
p.000151: LAR legally acceptable/authorized representative MoHFW Ministry of Health and Family
p.000151: Welfare MOU memorandum of understanding
p.000151: MTA material transfer agreement
p.000151: MTP medical termination of pregnancy
p.000151: NABH National Accreditation Board for Hospitals and Healthcare Providers NABL National
p.000151: Accreditation Board for Testing and Calibration Laboratories NACO National AIDS Control Organization
p.000151: NAC-SCRT National Apex Committee for Stem Cell Research and Therapy
p.000151: PGD/ PGS pre-implantation genetic diagnosis/screening
p.000151: PIS participant information sheet
p.000151: RCR responsible conduct of research
p.000151: SAE serious adverse events
p.000151: SIDCER Strategic Initiative for Developing Capacity in Ethical Review
p.000151: SOP standard operating procedure
p.000151: TM traditional medicines
p.000151: TOR terms of reference
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000151: 151
p.000152:
p.000152: GLOSSARY
p.000152: 1. Accountability The obligation of an individual or organization to account for its activities, accept
p.000152: responsibility for them and to disclose the results in a transparent manner.
...
Social / Racial Minority
Searching for indicator minority:
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p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
...
Searching for indicator race:
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p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
p.000158: 62 Theologian A person who is an expert in the study of religious faith(s), including the
p.000158: system of spirituality, practice and experience about the nature of the divine.
p.000158:
p.000158: 63 Test of
p.000158: understanding
p.000158: A simple oral or written test designed to identify if the participant
p.000158: has understood the details related to her/his voluntary participation in research before signing
p.000158: the ICD form. (Questions such as “If you decide not to take part in this research study, do you know what your options
p.000158: are?”, “Do you know that you do not have to take part in this research study, if you do not wish to?”, “Do you have any
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
p.000159: 66 Undue inducement
p.000159:
p.000159: 67 Unexpected ADR
p.000159: Offer of disproportionate benefit in cash or kind that compromises judgement which may lead to acceptance of
...
Searching for indicator racial:
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p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
p.000008: 2.5.1 If applicable, participants may be reimbursed for expenses incurred relating to their participation in
p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
p.000008: is applicable to all participants, including those in comparator/control groups.
p.000008: 2.5.3 If there are provisions, participants may also receive additional medical services at no cost.
p.000008: 2.5.4 When the LAR is giving consent on behalf of a participant, payment should not become an undue inducement and to
p.000008: be reviewed carefully by the EC. Reimbursement may be offered for travel and other incidental expenses incurred due to
p.000008: participation of the child/ward in the research.
p.000008: 2.5.5 ECs must review and approve the payments (in cash or kind or both) and free services and the processes
...
Social / Religion
Searching for indicator faith:
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p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
p.000158: 62 Theologian A person who is an expert in the study of religious faith(s), including the
p.000158: system of spirituality, practice and experience about the nature of the divine.
p.000158:
p.000158: 63 Test of
p.000158: understanding
p.000158: A simple oral or written test designed to identify if the participant
p.000158: has understood the details related to her/his voluntary participation in research before signing
p.000158: the ICD form. (Questions such as “If you decide not to take part in this research study, do you know what your options
p.000158: are?”, “Do you know that you do not have to take part in this research study, if you do not wish to?”, “Do you have any
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
p.000159: 66 Undue inducement
p.000159:
p.000159: 67 Unexpected ADR
p.000159: Offer of disproportionate benefit in cash or kind that compromises judgement which may lead to acceptance of
p.000159: serious risks that threaten fundamental interests.
p.000159: An adverse reaction, the nature or severity of which is not
p.000159: described in the informed consent/information sheet or the applicable product information, such as an
...
Searching for indicator religious:
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p. xii:
p. xii: PREFACE
p. xii: Medical profession is probably the oldest one to prescribe ethical guidelines. Such guidelines for practically all
p. xii: aspect of professional conduct were provided both in Caraksamhita and Susrutasamhita. Rapid advances in
p. xii: the whole field of biomedical sciences have added newer responsibilities and complex dilemmas for medical persons –
p. xii: both practitioner and researchers. It would be correct to say that every advance in medical science results in added
p. xii: moral responsibility. ICMR has always been on the forefront to set the standards for ethics in biomedical and health
p. xii: research. The Council brought out a policy document in 1980, which was revised in 2000 and further revised in 2006. The
p. xii: latest version of guidelines has addressed the newer emerging ethical issues keeping in view the social, cultural,
p. xii: economic, legal and religious aspects of our country. Ethics is a subject of discussions and debates and each and every
p. xii: word and line in the revised guidelines have been deliberated upon by a group of experts and have gone through a
p. xii: process of consultation and debate before it has been finalized. The new expanded document has separate sections on
p. xii: Responsible Conduct of Research, Informed Consent Process, Vulnerability, Public Health Research, Social and
p. xii: Behavioural Sciences Research for Health, Biological materials, Biobanking and Datasets, International Collaboration
p. xii: and Research during Humanitarian Emergencies and Disasters. The guidelines also highlight the need for capacity
p. xii: building in the area of ethics in order to improve the ethical conduct of research. These Guidelines are a result of
p. xii: in-depth discussions and debates, involving the diverse stake-holders and also the public. The ICMR ethical guidelines
p. xii: are well respected not only in India but a number of other countries. The new “National Ethical Guidelines for
p. xii: Biomedical and Health Research involving Human Participants, 2017” will serve as a guide to answer and meet the
p. xii: challenges and concerns raised by the emerging ethical issues.
p. xii: I wish that the society will be enormously benefitted by these revised guidelines in general and biomedical scientist
p. xii: in particular.
p. xii:
p. xii:
p. xii:
p. xii:
p. xii:
p. xii: New Delhi April 2017
p. xii: Dr. P N Tandon
p. xii: Chairperson
...
p.000010: 2.8.2 Researchers must ensure that the documents submitted to the EC include a disclosure of interests that may
p.000010: affect the research.
p.000010: 2.8.3 ECs must evaluate each study in light of any disclosed interests and ensure that appropriate means
p.000010: of mitigation are taken.
p.000010: 2.8.4 COI within the EC should be declared and managed in accordance with standard operating procedures
p.000010: (SOPs) of that EC.
p.000010: 2.9 Selection of vulnerable and special groups as research participants
p.000010: Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may
p.000010: be relatively (or absolutely) incapable of protecting their own interests.
p.000010: 2.9.1 Characteristics that make individuals vulnerable are legal status – children; clinical conditions –
p.000010: cognitive impairment, unconsciousness; or situational conditions –
p.000010:
p.000010: 10 INDIAN COUNCIL OF
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
...
p.000029: safety and pharmacodynamics.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: • Scientific review of protocols including review of the intervention, benefit-risk analysis, research
p.000029: design, methodology, sample size, site of study and statistics
p.000029: • Ongoing review of the protocol (SAE, protocol deviation
p.000029: or violation, progress and completion report)
p.000029: • Review medical care, facility and appropriateness of the principal investigator, provision for
p.000029: medical car, management and compensation.
p.000029: • Thorough review of protocol, investigators brochure (if applicable) and all other protocol details and
p.000029: submitted documents.
p.000029: • Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial
p.000029: Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s
p.000029: undertaking, protocol specific other permissions, such as, stem cell committee for stem cell research, HMSC
p.000029: for international collaboration, compliance with guidelines etc.
p.000029: • Interpret and inform EC members about new regulations
p.000029: if any
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000029: (Contd.)
p.000029:
p.000029: 29
p.000030:
p.000030:
p.000030: Ethical Review Procedures
p.000030:
p.000030:
p.000030: 6. Social scientist/ philosopher/ ethicist/theologian
p.000030: Affiliated/ non-affiliated
p.000030:
p.000030: Qualifications -
p.000030: • Should be an individual with social/ behavioural science/ philosophy/ religious qualification and training and/or
p.000030: expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities
p.000030: 7. Lay person(s)
p.000030: Non-affiliated Qualifications -
p.000030: • Literate person from the public or
p.000030: community
p.000030: • Has not pursued a medical science/ health-
p.000030: related career in the last 5 years
p.000030: • May be a representative of the community
p.000030: from which the participants are to be drawn
p.000030: • Is aware of the local language, cultural and
p.000030: moral values of the community
p.000030: • Desirable: involved in social and
p.000030: community welfare activities
p.000030: • Ethical review of the proposal, ICD along
p.000030: with the translations.
p.000030: • Assess impact on community involvement, socio–cultural context, religious or philosophical context, if
p.000030: any
p.000030: • Serve as a patient/participant/ societal / community representative and bring in ethical and societal
p.000030: concerns.
p.000030:
p.000030:
p.000030:
p.000030: • Ethical review of the proposal, ICD along
p.000030: with translation(s).
p.000030: • Evaluate benefits and risks from the participant’s perspective and opine whether
p.000030: benefits justify the risks.
p.000030: • Serve as a patient/participant/ community representative and bring in ethical and societal concerns.
p.000030: • Assess on societal aspects if any.
p.000030:
p.000030: 4.3.6 The quorum should be as specified in Box 4.2.
p.000030: Box 4.2 Quorum requirements for EC meetings
p.000030: 1. A minimum of five members present in the meeting room.
p.000030: 2. The quorum should include both medical, non medical or technical or/and non-technical members.*
p.000030: 3. Minimum one non-affiliated member should be part of the quorum.
p.000030: 4. Preferably the lay person should be part of the quorum.
p.000030: 5. The quorum for reviewing regulatory clinical trials should be in accordance with current CDSCO requirements.
p.000030: 6. No decision is valid without fulfilment of the quorum.
p.000030:
p.000030: *Medical members are clinicians with appropriate medical qualifications. Technical members are persons with
p.000030: qualifications related to a particular branch in which the study is conducted, for example social sciences.
p.000030: 30 INDIAN COUNCIL OF
p.000031: MEDICAL RESEARCH
p.000031:
p.000031:
p.000031: Ethical Review Procedures
p.000031:
p.000031: 4.3.7 So as to maintain independence, the head of the institution should not be part of the EC but should act as an
...
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
p.000104: evident due to multi-religious, caste, class, endogamic, gender and geo-ethnic variations which are important
p.000104: characteristics of society that need to be considered in socio-behavioural research proposals. In view of the above,
p.000104: ECs should be aware of the challenges that may be encountered in the process of conducting such studies.
p.000104: 9.1 Some key features
p.000104: 9.1.1. Conventional social science research on health underscores the importance of bringing contemporary contexts to
p.000104: biomedical and health research.
p.000104: 9.1.2. It has now emerged as a cross-cutting area of enquiry relevant to almost every type of
p.000104:
p.000104: 104 INDIAN COUNCIL OF MEDICAL
p.000105: RESEARCH
p.000105:
p.000105: Social and Behavioural Sciences
p.000105: Research for Health
p.000105:
p.000105: medical, biomedical, clinical and health research such as clinical trials, epidemiological research, programme
p.000105: evaluations, implementation research, genetics, research on disaster and conflict contexts.
p.000105: 9.1.3. The principles of social science research ethics, with rights and responsibilities of the different
p.000105: stakeholders including participants, researchers, reviewers, publishers, etc., are similar to those for biomedical and
p.000105: public health research.
p.000105: 9.1.4. There are, however, specific ethical issues involved in social and behavioural sciences studies as given in Box
p.000105: 9.1.
p.000105:
p.000105: Box 9.1 Ethical issues in social and behaviour sciences studies
p.000105:
...
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
p.000158: 62 Theologian A person who is an expert in the study of religious faith(s), including the
p.000158: system of spirituality, practice and experience about the nature of the divine.
p.000158:
p.000158: 63 Test of
p.000158: understanding
p.000158: A simple oral or written test designed to identify if the participant
p.000158: has understood the details related to her/his voluntary participation in research before signing
p.000158: the ICD form. (Questions such as “If you decide not to take part in this research study, do you know what your options
p.000158: are?”, “Do you know that you do not have to take part in this research study, if you do not wish to?”, “Do you have any
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
p.000159: 66 Undue inducement
p.000159:
p.000159: 67 Unexpected ADR
p.000159: Offer of disproportionate benefit in cash or kind that compromises judgement which may lead to acceptance of
p.000159: serious risks that threaten fundamental interests.
p.000159: An adverse reaction, the nature or severity of which is not
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000142: points to the policy makers and the community.
p.000142:
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p.000142:
p.000142: 142 INDIAN COUNCIL OF MEDICAL
p.000143: RESEARCH
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: LIST OF REFERENCES
p.000143: 1. Policy statement on ethical considerations involved in research on human subjects. New Delhi: Indian Council
p.000143: of Medical Research; 1980.
p.000143: 2. Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research;
p.000143: 2000.
p.000143: 3. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical
p.000143: Research; 2006.
p.000143: 4. Good clinical practice. New Delhi: Central Drugs Standard Control Organization; 2004. Available from:
p.000143: http://www.cdsco.nic.in/html/gcp1.html (accessed 31 Aug 2017).
p.000143: 5. Schedule Y of the Drugs and Cosmetics Act, 1940, amended on June 2005, India [statute on the
p.000143: Internet]. Available from: http://cdsco.nic.in/writereaddata/ Drugs&CosmeticAct.pdf (accessed 06 Aug 2017).
p.000143: 6. National guidelines for stem cell research. New Delhi: Indian Council of Medical Research and Department of
p.000143: Biotechnology; 2017.
p.000143: 7. The Nuremberg Code, 1947. In: Trials of war criminals before the Nuremberg Military Tribunals under Control
p.000143: Council Law No. 10. Washington DC: US Government Printing Office; 1949; 2:181-182.
p.000143: 8. Declaration of Helsinki: ethical principles for medical research involving human subjects.
p.000143: Fortaleza: World Medical Association. 2013; Available from: https://www.
p.000143: wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf (accessed 08 Sept 2017).
p.000143: 9. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The
p.000143: Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC:
p.000143: Department of Health, Education and Welfare; 1979.
p.000143: 10. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human
p.000143: Services; (1991); 2001, 2017.
p.000143: 11. Good clinical practice guidelines E6 (R1). The International Conference on Harmonization; 1996.
p.000143: Available from: https://www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
p.000143: (accessed 02 Sept 2017).
p.000143: 12. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Available from:
p.000143: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E6/E6_R2 Step_4.pdf (accessed 02 Sep
p.000143: 2017).
p.000143:
p.000143: INDIAN COUNCIL OF MEDICAL RESEARCH
...
Social / Student
Searching for indicator student:
(return to top)
p.000009: notified from time to time may be followed.
p.000009: • All research participants who suffer harm, whether related or not, should be offered appropriate
p.000009: medical care, psycho-social support, referrals, clinical facilities, etc.
p.000009: • Medical management should be free if the harm is related to the research.
p.000009: • Compensation should be given to any participant when the injury is related to the research. This is
p.000009: applicable to participants in any of the arms of research, such as intervention, control and standard of care.
p.000009: • While deliberating on the quantum of compensation to be awarded to participants who have suffered
p.000009: research-related injury, the EC should consider aspects including the type of research (interventional,
p.000009: observational, etc.), extent of injury (temporary/permanent, short/long term), loss of wages, etc.
p.000009: • For other sponsored research, it is the responsibility of the sponsor (whether a pharmaceutical company,
p.000009: government or non-governmental organization (NGO), national or international/bilateral/multilateral donor
p.000009: agency/institution) to include insurance coverage or provision for possible compensation for research related injury
p.000009: or harm within the budget.
p.000009: 2.6.3 All AEs should be recorded and reported to the EC according to a pre-planned timetable, depending on the level
p.000009: of risk and as recommended by the EC.
p.000009: 2.6.4 In investigator initiated research/student research, the investigator/institution where the research is
p.000009: conducted becomes the sponsor.
p.000009: • It is the responsibility of the host institution to provide compensation and/or cover for insurance for
p.000009: research related injury or harm to be paid as decided by the EC.
p.000009: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000009: 9
p.000010:
p.000010:
p.000010: General Ethical Issues
p.000010:
p.000010: • The institution should create in-built mechanism to be able to provide for
p.000010: compensation, such as a corpus fund in the institution.
p.000010: • In the applications for research grants to funding agencies – national or international,
p.000010: government or non-government agencies – the researcher should keep a budgetary provision for insurance coverage
p.000010: and/or compensation depending upon the type of research, anticipated risks and proposed number of participants.
p.000010: 2.7 Ancillary care
p.000010: 2.7.1 Participants may be offered free medical care for non-research-related conditions or incidental findings if
p.000010: these occur during the course of participation in the research, provided such compensation does not amount to undue
p.000010: inducement as determined by the EC.
p.000010: 2.8 Conflict of interest
p.000010: Conflict of interest (COI) is a set of conditions where professional judgement concerning a primary interest such as
p.000010: participants welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or
p.000010: non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or
...
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
p.000012: 2.11.1 Efforts should be made to communicate the findings of the research study to the
p.000012: individuals/communities wherever relevant.
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
p.000013: RESPONSIBLE CONDUCT OF RESEARCH
p.000013:
p.000013: 3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a
p.000013: significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide
p.000013: by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members
p.000013: of a research team are expected to maintain high standards and to uphold the fundamental values of research. The
p.000013: responsible conduct of research (RCR) involves the following major components: values; policies; planning and
p.000013: conducting research; reviewing and reporting research; and responsible authorship and publication.
p.000013: Institutions conducting research must establish a research office within their institution to facilitate research,
p.000013: manage grants, and oversee all aspects of RCR. The research office must work closely with the EC and with all
p.000013: stakeholders, including undergraduate and postgraduate students. SOPs should be in place to address all the major
p.000013: components of RCR as outlined in the following sections.
p.000013: 3.1 Values of research
...
p.000018: (ICMJE) on authorship23 which is largely accepted as a standard and is endorsed by the World Association of Medical
p.000018: Editors (WAME). See Box 3.3 for further details.
p.000018: Box 3.3 Criteria for authorship (ICMJE)
p.000018:
p.000018: According to the ICMJE, authorship entails the following criteria:
p.000018: 1. substantial contributions to the conception or design of the work, or the acquisition, analysis, or
p.000018: interpretation of data for the work;
p.000018: 2. drafting the work or revising it for important intellectual content;
p.000018: 3. final approval of the version to be published;
p.000018: 4. agreement to be accountable for all aspects of the work and ensuring that questions related to the accuracy or
p.000018: integrity of any part of the work are appropriately investigated and resolved.
p.000018:
p.000018: • Institutions and departments should have authorship policies. Editors of journals do not adjudicate on
p.000018: authorship disputes and would almost always refer these to the institution/researchers themselves to resolve.
p.000018: • Authorship should never be gifted and ‘ghost’ authors are not acceptable. The
p.000018: authorship of research should be considered at the time of its initiation.
p.000018: • The primary author should be the person who has done most of the research work
p.000018: related to the manuscript being submitted for publication. Research performed
p.000018:
p.000018: 18 INDIAN COUNCIL OF
p.000019: MEDICAL RESEARCH
p.000019:
p.000019:
p.000019: Responsible Conduct of Research
p.000019:
p.000019: as part of a mandatory requirement of a course/fellowship/training programme including student research should have the
p.000019: candidate as the primary author. All efforts must be made to provide the candidate with an opportunity to fulfil the
p.000019: second, third and fourth criteria of the ICMJE guidelines.
p.000019: 3.5.2 Peer review
p.000019: Scientific disclosure and progress has been dependent largely on peers evaluating research and judging the
p.000019: quality and utility of conducting and publishing research.
p.000019: • The present peer review system depends on fairness, honesty and transparency of all stakeholders – editors,
p.000019: reviewers and researchers. It can involve one or more reviewers and should be completed within a reasonable period of
p.000019: time.
p.000019: • Researchers must avoid mentioning friends, well-wishers and mentors as reviewers and must decline to
p.000019: review research of close associates, friends and students.
p.000019: • Funding agencies and journals must ask reviewers and researchers to inform
p.000019: them of COI, if any.
p.000019: • Reviewers must maintain the confidentiality of manuscripts sent to them for
p.000019: review.
p.000019: • If reviewers feel they are not competent to review papers, then they should inform editors
p.000019: immediately and should not pass on the manuscripts to friends and colleagues without seeking the consent of the
p.000019: editors.
p.000019: • Reviewers who are researchers must not misguide editors in an attempt to self
p.000019: evaluate their research (using another email ID and profile).
p.000019: 3.6 Research misconduct and policies for handling misconduct
p.000019: Research misconduct involves fabrication, falsification and plagiarism of data, which are serious issues both
...
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
p.000086: 86 INDIAN COUNCIL OF
p.000087: MEDICAL RESEARCH
p.000087:
p.000087: Clinical Trials of Drugs and
p.000087: other Interventions
p.000087:
p.000087: auditing, DSMB, etc.
p.000087: 7.16.4 When academic clinical trials are planned for “off-label” use of a drug (when a drug that is marketed is
p.000087: being used for a new indication/new dose/formulation/route) for purely academic purposes and not for commercial use,
p.000087: then such clinical trials designed by researchers/academicians may not currently require regulatory approval. However,
p.000087: an EC has to approve such studies after due consideration of benefits and risks and all other ethical aspects and the
p.000087: licensing authority has to be informed as per GSR 313(e) dated 16.3.2016 issued by CDSCO.
p.000087: 7.16.5 The trials must be registered in CTRI and there should be mechanism for appropriate methods for informed
p.000087: consent, conduct of trial and proper follow-up of patients.
p.000087: 7.16.6 For student conducting clinical trials as part of their academic thesis, the guide and the academic
p.000087: institution should take up the responsibilities of the sponsor.
p.000087: 7.17 Clinical trials on contraceptives
p.000087: Several methods of contraception are available including, barrier methods, hormonal methods, emergency contraception,
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
...
Social / Threat of Stigma
Searching for indicator stigma:
(return to top)
p.000039: incidental expenses and other inconveniences should be reviewed.
p.000039:
p.000039:
p.000039: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000039: (Contd.)
p.000039: 39
p.000040:
p.000040:
p.000040: Ethical Review Procedures
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 6 Protection of research participants’ privacy and confidentiality
p.000040:
p.000040: 7 Community considerations
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 8 Qualifications of researchers and adequacy assessment of study sites
p.000040: 9 Disclosure or declaration of potential COI
p.000040:
p.000040:
p.000040:
p.000040: 10 Plans for medical management and compensation for study related injury
p.000040: 11 Review of the informed consent process
p.000040: • There is a need to determine that payments are not so large as to encourage prospective participants to participate
p.000040: in the research without due consideration of the risks or against their better judgement. No undue inducement must be
p.000040: offered.
p.000040: • ECs should examine the processes that are put in place to
p.000040: safeguard participants’ privacy and confidentiality.
p.000040: • Research records to be filed separately than routine clinical
p.000040: records such as in a hospital setting.
p.000040: • The EC should ensure that due respect is given to the community, their interests are
p.000040: protected and the research addresses the community’s needs.
p.000040: • The proposed research should not lead to any stigma or
p.000040: discrimination. Harm, if any, should be minimized.
p.000040: • Plans for communication of results to the community at the
p.000040: end of the study should be carefully reviewed.
p.000040: • It is important to examine how the benefits of the research will
p.000040: be disseminated to the community.
p.000040: • The EC should look at the suitability of qualifications and experience of the PI to conduct the proposed
p.000040: research along with adequacy of site facilities for participants.
p.000040: • The EC should review any declaration of COI by a researcher
p.000040: and suggest ways to manage these.
p.000040: • The EC should manage COI within the EC and members with COI should leave the room at the time of decision making in
p.000040: a particular study.
p.000040: • The proposed plan for tackling any medical injuries or
p.000040: emergencies should be reviewed.
p.000040: • Source and means for compensation for study related injury
p.000040: should be ascertained.
p.000040: The informed consent process must be reviewed keeping in mind the following:
p.000040: • the process used for obtaining informed consent, including the
p.000040: identification of those responsible for obtaining consent and the procedures adopted for vulnerable populations;
p.000040: • the adequacy, completeness and understandability of the
p.000040: information to be given to the research participants, and when appropriate, their LARs;
p.000040:
p.000040: (Contd.)
p.000040:
...
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
p.000059: Researchers • Recognize the vulnerability of the participant and ensure additional
p.000059: safeguards are in place for their protection.
p.000059: • Justify inclusion/exclusion of vulnerable populations in the study.
...
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
...
p.000082: Clinical Trials of Drugs and
p.000082: other Interventions
p.000082:
p.000082: Box 7.6 Conditions for sham surgery
p.000082: 1. There has to be a clear description of the justifications to include a sham surgery group in the protocol, which
p.000082: must be assessed by the EC.
p.000082: 2. There should be no serious harm caused by the sham surgery.
p.000082: 3. The participant must get access to appropriate, relevant intervention at the end of the trial.
p.000082:
p.000082: 7.11 Community trials (public health interventions)
p.000082: Community trials are studies involving whole communities and are conducted to evaluate preventive strategies like mass
p.000082: drug administration (MDA) trials, fortification of food, etc. Such studies typically involve the whole community. The
p.000082: study unit could be a group, area, institution, village, block, district, etc. and the whole population is expected to
p.000082: participate in the study. In such studies, different communities are randomized and allocated to different arms (see
p.000082: section 8 for further details).
p.000082: 7.12 Clinical trials of interventions in HIV/AIDS
p.000082: Clinical trials in HIV positive patients could be for the evaluation of new drugs, vaccines, other
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
p.000082: 7.12.1 Global studies in HIV/AIDS in specific communities should receive approval from the relevant national
p.000082: authority and any other relevant authority, such as the HMSC, where applicable, in addition to approval from the EC.
p.000082: 7.12.2 When testing for HIV is done, consent and pre-test- and post-test counselling should be done as per National
p.000082: AIDS Control Organization (NACO) guidelines.
p.000082: 7.12.3 Issues that may arise because of discordant couples should be addressed before initiating any
p.000082: study in people living with HIV/AIDS.
p.000082: 7.12.4 As HIV is a sexually transmitted disease and is potentially life-threatening, the right to life of the
p.000082: sexual partner must be respected over the right to privacy of the HIV positive individual.
...
p.000093: 8.1 Principles of public health research ethics
p.000093: • Principle of respect for autonomy, rights and dignity – In public health research, the principle of autonomy
p.000093: is relational, since the interests of an individual as part of
p.000093:
p.000093: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000093: 93
p.000094:
p.000094:
p.000094: Public Health Research
p.000094:
p.000094: a community are relational in nature. Therefore, sometimes individual autonomy may not be appropriate as a stand-alone
p.000094: for application at the community level. While respect for the rights and dignity of all participants need to be
p.000094: considered and ensured, the same should be observed about the community. This can be facilitated by engaging the
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
...
p.000107: cultural context and associated harm related to dignity as well as social and informational harm. This will avoid
p.000107: hurting or transgressing rights of the participants/community.
p.000107: • Harm to dignity is likely to occur when individuals are not treated as persons with their own values,
p.000107: preferences, and commitments, but rather as mere means not deserving of respect. This is also sometimes classified as
p.000107: another form of negligence. It may result in individuals feeling hurt, humiliated, excluded, dismissed or
p.000107: unfairly treated.
p.000107: • Psychological and emotional harm may result from participating in a study where memories of
p.000107: traumatic experiences such as disasters (natural or otherwise), violence, conflict, abuse, assault and other such
p.000107: conditions need to be revisited by the participants. This may also affect and compound the vulnerabilities of
p.000107: participants already experiencing post-traumatic stress disorder (PTSD).
p.000107: • Social harm is a non-medical adverse consequence of study participation, including difficulties in
p.000107: personal relationships and stigma or discrimination from family or community. Social harm can be related to
p.000107: personal relationships, travel, employment, education, health, housing, institutions (government/non- government) and
p.000107: others.
p.000107: • Informational risk is the potential for harm from disclosure of information about an identified research
p.000107: participant to others. For much of social and behavioural research, informational risk is one of the primary risks.
p.000107: 9.2.4 Risk mitigation
p.000107: Measures should be employed to minimize potential risks and their negative impact, such as short- and long-term adverse
p.000107: impacts on participants of studies on abortion, sexual abuse and other sensitive subjects. These measures should be
p.000107: incorporated into research methods, with special reference to hierarchies that exist in the social context where the
p.000107: research is undertaken.
p.000107: 9.2.5 Community engagement
p.000107: While devising methods and interpreting observations, researchers should engage potential participants and
p.000107: communities in a meaningful participatory process
p.000107:
p.000107: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000107: 107
p.000108:
p.000108: Social and Behavioural Sciences
p.000108: Research for Health
p.000108:
p.000108: that involves them in an early and sustained manner in the design, development, implementation and
...
Searching for indicator threat:
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p.000007: inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,
p.000007: it may not be possible to do so under certain circumstances.
p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
p.000008: 2.5.1 If applicable, participants may be reimbursed for expenses incurred relating to their participation in
p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
...
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
...
p.000105: relationships. See section 3.8.3 for further details.
p.000105: 9.1.6 Appropriate experts/expertise of EC members in the social and behavioural sciences domain are an essential
p.000105: aspect to address the above challenges.
p.000105: 9.2 Addressing the ethical challenges
p.000105: 9.2.1 Design and conduct of the study is important for a meaningful outcome in social and behavioural research. See
p.000105: Box 9.2 for further details.
p.000105:
p.000105: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000105: 105
p.000106:
p.000106: Social and Behavioural Sciences
p.000106: Research for Health
p.000106: Box 9.2 Consideration for appropriate design and conduct of study
p.000106:
p.000106: 1. Like any other research, the researchers must ensure that the proposed studies are scientifically sound, built
p.000106: on an adequate prior knowledge base, and are likely to generate valuable information.
p.000106: 2. In socially stratified groups and communities, researchers must spend time to become conversant with
p.000106: cultural norms and practices in order to develop strategies to build trust and negotiate power in ways that do not put
p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
p.000106: from some other nearby village so that her/his vulnerability and perceived threat from other participants can be
p.000106: mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested
p.000106: communication plan.
p.000106: 4. The information about these norms/practices should be collected from reliable and multiple sources including
p.000106: multiple persons/groups, which should be mentioned in detail. This knowledge should be considered while
p.000106: deciding the group of participants and style of interview/investigation. However, the final decision about
p.000106: recruiting the participant should be based on the participant’s and her/his family’s opinion about
p.000106: norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or
p.000106: restrictive communities.
p.000106: 5. Field work challenges for research team – Research team members may sometimes be subjected to unforeseen
p.000106: situations which may involve trauma, humiliation and threats of violence. Training should be given to the
p.000106: research team to meet such challenges.
p.000106: 9.2.2 Ethical review
p.000106: There are some unique features of social and behavioural sciences research which need to be considered by the EC on a
p.000106: case-by-case basis. See Box 9.3 for further details.
p.000106: Box 9.3 Considerations by the EC for ethical review
p.000106: 1. Social and behavioural sciences research approaches are not always positivist and, therefore,
p.000106: articulation of a hypothesis may not be possible at the beginning of the research. Instruments/documents are developed
...
p.000136: such situations all reasonable measures must be adopted to respect and protect privacy and confidentiality of
p.000136: individuals as given in Box 11.6.
p.000136: Box 11.6 Measures to ensure privacy and confidentiality of individuals
p.000136:
p.000136: 1. Ensure physical safety and security of the involved devices and computer servers
p.000136: 2. Take data security measures such as password protection
p.000136: 3. Provide differential and role-based controlled access to data elements for members of the research team
p.000136: 4. Ensure use of data encryption when data is transferred from one location/device to another
p.000136: 5. Ensure benefit sharing with owners and related legal issues since, unlike some other countries, India
p.000136: does not have a data protection act as yet
p.000136: 11.8 Contingency plan
p.000136: One of the important but often neglected ethical issues related to biorepository is the legacy or
p.000136: contingency plan. Institutions should develop the contingent plans for sustainability of the biobanks.
p.000136:
p.000136: 136 INDIAN COUNCIL OF MEDICAL
p.000137: RESEARCH
p.000137:
p.000137: SECTION 12
p.000137:
p.000137:
p.000137: RESEARCH DURING HUMANITARIAN EMERGENCIES AND DISASTERS
p.000137:
p.000137: 12.0 A humanitarian emergency or disaster is an event or series of events that represents a critical threat to the
p.000137: health, safety, security or well-being of a community or other large group of people, usually covering a wide
p.000137: land area. For the purpose of these guidelines, humanitarian emergencies and disasters include both man-made and
p.000137: natural ones, some of which occur at periodic frequency. Emergencies, such as an earthquake, flood, mass migration,
p.000137: conflict and outbreak of disease, leading to substantial material damage affecting persons, communities, society
p.000137: and state(s), create an imbalance between capacity and resources to meet the needs of the survivors or the people
p.000137: whose lives are threatened during that period. Research is necessary in such circumstances to enable provision of
p.000137: efficient and appropriate health and humanitarian response during the ongoing emergency and to be able to plan for
p.000137: future emergency situations. Local, national or international responses and preparedness, without interfering with
p.000137: measures to control the crisis or ecology, are the key to reducing morbidity and mortality in such events.
p.000137: Humanitarian emergencies raise complex issues. The health system, communications, research infrastructure, and research
p.000137: governance frameworks may be adversely affected during such situations, which create challenges for the feasibility and
p.000137: oversight of conduct of research. While there may be a need to undertake research quickly, this should not impact
...
p.000153: behaviour or samples of their tissue for prevention, treatment and diagnosis of a disease condition/health disorder.
p.000153: 13. Clinical trial As per amended Schedule Y (2005) of the Drugs and Cosmetics
p.000153: Rules, 1945, a clinical trial refers to a systematic study of new drugs in human subjects to
p.000153: generate data for discovering and/or verifying the clinical, pharmacological (including
p.000153: pharmacodynamic and pharmacokinetic) and /or adverse effect with the objectives determining safety and/or
p.000153: efficacy of a new drug. The academic clinical trial as per GSR 313 (e) dated 16 March 2016 is a clinical trial
p.000153: intended for academic purposes in respect of approved drug formulations for any new indication or new route of
p.000153: administration or new dose or new dosage form.
p.000153:
p.000153: 14 Clinical trial
p.000153: registry
p.000153: An official platform for registering a clinical trial, such as Clinical
p.000153: Trial Registry-India
p.000153: 15 Clinician A person with recognized medical qualification and expertise/ training.
p.000153:
p.000153: 16 Cognitive
p.000153: impairment
p.000153: When a person has trouble remembering, learning new things,
p.000153: concentrating, or making decisions that affect their everyday life.
p.000153:
p.000153: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000153: 153
p.000154:
p.000154:
p.000154: Glossary
p.000154: 17 Coercion An overt or implicit threat of harm to a participant which is intentional to
p.000154: force compliance.
p.000154:
p.000154: 18 Collaborative
p.000154: research
p.000154: An umbrella term for methodologies that actively engage
p.000154: researchers, communities and/ or policy makers in the research process from start to finish.
p.000154: 19 Compensation Provision of financial payment to the research participants or their
p.000154: legal heirs when temporary or permanent injury or death occurs due to participation in biomedical and health research.
p.000154: 20 Confidentiality Keeping information confidential which an individual has disclosed
p.000154: in a relationship of trust and with the expectation that it shall not be divulged to others without permission.
p.000154:
p.000154: 21 Confidentiality
p.000154: agreement
p.000154:
p.000154: 22 Contract
p.000154: Research Organization (CRO)
p.000154: Secrecy or non-disclosure agreements designed to protect trade
p.000154: secrets, information and expertise from being misused by those who have learned about them.
p.000154: An institution or service organization which represents a sponsor
p.000154: in providing research support/services on a contractual basis nationally or internationally.
p.000154: 23 Custodian A person who has responsibility of taking care of or protecting
p.000154: entrusted assets, either biological samples or data.
p.000154: 24 Debriefing A process of providing a summary update of a condition or situation to the
p.000154: affected or concerned parties. It is an important ethical consideration in studies involving deception.
...
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p.000007: consideration and approval by the EC. See section 5 for further details.
p.000007: 2.3 Privacy and confidentiality
p.000007: Privacy is the right of an individual to control or influence the information that can be collected and stored and by
p.000007: whom and to whom that information may be disclosed or shared. Confidentiality is the obligation of the
p.000007: researcher/research team/organization to the participant to safeguard the entrusted information. It includes the
p.000007: obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft.
p.000007: 2.3.1 The researcher should safeguard the confidentiality of research related data of participants and the
p.000007: community.
p.000007: 2.3.2 Potential limitations to ensure strict confidentiality must be explained to the participant. Researchers must
p.000007: inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,
p.000007: it may not be possible to do so under certain circumstances.
p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
...
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000111: 111
p.000112:
p.000112: SECTION 10
p.000112: HUMAN GENETICS TESTING AND RESEARCH
p.000112:
p.000112: 10.0 In no other area of biomedical and health research has there been a greater concern for ethical issues
p.000112: than in the field of human genetics. In recent years this concern has grown even further because of direct
p.000112: to consumer testing and the possibilities of embryo manipulations. While the recent DNA technology has provided one of
p.000112: the most powerful tools in the hands of mankind to unravel the mysteries of the human genome and its manipulation, it
p.000112: has also led to a great deal of concern about scientists’ ability to handle such information. There is also a very
p.000112: narrow gap between routine genetic testing and research raising several ethical, legal and social issues (ELSI), which
p.000112: warrant continuous and prompt monitoring and judicious response to the emerging ethical issues.
p.000112: 10.1 General issues
p.000112: 10.1.1 The harm/risks associated with genetic testing may be psychosocial rather than physical in the form of
p.000112: anxiety, depression or disrupted family relationships.
p.000112: 10.1.2 Potential benefits and risks should be discussed thoroughly with prospective participants.
p.000112: Appropriate communication skills are required for genetic counselling which is akin to therapy.
p.000112: 10.1.3 There is a likelihood of social stigmatization and discrimination in schooling, employment, health
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
...
p.000115: • direct/indirect benefits and their implications including if there are no direct
p.000115: benefits to the participants;
p.000115: • how the data/samples will be stored, for how long, and procedures involved in
p.000115: anonymisation, sharing , etc. See section 11 for further details;
p.000115: • choice to opt out of testing/withdraw from research at any time;
p.000115: • whether the affected individual or the proband would like to share her/his genetic
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
p.000115: • In case of population or community based studies, it may be noted that the genetic research may generate
p.000115: information applicable to the community/populations from which the participants were drawn, and therefore, group
p.000115: consent must be taken from the community head and/or the culturally appropriate authority.
p.000115: • Even if group consent is taken, it will not be a replacement for individual consent
p.000115: as individual consent is important. See section 5 for further details.
p.000115: • Researchers should be aware of potential stigmatization of the entire group and must explain ways to
p.000115: avoid the same during the conduct of research and publication of research results.
p.000115: 10.5 Culturally sensitive issues
p.000115: 10.5.1 Transmission of a genetic abnormality from parents, especially the mother to the foetus, could be
p.000115: a very sensitive cultural issue. Such possibility arises when during routine testing or prenatal diagnosis it is
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
p.000115: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000115: 115
p.000116:
p.000116: Human
p.000116: Genetics Testing and Research
p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
p.000116: information is revealed to the husband or other members of the family, it may cause marital discord despite the fact
p.000116: that the husband himself is a carrier of the autosomal recessive disorder. Appropriate counselling should be part of
p.000116: the testing process.
p.000116: 10.5.2 Consanguineous marriages are common in some communities. If there are inherited diseases detected in the
...
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
p.000121: decision-making process, unless early intervention based on results of the test is likely to be of direct therapeutic
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
p.000121: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000121: 121
p.000122:
p.000122: Human
p.000122: Genetics Testing and Research
p.000122:
p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
p.000122: linked), the individual should be tested after administering informed consent when she/he is able to comprehend the
p.000122: benefits and risks of screening. Stigmatization for carrier status is common and therefore, the information should be
p.000122: kept confidential.
p.000122: • Chromosomal: If there is a family history of balanced translocation in any individual, then
p.000122: immediate relatives may be at risk. The same principles as for carrier testing should be followed.
p.000122: 10.14 Gene therapy
p.000122: All gene therapies are considered as research and all protections for human research participants should be in place.
p.000122: 10.14.1 Somatic cell gene therapy is permissible for the purpose of preventing or treating a serious
p.000122: disease when it is the only therapeutic option. It should be restricted to alleviation of life
p.000122: threatening or seriously disabling genetic disease in individual patients and should not be permitted to change
p.000122: normal human traits.
p.000122: 10.14.2 Prior to obtaining approval for initiating a gene therapy trial, an approval from the local EC and DBT has to
p.000122: be obtained for the gene construct.
p.000122: 10.14.3 If the trial is for a product for commercial use or for marketing purposes, approval needs to be taken from
p.000122: CDSCO.
p.000122: 10.14.4 All gene therapy trials should have the provision for long-term surveillance.
p.000122: 10.14.5 Informed consent must be taken, especially regarding uncertainties about outcome.
p.000122: 10.14.6 Children could be candidates for therapy, if the therapy is meant for a childhood disorder.
p.000122: 10.14.7 Germ line therapy is prohibited under the present state of knowledge.
...
p.000139: only with the prior approval of the EC.
p.000139: 12.3 Risk-minimization and equitable distribution of benefits and risks
p.000139: 12.3.1 Considerations for fair selection of participants are described in Box 12.1.
p.000139:
p.000139: Box 12.1 Considerations for fair selection of participants
p.000139:
p.000139: 1. The overall effort is not to over-sample, particularly vulnerable segments of the population.
p.000139: 2. Explicit selection criteria or prioritization of participants with proper justification should be provided in the
p.000139: protocol.
p.000139: 3. Efforts should be taken to ensure that research participants are not exploited during the research project by
p.000139: imposing additional burdens on them.
p.000139: 4. It is desirable to set up a DSMB to frequently review the data to check on risk quantum.
p.000139:
p.000139: 12.3.2 Efforts should be made to see that the positive results of a specific research are applicable to future similar
p.000139: disaster situations.
p.000139: 12.3.3 Whenever possible, a priori agreement could be reached between researcher(s) and disaster affected communities
p.000139: for benefit sharing, which could be extended to future disaster affected communities wherever applicable.
p.000139: 12.4 Privacy and confidentiality
p.000139: 12.4.1 Disruption of governance, infrastructure and communication networks and inflow of visitors during emergencies
p.000139: can lead to a breach of privacy and confidentiality. In some situations, there can be stigmatization and discrimination
p.000139: which should be minimized at all stages of research.
p.000139: 12.4.2 Special efforts (culturally appropriate and scientifically valid) are required to maintain dignity, privacy and
p.000139: confidentiality of individuals and the communities.
p.000139:
p.000139: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000139: 139
p.000140:
p.000140: Research during Humanitarian Emergencies and
p.000140: Disasters
p.000140:
p.000140: 12.4.3 Efforts should be made to protect the identifying information about individuals and communities, for example,
p.000140: from exploitation by the print and visual media.
p.000140: 12.5 Ethics review procedures
p.000140: 12.5.1 Research during humanitarian emergencies and disasters can be reviewed through an expedited
p.000140: review/scheduled/unscheduled full committee meetings and this may be decided by the Member Secretary on a case-to-case
p.000140: basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as
p.000140: possible.
p.000140: 12.5.2 Meticulous documentation and archiving are required to enable future application in similar situations.
p.000140: 12.5.3 Suggestions to expedite the review process are given below:
p.000140: • Measures such as virtual or tele-conferences should be attempted when face-to-
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
...
p.000157: hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to
p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
p.000158: 62 Theologian A person who is an expert in the study of religious faith(s), including the
p.000158: system of spirituality, practice and experience about the nature of the divine.
p.000158:
p.000158: 63 Test of
p.000158: understanding
p.000158: A simple oral or written test designed to identify if the participant
p.000158: has understood the details related to her/his voluntary participation in research before signing
p.000158: the ICD form. (Questions such as “If you decide not to take part in this research study, do you know what your options
p.000158: are?”, “Do you know that you do not have to take part in this research study, if you do not wish to?”, “Do you have any
p.000158: questions?”, etc. will clarify the understanding of the participant.)
p.000158: 64 Transparency It implies intentional openness, communication, and accountability
p.000158: operating in such a way that it is easy for others to see what actions are performed.
p.000158:
p.000158: 65 Therapeutic
p.000158: misconception
p.000158: It is a misconception by participants believing that the purpose of
p.000158: clinical trials/research study is to administer treatment rather than to conduct research.
p.000158: 158 INDIAN COUNCIL OF MEDICAL
p.000159: RESEARCH
p.000159:
p.000159: Glossary
p.000159:
p.000159:
...
Social / Threat of Violence
Searching for indicator violence:
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p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
...
p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
p.000106: from some other nearby village so that her/his vulnerability and perceived threat from other participants can be
p.000106: mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested
p.000106: communication plan.
p.000106: 4. The information about these norms/practices should be collected from reliable and multiple sources including
p.000106: multiple persons/groups, which should be mentioned in detail. This knowledge should be considered while
p.000106: deciding the group of participants and style of interview/investigation. However, the final decision about
p.000106: recruiting the participant should be based on the participant’s and her/his family’s opinion about
p.000106: norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or
p.000106: restrictive communities.
p.000106: 5. Field work challenges for research team – Research team members may sometimes be subjected to unforeseen
p.000106: situations which may involve trauma, humiliation and threats of violence. Training should be given to the
p.000106: research team to meet such challenges.
p.000106: 9.2.2 Ethical review
p.000106: There are some unique features of social and behavioural sciences research which need to be considered by the EC on a
p.000106: case-by-case basis. See Box 9.3 for further details.
p.000106: Box 9.3 Considerations by the EC for ethical review
p.000106: 1. Social and behavioural sciences research approaches are not always positivist and, therefore,
p.000106: articulation of a hypothesis may not be possible at the beginning of the research. Instruments/documents are developed
p.000106: during the course of the research; are reflective; and may keep changing as the research progresses. The EC must be
p.000106: kept informed about these changes and appropriate re-consent taken from participants.
p.000106: 2. The researcher must take prior permission from the EC with justifiable reasons for audio/
p.000106: video recording of participants’ interviews.
p.000106:
p.000106:
p.000106: 106 INDIAN COUNCIL OF MEDICAL
p.000107: RESEARCH
p.000107:
p.000107: Social and Behavioural Sciences
p.000107: Research for Health
p.000107:
p.000107: 9.2.3 Risk assessment
p.000107: Participants of research in behavioural and social science face the potential of being exposed to significant and
p.000107: unique harm which may not be limited to physical harm. The researchers, research team and EC must recognize the
p.000107: cultural context and associated harm related to dignity as well as social and informational harm. This will avoid
p.000107: hurting or transgressing rights of the participants/community.
p.000107: • Harm to dignity is likely to occur when individuals are not treated as persons with their own values,
p.000107: preferences, and commitments, but rather as mere means not deserving of respect. This is also sometimes classified as
p.000107: another form of negligence. It may result in individuals feeling hurt, humiliated, excluded, dismissed or
p.000107: unfairly treated.
p.000107: • Psychological and emotional harm may result from participating in a study where memories of
p.000107: traumatic experiences such as disasters (natural or otherwise), violence, conflict, abuse, assault and other such
p.000107: conditions need to be revisited by the participants. This may also affect and compound the vulnerabilities of
p.000107: participants already experiencing post-traumatic stress disorder (PTSD).
p.000107: • Social harm is a non-medical adverse consequence of study participation, including difficulties in
p.000107: personal relationships and stigma or discrimination from family or community. Social harm can be related to
p.000107: personal relationships, travel, employment, education, health, housing, institutions (government/non- government) and
p.000107: others.
p.000107: • Informational risk is the potential for harm from disclosure of information about an identified research
p.000107: participant to others. For much of social and behavioural research, informational risk is one of the primary risks.
p.000107: 9.2.4 Risk mitigation
p.000107: Measures should be employed to minimize potential risks and their negative impact, such as short- and long-term adverse
p.000107: impacts on participants of studies on abortion, sexual abuse and other sensitive subjects. These measures should be
...
p.000109: study, if appropriate;
p.000109: • disseminate results of research to the participants, if applicable; and
p.000109: • be carefully reviewed by the EC.
p.000109: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000109: 109
p.000110:
p.000110: Social and Behavioural Sciences
p.000110: Research for Health
p.000110: Box 9.5 Types of deception
p.000110:
p.000110: 1. Active deception: Selective withholding of the information/hypothesis of the study in the consent form along with
p.000110: giving incorrect information for achieving public good without influencing the outcome of the study, for example,
p.000110: psychology, neuro- behavioural, behaviour intervention study.
p.000110: 2. Incomplete disclosure: If research involves incomplete disclosure but no deception.
p.000110: 3. Authorized deception: Unlike in active deception, participants are informed that they would be deceived prior to
p.000110: the research but the nature of the deception will not be disclosed or research will not be described accurately or some
p.000110: procedures will be deceptive. Such revelation provides the participants an opportunity to decide whether or not to
p.000110: participate on these terms.
p.000110:
p.000110: 9.2.10 Safety of participants
p.000110: Support systems, such as access to counselling centres, rehabilitation centres, police protection, etc., should be in
p.000110: place when research is on a sensitive issue, such as mental health, gender based violence and social exclusion and
p.000110: discrimination.
p.000110: 9.2.11 Safety of research teams in the field
p.000110: The safety of the research team is the responsibility of the institution, sponsors and local authorities, particularly
p.000110: in research on sensitive topics or in sensitive research settings since there would be a possibility of the researcher
p.000110: or research team being subjected to disturbing instances while conducting the research. Besides providing safety,
p.000110: including insurance coverage, and giving training to the researcher or research team to meet such challenges, setting
p.000110: up community advisory boards could be helpful to ease the situation.
p.000110: 9.2.12 Qualitative research
p.000110: The knowledge gathered through qualitative research is interpretative based on the observation and its
p.000110: analysis by the researcher or research team which is socially constructed at individual and socio-cultural levels.
p.000110: • Informed consent is very often dynamic in nature and negotiable. When written
p.000110: consent may not be possible, other means could be used and documented.
p.000110: • The EC may look at issues that pertain to the design involving researcher–
p.000110: participant relationships, informed consent process and conduct of the research.
p.000110: • Preliminary activity of observation for preparing notes, before actually initiating
p.000110: research based on the observation, need not be submitted for EC’s review.
p.000110:
...
p.000137: scientific validity and the need to uphold ethical requirements. Close attention should be paid to the effect of the
p.000137: emergency on perceptions of ethical questions, altered or increased vulnerabilities, provider–patient and
p.000137: researcher–participant relationships, issues related to integrity of studies and ethical review processes. A unique
p.000137: challenge would be the response to rapidly evolving health needs or priorities of those impacted by the humanitarian
p.000137: emergency when the research cannot be conducted outside the humanitarian emergency situation. Designing or adopting
p.000137: innovative relevant research, based on rapidly evolving scientific and ethical uncertainties, which is expected to
p.000137: yield scientifically valid results is another significant challenge. The other challenges are inadequate time
p.000137: to design a study and lack of infrastructure facilities and resources to
p.000137: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000137: 137
p.000138:
p.000138: Research during Humanitarian Emergencies and
p.000138: Disasters
p.000138:
p.000138: conduct it within a disrupted physical-socio-cultural environment. The role of ECs in such circumstances is very
p.000138: important in reviewing protocols prepared for such emergency situation(s). Responsiveness to the situation,
p.000138: supervision, training and prevention of heightened risk of violence are other factors to be considered and planned.
p.000138: 12.1 Pre-emptive research preparation for future humanitarian emergency
p.000138: A natural disaster of cyclical frequency is an expected phenomenon. The following will be acceptable if a research is
p.000138: planned to study various implications on humans and ecological effects on humans in these circumstances.
p.000138: 12.1.1 Researchers and sponsors could make arrangements about research questions to be addressed in the design,
p.000138: collection of samples and data, and sharing mechanisms much in advance of a future humanitarian emergency.
p.000138: 12.1.2 Researchers could screen available and/or relevant draft research protocols to expedite the review process.
p.000138: 12.1.3 The EC could review proposals prior to the occurrence of the emergency and determine who could be an
p.000138: acceptable LAR in the absence of intended LARs (authorized/ acceptable) in such situations.
p.000138: 12.2 Informed consent requirements
p.000138: 12.2.1 Obtaining valid informed consent in humanitarian emergencies is a challenge as the decisional capacity of the
p.000138: participants would be so low that they may not be able to differentiate between reliefs offered and research
p.000138: components. This should be very clearly distinguished during the informed consent process.
...
Social / Trade Union Membership
Searching for indicator union:
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p. ix:
p. ix: NATIONAL ETHICAL GUIDELINES
p. ix: FOR BIOMEDICAL AND HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS
p. ix:
p. ix:
p. ix:
p. ix:
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p. ix:
p. ix:
p. ix: INDIAN COUNCIL OF MEDICAL RESEARCH 2017
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix:
p. ix: Compiled & Edited by:
p. ix: Dr. Roli Mathur
p. ix: Head, ICMR Bioethics Unit NCDIR, Bengaluru
p. ix:
p. ix: Published by:
p. ix: Director-General
p. ix: Indian Council of Medical Research New Delhi 110 029 www.icmr.nic.in
p. ix:
p. ix: ISBN: 978-81-910091-94
p. ix:
p. ix: October, 2017
p. ix: Price: ₹ 500.00
p. ix:
p. ix:
p. ix: © Copyright Indian Council of Medical Research
p. ix:
p. ix:
p. ix: The use of content from this book is permitted for all non-commercial purposes giving full acknowledgement to ICMR
p. ix: which shall not be held liable for any damages whatsoever as a result of the use or application of the contents of this
p. ix: document. ICMR reserves the right to update and change the contents without notice and accepts no liability
p. ix: for any errors or omissions in this regard. Care has been taken to present the information accurately, however the
p. ix: reader is urged to check latest notifications/rules/regulations by GOI from time to time.
p. ix:
p. ix: Design and layout:
p. ix: The cover page drawing depicts the sections of this document.
p. ix: Tejeswini Padma, Kalyani Thakur, Rajib K Hazam and Monesh B Vishwakarma
p. ix:
p. ix: TABLE OF CONTENTS
p. ix: Message from Hon’ble Union Minister for Health and Family Welfare, Government of India
p. ix: ix
p. x: Foreword by DG ICMR and Secretary DHR x
p. x: Message from President, Medical Council of India xi
p. x: Preface by Chairperson, Central Ethics Committee on Human Research xii
p. x: Message from Chairperson, Advisory Group xiii
p. x: Acknowledgement
p. xiv: xiv
p. xv: Introduction
p.000001: 1
p.000002: Scope
p.000002: 2
p.000003: Section 1 Statement of general principles 3
p.000003: 1.1 General principles 3
p.000003: Section 2 General ethical issues
p.000005: 5
p.000006: 2.1 Benefit-risk assessment 5
p.000006: 2.2 Informed consent process 5
p.000006: 2.3 Privacy and confidentiality 7
p.000006: 2.4 Distributive justice 8
p.000006: 2.5 Payment for participation 8
...
p.000148: Prevention of Cruelty to Animals Act, 1960, amended in 1982, India [statute on the Internet]. Available from:
p.000148: http://www.envfor.nic.in/legis/awbi/awbi01.pdf (accessed 31 Aug 2017).
p.000148: Principles of the ethical practice of public health. Public Health Leadership Society; 2002. Available from:
p.000148: https://www.apha.org/~/media/files/pdf/membergroups/ ethics_brochure.ashx (accessed 09 Sept 2017).
p.000148: Public health ethics [homepage on the Internet]. Center for Disease Control and Prevention. Available from:
p.000148: https://www.cdc.gov/od/science/integrity/phethics/index. htm(accessed 18 May 2017).
p.000148: Public health: ethical issues. London: Nuffield Council on Bioethics; 2007. Available from:
p.000148: https://nuffieldbioethics.org/wp-content/uploads/2014/07/Public-health-ethical- issues.pdf (accessed 09 Sept 2017).
p.000148: Report of the Prof. Ranjit Roy Chaudhury expert committee to formulate policy and guidelines for approval
p.000148: of new drugs, clinical trials and banning of drugs. Ministry of Health and Family Welfare; 2013. Available from:
p.000148: http://www.cdsco.nic.in/ writereaddata/report_of_dr_ranjit_roy.pdf (accessed 09 Sept 2017).
p.000148: Review Committee on Genetic Manipulation [homepage on the Internet]. Department of Biotechnology. Available from:
p.000148: http://dbtbiosafety.nic.in/committee/rcgm.htm (accessed 09 Sept 2017).
p.000148: Statement on behalf of The Government – on The Supreme Court Judgement on Right to Privacy. Available from:
p.000148: http://pib.nic.in/newsite/PrintRelease.aspx?relid=170206 (accessed 09 Sept 2017).
p.000148: Swasthya Adhikar Manch and Anr. v. Union of India and Ors. Supreme Court of India. 2012. [document on the Internet].
p.000148: Available from: http://cdsco.nic.in/writereaddata/
p.000148:
p.000148: 148 INDIAN COUNCIL OF MEDICAL
p.000149: RESEARCH
p.000149:
p.000149:
p.000149: Suggested Further Reading
p.000149:
p.000149: sc%20order%2030th%20sept%202013.pdf (accessed 09 Sept 2017).
p.000149: The ethics of research related to healthcare in developing countries.: The Nuffield Council on Bioethics; 2002.
p.000149: Available from: https://nuffieldbioethics.org/wp-content/
p.000149: uploads/2014/07/Ethics-of-research-related-to-healthcare-in-developing-countries-I. pdf (accessed 09 Sept 2017).
p.000149: Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical.
p.000149: International Committee of Medical Journal Editors; 2006. Available from:
p.000149: http://www.icmje.org/recommendations/archives/2008_urm.pdf (accessed 09 Sept 2017).
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p.000150:
p.000150: ABBREVIATIONS AND ACRONYMS
p.000150:
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Social / Unemployment
Searching for indicator unemployed:
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p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
...
Social / Victim of Abuse
Searching for indicator trauma:
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p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
p.000106: from some other nearby village so that her/his vulnerability and perceived threat from other participants can be
p.000106: mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested
p.000106: communication plan.
p.000106: 4. The information about these norms/practices should be collected from reliable and multiple sources including
p.000106: multiple persons/groups, which should be mentioned in detail. This knowledge should be considered while
p.000106: deciding the group of participants and style of interview/investigation. However, the final decision about
p.000106: recruiting the participant should be based on the participant’s and her/his family’s opinion about
p.000106: norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or
p.000106: restrictive communities.
p.000106: 5. Field work challenges for research team – Research team members may sometimes be subjected to unforeseen
p.000106: situations which may involve trauma, humiliation and threats of violence. Training should be given to the
p.000106: research team to meet such challenges.
p.000106: 9.2.2 Ethical review
p.000106: There are some unique features of social and behavioural sciences research which need to be considered by the EC on a
p.000106: case-by-case basis. See Box 9.3 for further details.
p.000106: Box 9.3 Considerations by the EC for ethical review
p.000106: 1. Social and behavioural sciences research approaches are not always positivist and, therefore,
p.000106: articulation of a hypothesis may not be possible at the beginning of the research. Instruments/documents are developed
p.000106: during the course of the research; are reflective; and may keep changing as the research progresses. The EC must be
p.000106: kept informed about these changes and appropriate re-consent taken from participants.
p.000106: 2. The researcher must take prior permission from the EC with justifiable reasons for audio/
p.000106: video recording of participants’ interviews.
p.000106:
p.000106:
p.000106: 106 INDIAN COUNCIL OF MEDICAL
p.000107: RESEARCH
p.000107:
p.000107: Social and Behavioural Sciences
p.000107: Research for Health
p.000107:
p.000107: 9.2.3 Risk assessment
p.000107: Participants of research in behavioural and social science face the potential of being exposed to significant and
p.000107: unique harm which may not be limited to physical harm. The researchers, research team and EC must recognize the
...
Searching for indicator abuse:
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p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
p.000058: 58 INDIAN COUNCIL OF
p.000059: MEDICAL RESEARCH
p.000059:
p.000059:
p.000059: Vulnerability
p.000059:
p.000059: Table 6.1 Obligations/duties of stakeholders
p.000059: Stakeholders Obligations / duties
...
p.000063: minimal risk and/or that offers direct benefit to the child. Consent from both parents may have to be obtained when the
p.000063: research involves more than minimal risk and/or offers no benefit to the child.
p.000063: 3. Only one parent’s consent is acceptable if the other parent is deceased, unknown, incompetent, not
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
...
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
...
p.000106:
p.000106:
p.000106: 106 INDIAN COUNCIL OF MEDICAL
p.000107: RESEARCH
p.000107:
p.000107: Social and Behavioural Sciences
p.000107: Research for Health
p.000107:
p.000107: 9.2.3 Risk assessment
p.000107: Participants of research in behavioural and social science face the potential of being exposed to significant and
p.000107: unique harm which may not be limited to physical harm. The researchers, research team and EC must recognize the
p.000107: cultural context and associated harm related to dignity as well as social and informational harm. This will avoid
p.000107: hurting or transgressing rights of the participants/community.
p.000107: • Harm to dignity is likely to occur when individuals are not treated as persons with their own values,
p.000107: preferences, and commitments, but rather as mere means not deserving of respect. This is also sometimes classified as
p.000107: another form of negligence. It may result in individuals feeling hurt, humiliated, excluded, dismissed or
p.000107: unfairly treated.
p.000107: • Psychological and emotional harm may result from participating in a study where memories of
p.000107: traumatic experiences such as disasters (natural or otherwise), violence, conflict, abuse, assault and other such
p.000107: conditions need to be revisited by the participants. This may also affect and compound the vulnerabilities of
p.000107: participants already experiencing post-traumatic stress disorder (PTSD).
p.000107: • Social harm is a non-medical adverse consequence of study participation, including difficulties in
p.000107: personal relationships and stigma or discrimination from family or community. Social harm can be related to
p.000107: personal relationships, travel, employment, education, health, housing, institutions (government/non- government) and
p.000107: others.
p.000107: • Informational risk is the potential for harm from disclosure of information about an identified research
p.000107: participant to others. For much of social and behavioural research, informational risk is one of the primary risks.
p.000107: 9.2.4 Risk mitigation
p.000107: Measures should be employed to minimize potential risks and their negative impact, such as short- and long-term adverse
p.000107: impacts on participants of studies on abortion, sexual abuse and other sensitive subjects. These measures should be
p.000107: incorporated into research methods, with special reference to hierarchies that exist in the social context where the
p.000107: research is undertaken.
p.000107: 9.2.5 Community engagement
p.000107: While devising methods and interpreting observations, researchers should engage potential participants and
p.000107: communities in a meaningful participatory process
p.000107:
p.000107: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000107: 107
p.000108:
p.000108: Social and Behavioural Sciences
p.000108: Research for Health
p.000108:
p.000108: that involves them in an early and sustained manner in the design, development, implementation and
p.000108: monitoring of research, and in the dissemination of its results.
p.000108: 9.2.6 Informed consent
p.000108: Human participants in a proposed research study must be informed about the nature of the research project, and
p.000108: researchers/research teams must obtain their voluntary consent prior to their participation in the study. The different
p.000108: types of informed consent processes in social and behavioural sciences research are provided in Box 9.4.
p.000108: Box 9.4 Informed consent in social and behavioural sciences research on health
p.000108: 1. Community consent/gatekeeper consent/individual consent: Individual informed consent has to be taken after
...
Social / Women
Searching for indicator women:
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p.000011: 5.4 Documentation of informed consent process 52
p.000011: 5.5 Electronic consent 53
p.000011: 5.6 Specific issues in clinical trials 53
p.000011: 5.7 Waiver of consent 53
p.000011: 5.8 Re-consent or fresh consent 54
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
...
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
p.000006: obtain the written, informed consent of the prospective participant or legally acceptable/authorized representative
p.000006: (LAR). In case of an individual who is not capable of giving informed consent, the consent of the LAR should be
...
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
...
p.000059: • ECs have special responsibilities when research is conducted on
p.000059: participants who are suffering from mental illness and/or cognitive impairment. They should exercise
p.000059: caution and require researchers to justify cases for exceptions to the usual requirements of participation or
p.000059: essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are
p.000059: as minimal as possible and are clearly spelt out in the ICD.
p.000059: • ECs should have SOPs for handling proposals involving vulnerable
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
p.000060: 2. If women in the reproductive age are to be recruited, they should be informed of the potential risk to the foetus
p.000060: if they become pregnant. They should be asked to use an effective contraceptive method and be told about the options
p.000060: available in case of failure of contraception.
p.000060: 3. A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing
p.000060: potential harm to the foetus. The matter should be carefully reviewed and she must be offered the option to withdraw or
p.000060: continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and
p.000060: offer support to the woman for as long as necessary.
p.000060:
p.000060:
p.000060: 60 INDIAN COUNCIL OF
p.000061: MEDICAL RESEARCH
p.000061:
p.000061:
p.000061: Vulnerability
p.000061:
p.000061: 6.4.2 Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
...
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
...
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
p.000086: 86 INDIAN COUNCIL OF
p.000087: MEDICAL RESEARCH
p.000087:
...
p.000087: licensing authority has to be informed as per GSR 313(e) dated 16.3.2016 issued by CDSCO.
p.000087: 7.16.5 The trials must be registered in CTRI and there should be mechanism for appropriate methods for informed
p.000087: consent, conduct of trial and proper follow-up of patients.
p.000087: 7.16.6 For student conducting clinical trials as part of their academic thesis, the guide and the academic
p.000087: institution should take up the responsibilities of the sponsor.
p.000087: 7.17 Clinical trials on contraceptives
p.000087: Several methods of contraception are available including, barrier methods, hormonal methods, emergency contraception,
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
p.000088: effective contraceptive methods. These must be stated in the ICD and it should be ensured that these methods are
p.000088: understood and followed by the woman participant.
p.000088: 7.18.2 In clinical trials that include women of reproductive age, there may be occasional inadvertent pregnancy. In
p.000088: such an instance the woman should be withdrawn from the study and efforts should be made to collect data on the drug
p.000088: effects as well as the outcome for both mother and foetus. This follow-up plan of pregnancy and care of foetus must be
p.000088: stated in the protocol and ICD.
p.000088: 7.18.3 EC to review the need if, during research participation, the female sexual partner of a male participant
p.000088: gets pregnant, the protocol and ICD must state a plan to document this and both pregnant partner and foetus must be
p.000088: followed for outcome and reported.
p.000088: 7.18.4 Pregnant women have the right to participate in clinical research relevant to their healthcare needs such as
p.000088: gestational diabetes, pregnancy induced hypertension and HIV.
p.000088: 7.18.5 Benefit–risk assessment must be done at all stages for both the mother and the foetus.
p.000088: 7.18.6 Research involving pregnant women and foetuses must only take place when the object of the research is to
p.000088: obtain new knowledge directly relevant to the foetus, the pregnancy or lactation. The criteria described in Box 7.8
p.000088: must be fulfilled.
p.000088: 7.18.7 Women should not be encouraged to discontinue nursing for the sake of participation in research except in
p.000088: those studies where breast-feeding is harmful to the infant. In case a woman decides to cease breastfeeding, harm of
p.000088: cessation to the nursing child
p.000088:
p.000088: 88 INDIAN COUNCIL OF
p.000089: MEDICAL RESEARCH
p.000089:
p.000089: Clinical Trials of Drugs and
p.000089: other Interventions
p.000089:
p.000089: Box 7.8 Criteria for research involving pregnant women and foetuses
p.000089:
p.000089: 1. Appropriate studies on animals and non-pregnant individuals should have been completed (if applicable).
p.000089: 2. The risk to the foetus must be the least possible risk for achieving the objectives of the trials, including when
p.000089: the purpose of the trial is to meet the health needs of the mother or the foetus, or the risk to the foetus is minimal.
p.000089: 3. Researchers should not participate in decision making regarding any termination of a pregnancy.
p.000089: 4. No procedural changes, which will cause greater than minimal risk to the woman or foetus, will be introduced into
p.000089: the procedure for terminating the pregnancy solely in the interest of the trial.
p.000089:
p.000089: should be properly assessed. Supplementary food, such as milk formula should be considered in such instances.
p.000089: 7.18.8 For the conduct of research related to termination of pregnancy only pregnant women who undergo MTP as per
p.000089: the Medical Termination of Pregnancy Act, 1971 can be included.
p.000089: 7.19 Clinical trials in oncology
p.000089: There are several ethical issues when research is conducted in terminally ill patients for whom this may be a last hope
p.000089: for cure, or a way to get free treatment for their disease which may be otherwise beyond their reach. These
p.000089: need to be addressed during planning, conduct, oversight and publication of such trials. Three primary factors
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
...
p.000119: addition to individual informed consent.
p.000119: • Researchers may conduct coded or reversible anonymized testing on general
p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
p.000119: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000119: 119
p.000120:
p.000120: Human
p.000120: Genetics Testing and Research
p.000120:
p.000120: the approval of the EC.
p.000120: 10.13.5 Prenatal screening: Prenatal screening is aimed to screen mothers and foetuses that are at high risk of having
p.000120: functional or structural defects including chromosomal and single gene disorders. There are many screening tests
p.000120: which are recommended in routine practice.
p.000120: • Biochemical and ultrasound screening: Various combinations of serum screening and ultrasound screening tests
p.000120: are done either during first (dual marker) or second trimester (triple or quadruple screening) for aneuploidy
p.000120: screening. It is important to discuss detection rates, false positive and negative results with participants.
p.000120: • Invasive testing for prenatal diagnosis: Preliminary genetic counselling of women for invasive prenatal
p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
...
p.000160:
p.000160: 160 INDIAN COUNCIL OF MEDICAL
p.000161: RESEARCH
p.000161:
p.000161: ANNEX 2
p.000161:
p.000161: LIST OF MEMBERS OF COMMITTEES INVOLVED IN REVISION OF GUIDELINES (2015-2017)
p.000161:
p.000161: A. Members of Central Ethics Committee on Human Research
p.000161: P. N. Tandon (Chairperson), National Brain Research Centre, Manesar
p.000161: B. N. Dhawan (Late), Formerly at Central Drug Research Institute, Lucknow
p.000161: Sunil K. Pandya, Jaslok Hospital, Mumbai
p.000161: Madhav Menon, Bar Council of Kerala, M.K.Nambyar Academy for Continuing Legal Education, Kochi
p.000161: G. Padmanaban, Indian Institute of Science, Bengaluru
p.000161: Lt. Gen. D. Raghunath, Formerly at Sir Dorabji Tata Centre for Research in Tropical Diseases, Bengaluru
p.000161: K.N. Chaturvedi, Supreme Court, New Delhi
p.000161: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000161: C.A.K. Yesudian, Formerly at Tata Institute of Social Sciences, Mumbai
p.000161: Vinod K. Paul, All India Institute of Medical Sciences, New Delhi
p.000161: Mira Shiva, Initiative for Health & Equity in Society, New Delhi
p.000161: Vasantha Muthuswamy, Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR,
p.000161: New Delhi
p.000161: Amar Jesani, Indian Journal of Medical Ethics, Mumbai
p.000161: Amita Singh, Jawaharlal Nehru University, New Delhi
p.000161: N. Sarojini, SAMA- Resource Group for Women & Health, New Delhi
p.000161: Sanjiv Datta, Former Financial Advisor, Indian Council of Medical Research, New Delhi
p.000161: Vijay Kumar, Indian Council of Medical Research, New Delhi
p.000161: Roli Mathur, Indian Council of Medical Research, National Centre for Disease Informatics and Research, Bengaluru
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000161: 161
p.000162:
p.000162:
p.000162:
p.000162: B. Chaipersons of Sub-Committees and Members of Advisory Group Vasantha Muthuswamy (Chairperson)
p.000162: Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR, New Delhi and President,
p.000162: Forum for Ethics Review Committees in India (FERCI)
p.000162: S D Seth (Co-Chairperson)
p.000162: Former Chair in Clinical Pharmacology & Advisor Clinical Trials Registry, ICMR, New Delhi and former Professor and
p.000162: Head, Dept of Pharmacology, AIIMS, New Delhi
p.000162: Nandini K Kumar
p.000162: Former Deputy Director General (Senior Grade), ICMR, New Delhi and Vice- President, Forum for Ethics Review Committees
p.000162: in India (FERCI)
p.000162: Narendra K Arora
p.000162: Executive Director, The INCLEN (International Clinical Epidemiology Network) Trust International, New Delhi and
p.000162: Formerly professor, Dept of Paediatrics, AIIMS, New Delhi
p.000162: Urmila Thatte
p.000162: Professor and Head, Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai
p.000162: Vijay Kumar
p.000162: Scientist - G & Head, Division of BMS, Indian Council of Medical Research, New Delhi
p.000162: Roli Mathur
p.000162: Scientist E, Division of BMS, Indian Council of Medical Research, New Delhi (2015-2016) and presently Head, ICMR
...
p.000165: Henk Bekedam, WHO Country Office for India, New Delhi
p.000165: I.C. Verma, Sir Ganga Ram Hospital, New Delhi
p.000165: Indira Nath, Formerly at All India Institute of Medical Sciences, New Delhi
p.000165: Kalyani Thakur, National Centre for Disease Informatics and Research, Bengaluru
p.000165: K.N. Chaturvedi, Supreme Court, New Delhi
p.000165: Kusum Verma, Sir Ganga Ram Hospital, New Delhi
p.000165: Madhulika Kabra, All India Institute of Medical Sciences, New Delhi
p.000165: Madhur Gupta, WHO Country Office for India, New Delhi
p.000165: Mausumi Bharadwaj, National Institute of Cancer Prevention and Research, Noida
p.000165: Monika Pahuja, Indian Council of Medical Research, New Delhi
p.000165: Mukesh Kumar, Indo French Centre for the Promotion of Advanced Research, New Delhi
p.000165: Nalin Mehta, All India Institute of Medical Sciences, New Delhi
p.000165: Nandini K Kumar, Kasturba Medical College, Manipal
p.000165: Nandita Chopra, U.S. Department of Health and Human Services, Office South Asia, New Delhi
p.000165: Narinder K Mehra, All India Institute of Medical Sciences, New Delhi
p.000165: Neena Valecha, National Institute of Malaria Research, New Delhi
p.000165:
p.000165:
p.000165: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000165: 165
p.000166:
p.000166:
p.000166:
p.000166: Neerja Gupta, All India Institute of Medical Sciences, New Delhi
p.000166: Nikhil Tandon, All India Institute of Medical Sciences, New Delhi
p.000166: Nithya Gogtay, Seth GS Medical College & King Edward Memorial Hospital, Mumbai
p.000166: Nitya Wadhwa, Translational Health Science and Technology Institute, Faridabad
p.000166: Nita Bhandari, Society for Applied Studies, New Delhi
p.000166: Narendra K. Arora, The INCLEN Trust International, New Delhi
p.000166: N. Sarojini, Sama- Resource Group for Women & Health, New Delhi
p.000166: N. Srikanth, Central Council for Research in Ayurvedic Sciences, New Delhi
p.000166: O.P. Agarwal, Indian Council of Medical Research, New Delhi
p.000166: P.N. Tandon, National Brain Research Centre, Manesar
p.000166: Pooja Sharma, Medanta-The Medicity, Gurgaon
p.000166: Poonam Salotra, National Institute of Pathology, New Delhi
p.000166: Prashant Mathur, National Centre for Disease Informatics and Research, Bengaluru
p.000166: Prabha Desikan, Bhopal Memorial Hospital & Research Centre, Bhopal Prasanna Kumar B Shirol, Organisation for Rare
p.000166: Diseases India, Bengaluru Priyanka Das, National Centre for Disease Informatics and Research, Bengaluru
p.000166: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000166: Rajib Kishore Hazam, National Centre for Disease Informatics and Research, Bengaluru
p.000166: Rajni Kaul, Indian Council of Medical Research, New Delhi
p.000166: Ravi Verma, International Center for Research on Women’s, New Delhi
p.000166: Ratna Puri, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi
p.000166: Ritu Dhillon, Indian Council of Medical Research, New Delhi
p.000166: Roli Mathur, National Centre for Disease Informatics and Research, Bengaluru Sanjay Mehendale, Indian Council of
p.000166: Medical Research, New Delhi Sanghmitra Pati, Regional Medical Research Centre, Bhubaneswar
p.000166:
p.000166:
p.000166:
p.000166: 166 INDIAN COUNCIL OF MEDICAL
p.000167: RESEARCH
p.000167:
p.000167:
p.000167:
p.000167: S.D. Seth, Formerly at All India Institute of Medical Sciences, New Delhi Sita Naik, Apollo Hospitals Educational &
p.000167: Research Foundation, New Delhi Soumya Swaminathan, Indian Council of Medical Research, New Delhi Suneeta Singh, Amaltas
p.000167: Consulting Pvt. Ltd, New Delhi.
p.000167: T.S. Rao, Department of Biotechnology (Retired), New Delhi
p.000167: Upendra Kaul, Formerly at Fortis Escort Heart Institute, New Delhi
p.000167: Urmila Thatte, Seth GS Medical College & King Edward Memorial Hospital, Mumbai
p.000167: V.G. Somani, Central Drugs Standard Control Organisation, New Delhi
p.000167: Vijay Kumar, Indian Council of Medical Research, New Delhi
p.000167: Vid Nukala, U.S. Department of Health and Human Services, New Delhi.
p.000167: V.M. Katoch, Formerly at Indian Council of Medical Research New Delhi
p.000167: Y.K. Gupta, All India Institute of Medical Sciences, New Delhi
p.000167:
p.000167: E. List of Members Regional Consultation, NCDIR, BENGALURU
p.000167: Alok Kumar Deb, National Institute of Cholera and Enteric Diseases, Kolkata
p.000167: Alok Srivastava, Christian Medical College, Vellore
p.000167: A. Nandkumar, National Centre for Disease Informatics and Research, Bengaluru
p.000167: Bishnu Ram Das, Jorhat Medical College, Jorhat
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000005: is comprehended by them and assuring voluntariness of participation. Informed consent should explain medical
p.000005: terminology in simple terms and be in a language that the participant understands.
p.000005: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000005: 5
p.000006:
p.000006:
p.000006: General Ethical Issues
p.000006: Table 2.1 Categories of Risk
p.000006: Type of risk Definition/description
p.000006:
p.000006: Less than minimal risk
p.000006: Probability of harm or discomfort anticipated in the research is nil or not expected. For example, research on
p.000006: anonymous or non-identified data/samples, data available in the public domain, meta-analysis, etc.
p.000006: Minimal risk Probability of harm or discomfort anticipated in the research is not greater than that ordinarily
p.000006: encountered in routine daily life activities of an average healthy individual or general population or during the
p.000006: performance of routine tests where occurrence of serious harm or an adverse event (AE) is unlikely. Examples include
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
...
p.000036: Proposals with less than minimal risk where there are no linked identifiers, for example;
p.000036: • research conducted on data available in the public domain for systematic
p.000036: reviews or meta-analysis;
p.000036: • observation of public behaviour when information is recorded without any linked identifiers and disclosure
p.000036: would not harm the interests of the observed person;
p.000036: • quality control and quality assurance audits in the institution;
p.000036: • comparison of instructional techniques, curricula, or classroom management
p.000036: methods;
p.000036: • consumer acceptance studies related to taste and food quality; and
p.000036: • public health programmes by Govt agencies such as programme evaluation where the sole purpose of the exercise is
p.000036: refinement and improvement of the programme or monitoring (where there are no individual identifiers).
p.000036: Proposals that pose no more than minimal risk may undergo expedited review, for example;
p.000036: • research involving non-identifiable specimen and human tissue from
p.000036: sources like blood banks, tissue banks and left-over clinical samples;
p.000036: • research involving clinical documentation materials that are non-identifiable
p.000036: (data, documents, records);
p.000036: • modification or amendment to an approved protocol including administrative changes or
p.000036: correction of typographical errors and change in researcher(s);
p.000036: • revised proposals previously approved through expedited review, full
p.000036: review or continuing review of approved proposals;
p.000036: • minor deviations from originally approved research causing no risk or
p.000036: minimal risk;
p.000036: • progress/annual reports where there is no additional risk, for example activity limited to data analysis.
p.000036: Expedited review of SAEs/unexpected AEs will be conducted by SAE subcommittee; and
p.000036: • for multicentre research where a designated main EC among the participating sites has reviewed
p.000036: and approved the study, a local EC may conduct only an expedited review for site specific requirements in addition to
p.000036: the full committee common review.
p.000036: • research during emergencies and disasters (See Section 12 for further details).
p.000036: (Contd.)
p.000036: 36 INDIAN COUNCIL OF
p.000037: MEDICAL RESEARCH
p.000037:
p.000037:
p.000037: Ethical Review Procedures
p.000037:
p.000037:
p.000037: 3 Full committee review
p.000037: All research proposals presenting more than minimal risk that are not covered under exempt or expedited review
p.000037: should be subjected to full committee review, some examples are;
p.000037: • research involving vulnerable populations, even if the risk is minimal;
p.000037: • research with minor increase over minimal risk (see Table 2.1 for further
p.000037: details);
p.000037: • studies involving deception of participants (see section 5.11 for further
p.000037: details);
p.000037: • research proposals that have received exemption from review, or have undergone expedited review/undergone
p.000037: subcommittee review should be ratified by the full committee, which has the right to reverse/or modify any decision
p.000037: taken by the subcommittee or expedited committee;
p.000037: • amendments of proposals/related documents (including but not limited
p.000037: to informed consent documents, investigator’s brochure, advertisements, recruitment methods, etc.) involving an
p.000037: altered risk;
p.000037: • major deviations and violations in the protocol;
p.000037: • any new information that emerges during the course of the research for deciding whether or not to
p.000037: terminate the study in view of the altered benefit–risk assessment;
p.000037: • research during emergencies and disasters either through an expedited
p.000037: review/ scheduled or unscheduled full committee meetings. This may be decided by Member Secretary depending on the
p.000037: urgency and need;
p.000037: • prior approval of research on predictable emergencies or disasters before
p.000037: the actual crisis occurs for implementation later when the actual emergency or disaster occurs.
p.000037:
...
p.000042:
p.000042: 4.9.11 The researcher may be called in to present a proposal or provide clarifications on the study protocol that
p.000042: has been submitted for review but should not be present at the time of decision making.
p.000042: 4.9.12 The primary and secondary reviewers can brief the members about the study proposal and review carried out
p.000042: as per EC SOPs.
p.000042: 4.9.13 The comments of an independent consultant (if applicable) could be presented by the Member Secretary or
p.000042: subject experts could be invited to offer their views, but they should not participate in the decision-making process.
p.000042: However, her/his opinion must be recorded.
p.000042: 4.9.14 Representative(s) of the study group population can be invited during deliberations to offer their
p.000042: viewpoint but should not participate in the decision-making process.
p.000042: 4.9.15 The EC may utilize electronic methods such as video/conference calls for connecting with other subject
p.000042: experts/independent consultants during the meeting.
p.000042: 4.9.16 All members of the EC (including the Chairperson and the Member Secretary) present in the room have the
p.000042: right to vote/express their decision and should exercise this right.
p.000042: 4.9.17 The decision must be taken either by a broad consensus or majority vote (as per SOP) and should be
p.000042: recorded. Any negative opinion should be recorded with reasons.
p.000042: 4.9.18 The decisions may be as shown in Box 4.5.
p.000042:
p.000042: Box 4.5 Types of decisions by EC
p.000042: An EC can give one of the following decisions:
p.000042: • approved – with or without suggestions or comments;
p.000042: • revision with minor modifications/amendments – approval is given after
p.000042: examination by the Member Secretary or expedited review, as the case may be;
p.000042: • revision with major modifications for resubmission – this will be placed before
p.000042: the full committee for reconsideration for approval; or
p.000042: • not approved (or termination/revoking of permission if applicable) – clearly defined reasons must be
p.000042: given for not approving/terminating/revoking of permission.
p.000042:
p.000042: 4.9.19 Approval may be granted for the entire duration of the proposed research or can be subject to annual
p.000042: review depending on the type of study. The EC should review the annual report (counted from the day of approval or date
p.000042: of actual start of the study) for continuation as per SOP.
p.000042: 42 INDIAN COUNCIL OF
p.000043: MEDICAL RESEARCH
p.000043:
p.000043:
p.000043: Ethical Review Procedures
p.000043:
p.000043: 4.9.20 Depending on the risk involved, the progress of the proposal may be monitored annually or at
p.000043: shorter intervals (quarterly, half yearly) as per EC decision. Approval may be continued if progress is satisfactory.
p.000043: 4.9.21 An EC may decide to reverse its positive decision on a study if it receives information that may adversely
p.000043: affect the benefit-risk assessment.
p.000043: 4.9.22 The Member Secretary (assisted by the Secretariat) should record the discussions and prepare the minutes
p.000043: which should be circulated to all the members for comments before final approval by the
p.000043: Chairperson/Vice-Chairperson/designated member of the committee.
...
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
p.000062: 7. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is
p.000062: age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
...
Social / access to healthcare
Searching for indicator access to healthcare:
(return to top)
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
...
p.000102: 8.5 Role of the EC
p.000102: 8.5.1 ECs should ensure that the researcher has taken adequate measures for data security, confidentiality of
p.000102: information, disclosure permissions, and stated appropriate use of the accessed data.
p.000102: 8.5.2 EC members need to give appropriate importance to the social benefit, public good and public health impact
p.000102: these studies may be addressing. The ECs must take decisions regarding consent on a case- by-case basis.
p.000102: 8.5.3 EC membership should include experts in public health or the EC should get comments from, or invite experts
p.000102: for, the relevant meeting.
p.000102: 8.5.4 ECs should consider the following while assessing a public health research:
p.000102: • standards of care in public health;
p.000102:
p.000102: 102 INDIAN COUNCIL OF MEDICAL
p.000103: RESEARCH
p.000103:
p.000103:
p.000103: Public Health Research
p.000103:
p.000103: • ancillary care in public health;
p.000103: • stakeholder engagement – identifying and defining stakeholders’ roles especially
p.000103: in IR, health systems and policy research; and
p.000103: • responsibility of the researcher to scale-up, advocate, promote uptake, or sustain
p.000103: the public health intervention.
p.000103: 8.6 Protecting participants and communities
p.000103: 8.6.1 Special provisions should be provided in the design and execution of public health studies that are likely to
p.000103: have the potential to exploit research participants, especially socioeconomically deprived ones.
p.000103: 8.6.2 People who have limited access to healthcare may misunderstand the research as an opportunity to receive
p.000103: medical care and other benefits, besides financial incentives.
p.000103: 8.6.3 ECs have to consider these issues proactively and mindfully. Specific measures should also be established to
p.000103: protect the welfare of related community members who have not participated.
p.000103: 8.7 Stakeholders in public health research
p.000103: 8.7.1 It is important for ethical conduct of research to engage with all stakeholders, such as researchers, public
p.000103: health providers/professionals, sponsors, government agencies, participants, ECs, institutions, NGOs, and others
p.000103: who are involved in public health research in any manner.
p.000103: 8.7.2 The involved stakeholders must make every effort to provide post-research public health interventions,
p.000103: post-research use of the findings, or sustainability of the public health action.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000103: 103
p.000104:
p.000104: SECTION 9
p.000104:
p.000104: SOCIAL AND BEHAVIOURAL SCIENCES RESEARCH FOR HEALTH
p.000104: 9.0 The context of health research using methods from the social and behavioural sciences is often
p.000104: different from clinical, biomedical and public health research. Social and behavioural sciences include, but are
p.000104: not limited to, anthropology, sociology, psychology, philosophy, political science, economics, history,
...
Social / education
Searching for indicator education:
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p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
p.000012: General Ethical Issues
p.000012:
p.000012: representative, local institution or the government department from where the data was collected to help in
p.000012: dissemination of the results to the entire community.
p.000012: See sections 8 and 9 for further details.
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
p.000012: 2.11.1 Efforts should be made to communicate the findings of the research study to the
p.000012: individuals/communities wherever relevant.
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
...
p.000013: accountability, transparency, personal integrity, and knowledge of current best practices, and these should be
p.000013: reflected in the policies related to RCR.
p.000013: 3.1.1 The scientist as a responsible member of society
p.000013: Scientific research is vital to improving our understanding of various health related problems and their solutions.
p.000013: All research components depend on cooperation and shared expectations as part of inter-professional ethics.
p.000013: Unethical behaviour in scientific research can destroy the public’s trust in science and have a negative impact on the
p.000013: research team. Without trust between scientists and the public, or within research teams, meaningful research is
p.000013: compromised. Researchers should be aware that the resources of biomedical research are precious and to be used
p.000013: judiciously. Whereever possible they should also seek oppurtunities to plan translation of research findings into
p.000013: public health outcomes.
p.000013: 3.1.2 Contemporary ethical issues in biomedical and health research
p.000013: Emerging new areas of research give rise to new ethical issues. Among the contemporary
p.000013: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000013: 13
p.000014:
p.000014:
p.000014: Responsible Conduct of Research
p.000014:
p.000014: issues recently under debate are the use of underprivileged and vulnerable groups as participants, post-trial access of
p.000014: research benefits to participants and their communities, research on emerging technologies, etc. Continuing
p.000014: education is necessary to keep researchers apprised of contemporary issues.
p.000014: 3.1.3 Sensitivity to societal and cultural impact of biomedical and health research
p.000014: To understand the social and cultural impact of research, one must analyse how the health sector and general public
p.000014: engage with the results of biomedical and health research. It is essential that researchers bear this in mind
p.000014: while planning, conducting and evaluating research as it will improve public accountability and enhance public, private
p.000014: and political advocacy.
p.000014: 3.1.4 Mentoring
p.000014: Mentoring is one of the primary means for one generation of scientists to pass on their knowledge, values and
p.000014: principles to succeeding generations. Mentors, through their experience, can guide researchers in ways above and beyond
p.000014: what can be gathered from reading textbooks. The relationship between mentors and trainees should enable trainees to
p.000014: become responsible researchers. Mentors should ensure their trainees conduct research honestly, do not interfere
p.000014: with the work of other researchers and use resources judiciously. A mentor should be knowledgeable, teach and lead by
p.000014: example and understand that trainees differ in their abilities. She/he should devote sufficient time and be
p.000014: available to discuss, debate and guide trainees ably. A mentor should encourage decision making by the
p.000014: trainees and the trainee should take an active role in communicating her/his needs.
p.000014: 3.2 Policies
p.000014: 3.2.1 The protection of human participants
...
p.000033: MEDICAL RESEARCH
p.000033:
p.000033:
p.000033: Ethical Review Procedures
p.000033:
p.000033: 4.6.2 EC members should undergo initial and continuing training in human research protection, applicable EC
p.000033: SOPs and related regulatory requirements. All trainings should be documented.
p.000033: 4.6.3 Any change in the relevant guidelines or regulatory requirements should be brought to the attention of all EC
p.000033: members.
p.000033: 4.6.4 EC members should be aware of local, social and cultural norms and emerging ethical issues.
p.000033: 4.7 Roles and responsibilities of the EC
p.000033: 4.7.1 The basic responsibility of an EC is to ensure protection of the dignity, rights, safety and well-being of the
p.000033: research participants.
p.000033: 4.7.2 The EC must ensure ethical conduct of research by the investigator team.
p.000033: 4.7.3 The EC is responsible for declaration of conflicts of interest to the Chairperson, if any, at each meeting and
p.000033: ensuring these are recorded in the minutes.
p.000033: 4.7.4 The EC should perform its function through competent initial and continuing review of all scientific, ethical,
p.000033: medical and social aspects of research proposals received by it in an objective, timely and independent manner by
p.000033: attending meetings, participation in discussion and deliberations.
p.000033: 4.7.5 The EC must ensure that universal ethical values and international scientific standards are followed in terms
p.000033: of local community values and customs.
p.000033: 4.7.6 The EC should assist in the development and education of the research community in the given institute
p.000033: (including researchers, clinicians, students and others), responsive to local healthcare requirements.
p.000033: 4.7.7 Responsibilities of members should be clearly defined (details in Table 4.1). The SOPs should be given to EC
p.000033: members at the time of their appointment.
p.000033: 4.7.8 The Secretariat should support the Member Secretary and Alternate Member Secretary (if applicable) in all their
p.000033: functions and should be trained in documentation and filing procedures under confidentiality agreement.
p.000033: 4.7.9 The EC should ensure that privacy of the individual and confidentiality of data including the documents of EC
p.000033: meetings is protected.
p.000033: 4.7.10 The EC reviews progress reports, final reports and AE/SAE and gives needful suggestions regarding care of the
p.000033: participants and risk minimization procedures, if applicable.
p.000033: 4.7.11 The EC should recommend appropriate compensation for research related injury, wherever required.
p.000033: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000033: 33
p.000034:
p.000034:
p.000034: Ethical Review Procedures
p.000034: 4.7.12 The EC should carry out monitoring visits at study sites as and when needed.
p.000034: 4.7.13 The EC should participate in continuing education activities in research ethics and get updated on relevant
p.000034: guidelines and regulations.
p.000034: 4.7.14 The EC may see that conduct of same/similar research by different investigators from same institution
p.000034: is harmonized. ‘Me too’ research (replicative) should not to be encouraged and submission of same research to different
p.000034: funding agencies should not be accepted.
p.000034: 4.8 Submission and review procedures
p.000034: 4.8.1 Researchers should submit research proposals as soft or hard copies to the Secretariat for review in the
p.000034: prescribed format and required documents as per EC SOPs. The EC should prepare a checklist for the required documents
p.000034: as given in Box 4.4 (a) and 4.4 (b). This list is subject to modifications, depending on the type of research, EC SOPs
p.000034: and institutional policies.
p.000034: Box 4.4 (a) Details of documents to be submitted for EC review
p.000034:
p.000034: 1. Cover letter to the Member Secretary
p.000034: 2. Type of review requested
p.000034: 3. Application form for initial review
p.000034: 4. The correct version of the informed consent document (ICD) in English and the local language(s).
p.000034: Translation and back translation certificates (if applicable)
p.000034: 5. Case record form/questionnaire
p.000034: 6. Recruitment procedures: advertisement, notices (if applicable)
p.000034: 7. Patient instruction card, diary, etc. (if applicable)
p.000034: 8. Investigator’s brochure (as applicable for drug/biologicals/device trials)
p.000034: 9. Details of funding agency/sponsor and fund allocation (if applicable)
...
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
p.000058: 6.2.13 Whenever possible, ancillary care may be provided such as setting up of a facility, school for unattended
p.000058: children of the participants or a hospital, or counselling centre.
p.000058: 6.3 Obligations/duties of stakeholders
p.000058: All stakeholders have different responsibilities to protect vulnerable participants. See Table 6.1 for further details.
p.000058:
...
p.000103: medical care and other benefits, besides financial incentives.
p.000103: 8.6.3 ECs have to consider these issues proactively and mindfully. Specific measures should also be established to
p.000103: protect the welfare of related community members who have not participated.
p.000103: 8.7 Stakeholders in public health research
p.000103: 8.7.1 It is important for ethical conduct of research to engage with all stakeholders, such as researchers, public
p.000103: health providers/professionals, sponsors, government agencies, participants, ECs, institutions, NGOs, and others
p.000103: who are involved in public health research in any manner.
p.000103: 8.7.2 The involved stakeholders must make every effort to provide post-research public health interventions,
p.000103: post-research use of the findings, or sustainability of the public health action.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000103: 103
p.000104:
p.000104: SECTION 9
p.000104:
p.000104: SOCIAL AND BEHAVIOURAL SCIENCES RESEARCH FOR HEALTH
p.000104: 9.0 The context of health research using methods from the social and behavioural sciences is often
p.000104: different from clinical, biomedical and public health research. Social and behavioural sciences include, but are
p.000104: not limited to, anthropology, sociology, psychology, philosophy, political science, economics, history,
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
p.000104: evident due to multi-religious, caste, class, endogamic, gender and geo-ethnic variations which are important
...
p.000107: hurting or transgressing rights of the participants/community.
p.000107: • Harm to dignity is likely to occur when individuals are not treated as persons with their own values,
p.000107: preferences, and commitments, but rather as mere means not deserving of respect. This is also sometimes classified as
p.000107: another form of negligence. It may result in individuals feeling hurt, humiliated, excluded, dismissed or
p.000107: unfairly treated.
p.000107: • Psychological and emotional harm may result from participating in a study where memories of
p.000107: traumatic experiences such as disasters (natural or otherwise), violence, conflict, abuse, assault and other such
p.000107: conditions need to be revisited by the participants. This may also affect and compound the vulnerabilities of
p.000107: participants already experiencing post-traumatic stress disorder (PTSD).
p.000107: • Social harm is a non-medical adverse consequence of study participation, including difficulties in
p.000107: personal relationships and stigma or discrimination from family or community. Social harm can be related to
p.000107: personal relationships, travel, employment, education, health, housing, institutions (government/non- government) and
p.000107: others.
p.000107: • Informational risk is the potential for harm from disclosure of information about an identified research
p.000107: participant to others. For much of social and behavioural research, informational risk is one of the primary risks.
p.000107: 9.2.4 Risk mitigation
p.000107: Measures should be employed to minimize potential risks and their negative impact, such as short- and long-term adverse
p.000107: impacts on participants of studies on abortion, sexual abuse and other sensitive subjects. These measures should be
p.000107: incorporated into research methods, with special reference to hierarchies that exist in the social context where the
p.000107: research is undertaken.
p.000107: 9.2.5 Community engagement
p.000107: While devising methods and interpreting observations, researchers should engage potential participants and
p.000107: communities in a meaningful participatory process
p.000107:
p.000107: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000107: 107
p.000108:
p.000108: Social and Behavioural Sciences
p.000108: Research for Health
p.000108:
p.000108: that involves them in an early and sustained manner in the design, development, implementation and
p.000108: monitoring of research, and in the dissemination of its results.
p.000108: 9.2.6 Informed consent
p.000108: Human participants in a proposed research study must be informed about the nature of the research project, and
...
p.000119: reliability of the screening test, and what will be done with the collected samples.
p.000119: • Although screening may be permissible to allay anxiety, the response of different individuals might vary,
p.000119: which should be borne in mind by the health-care provider.
p.000119: • Confidentiality should be maintained in handling of results with emphasis on responsibility of individuals with
p.000119: an abnormal result to inform partners and family members. In case of refusal, the duty of confidentiality shall weigh
p.000119: higher than the duty for beneficence to family members unless sharing of information is vital to prevent serious harm
p.000119: to the beneficiary in the family. In such case, appropriate precautions may be taken to ensure that only the genetic
p.000119: information needed for diagnosis/treatment is shared.
p.000119: • Screening tests should be sensitive enough to identify a significant proportion of affected persons (the
p.000119: detection rate) with minimal misidentification of unaffected persons (the false positive rate). Screening tests do not
p.000119: aim to make a diagnosis, but rather rationalize the use of more accurate confirmatory tests.
p.000119: 10.13.4 Population screening: Genetic disorders can be population specific (for example,
p.000119: -thalassemia and sickle cell disease in some population groups in India).
p.000119: • Population screening should not be undertaken without prior education of the population to be
p.000119: screened and counselling should be integrated with the programme.
p.000119: • Screening tests should be robust with acceptable sensitivity and specificity.
p.000119: • Wherever applicable, community permission/group consent should be taken in
p.000119: addition to individual informed consent.
p.000119: • Researchers may conduct coded or reversible anonymized testing on general
p.000119: population in order to establish prevalence of genetic traits/diseases. See Table
p.000119: 11.1 for further details. Blood spots collected for screening newborns for treatable disorders could also be used for
p.000119: this purpose. In case information derived from stored specimens might be useful to an individual, the code may be
p.000119: broken with
p.000119:
p.000119: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000119: 119
p.000120:
p.000120: Human
p.000120: Genetics Testing and Research
p.000120:
p.000120: the approval of the EC.
p.000120: 10.13.5 Prenatal screening: Prenatal screening is aimed to screen mothers and foetuses that are at high risk of having
p.000120: functional or structural defects including chromosomal and single gene disorders. There are many screening tests
p.000120: which are recommended in routine practice.
p.000120: • Biochemical and ultrasound screening: Various combinations of serum screening and ultrasound screening tests
p.000120: are done either during first (dual marker) or second trimester (triple or quadruple screening) for aneuploidy
...
p.000121: RESEARCH
p.000121:
p.000121: Human
p.000121: Genetics Testing and Research
p.000121:
p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
p.000121: intervention for management.
p.000121: • The family should have a choice to decide if they would like to be part of newborn screening program with
p.000121: appropriate consent explaining the requirements and implications of the screening with provision to “optout”.
p.000121: • Community education and advocacy regarding NBS should precede the initiation
p.000121: of the programme.
p.000121: • Availability of facilities for confirmatory diagnosis and experts for management
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
p.000121: decision-making process, unless early intervention based on results of the test is likely to be of direct therapeutic
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
p.000121: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000121: 121
p.000122:
p.000122: Human
p.000122: Genetics Testing and Research
p.000122:
p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
...
p.000134: clauses for clarity about benefit sharing. See Box 11.5 for further details.
p.000134: Box 11.5 Considerations for benefit sharing
p.000134:
p.000134: 1. The document should describe whether donors, their families, or communities would receive any financial or
p.000134: non-financial benefits by having access to the products, tests, or discoveries resulting from the research.
p.000134: 2. The benefits accrued, if any, should be returned to the communities from where the donors were drawn in
p.000134: community-based studies.
p.000134: 3. To the maximum extent possible, benefits should be indirect or in kind.
p.000134:
p.000134: 11.4.6 Role of the EC
p.000134: ECs play a key role in oversight and use of the bio- and data repositories for research, scientific and public health
p.000134: programmes. Research proposals, which require biorepository services including material transfer and available data
p.000134: sets, should be reviewed by the EC, either an institutional one or that of the biorepository.
p.000134: 11.5 Biological material/data in forensic departments of laboratories
p.000134: Specimens collected for forensic purposes and related or unrelated data (DNA profiling) offer a good source for
p.000134: academic research after the initial purpose has been served. Data sharing with researchers across the globe is a common
p.000134: practice for refining techniques to develop biomarkers, which could identify missing persons in most difficult
p.000134: circumstances (for example, highly decomposed bodies, disaster situations). In academic institutions, there is a demand
p.000134: for organs and tissues for education, training and research purposes.
p.000134: 11.5.1 Informed consent: If there is no written consent by the deceased person permitting use of organs or tissues, the
p.000134: family can be approached for consent for use of left-over organs or tissues.
p.000134: 11.5.2 No consent would be required if sample or data is anonymized.
p.000134: 11.5.3 If the deceased has no claimant then forensic officials will be authorized to give permission for
p.000134: use of material/data from its sources and be responsible for use of unclaimed cadavers.
p.000134: 11.5.4 The quantity of tissue taken should ideally be minimal, particularly if it is seen externally on the body in
p.000134: order to preserve the dignity of the dead and be culturally acceptable by
p.000134:
p.000134: 134 INDIAN COUNCIL OF MEDICAL
p.000135: RESEARCH
p.000135:
p.000135: Biological Materials,
p.000135: Biobanking and Datasets
p.000135:
p.000135: the next of kin or closest relative or friend.
p.000135: 11.5.5 The information in the informed consent document should state what tissue/organ will be retained, who will be
p.000135: the custodian, duration of storage of sample, what type of research would be conducted and method for disposal of the
p.000135: remains.
...
p.000143: 2000.
p.000143: 3. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical
p.000143: Research; 2006.
p.000143: 4. Good clinical practice. New Delhi: Central Drugs Standard Control Organization; 2004. Available from:
p.000143: http://www.cdsco.nic.in/html/gcp1.html (accessed 31 Aug 2017).
p.000143: 5. Schedule Y of the Drugs and Cosmetics Act, 1940, amended on June 2005, India [statute on the
p.000143: Internet]. Available from: http://cdsco.nic.in/writereaddata/ Drugs&CosmeticAct.pdf (accessed 06 Aug 2017).
p.000143: 6. National guidelines for stem cell research. New Delhi: Indian Council of Medical Research and Department of
p.000143: Biotechnology; 2017.
p.000143: 7. The Nuremberg Code, 1947. In: Trials of war criminals before the Nuremberg Military Tribunals under Control
p.000143: Council Law No. 10. Washington DC: US Government Printing Office; 1949; 2:181-182.
p.000143: 8. Declaration of Helsinki: ethical principles for medical research involving human subjects.
p.000143: Fortaleza: World Medical Association. 2013; Available from: https://www.
p.000143: wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf (accessed 08 Sept 2017).
p.000143: 9. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The
p.000143: Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC:
p.000143: Department of Health, Education and Welfare; 1979.
p.000143: 10. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human
p.000143: Services; (1991); 2001, 2017.
p.000143: 11. Good clinical practice guidelines E6 (R1). The International Conference on Harmonization; 1996.
p.000143: Available from: https://www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
p.000143: (accessed 02 Sept 2017).
p.000143: 12. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Available from:
p.000143: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E6/E6_R2 Step_4.pdf (accessed 02 Sep
p.000143: 2017).
p.000143:
p.000143: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000143: 143
p.000144:
p.000144:
p.000144: List of references
p.000144:
p.000144: 13. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda: The National
p.000144: Bioethics Advisory Commission; August, 2001.
p.000144: 14. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2002.
p.000144: 15. International ethical guidelines for health-related research involving humans. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2016.
p.000144: 16. Nuffield Council on Bioethics; 2007.
p.000144: 17. Universal Declaration on Bioethics and Human Rights. Paris: Adopted by United Nations Educational, Scientific
...
p.000160: 14 Review of Final Reports
p.000160: 15 Review of Serious Adverse Events (SAE) Reports
p.000160: 16 Review of Study Completion Reports
p.000160: 17 Management of Premature Termination, Suspension, Discontinuation of the Study
p.000160: 18 Waiver of Written or Verbal/oral Informed Consent
p.000160: 19 Site Monitoring Visits
p.000160: 20 Dealing with Participants’ Requests and Complaints
p.000160: 21 Emergency Meetings
p.000160: 22 Communication Records
p.000160: 23 Maintenance of Active Study Files
p.000160: 24 Archive and Retrieval of Documents
p.000160: 25 Maintaining Confidentiality of EC’s Documents
p.000160: 26 Reviewing Proposals involving Vulnerable Populations
p.000160: 27 Review and Inspection of the EC
p.000160: 28 Audio Visual Recording of the Informed Consent Process
p.000160:
p.000160: 160 INDIAN COUNCIL OF MEDICAL
p.000161: RESEARCH
p.000161:
p.000161: ANNEX 2
p.000161:
p.000161: LIST OF MEMBERS OF COMMITTEES INVOLVED IN REVISION OF GUIDELINES (2015-2017)
p.000161:
p.000161: A. Members of Central Ethics Committee on Human Research
p.000161: P. N. Tandon (Chairperson), National Brain Research Centre, Manesar
p.000161: B. N. Dhawan (Late), Formerly at Central Drug Research Institute, Lucknow
p.000161: Sunil K. Pandya, Jaslok Hospital, Mumbai
p.000161: Madhav Menon, Bar Council of Kerala, M.K.Nambyar Academy for Continuing Legal Education, Kochi
p.000161: G. Padmanaban, Indian Institute of Science, Bengaluru
p.000161: Lt. Gen. D. Raghunath, Formerly at Sir Dorabji Tata Centre for Research in Tropical Diseases, Bengaluru
p.000161: K.N. Chaturvedi, Supreme Court, New Delhi
p.000161: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000161: C.A.K. Yesudian, Formerly at Tata Institute of Social Sciences, Mumbai
p.000161: Vinod K. Paul, All India Institute of Medical Sciences, New Delhi
p.000161: Mira Shiva, Initiative for Health & Equity in Society, New Delhi
p.000161: Vasantha Muthuswamy, Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR,
p.000161: New Delhi
p.000161: Amar Jesani, Indian Journal of Medical Ethics, Mumbai
p.000161: Amita Singh, Jawaharlal Nehru University, New Delhi
p.000161: N. Sarojini, SAMA- Resource Group for Women & Health, New Delhi
p.000161: Sanjiv Datta, Former Financial Advisor, Indian Council of Medical Research, New Delhi
p.000161: Vijay Kumar, Indian Council of Medical Research, New Delhi
p.000161: Roli Mathur, Indian Council of Medical Research, National Centre for Disease Informatics and Research, Bengaluru
p.000161:
p.000161:
p.000161:
p.000161:
p.000161: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000161: 161
p.000162:
p.000162:
p.000162:
p.000162: B. Chaipersons of Sub-Committees and Members of Advisory Group Vasantha Muthuswamy (Chairperson)
p.000162: Former Senior Deputy Director General & Head, Division of Basic Medical Sciences, ICMR, New Delhi and President,
p.000162: Forum for Ethics Review Committees in India (FERCI)
p.000162: S D Seth (Co-Chairperson)
...
p.000164: Sangeeta Desai, Tata Memorial Centre, Mumbai
p.000164: Sanjay Mehendale, Indian Council of Medical Research, New Delhi
p.000164: Sanjay Zodpe, Public Health Foundation of India, New Delhi
p.000164: Shakti Kumar Gupta, All India Institute of Medical Sciences, New Delhi
p.000164: Shuba Kumar, Samarth, Research for Change, Chennai
p.000164: Shubha Phadke, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
p.000164: Siddhartha Laskar, Tata Memorial Hospital, Mumbai
p.000164: Smita Deshpande, Dr. Ram Manohar Lohia Hospital, New Delhi
p.000164: Sudha Ramalingam, PSG Institute of Medical Sciences and Research, Coimbatore Sunita Bandewar, Independent Senior
p.000164: Research Professional and Consultant, Pune
p.000164: S.V. Joga Rao, Formerly at National Law School of India University, Bengaluru Thelma Narayan, Society for Community
p.000164: Health, Awareness, Research and Action, Bengaluru
p.000164: Vivek Shankar, Safdarjung Hospital, New Delhi
p.000164: Yashashri Shetty, Seth GS Medical College & King Edward Memorial Hospital, Mumbai
p.000164: D. List of Members National Consultation, ICMR, New Delhi Alka Sharma, Department of Biotechnology, New Delhi
p.000164: Amar Jesani, Indian Journal of Medical Ethics, Mumbai
p.000164: Amita Singh, Jawaharlal Nehru University, New Delhi
p.000164: Anant Bhan, International AIDS Vaccine Initiative, New Delhi
p.000164: Annam Visala, Central Drugs Standard Control Organisation, New Delhi
p.000164:
p.000164:
p.000164: 164 INDIAN COUNCIL OF MEDICAL
p.000165: RESEARCH
p.000165:
p.000165:
p.000165:
p.000165: Arun Bhatt, Indian Society for Clinical Research, Mumbai
p.000165: Bikash Medhi, Postgraduate Institute of Medical Education & Research, Chandigarh
p.000165: C.A.K. Yesudian, Formerly at Tata Institute of Social Sciences, Mumbai
p.000165: Lt. Gen. D. Raghunath, Formerly at Sir Dorabji Tata Centre for Research in Tropical Diseases, Bengaluru
p.000165: Ganapathy Murugan, Public Health Resource Society, New Delhi Gangandeep Kang, Translational Health Science and
p.000165: Technology Institute, Faridabad
p.000165: Geeta Jotwani, Indian Council of Medical Research, New Delhi
p.000165: G.N. Singh, Central Drugs Standard Control Organisation, New Delhi
p.000165: Henk Bekedam, WHO Country Office for India, New Delhi
p.000165: I.C. Verma, Sir Ganga Ram Hospital, New Delhi
p.000165: Indira Nath, Formerly at All India Institute of Medical Sciences, New Delhi
p.000165: Kalyani Thakur, National Centre for Disease Informatics and Research, Bengaluru
p.000165: K.N. Chaturvedi, Supreme Court, New Delhi
p.000165: Kusum Verma, Sir Ganga Ram Hospital, New Delhi
p.000165: Madhulika Kabra, All India Institute of Medical Sciences, New Delhi
p.000165: Madhur Gupta, WHO Country Office for India, New Delhi
p.000165: Mausumi Bharadwaj, National Institute of Cancer Prevention and Research, Noida
p.000165: Monika Pahuja, Indian Council of Medical Research, New Delhi
p.000165: Mukesh Kumar, Indo French Centre for the Promotion of Advanced Research, New Delhi
p.000165: Nalin Mehta, All India Institute of Medical Sciences, New Delhi
p.000165: Nandini K Kumar, Kasturba Medical College, Manipal
p.000165: Nandita Chopra, U.S. Department of Health and Human Services, Office South Asia, New Delhi
p.000165: Narinder K Mehra, All India Institute of Medical Sciences, New Delhi
p.000165: Neena Valecha, National Institute of Malaria Research, New Delhi
p.000165:
p.000165:
p.000165: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000165: 165
p.000166:
p.000166:
p.000166:
p.000166: Neerja Gupta, All India Institute of Medical Sciences, New Delhi
...
p.000168: Meenakshi Bhat, Centre for Human Genetics, Bengaluru
p.000168: Meesha Chaturvedi, National Centre for Disease Informatics and Research, Bengaluru
p.000168: M.K. Sudarshan, Rajiv Gandhi Institute of Public Health Rajiv Gandhi University
p.000168: of Health Sciences, Bengaluru
p.000168: Mudgal Kothekar, Biocon, Bengaluru
p.000168: Nandini K Kumar, Formerly at Indian Council of Medical Research, New Delhi
p.000168: Narendra K Arora, The INCLEN Trust International, New Delhi
p.000168: N. Medappa, Formerly at Indian Council of Medical Research, New Delhi Nirmala Murthy, Foundation for Research on Health
p.000168: Systems, Bengaluru Olinda Timms, St. John's Research Institute, Bengaluru
p.000168: P. Jambulingam, Vector Control Research Centre, Puducherry
p.000168:
p.000168:
p.000168: 168 INDIAN COUNCIL OF MEDICAL
p.000169: RESEARCH
p.000169:
p.000169:
p.000169:
p.000169: Pradeep Aravindan Menon, National Institute for Research in Tuberculosis, Chennai
p.000169: Prashant Mathur, National Centre for Disease Informatics and Research,
p.000169: Bengaluru
p.000169: Pratima Murthy, National Institute of Mental Health & Neurosciences, Bengaluru Praveen Vemula, inStem, National Centre
p.000169: for Biological Sciences, Bengaluru Priyanka Das, National Centre for Disease Informatics and Research, Bengaluru
p.000169: P. Satish Chandra, National Institute of Mental Health & Neurosciences,
p.000169: Bengaluru
p.000169: Raghu Padinjat, National Centre for Biological Sciences, Bengaluru
p.000169: Ragini Kulkarni, National Institute for Research in Reproductive Health, Mumbai Rajib Kishore Hazam, National Centre
p.000169: for Disease Informatics and Research, Bengaluru
p.000169: R.C. Mahajan, Postgraduate Institute of Medical Education & Research,
p.000169: Chandigarh
p.000169: Roli Mathur, National Centre for Disease Informatics and Research, Bengaluru
p.000169: R. Prabhu, National Institute of Epidemiology, Chennai
p.000169: R.R. Gangakhedkar, National AIDS Research Institute, Pune
p.000169: R.S. Ramaswamy, Central Council for Research in Siddha, Chennai
p.000169: Sanish Davis, Formerly at Covance India Pharmaceutical Services Pvt. Ltd, Mumbai
p.000169: Santanu K. Tripathi, Calcutta School of Tropical Medicine, Kolkata
p.000169: Sathish Kumar K., National Centre for Disease Informatics and Research, Bengaluru
p.000169: Sathya Prakash M., National Centre for Disease Informatics and Research,
p.000169: Bengaluru
p.000169: Siddhartha Laskar, Tata Memorial Hospital Parel, Mumbai
p.000169: Sudarshan K.L., National Centre for Disease Informatics and Research, Bengaluru
p.000169: Sukanya R., National Centre for Disease Informatics and Research, Bengaluru Sushant K. Ghosh, National Institute of
p.000169: Malaria Research, Field Unit Epidemic Disease Hospital, Bengaluru
p.000169:
p.000169:
p.000169: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000169: 169
p.000170:
p.000170:
p.000170:
p.000170: S.V. Joga Rao, National Law School of India University, Bengaluru
p.000170: Tarun Bhatnagar, National Institute of Epidemiology, Chennai
p.000170: Urmila Thatte, Seth GS Medical College & King Edward Memorial Hospital, Mumbai
p.000170: Vasantha Muthuswamy, Formerly at Indian Council of Medical Research, New
p.000170: Delhi
p.000170: Vijay Kumar, Indian Council of Medical Research, New Delhi
p.000170: Vijay Prakash Mathur, All India Institute of Medical Sciences, New Delhi
p.000170: Vinay Urs K.S., National Centre for Disease Informatics and Research, Bengaluru
p.000170: V. Raju Naik, National Centre for Disease Informatics and Research, Bengaluru
p.000170: F. Secretariat
...
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p.000020:
p.000020: confidential until the enquiry is complete.
p.000020: 3.6.4 Simultaneous submission of the same grant application to different funding agencies or submitting
p.000020: papers/overlapping publications to journals is not acceptable, as this could lead to unnecessary duplication in review
p.000020: process or in meta analysis. .
p.000020: 3.7 Registration with Clinical Trials Registry–India
p.000020: The Clinical Trials Registry–India, linked to WHO registry, was launched on 20 July 2007 by ICMR, as a free and online
p.000020: public record system for registration of clinical trials, PG thesis and other biomedical research being conducted in
p.000020: the country. Trial registration in the CTRI was made mandatory by CDSCO on 15 June 2009 for clinical trials that are
p.000020: registered under the Drugs and Cosmetics Act and its Rules. Registration with CTRI is voluntary for other
p.000020: biomedical and health research. In addition, editors of major biomedical journals of India declared that only
p.000020: trials on any of the public databases would be considered for publication in journals. According to 64th WMA
p.000020: General Assembly, held at Fortaleza, Brazil, in October 2013, the Declaration of Helsinki clearly states that “Every
p.000020: research study involving human subjects must be registered in a publicly accessible database before recruitment of the
p.000020: first subject.” Under the aegis of WHO, a joint statement on public disclosure of results from all international trials
p.000020: was signed by ICMR and others in May 2017.
p.000020: 3.7.1 All clinical research involving human participants including any intervention such as drugs, surgical
p.000020: procedures, devices, biomedical, educational or behavioural research, public health intervention studies, observational
p.000020: studies, implementation research and preclinical studies of experimental therapeutics and preventives or AYUSH studies
p.000020: may be registered prospectively with the CTRI.
p.000020: 20 INDIAN COUNCIL OF
p.000021: MEDICAL RESEARCH
p.000021:
p.000021:
p.000021: Responsible Conduct of Research
p.000021:
p.000021: 3.7.2 Trial registration involves providing information regarding the study, investigators, sites, sponsor, ethics
p.000021: committees, regulatory clearances, disease/condition, types of study, methodologies, outcomes, etc.
p.000021: 3.7.3 Registration of research in CTRI ensures that more complete, authenticated, readily available data on
p.000021: research is available publicly. This improves transparency, accountability and accessibility.
p.000021: 3.8 Collaborative research
p.000021: Researchers are increasingly collaborating with colleagues who have the expertise and/or for resources needed to carry
p.000021: out particular research. This could be inter-departmental/ inter-institutional or international and also multicentre
p.000021: involving public and/or private research centres and agencies. The main ethical issues surrounding
p.000021: collaborations pertain to sharing techniques, ownership of materials and data, IPRs, joint publications, managing
p.000021: research findings, managing COI and commercializing research outcomes. Researchers should familiarize themselves with
p.000021: all aspects including local, national and international requirements for research collaboration including necessary
p.000021: approvals, memorandums of understanding (MoUs) and material transfer agreements (MTA) and EC approval of collaborating
...
p.000087: 7.16.5 The trials must be registered in CTRI and there should be mechanism for appropriate methods for informed
p.000087: consent, conduct of trial and proper follow-up of patients.
p.000087: 7.16.6 For student conducting clinical trials as part of their academic thesis, the guide and the academic
p.000087: institution should take up the responsibilities of the sponsor.
p.000087: 7.17 Clinical trials on contraceptives
p.000087: Several methods of contraception are available including, barrier methods, hormonal methods, emergency contraception,
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
p.000088: child.
p.000088: 7.17.8 Children born due to failure of contraceptives under study should be followed-up for any abnormalities if
p.000088: the woman does not opt for medical termination of pregnancy (MTP).
p.000088: 7.17.9 A compensation policy must be established at the beginning of the trial to provide a cover for this
p.000088: contingency or issues related to trial.
p.000088: 7.18 Pregnancy and clinical trials
p.000088: Any clinical trial conducted in women of childbearing age raises ethical issues that need to be addressed. Similarly,
p.000088: studies conducted in women who are pregnant need to be evaluated with care and ethical issues addressed.
p.000088: 7.18.1 When clinical trials are conducted in women of childbearing age, they must be counselled to use
...
p.000143: 10. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human
p.000143: Services; (1991); 2001, 2017.
p.000143: 11. Good clinical practice guidelines E6 (R1). The International Conference on Harmonization; 1996.
p.000143: Available from: https://www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
p.000143: (accessed 02 Sept 2017).
p.000143: 12. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Available from:
p.000143: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E6/E6_R2 Step_4.pdf (accessed 02 Sep
p.000143: 2017).
p.000143:
p.000143: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000143: 143
p.000144:
p.000144:
p.000144: List of references
p.000144:
p.000144: 13. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda: The National
p.000144: Bioethics Advisory Commission; August, 2001.
p.000144: 14. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2002.
p.000144: 15. International ethical guidelines for health-related research involving humans. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2016.
p.000144: 16. Nuffield Council on Bioethics; 2007.
p.000144: 17. Universal Declaration on Bioethics and Human Rights. Paris: Adopted by United Nations Educational, Scientific
p.000144: and Cultural Organization’s General Conference; 2005.
p.000144: 18. Guidelines for laboratory animal facilities. Committee for the Purpose of Control and Supervision of
p.000144: Experiments on Animals; 2003.
p.000144: 19. Guidelines for international collaboration/research projects in health research [homepage on the
p.000144: Internet]. Indian Council of Medical Research. Available from: http://www.icmr.nic.in/guide.htm (accessed 31 Aug 2017).
p.000144: 20. Environmental Protection Act, 1986, India [statute of the Internet]. Available from:
p.000144: http://envfor.nic.in/legis/env/env1.html (accessed 31 Aug 2017).
p.000144: 21. The Biological Diversity Act, 2002, India [statute on the Internet]. Available from:
p.000144: http://www.bamu.ac.in/Portals/0/3_%20The%20biological%20Diversity%20 act%2C%202002.pdf (accessed 31 Aug 2017).
p.000144: 22. Foreign Contribution (Regulation) Act, 2010, India [statute on the Internet]. Available from:
p.000144: http://lawmin.nic.in/ld/regionallanguages/THE%20FOREIGN%20
p.000144: CONTRIBUTION%20(REGULATION)%20ACT,2010.%20(42%20OF%202010).pdf (accessed 13 Sept 2017).
p.000144: 23. Defining the role of authors and contributors [homepage on the Internet]. International Committee of Medical
p.000144: Journal Editors. Available from: http://www.icmje.org/
p.000144: recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors- and-contributors.html (accessed 02 Sept
p.000144: 2017).
p.000144: 24. National ethical guidelines for bio-medical research involving children, 2017.
...
p.000166: N. Sarojini, Sama- Resource Group for Women & Health, New Delhi
p.000166: N. Srikanth, Central Council for Research in Ayurvedic Sciences, New Delhi
p.000166: O.P. Agarwal, Indian Council of Medical Research, New Delhi
p.000166: P.N. Tandon, National Brain Research Centre, Manesar
p.000166: Pooja Sharma, Medanta-The Medicity, Gurgaon
p.000166: Poonam Salotra, National Institute of Pathology, New Delhi
p.000166: Prashant Mathur, National Centre for Disease Informatics and Research, Bengaluru
p.000166: Prabha Desikan, Bhopal Memorial Hospital & Research Centre, Bhopal Prasanna Kumar B Shirol, Organisation for Rare
p.000166: Diseases India, Bengaluru Priyanka Das, National Centre for Disease Informatics and Research, Bengaluru
p.000166: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000166: Rajib Kishore Hazam, National Centre for Disease Informatics and Research, Bengaluru
p.000166: Rajni Kaul, Indian Council of Medical Research, New Delhi
p.000166: Ravi Verma, International Center for Research on Women’s, New Delhi
p.000166: Ratna Puri, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi
p.000166: Ritu Dhillon, Indian Council of Medical Research, New Delhi
p.000166: Roli Mathur, National Centre for Disease Informatics and Research, Bengaluru Sanjay Mehendale, Indian Council of
p.000166: Medical Research, New Delhi Sanghmitra Pati, Regional Medical Research Centre, Bhubaneswar
p.000166:
p.000166:
p.000166:
p.000166: 166 INDIAN COUNCIL OF MEDICAL
p.000167: RESEARCH
p.000167:
p.000167:
p.000167:
p.000167: S.D. Seth, Formerly at All India Institute of Medical Sciences, New Delhi Sita Naik, Apollo Hospitals Educational &
p.000167: Research Foundation, New Delhi Soumya Swaminathan, Indian Council of Medical Research, New Delhi Suneeta Singh, Amaltas
p.000167: Consulting Pvt. Ltd, New Delhi.
p.000167: T.S. Rao, Department of Biotechnology (Retired), New Delhi
p.000167: Upendra Kaul, Formerly at Fortis Escort Heart Institute, New Delhi
p.000167: Urmila Thatte, Seth GS Medical College & King Edward Memorial Hospital, Mumbai
p.000167: V.G. Somani, Central Drugs Standard Control Organisation, New Delhi
p.000167: Vijay Kumar, Indian Council of Medical Research, New Delhi
p.000167: Vid Nukala, U.S. Department of Health and Human Services, New Delhi.
p.000167: V.M. Katoch, Formerly at Indian Council of Medical Research New Delhi
p.000167: Y.K. Gupta, All India Institute of Medical Sciences, New Delhi
p.000167:
p.000167: E. List of Members Regional Consultation, NCDIR, BENGALURU
p.000167: Alok Kumar Deb, National Institute of Cholera and Enteric Diseases, Kolkata
p.000167: Alok Srivastava, Christian Medical College, Vellore
p.000167: A. Nandkumar, National Centre for Disease Informatics and Research, Bengaluru
p.000167: Bishnu Ram Das, Jorhat Medical College, Jorhat
p.000167: B. Ravichandran, Regional Occupational Health Center(S), Bengaluru
p.000167: Debjit Chakraborty, National Centre for Disease Informatics and Research, Bengaluru
p.000167: Dorothy Lall, Institute of Public Health, Bengaluru
p.000167: F.S. Roselind, National Centre for Disease Informatics and Research, Bengaluru
p.000167: G.D. Ravindran, St. John’s Medical College, Bengaluru
p.000167: George Thomas, St. Isabel's Hospital, Chennai
p.000167: G.K. Rath, All India Institute of Medical Sciences, New Delhi
p.000167: H.L. Gundu Rao, Sri Ramana Free Clinic Trust, Bengaluru
p.000167:
p.000167:
p.000167:
p.000167: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000167: 167
p.000168:
p.000168:
p.000168:
...
Searching for indicator schooling:
(return to top)
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000111: 111
p.000112:
p.000112: SECTION 10
p.000112: HUMAN GENETICS TESTING AND RESEARCH
p.000112:
p.000112: 10.0 In no other area of biomedical and health research has there been a greater concern for ethical issues
p.000112: than in the field of human genetics. In recent years this concern has grown even further because of direct
p.000112: to consumer testing and the possibilities of embryo manipulations. While the recent DNA technology has provided one of
p.000112: the most powerful tools in the hands of mankind to unravel the mysteries of the human genome and its manipulation, it
p.000112: has also led to a great deal of concern about scientists’ ability to handle such information. There is also a very
p.000112: narrow gap between routine genetic testing and research raising several ethical, legal and social issues (ELSI), which
p.000112: warrant continuous and prompt monitoring and judicious response to the emerging ethical issues.
p.000112: 10.1 General issues
p.000112: 10.1.1 The harm/risks associated with genetic testing may be psychosocial rather than physical in the form of
p.000112: anxiety, depression or disrupted family relationships.
p.000112: 10.1.2 Potential benefits and risks should be discussed thoroughly with prospective participants.
p.000112: Appropriate communication skills are required for genetic counselling which is akin to therapy.
p.000112: 10.1.3 There is a likelihood of social stigmatization and discrimination in schooling, employment, health
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
p.000112: against potential dangers is necessary.
p.000112: 10.1.7 Emerging genetic/genomic technologies cause emergence of newer ethical concerns and issues. Therefore, there
p.000112: is a need for professionals to keep abreast of such advancements
p.000112:
p.000112: 112 INDIAN COUNCIL OF MEDICAL
p.000113: RESEARCH
p.000113:
p.000113: Human
p.000113: Genetics Testing and Research
p.000113:
p.000113: and understand their implications.
p.000113: 10.1.8 The EC reviewing genetic research should have necessary expertise to understand the ethical implications and
p.000113: provide safeguards for research participants.
p.000113: 10.1.9 There is a need to have a team of clinicians, geneticists, genetic counsellors and laboratory
p.000113: personnel to work together.
p.000113: 10.1.10 Genetic testing and research often require dealing with persons who are unable to protect their rights and
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
p.000086: 86 INDIAN COUNCIL OF
p.000087: MEDICAL RESEARCH
p.000087:
p.000087: Clinical Trials of Drugs and
p.000087: other Interventions
p.000087:
p.000087: auditing, DSMB, etc.
p.000087: 7.16.4 When academic clinical trials are planned for “off-label” use of a drug (when a drug that is marketed is
p.000087: being used for a new indication/new dose/formulation/route) for purely academic purposes and not for commercial use,
p.000087: then such clinical trials designed by researchers/academicians may not currently require regulatory approval. However,
p.000087: an EC has to approve such studies after due consideration of benefits and risks and all other ethical aspects and the
...
p.000111: for maintaining privacy and confidentiality are justified.
p.000111: • In collaborative research, it is desirable to establish a rapport with the community
p.000111: to be engaged in research through the gatekeepers or community advisory boards.
p.000111: • Sharing raw data and notes with repositories, researchers, peer community, institutions, and funders
p.000111: is increasingly becoming a requirement for transparency in research.
p.000111: • Sharing raw data including audio-visual material should protect confidentiality of the individual and
p.000111: research setting by sufficiently processing data to mask identifiers before sharing.
p.000111: • Researchers have a duty of disclosure to share research findings in aggregated form and relevant information
p.000111: in a user-friendly format with community leaders, gatekeepers and communities without disclosing individual identities.
p.000111: They must also share these findings and relevant information with the participants.
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000111: 111
p.000112:
p.000112: SECTION 10
p.000112: HUMAN GENETICS TESTING AND RESEARCH
p.000112:
p.000112: 10.0 In no other area of biomedical and health research has there been a greater concern for ethical issues
p.000112: than in the field of human genetics. In recent years this concern has grown even further because of direct
p.000112: to consumer testing and the possibilities of embryo manipulations. While the recent DNA technology has provided one of
p.000112: the most powerful tools in the hands of mankind to unravel the mysteries of the human genome and its manipulation, it
p.000112: has also led to a great deal of concern about scientists’ ability to handle such information. There is also a very
p.000112: narrow gap between routine genetic testing and research raising several ethical, legal and social issues (ELSI), which
p.000112: warrant continuous and prompt monitoring and judicious response to the emerging ethical issues.
p.000112: 10.1 General issues
p.000112: 10.1.1 The harm/risks associated with genetic testing may be psychosocial rather than physical in the form of
p.000112: anxiety, depression or disrupted family relationships.
p.000112: 10.1.2 Potential benefits and risks should be discussed thoroughly with prospective participants.
p.000112: Appropriate communication skills are required for genetic counselling which is akin to therapy.
p.000112: 10.1.3 There is a likelihood of social stigmatization and discrimination in schooling, employment, health
p.000112: and general insurance, which requires greater care in recruiting participants in research.
p.000112: 10.1.4 Maintaining confidentiality is very important in genetic testing as results have social implications.
p.000112: 10.1.5 There is often an overlap between genetic research and services for the physician as well as the patient and
p.000112: therefore, adequate safeguards against therapeutic misconception are needed.
p.000112: 10.1.6 Genetic manipulations may have known or unknown consequences for the future and therefore, greater caution
...
Social / employees
Searching for indicator employees:
(return to top)
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
...
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
...
Social / gender
Searching for indicator gender:
(return to top)
p.000011: MEDICAL RESEARCH
p.000011:
p.000011:
p.000011: General Ethical Issues
p.000011:
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
...
p.000027: • It should function according to SOPs that follow the national guidelines for
p.000027: functioning of ECs.
p.000027: • It should not accept research proposals from investigators affiliated to institutions
p.000027: that have their own ECs unless there is an MoU.
p.000027: • It will have rights and responsibilities related to the projects submitted to it.
p.000027: • It should have access to all research records, including the source documents and
p.000027: research participants.
p.000027: • It should undertake continuing review of the implemented project including site
p.000027: visits.
p.000027: • It should familiarize itself with local socio-cultural norms that may help to ensure
p.000027: protection of rights and well-being of research participants.
p.000027: 4.2.6 Institutions could have subcommittees such as the SAE subcommittee or expedited review committee. These should
p.000027: be part of the main committee and comprise Chairperson/ Member Secretary and one to two appropriate designated members
p.000027: of the main EC as defined in the SOPs. These subcommittees can report to the concerned main EC.
p.000027: 4.2.7 Institutions could have separate committee for SAE in which one or two members of EC could be included to
p.000027: facilitate continuity of EC activity and its report should be reviewed by main EC.
p.000027: 4.3 Composition of an EC
p.000027: 4.3.1 ECs should be multi-disciplinary and multi-sectoral.
p.000027: 4.3.2 There should be adequate representation of age and gender.
p.000027: 4.3.3 Preferably 50% of the members should be non-affiliated or from outside the institution.
p.000027: 4.3.4 The number of members in an EC should preferably be between seven and 15 and a minimum of five members should
p.000027: be present to meet the quorum requirements.
p.000027: 4.3.5 The EC should have a balance between medical and non-medical members/technical and non-technical members,
p.000027: depending upon the needs of the institution.
p.000027: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000027: 27
p.000028:
p.000028:
p.000028: Ethical Review Procedures
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: S.
p.000028: No.
p.000028:
p.000028: The composition, affiliations, qualifications, member specific roles and responsibilities are given in Table 4.1.
p.000028: Table 4.1 Composition, affiliations, qualifications, member specific roles and responsibilities of an EC
p.000028:
p.000028: Members of EC Definition/description
p.000028:
p.000028: 1. Chairperson/
p.000028: Vice Chairperson (optional) Non-affiliated
p.000028: Qualifications -
p.000028: A well-respected person from any background with prior experience of having served/ serving in an EC
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 2. Member Secretary/ Alternate Member Secretary (optional)
p.000028: Affiliated
p.000028:
p.000028: Qualifications -
p.000028: • Should be a staff member of
p.000028: the institution
p.000028: • Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills
p.000028: • Conduct EC meetings and be accountable for independent
p.000028: and efficient functioning of the committee
...
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
p.000104: evident due to multi-religious, caste, class, endogamic, gender and geo-ethnic variations which are important
p.000104: characteristics of society that need to be considered in socio-behavioural research proposals. In view of the above,
p.000104: ECs should be aware of the challenges that may be encountered in the process of conducting such studies.
p.000104: 9.1 Some key features
p.000104: 9.1.1. Conventional social science research on health underscores the importance of bringing contemporary contexts to
p.000104: biomedical and health research.
p.000104: 9.1.2. It has now emerged as a cross-cutting area of enquiry relevant to almost every type of
p.000104:
p.000104: 104 INDIAN COUNCIL OF MEDICAL
p.000105: RESEARCH
p.000105:
p.000105: Social and Behavioural Sciences
p.000105: Research for Health
p.000105:
p.000105: medical, biomedical, clinical and health research such as clinical trials, epidemiological research, programme
p.000105: evaluations, implementation research, genetics, research on disaster and conflict contexts.
p.000105: 9.1.3. The principles of social science research ethics, with rights and responsibilities of the different
p.000105: stakeholders including participants, researchers, reviewers, publishers, etc., are similar to those for biomedical and
p.000105: public health research.
p.000105: 9.1.4. There are, however, specific ethical issues involved in social and behavioural sciences studies as given in Box
p.000105: 9.1.
p.000105:
p.000105: Box 9.1 Ethical issues in social and behaviour sciences studies
p.000105:
p.000105: 1. Risks are non-measurable and dynamic in nature and therefore might be misconstrued as no/minimum risk research.
...
p.000108: individual consent unless a waiver has been granted.
p.000108: 2. Participant consent: Researchers must develop culturally appropriate ways to communicate information
p.000108: necessary for adherence to the standard required in the informed consent process.
p.000108: 3. Selective withholding of study information: ECs may permit selective withholding of
p.000108: information/hypothesis of the study in the consent form for achieving overall social and public good, without
p.000108: influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
p.000108: support and conditions for self-respect. Accordingly, concerns about social justice must be central to any
p.000108: adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the
p.000108: vulnerable status of prospective participants during review, for example, a woman asking her husband or family before
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
p.000108: practices. See section 5.7 for further details.
p.000108: 108 INDIAN COUNCIL OF MEDICAL
p.000109: RESEARCH
p.000109:
p.000109: Social and Behavioural Sciences
p.000109: Research for Health
p.000109:
p.000109: 9.2.7 Privacy and confidentiality
p.000109: Privacy and confidentiality of research participants should be considered while selecting sites for data collection,
...
p.000109: • have an adequate plan for debriefing the participants after completion of the
p.000109: study, if appropriate;
p.000109: • disseminate results of research to the participants, if applicable; and
p.000109: • be carefully reviewed by the EC.
p.000109: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000109: 109
p.000110:
p.000110: Social and Behavioural Sciences
p.000110: Research for Health
p.000110: Box 9.5 Types of deception
p.000110:
p.000110: 1. Active deception: Selective withholding of the information/hypothesis of the study in the consent form along with
p.000110: giving incorrect information for achieving public good without influencing the outcome of the study, for example,
p.000110: psychology, neuro- behavioural, behaviour intervention study.
p.000110: 2. Incomplete disclosure: If research involves incomplete disclosure but no deception.
p.000110: 3. Authorized deception: Unlike in active deception, participants are informed that they would be deceived prior to
p.000110: the research but the nature of the deception will not be disclosed or research will not be described accurately or some
p.000110: procedures will be deceptive. Such revelation provides the participants an opportunity to decide whether or not to
p.000110: participate on these terms.
p.000110:
p.000110: 9.2.10 Safety of participants
p.000110: Support systems, such as access to counselling centres, rehabilitation centres, police protection, etc., should be in
p.000110: place when research is on a sensitive issue, such as mental health, gender based violence and social exclusion and
p.000110: discrimination.
p.000110: 9.2.11 Safety of research teams in the field
p.000110: The safety of the research team is the responsibility of the institution, sponsors and local authorities, particularly
p.000110: in research on sensitive topics or in sensitive research settings since there would be a possibility of the researcher
p.000110: or research team being subjected to disturbing instances while conducting the research. Besides providing safety,
p.000110: including insurance coverage, and giving training to the researcher or research team to meet such challenges, setting
p.000110: up community advisory boards could be helpful to ease the situation.
p.000110: 9.2.12 Qualitative research
p.000110: The knowledge gathered through qualitative research is interpretative based on the observation and its
p.000110: analysis by the researcher or research team which is socially constructed at individual and socio-cultural levels.
p.000110: • Informed consent is very often dynamic in nature and negotiable. When written
p.000110: consent may not be possible, other means could be used and documented.
p.000110: • The EC may look at issues that pertain to the design involving researcher–
p.000110: participant relationships, informed consent process and conduct of the research.
p.000110: • Preliminary activity of observation for preparing notes, before actually initiating
...
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
p.000157: it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the
p.000157: intervention, whenever they occur, as well as any medical injury caused due to procedures.
p.000157: 53 Risk Probability of harm or discomfort to research participants.
p.000157: Acceptable risk differs depending on the conditions inherent in the conduct of research.
p.000157:
p.000157: 54 Serious adverse
p.000157: event (SAE)
p.000157: An adverse event is serious when the research outcome for
p.000157: the participant is death, life-threatening injury requiring hospitalization, prolongation of
p.000157: hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to
p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
p.000158: differences from the population at large. It may occur on the basis of physical appearance, race or sex.
p.000158: 61 Surrogate A substitute or deputy for another person in a specific role.
p.000158: 62 Theologian A person who is an expert in the study of religious faith(s), including the
p.000158: system of spirituality, practice and experience about the nature of the divine.
p.000158:
p.000158: 63 Test of
p.000158: understanding
p.000158: A simple oral or written test designed to identify if the participant
...
Social / parents
Searching for indicator parent:
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p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
...
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
p.000063: Box 6.5 Consent of parent/LAR
p.000063:
p.000063: 1. The EC should determine if consent of one or both parents would be required before a child could be enrolled.
p.000063: 2. Generally, consent from one parent/LAR may be considered sufficient for research involving no more than
p.000063: minimal risk and/or that offers direct benefit to the child. Consent from both parents may have to be obtained when the
p.000063: research involves more than minimal risk and/or offers no benefit to the child.
p.000063: 3. Only one parent’s consent is acceptable if the other parent is deceased, unknown, incompetent, not
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
...
p.000120: diagnosis should include the following:
p.000120: m risk of the fetus being affected;
p.000120: m natural course and prognosis of the specific disorder;
p.000120: m risks and limitations of the invasive procedures to be used;
p.000120: m time required before a report can be issued;
p.000120: m possible need for a repeat procedure in the event of a failed attempt; and
p.000120: m limitation of a test due to laboratory error.
p.000120: • Non-invasive prenatal screening/testing (NIPS/NIPT): Recent advances in genomic technologies have
p.000120: resulted in the shift of antenatal aneuploidy screening towards the development of NIPS methods by using cell-free
p.000120: foetal (CFF) DNA sequences isolated from a maternal blood sample. This test prevents the risk of an invasive
p.000120: procedure which would also be beneficial for high risk mothers. However, there are several limitations of
p.000120: these techniques which should be clearly explained.
p.000120: Utmost caution should be taken while reporting the foetal status after prenatal testing. HLA testing on embryos and
p.000120: foetuses should not be done.
p.000120: 10.13.6 Pre-implantation genetic screening and diagnosis (PGS and PGD)
p.000120: In this technique, in vitro screening is done on early embryos for a panel of common genetic disorders, such as
p.000120: aneuploides, and specific disorders with family history or proven carrier status in parent(s) to implant unaffected
p.000120: embryos. This obviates the need for invasive testing for associated risks and also termination of the affected foetus,
p.000120: which is traumatic for the family.
p.000120: • Advanced techniques like chromosomal micro array (CMA) are being used for
p.000120:
p.000120: 120 INDIAN COUNCIL OF MEDICAL
p.000121: RESEARCH
p.000121:
p.000121: Human
p.000121: Genetics Testing and Research
p.000121:
p.000121: PGS and NGS for screening which might theoretically raise ethical issues regarding eugenics and designer babies based
p.000121: on selection of embryos.
p.000121: • This also raises ethical concerns regarding selection of sex and therefore adequate
p.000121: safeguards should be in place to prevent misuse.
p.000121: 10.13.7 Newborn screening (NBS): Newborn screening is a robust measure for secondary prevention of genetic diseases
p.000121: through early diagnosis with timely intervention and should ideally be in a programme mode and providing not only
p.000121: diagnosis, but also management and treatment alongwith counseling.
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
...
p.000151: TM traditional medicines
p.000151: TOR terms of reference
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000151: 151
p.000152:
p.000152: GLOSSARY
p.000152: 1. Accountability The obligation of an individual or organization to account for its activities, accept
p.000152: responsibility for them and to disclose the results in a transparent manner.
p.000152: 2. Adverse event Any untoward medical occurrence in a patient or participant involved in a study
p.000152: which does not necessarily have a causal relationship with the intervention. The adverse event can therefore be
p.000152: any unfavourable or unintended sign or experience, whether or not related to the product under investigation.
p.000152:
p.000152: 3. Appellate
p.000152: authority
p.000152: It decides on the appeal filed against a decision of the lower authority. Its mandate is to ensure
p.000152: that due process of law is followed.
p.000152: 4. Assent To agree or approve after thoughtful consideration an idea or suggestion to
p.000152: participate in research by a young person below the age of 18 years who is old enough to understand the implications of
p.000152: any proposed research but not legally eligible to give consent. The assent has to be corroborated with informed consent
p.000152: of parent/ LAR.
p.000152: 5. Audit A systematic and independent examination of research activities and documents to
p.000152: determine whether the review and approval activities were conducted, data recorded and accurately reported as per
p.000152: applicable guidelines and regulatory requirements.
p.000152: 6. Autonomy The ability and capacity of a rational individual to make an independently
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
p.000152: 152 INDIAN COUNCIL OF MEDICAL
p.000153: RESEARCH
p.000153:
p.000153:
p.000153: Glossary
p.000153:
p.000153:
p.000153: 8. Biomedical and health research
p.000153: Research including studies on basic, applied and operational research designed primarily to increase the
p.000153: scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and
p.000153: evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical
p.000153: research.
p.000153: 9. Beneficence To try to do good or an action which weighs the risks against
...
Searching for indicator parents:
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p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
p.000061: 6.5.2 The EC should take into consideration the circumstances of the children to be enrolled in the study including
p.000061: their age, health status, and other factors and potential benefits to other children with the same disease or
p.000061: condition, or to society as a whole.
p.000061: 6.5.3 Consent of the parent/LAR is required when research involves children. See Box 6.5 for further details.
p.000061: 6.5.4 Assent
p.000061: In addition to consent from parents/LARs, verbal/oral or written assent, as approved by the EC, should be obtained from
p.000061: children of 7–18 years of age. As children grow, their mental faculties develop and they are able to understand and
p.000061: respond. Respecting the child’s reaction, the child is made a party to the consent process by the researcher, who
p.000061:
p.000061: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000061: 61
p.000062:
p.000062:
p.000062: Vulnerability
p.000062: Box 6.4 Conditions for research on children
p.000062:
p.000062: Children can be included in research if the situation, condition, disorder or disease fulfils one of the following
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
...
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
p.000063: Box 6.5 Consent of parent/LAR
p.000063:
p.000063: 1. The EC should determine if consent of one or both parents would be required before a child could be enrolled.
p.000063: 2. Generally, consent from one parent/LAR may be considered sufficient for research involving no more than
p.000063: minimal risk and/or that offers direct benefit to the child. Consent from both parents may have to be obtained when the
p.000063: research involves more than minimal risk and/or offers no benefit to the child.
p.000063: 3. Only one parent’s consent is acceptable if the other parent is deceased, unknown, incompetent, not
p.000063: reasonably available, or when only one parent has legal responsibility for the care and custody of the child,
p.000063: irrespective of the risk involved.
p.000063: 4. Whenever relevant, the protocol should include a parent/LAR information sheet that contains information about
p.000063: specific aspects relevant to the child such as effects on growth and development, psychological well-being and
p.000063: school attendance, in addition to all components described in the participant information sheet.
p.000063: 5. When the research involves sensitive issues related to neglect and abuse of a child, the EC may waive the
p.000063: requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests
p.000063: of the child.
p.000063: 6. Cognitively impaired children or children with developmental disorders form one of the most vulnerable
p.000063: populations. In fact, their parents are also vulnerable and there is a high likelihood of therapeutic misconception.
p.000063: The potential benefits and risks must be carefully explained to parents so as to make them understand the proposed
p.000063: research.
p.000063: 7. Research involving institutionalized children would require assent of the child, consent of parents/LAR,
p.000063: permission of the relevant institutional authorities (for example, for research in a school setting: the child,
p.000063: parents, teacher, principal or management may be involved).
p.000063:
p.000063: • Content of the assent form has to be in accordance with the developmental level and maturity of the children
p.000063: to be enrolled and explained while considering the differences in individual understanding. The language of the assent
p.000063: form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate
p.000063: to the age of the child. Points to be included in the assent form are as given below:
p.000063: m an explanation about the study and how it will help the child;
p.000063: m an explanation of what will be done in the study, including a description
p.000063:
p.000063: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000063: 63
p.000064:
p.000064:
p.000064: Vulnerability
p.000064:
p.000064: of any discomfort that the child is likely to feel;
p.000064: m the contact information of the person whom the child can approach if she/ he needs an explanation; and
p.000064: m a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so,
p.000064: the treatment at the centre will not be compromised.
p.000064: The above list is not exhaustive and may be dealt with on a case to case basis.
p.000064: • Waiver of assent: All the conditions that are applicable to waiver of informed consent in adults also apply
p.000064: for waiver of assent in children. See section 5.7 for further details. If the available intervention is anticipated to
p.000064: definitely benefit the child but would be available only if the child participates in the study, waiver of assent could
p.000064: be allowed. However, this situation should be accepted only in exceptional cases where all forms of assent/consent have
p.000064: failed. In such cases, approval of the EC should be obtained.
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
...
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
p.000115: • In case of population or community based studies, it may be noted that the genetic research may generate
p.000115: information applicable to the community/populations from which the participants were drawn, and therefore, group
p.000115: consent must be taken from the community head and/or the culturally appropriate authority.
p.000115: • Even if group consent is taken, it will not be a replacement for individual consent
p.000115: as individual consent is important. See section 5 for further details.
p.000115: • Researchers should be aware of potential stigmatization of the entire group and must explain ways to
p.000115: avoid the same during the conduct of research and publication of research results.
p.000115: 10.5 Culturally sensitive issues
p.000115: 10.5.1 Transmission of a genetic abnormality from parents, especially the mother to the foetus, could be
p.000115: a very sensitive cultural issue. Such possibility arises when during routine testing or prenatal diagnosis it is
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
p.000115: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000115: 115
p.000116:
p.000116: Human
p.000116: Genetics Testing and Research
p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
p.000116: information is revealed to the husband or other members of the family, it may cause marital discord despite the fact
p.000116: that the husband himself is a carrier of the autosomal recessive disorder. Appropriate counselling should be part of
p.000116: the testing process.
p.000116: 10.5.2 Consanguineous marriages are common in some communities. If there are inherited diseases detected in the
p.000116: family, it is the responsibility of the health professionals/ researchers to inform participants regarding the possible
p.000116: implications that may arise due to consanguinity. Appropriate pedigrees need to be prepared and stored, as these can
p.000116: reveal a lot regarding disease inheritance in affected families.
p.000116: 10.6 Storage of samples for future genetic research
...
p.000121: • Screening of newborns is recommended for treatable genetic diseases, the serious effects of which could be
p.000121: prevented by a suitable intervention, such as a special diet or drug. Examples of such conditions include
p.000121: hypothyroidism, phenylketonuria and many other inborn errors of metabolism.
p.000121: • Such screening should not be generally done when there are no existing therapeutic modalities available (such
p.000121: as special diets) or treatment may not be affordable (such as lysosomal storage disorders). There may also be no known
p.000121: intervention for management.
p.000121: • The family should have a choice to decide if they would like to be part of newborn screening program with
p.000121: appropriate consent explaining the requirements and implications of the screening with provision to “optout”.
p.000121: • Community education and advocacy regarding NBS should precede the initiation
p.000121: of the programme.
p.000121: • Availability of facilities for confirmatory diagnosis and experts for management
p.000121: of the disorders have to be in place before initiating the programme.
p.000121: • Use of advanced technologies like chromosomal micro array (CMA) and WES for
p.000121: NBS will generate many new dimensions for debate in this area.
p.000121: 10.13.8 Screening of children
p.000121: • Children should not be screened for carrier status or disease merely at the request
p.000121: of their parents.
p.000121: • Testing of children should be deferred until they are able to comprehend and are able to participate in the
p.000121: decision-making process, unless early intervention based on results of the test is likely to be of direct therapeutic
p.000121: benefit to them.
p.000121: • Screening for late onset diseases should not be done in children unless there is
p.000121: any suitable intervention available for treatment during the childhood stage.
p.000121:
p.000121: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000121: 121
p.000122:
p.000122: Human
p.000122: Genetics Testing and Research
p.000122:
p.000122: 10.13.9 Screening for carrier status
p.000122: • Single gene: If there is a family history of a single gene disorder (autosomal recessive, X
p.000122: linked), the individual should be tested after administering informed consent when she/he is able to comprehend the
p.000122: benefits and risks of screening. Stigmatization for carrier status is common and therefore, the information should be
p.000122: kept confidential.
p.000122: • Chromosomal: If there is a family history of balanced translocation in any individual, then
p.000122: immediate relatives may be at risk. The same principles as for carrier testing should be followed.
p.000122: 10.14 Gene therapy
...
p.000125: efficacy and safety of CRISPR technology.
p.000125: 10.15.4 Genome-wide association study (GWAS)
p.000125: Genetic epidemiology, also known as whole genome-wide association study, involves an examination of many common genetic
p.000125: variants in different individuals to see if any variant is associated with a trait. A GWAS typically focuses on
p.000125: associations between single-nucleotide polymorphisms (SNPs) and traits like major diseases, particularly multifactorial
p.000125: disorders.
p.000125: 10.15.5 As in other techniques there is a possibility of getting variations of known or unknown significance and
p.000125: participants should be aware of these facts.
p.000125: 10.16 Research on human embryos
p.000125: Embryonic state is the period between 15 days and 8 weeks post-conception of a pregnancy and in the
p.000125: absence of more precise information (such as menstrual cycle length), conception is presumed to have taken place 2
p.000125: weeks after the beginning of the woman’s last menstrual period. The distinction of the 15-day stage as the beginning of
p.000125: the embryonic stage is because of the formation of neural crest (future nervous system symbolizing moral being or
p.000125: personhood) by then. At 8 weeks, the rudiments of nearly all the main structures are developed giving a general
p.000125: appearance of a mammal-to-be with four limbs and a head. Research on human embryos raises a number of ethical issues.
p.000125: The concerns are more social, including questions about the rights of unborn babies and the roles of humans in making
p.000125: permanent genetic changes. If research is planned on embryos, consent of both parents should be taken.
p.000125: 10.16.1 The concerns are more social, including questions about the rights of unborn babies and the roles of humans
p.000125: in making permanent genetic changes.
p.000125: 10.16.2 If research is planned on embryos, consent of both parents should be taken.
p.000125:
p.000125:
p.000125:
p.000125: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000125: 125
p.000126:
p.000126: Human
p.000126: Genetics Testing and Research
p.000126:
p.000126: 10.17 Foetal autopsy
p.000126: 10.17.2 Foetal autopsy should be done after informed consent, preferably from both parents/ LARs.
p.000126: 10.17.3 Relevant samples may be stored for possible future use following the guidelines of biological materials,
p.000126: biobanking and datasets given in section 11.
p.000126: 10.17.4 Adequate genetic counselling should be done to explain the requirements and benefits of autopsy to the family.
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126: 126 INDIAN COUNCIL OF MEDICAL
p.000127: RESEARCH
p.000127:
p.000127: SECTION 11
p.000127:
p.000127:
p.000127: BIOLOGICAL MATERIALS, BIOBANKING AND DATASETS
p.000127:
p.000127: 11.0 Biological materials or biospecimens or samples include biological fluids, such as blood, dried blood spots,
p.000127: body fluids, urine, tissues, organs, cord blood, oocytes, sperm, semen or embryos. These may be stored or prospectively
p.000127: collected.
p.000127: A repository or biobank is an organized collection of resources that can be accessed to retrieve human biological
p.000127: material and data for research purposes. The bio resources would therefore be protocol-based prospective
p.000127: collection of biospecimens, left-over samples after clinical investigations or research proposals, biopsy materials,
p.000127: surgical or autopsy specimens/tissues, embryos or foetuses, cell lines, or waste materials like abandoned
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000030: 6. No decision is valid without fulfilment of the quorum.
p.000030:
p.000030: *Medical members are clinicians with appropriate medical qualifications. Technical members are persons with
p.000030: qualifications related to a particular branch in which the study is conducted, for example social sciences.
p.000030: 30 INDIAN COUNCIL OF
p.000031: MEDICAL RESEARCH
p.000031:
p.000031:
p.000031: Ethical Review Procedures
p.000031:
p.000031: 4.3.7 So as to maintain independence, the head of the institution should not be part of the EC but should act as an
p.000031: appellate authority to appoint the committee or to handle disputes.
p.000031: 4.3.8 The Chairperson and Member Secretary could have dual roles in the ethics committee. They could fulfil a role
p.000031: based on their qualifications (such as that of clinician, legal expert, basic scientist, social scientist, lay person
p.000031: etc.) in addition to taking on the role of Chairperson or Member Secretary.
p.000031: 4.3.9 The EC can also have a set of alternate members who can be invited as members with decision-making powers to
p.000031: meet the quorum requirements. These members have the same TORs as regular members and can attend meetings in
p.000031: the absence of regular members.
p.000031: 4.3.10 The EC can maintain a panel of subject experts who are consulted for their subject expertise, for
p.000031: instance, a paediatrician for research in children, a cardiologist for research on heart disorders, etc. They may be
p.000031: invited to attend the meeting to give an expert opinion on a specific proposal but will not have decision making
p.000031: power/voting rights.
p.000031: 4.3.11 The EC may invite subject experts as independent consultants or include a representative from a specific
p.000031: patient group as a member of the EC or special invitee, for opinion on a specific proposal, for example HIV, genetic
p.000031: disorders, or cancer, with appropriate decision making power.
p.000031: 4.3.12 As far as possible a separate scientific committee should priorly also review proposal before it is referred to
p.000031: EC. EC can raise scientific queries besides ethical ones as both good science and ethics are important to ensure
p.000031: quality of research and participant protection.
p.000031: 4.4 Terms of reference for EC members
p.000031: 4.4.1 The head of the institution should appoint all EC members, including the Chairperson.
p.000031: 4.4.2 The appointment letter issued to all members should specify the TORs. The letter issued by the head of the
p.000031: institution should include, at the minimum, the following:
p.000031: • Role and responsibility of the member in the committee
p.000031: • Duration of appointment
p.000031: • Conditions of appointment
p.000031: 4.4.3 Generally, the term of EC membership may be 2–3 years. The duration could be extended as specified in the SOPs.
p.000031: A defined percentage of EC members could be changed on a regular basis.
p.000031: 4.4.4 EC members may be given a reasonable honorarium for attendance at the meeting.
p.000031:
p.000031: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000031: 31
p.000032:
p.000032:
p.000032: Ethical Review Procedures
p.000032: 4.4.5 Members to be appointed on the EC should be willing to fulfil the EC requirements as given in Box 4.3.
p.000032: Box 4.3 Requirements for EC members
p.000032:
p.000032: Every EC member must:
...
p.000041: 4.9.5 The member who has declared COI should withdraw from the EC meeting (leave the room) while the research
p.000041: proposal is being discussed upon. This should be minuted and the quorum rechecked.
p.000041: 4.9.6 A list of absentee members as well as members leaving or entering in-between the meeting should be
p.000041: recorded.
p.000041: 4.9.7 Proposals should be taken up item-wise, as given in the agenda.
p.000041: 4.9.8 No of proposals reviewed in a meeting should justify that there is ample time devoted for review of each
p.000041: proposal. If there are more number of proposals for consideration per meeting either meetings may be more frequent or
p.000041: more EC’s to be constituted as per requirement of the institution.
p.000041: 4.9.9 Time allotted for the meeting should be reasonable to allow ample discussion on each agenda item.
p.000041: 4.9.10 The minutes of the previous meeting and list of protocols that were exempt from review or underwent
p.000041: expedited review should be ratified.
p.000041: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000041: 41
p.000042:
p.000042:
p.000042: Ethical Review Procedures
p.000042:
p.000042: 4.9.11 The researcher may be called in to present a proposal or provide clarifications on the study protocol that
p.000042: has been submitted for review but should not be present at the time of decision making.
p.000042: 4.9.12 The primary and secondary reviewers can brief the members about the study proposal and review carried out
p.000042: as per EC SOPs.
p.000042: 4.9.13 The comments of an independent consultant (if applicable) could be presented by the Member Secretary or
p.000042: subject experts could be invited to offer their views, but they should not participate in the decision-making process.
p.000042: However, her/his opinion must be recorded.
p.000042: 4.9.14 Representative(s) of the study group population can be invited during deliberations to offer their
p.000042: viewpoint but should not participate in the decision-making process.
p.000042: 4.9.15 The EC may utilize electronic methods such as video/conference calls for connecting with other subject
p.000042: experts/independent consultants during the meeting.
p.000042: 4.9.16 All members of the EC (including the Chairperson and the Member Secretary) present in the room have the
p.000042: right to vote/express their decision and should exercise this right.
p.000042: 4.9.17 The decision must be taken either by a broad consensus or majority vote (as per SOP) and should be
p.000042: recorded. Any negative opinion should be recorded with reasons.
p.000042: 4.9.18 The decisions may be as shown in Box 4.5.
p.000042:
p.000042: Box 4.5 Types of decisions by EC
p.000042: An EC can give one of the following decisions:
p.000042: • approved – with or without suggestions or comments;
p.000042: • revision with minor modifications/amendments – approval is given after
p.000042: examination by the Member Secretary or expedited review, as the case may be;
p.000042: • revision with major modifications for resubmission – this will be placed before
p.000042: the full committee for reconsideration for approval; or
p.000042: • not approved (or termination/revoking of permission if applicable) – clearly defined reasons must be
p.000042: given for not approving/terminating/revoking of permission.
p.000042:
p.000042: 4.9.19 Approval may be granted for the entire duration of the proposed research or can be subject to annual
p.000042: review depending on the type of study. The EC should review the annual report (counted from the day of approval or date
p.000042: of actual start of the study) for continuation as per SOP.
p.000042: 42 INDIAN COUNCIL OF
p.000043: MEDICAL RESEARCH
p.000043:
p.000043:
p.000043: Ethical Review Procedures
p.000043:
p.000043: 4.9.20 Depending on the risk involved, the progress of the proposal may be monitored annually or at
p.000043: shorter intervals (quarterly, half yearly) as per EC decision. Approval may be continued if progress is satisfactory.
p.000043: 4.9.21 An EC may decide to reverse its positive decision on a study if it receives information that may adversely
...
p.000106: on an adequate prior knowledge base, and are likely to generate valuable information.
p.000106: 2. In socially stratified groups and communities, researchers must spend time to become conversant with
p.000106: cultural norms and practices in order to develop strategies to build trust and negotiate power in ways that do not put
p.000106: research participants at risk.
p.000106: 3. In some types of research within communities, appropriate interpreters would be required. They need to be
p.000106: carefully selected, keeping in mind the hierarchies existing in the context. A local person from the same village in
p.000106: which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen
p.000106: from some other nearby village so that her/his vulnerability and perceived threat from other participants can be
p.000106: mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested
p.000106: communication plan.
p.000106: 4. The information about these norms/practices should be collected from reliable and multiple sources including
p.000106: multiple persons/groups, which should be mentioned in detail. This knowledge should be considered while
p.000106: deciding the group of participants and style of interview/investigation. However, the final decision about
p.000106: recruiting the participant should be based on the participant’s and her/his family’s opinion about
p.000106: norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or
p.000106: restrictive communities.
p.000106: 5. Field work challenges for research team – Research team members may sometimes be subjected to unforeseen
p.000106: situations which may involve trauma, humiliation and threats of violence. Training should be given to the
p.000106: research team to meet such challenges.
p.000106: 9.2.2 Ethical review
p.000106: There are some unique features of social and behavioural sciences research which need to be considered by the EC on a
p.000106: case-by-case basis. See Box 9.3 for further details.
p.000106: Box 9.3 Considerations by the EC for ethical review
p.000106: 1. Social and behavioural sciences research approaches are not always positivist and, therefore,
p.000106: articulation of a hypothesis may not be possible at the beginning of the research. Instruments/documents are developed
p.000106: during the course of the research; are reflective; and may keep changing as the research progresses. The EC must be
p.000106: kept informed about these changes and appropriate re-consent taken from participants.
p.000106: 2. The researcher must take prior permission from the EC with justifiable reasons for audio/
p.000106: video recording of participants’ interviews.
p.000106:
p.000106:
p.000106: 106 INDIAN COUNCIL OF MEDICAL
p.000107: RESEARCH
p.000107:
p.000107: Social and Behavioural Sciences
p.000107: Research for Health
p.000107:
p.000107: 9.2.3 Risk assessment
...
p.000144: www.prsindia.org/uploads/media/Mental%20Health/Mental%20Healthcare%20 Act,%202017.pdf (accessed 12 Sept 2017).
p.000144: 27. G.S.R. 313(E) dated 16th Mar 2016. New Delhi: Gazette of India. Available from: http://
p.000144: www.cdsco.nic.in/writereaddata/GSR%20313%20(E)%20dated%2016_03_2016.pdf (accessed 12 Sept 2017).
p.000144: 28. Clinical Trials Registry - India [homepage on the Internet]. Available from: http://
p.000144:
p.000144: 144 INDIAN COUNCIL OF MEDICAL
p.000145: RESEARCH
p.000145:
p.000145:
p.000145: List of references
p.000145:
p.000145: www.ctri.nic.in (accessed 12 Sept 2017).
p.000145: 29. GSR 918 (E) dated 30th Nov 2015. New Delhi : Gazette of India. Available from: http://
p.000145: www.cdsco.nic.in/writereaddata/GSR%20918-E-dated-30-11-2015.pdf (accessed 13th Sept 2017).
p.000145: 30. Guidelines for Good Clinical Laboratory Practices (GCLP).New Delhi. Indian Council of Medical Research.
p.000145: Available from: http://icmr.nic.in/guidelines/GCLP.pdf (accessed 18 May 2017).
p.000145: 31. Good Manufacturing Practices. New Delhi: Central Drugs Standard Control Organization. Available
p.000145: from:http://www.cdsco.nic.in/writereaddata/ schedulem(gmp)6.pdf (accessed 12 Sept 2017).
p.000145: 32. Good Clinical Practice Guidelines for clinical trials of ASU Medicine. New Delhi: Department of AYUSH,
p.000145: Ministry of Health and Family Welfare, Government of India; 2013. Available from:
p.000145: http://ayush.gov.in/acts-rules-and-notifications/good-clinical- practice-guidelines-clinical-trials-asu-medicine
p.000145: (accessed 31 Aug 2017).
p.000145: 33. Opinion on Synthetic Biology I [document on the Internet]. Scientific Committee on Health and
p.000145: Environmental Risks, Scientific Committee on Emerging and Newly Identified Health Risks, Scientific Committee on
p.000145: Consumer Safety. Available from: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_044. pdf
p.000145: (accessed 09 Sept 2017).
p.000145: 34. Atomic Energy Regulatory Board [homepage on the Internet]. Available from: http://
p.000145: www.aerb.gov.in/index.php/english/ (accessed 12 Sept 2017).
p.000145: 35. Biomedical Waste Management Rules [document on the Internet]. New Delhi: Ministry of Environment, Forest and
p.000145: Climate Change, Government of India. 2016. Available from: http://cpcbenvis.nic.in/pdf/bmw_rules_2016.pdf (accessed 31
p.000145: Aug 2017).
p.000145: 36. American Society for Testing and Materials [home page on the Internet]. Available from: https://www.astm.org/
p.000145: (accessed 31 Aug 2017).
p.000145: 37. The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, amended in
p.000145: 2003, India [statute on the Internet]. Available from: http:// pndt.gov.in/writereaddata/mainlinkfile/File22.pdf
p.000145: (accessed 31 Aug 2017).
p.000145: 38. Import/export policy for human biological samples for commercial purposes: amendment. Schedule–1
p.000145: (Import Policy) and Schedule–2 (Export Policy) of ITC (HS), 2012 (notification of 2016). Ministry of Commerce and
p.000145: Industry, Government of India. Available from: http://www.icmr.nic.in/IHD/DGFT%20notification%204-8-16.pdf (accessed 09
p.000145: Sept 2017).
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000145: 145
p.000146:
p.000146:
p.000146: SUGGESTED FURTHER READING
...
Searching for indicator philosophy:
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p.000029: safety and pharmacodynamics.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: • Scientific review of protocols including review of the intervention, benefit-risk analysis, research
p.000029: design, methodology, sample size, site of study and statistics
p.000029: • Ongoing review of the protocol (SAE, protocol deviation
p.000029: or violation, progress and completion report)
p.000029: • Review medical care, facility and appropriateness of the principal investigator, provision for
p.000029: medical car, management and compensation.
p.000029: • Thorough review of protocol, investigators brochure (if applicable) and all other protocol details and
p.000029: submitted documents.
p.000029: • Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial
p.000029: Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s
p.000029: undertaking, protocol specific other permissions, such as, stem cell committee for stem cell research, HMSC
p.000029: for international collaboration, compliance with guidelines etc.
p.000029: • Interpret and inform EC members about new regulations
p.000029: if any
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000029: (Contd.)
p.000029:
p.000029: 29
p.000030:
p.000030:
p.000030: Ethical Review Procedures
p.000030:
p.000030:
p.000030: 6. Social scientist/ philosopher/ ethicist/theologian
p.000030: Affiliated/ non-affiliated
p.000030:
p.000030: Qualifications -
p.000030: • Should be an individual with social/ behavioural science/ philosophy/ religious qualification and training and/or
p.000030: expertise and be sensitive to local cultural and moral values. Can be from an NGO involved in health-related activities
p.000030: 7. Lay person(s)
p.000030: Non-affiliated Qualifications -
p.000030: • Literate person from the public or
p.000030: community
p.000030: • Has not pursued a medical science/ health-
p.000030: related career in the last 5 years
p.000030: • May be a representative of the community
p.000030: from which the participants are to be drawn
p.000030: • Is aware of the local language, cultural and
p.000030: moral values of the community
p.000030: • Desirable: involved in social and
p.000030: community welfare activities
p.000030: • Ethical review of the proposal, ICD along
p.000030: with the translations.
p.000030: • Assess impact on community involvement, socio–cultural context, religious or philosophical context, if
p.000030: any
p.000030: • Serve as a patient/participant/ societal / community representative and bring in ethical and societal
p.000030: concerns.
p.000030:
p.000030:
p.000030:
p.000030: • Ethical review of the proposal, ICD along
p.000030: with translation(s).
p.000030: • Evaluate benefits and risks from the participant’s perspective and opine whether
p.000030: benefits justify the risks.
...
p.000103: 8.6.2 People who have limited access to healthcare may misunderstand the research as an opportunity to receive
p.000103: medical care and other benefits, besides financial incentives.
p.000103: 8.6.3 ECs have to consider these issues proactively and mindfully. Specific measures should also be established to
p.000103: protect the welfare of related community members who have not participated.
p.000103: 8.7 Stakeholders in public health research
p.000103: 8.7.1 It is important for ethical conduct of research to engage with all stakeholders, such as researchers, public
p.000103: health providers/professionals, sponsors, government agencies, participants, ECs, institutions, NGOs, and others
p.000103: who are involved in public health research in any manner.
p.000103: 8.7.2 The involved stakeholders must make every effort to provide post-research public health interventions,
p.000103: post-research use of the findings, or sustainability of the public health action.
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000103: 103
p.000104:
p.000104: SECTION 9
p.000104:
p.000104: SOCIAL AND BEHAVIOURAL SCIENCES RESEARCH FOR HEALTH
p.000104: 9.0 The context of health research using methods from the social and behavioural sciences is often
p.000104: different from clinical, biomedical and public health research. Social and behavioural sciences include, but are
p.000104: not limited to, anthropology, sociology, psychology, philosophy, political science, economics, history,
p.000104: communications and education. Many of these research initiatives are relevant in the mid to long term for
p.000104: knowledge production, science and society. Such research efforts will also have scholarship value besides
p.000104: relevance for policy and programme development, providing a deeper understanding of explanatory factors. Moreover,
p.000104: social science research informs policy-making activities about the various facets that can be considered to ensure that
p.000104: social equity and intersectionality of populations are accounted for. Sometimes such studies are done as a precursor to
p.000104: the execution of major IR and programme evaluation projects. Similarly, community behavioural studies or formative
p.000104: research on cultural and geographical contexts are conducted before introduction of new interventions and refinement of
p.000104: existing ones. Thus, depending upon the context, social science studies can also have immediate and immense relevance
p.000104: to development and refinement of programmes and policies. To be judicious and ethical in understanding and assessing
p.000104: human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge,
p.000104: attitudes, values and motives, have to first be understood as they influence a participant’s response to research.
p.000104: Ethical relativism applies to moral diversity among different cultures and societies. In the Indian context, this is
...
Social / sex worker
Searching for indicator sex workers:
(return to top)
p.000011: 5.7 Waiver of consent 53
p.000011: 5.8 Re-consent or fresh consent 54
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
...
p.000064: Box 6.6 Considerations for assent
p.000064:
p.000064: • There is no need to document assent for children below 7 years of age.
p.000064: • For children between 7 and 12 years, verbal/oral assent must be obtained in the presence
p.000064: of the parents/LAR and should be recorded.
p.000064: • For children between 12 and 18 years, written assent must be obtained. This assent form
p.000064: also has to be signed by the parents/LAR.
p.000064: • Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to
p.000064: provide consent, it is termed as assent and the consent of the parents/LAR should be obtained. If the latter will
p.000064: affect the validity of the study, waiver of consent from the relevant adult should be taken and recorded with the
p.000064: approval of the EC, for example, in behavioural studies in IV drug users where parental consent may not be possible.
p.000064: 6.6 Research involving sexual minorities and sex workers
p.000064: There are unique challenges associated with research on sexual minorities and sex workers such as
p.000064: privacy, confidentiality, possibility of stigma, discrimination and exploitation resulting in increased
p.000064: vulnerability.
p.000064: 6.6.1 Protection of their dignity and provision of quality healthcare under these circumstances should be well
p.000064: addressed in the research proposal, preferably in consultation with the community before the proposal is finalized.
p.000064:
p.000064: 64 INDIAN COUNCIL OF
p.000065: MEDICAL RESEARCH
p.000065:
p.000065:
p.000065: Vulnerability
p.000065:
p.000065: 6.6.2 It would be advisable to have a representative of the sexual minority group/ lesbian/ gay/bisexual and
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000038: 4.8.9 The EC may have a system of appointing primary and secondary reviewers. The Member Secretary should
p.000038: identify the primary and secondary reviewers for reviewing the scientific content and the ethical aspects in the
p.000038: proposal as well as the informed consent document, depending upon their individual expertise.
p.000038: 4.8.10 The Member Secretary may identify subject experts to review the proposal as per need. These experts may be
p.000038: invited to the EC meeting or join via video/tele conference but will not participate in final decision making.
p.000038: 4.8.11 The EC should meet regularly, adopt best practices, try to reduce turnaround time or have procedures in place
p.000038: for early decision making so that research is not delayed.
p.000038: 4.8.12 The designated (primary and secondary) reviewers and subject experts should conduct the initial review of the
p.000038: study protocol and study related documents as per the pre- defined study assessment form and for factors as described
p.000038: in Table 4.3.
p.000038:
p.000038: Table 4.3 Ethical issues related to reviewing a protocol
p.000038: 1 Social values • The basic requirement for health research to be ethically
p.000038: permissible is that it must have anticipated social value. The outcome of the research should be relevant to
p.000038: the health problems of society. All stakeholders, including sponsors, researchers and ECs must ensure that the
p.000038: planned research has social value.
p.000038:
p.000038: 2 Scientific design and conduct of the study
p.000038: • Valid scientific methods are essential to make the research ethically viable as poor science can expose
p.000038: research participants or communities to risks without any possibility of benefit.
p.000038: (Contd.)
p.000038:
p.000038:
p.000038: 38 INDIAN COUNCIL OF
p.000039: MEDICAL RESEARCH
p.000039:
p.000039:
p.000039: Ethical Review Procedures
p.000039:
p.000039: • Although ECs may obtain documentation from a prior scientific review, they should also determine that
p.000039: the research methods are scientifically sound, and should examine the ethical implications of the chosen
p.000039: research design or strategy.
p.000039: • The EC can raise scientific concerns (even if the study has prior
p.000039: approval of a scientific committee) if it may affect quality of research and or safety of research participants.
p.000039: 3 Benefit-risk assessment • The benefits accruing from the planned research either to the
p.000039: participants or to the community or society in general must justify the risks inherent in the research.
p.000039: • Risks may be physical, psychological, economic, social or legal
p.000039: and harm may occur either at an individual level or at the family, community or societal level. It is
p.000039: necessary to first look at the intervention under investigation and assess its potential harm and benefits and then
p.000039: consider the aggregate of harm and benefits of the study as a whole.
...
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
...
Searching for indicator poverty:
(return to top)
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
p.000056: 56 INDIAN COUNCIL OF
p.000057: MEDICAL RESEARCH
p.000057:
p.000057:
p.000057: Vulnerability
p.000057:
p.000057: Box 6.2 Vulnerable populations or groups
p.000057:
p.000057: Following are some examples of vulnerable populations or groups:
p.000057: • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the
p.000057: poverty line, ethnic minorities, sexual minorities – lesbian/ gay/bisexual and transgender (LGBT), etc.);
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
...
p.000093: • Principle of respect for autonomy, rights and dignity – In public health research, the principle of autonomy
p.000093: is relational, since the interests of an individual as part of
p.000093:
p.000093: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000093: 93
p.000094:
p.000094:
p.000094: Public Health Research
p.000094:
p.000094: a community are relational in nature. Therefore, sometimes individual autonomy may not be appropriate as a stand-alone
p.000094: for application at the community level. While respect for the rights and dignity of all participants need to be
p.000094: considered and ensured, the same should be observed about the community. This can be facilitated by engaging the
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
p.000013: RESPONSIBLE CONDUCT OF RESEARCH
p.000013:
p.000013: 3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a
p.000013: significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide
p.000013: by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members
p.000013: of a research team are expected to maintain high standards and to uphold the fundamental values of research. The
p.000013: responsible conduct of research (RCR) involves the following major components: values; policies; planning and
p.000013: conducting research; reviewing and reporting research; and responsible authorship and publication.
p.000013: Institutions conducting research must establish a research office within their institution to facilitate research,
p.000013: manage grants, and oversee all aspects of RCR. The research office must work closely with the EC and with all
p.000013: stakeholders, including undergraduate and postgraduate students. SOPs should be in place to address all the major
p.000013: components of RCR as outlined in the following sections.
p.000013: 3.1 Values of research
p.000013: RCR is guided by shared values including honesty, accuracy, efficiency, fairness, objectivity, reliability,
p.000013: accountability, transparency, personal integrity, and knowledge of current best practices, and these should be
p.000013: reflected in the policies related to RCR.
p.000013: 3.1.1 The scientist as a responsible member of society
p.000013: Scientific research is vital to improving our understanding of various health related problems and their solutions.
p.000013: All research components depend on cooperation and shared expectations as part of inter-professional ethics.
p.000013: Unethical behaviour in scientific research can destroy the public’s trust in science and have a negative impact on the
...
p.000018: 1. substantial contributions to the conception or design of the work, or the acquisition, analysis, or
p.000018: interpretation of data for the work;
p.000018: 2. drafting the work or revising it for important intellectual content;
p.000018: 3. final approval of the version to be published;
p.000018: 4. agreement to be accountable for all aspects of the work and ensuring that questions related to the accuracy or
p.000018: integrity of any part of the work are appropriately investigated and resolved.
p.000018:
p.000018: • Institutions and departments should have authorship policies. Editors of journals do not adjudicate on
p.000018: authorship disputes and would almost always refer these to the institution/researchers themselves to resolve.
p.000018: • Authorship should never be gifted and ‘ghost’ authors are not acceptable. The
p.000018: authorship of research should be considered at the time of its initiation.
p.000018: • The primary author should be the person who has done most of the research work
p.000018: related to the manuscript being submitted for publication. Research performed
p.000018:
p.000018: 18 INDIAN COUNCIL OF
p.000019: MEDICAL RESEARCH
p.000019:
p.000019:
p.000019: Responsible Conduct of Research
p.000019:
p.000019: as part of a mandatory requirement of a course/fellowship/training programme including student research should have the
p.000019: candidate as the primary author. All efforts must be made to provide the candidate with an opportunity to fulfil the
p.000019: second, third and fourth criteria of the ICMJE guidelines.
p.000019: 3.5.2 Peer review
p.000019: Scientific disclosure and progress has been dependent largely on peers evaluating research and judging the
p.000019: quality and utility of conducting and publishing research.
p.000019: • The present peer review system depends on fairness, honesty and transparency of all stakeholders – editors,
p.000019: reviewers and researchers. It can involve one or more reviewers and should be completed within a reasonable period of
p.000019: time.
p.000019: • Researchers must avoid mentioning friends, well-wishers and mentors as reviewers and must decline to
p.000019: review research of close associates, friends and students.
p.000019: • Funding agencies and journals must ask reviewers and researchers to inform
p.000019: them of COI, if any.
p.000019: • Reviewers must maintain the confidentiality of manuscripts sent to them for
p.000019: review.
p.000019: • If reviewers feel they are not competent to review papers, then they should inform editors
p.000019: immediately and should not pass on the manuscripts to friends and colleagues without seeking the consent of the
p.000019: editors.
p.000019: • Reviewers who are researchers must not misguide editors in an attempt to self
p.000019: evaluate their research (using another email ID and profile).
p.000019: 3.6 Research misconduct and policies for handling misconduct
p.000019: Research misconduct involves fabrication, falsification and plagiarism of data, which are serious issues both
p.000019: nationally and internationally. See Box 3.4 for further details.
p.000019: 3.6.1 Institutions should develop policies to address scientific/research misconduct.
p.000019: 3.6.2 Research misconduct, if suspected, needs to be investigated. An institution must investigate all
...
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
p.000058: 6.2.7 Vulnerable persons may require repeated education/information about the research, benefits, risks and
p.000058: alternatives, if any.
p.000058: 6.2.8 Research on sensitive issues such as mental health, sexual practices/preferences, HIV/ AIDS, substance abuse,
p.000058: etc. may present special risks to research participants.
p.000058: 6.2.9 Researchers should be cognisant of the possibility of conflicting interests between the prospective participant
p.000058: and LAR and should be more careful.
p.000058: 6.2.10 Participants may be prone to stigma or discrimination, specifically when the participant is enrolled as a normal
p.000058: control or is recruited from the general population in certain types of research.
p.000058: 6.2.11 Efforts should be made to set up support systems to deal with associated medical and social problems.
p.000058: 6.2.12 Protection of their privacy, confidentiality and rights is required at all times – during conduct of research
p.000058: and even after its completion.
...
p.000062: conditions:
p.000062: 1. It is exclusively seen in childhood.
p.000062: 2. Both adults as well as children are involved, but the issues involved are likely to be
p.000062: significantly different in both these populations.
p.000062: 3. Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity,
p.000062: severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
p.000062: efficacy.
p.000062: 4. Test interventions are likely to be at least as advantageous to the individual child participant as
p.000062: any available alternative intervention.
p.000062: 5. Risk of test interventions that is not intended to benefit the individual child participant is low as compared to
p.000062: the importance of the knowledge expected to be gained (minor increase over minimal risk).
p.000062: 6. Research is generally permitted in children if safety has been established in the adult population or if the
p.000062: information likely to be generated cannot be obtained by other means.
p.000062: 7. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is
p.000062: age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs
p.000062: much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given,
p.000062: is much higher in children as compared to adults. The absorption of drugs also varies with age. Pharmacokinetics and
p.000062: toxicity profile varies with growth and maturation from infancy to adulthood.
p.000062: 8. The adverse effects of many drugs may also be different in children as compared to adults. For
p.000062: instance, tetracyclines cause teeth discoloration in young children, aspirin use is associated with Reye’s syndrome in
p.000062: children.
p.000062: 9. Age appropriate delivery vehicles and formulations (e.g. syrups) are needed for accurate, safe, and palatable
p.000062: administration of medicines to infants and children.
p.000062: 10. The pathophysiology of many disorders is dependent on a child’s growth, development and adaptive plasticity.
p.000062: Examples include adaptive changes in the motor system following a perinatal stroke.
p.000062: explains the proposed research in a very simple manner, in a language that ensures, that the child understands the
p.000062: request to participate in the research. A child’s agreement to participate in research is called assent. If the child
p.000062: objects, this wish has to be respected. At the same time, mere failure to object should not be construed as assent.
p.000062: However, if the test intervention is likely to be lifesaving and is available only if the child participates
p.000062:
p.000062: 62 INDIAN COUNCIL OF
p.000063: MEDICAL RESEARCH
p.000063:
p.000063:
p.000063: Vulnerability
p.000063:
p.000063: in the study, the dissent by the child may be disregarded provided parental consent and prior approval from the EC is
p.000063: obtained. Requirements of assent are given in Box 6.6.
p.000063: Box 6.5 Consent of parent/LAR
p.000063:
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000011:
p.000011: 5.9 Procedures after the consent process 54
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
...
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
...
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000011: 5.10 Special situations 55
p.000011: 5.11 Consent for studies using deception 55
p.000011: Section 6 Vulnerability
p.000056: 56
p.000057: 6.1 Principles of research among vulnerable populations 56
p.000057: 6.2 Additional safeguards/protection mechanisms 57
p.000057: 6.3 Obligations/duties of stakeholders 58
p.000057: 6.4 Women in special situations 60
p.000057: 6.5 Children 61
p.000057: 6.6 Research involving sexual minorities and sex workers 64
p.000057: 6.7 Research among tribal population 65
p.000057: 6.8 Research involving individuals with mental illness
p.000057: or cognitively impaired/affected individuals 65
p.000057: 6.9 Individuals who have diminished autonomy due to
p.000057: dependency or being under a hierarchical system 67
p.000057: 6.10 Patients who are terminally ill 67
p.000057: 6.11 Other vulnerable groups 68
p.000057: Section 7 Clinical trials of drugs and other interventions 69
p.000057: 7.1 General guidelines 69
p.000057: 7.2 Clinical drug/vaccine development 71
p.000057: 7.3 Bioavailability/bioequivalence study 75
p.000057: 7.4 Ethical implications of study designs 76
p.000057: 7.5 Multicentric trials 77
p.000057: 7.6 Phytopharmaceutical drugs 78
p.000057: 7.7 Device trials 78
p.000057: 7.8 Biologicals and biosimilars 80
p.000057: 7.9 Clinical trials with stem cells 80
p.000057: 7.10 Surgical interventions 81
...
p.000002: that human beings who are participating in any biomedical and/ or health research or scientific experimentation are
p.000002: dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional
p.000002: fair treatment and transparency; and
p.000002: iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of
p.000002: the results thereof.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2 INDIAN COUNCIL OF
p.000003: MEDICAL RESEARCH
p.000003:
p.000003: SECTION 1
p.000003:
p.000003: STATEMENT OF GENERAL PRINCIPLES
p.000003: 1.0 Research on human participants pertains to a broad range of scientific enquiry aimed at developing
p.000003: generalizable knowledge that improves health, increases understanding of disease and is ethically justified by its
p.000003: social value. Every research has some inherent risks and probabilities of harm or inconvenience to
p.000003: participants/communities. Therefore, protection of participants should be built into the design of the study. Do no
p.000003: harm (non-maleficence) has been the underlying universal principle guiding health care in all systems of medicine
p.000003: around the world. While conducting biomedical and health research, the four basic ethical principles namely; respect
p.000003: for persons (autonomy), beneficence, non-maleficence and justice have been enunciated for protecting the dignity,
p.000003: rights, safety and well-being of research participants. These four basic principles have been expanded into 12 general
p.000003: principles described below, and are to be applied to all biomedical, social and behavioural science research for
p.000003: health involving human participants, their biological material and data.
p.000003: 1.1 General Principles
p.000003: 1.1.1 Principle of essentiality whereby after due consideration of all alternatives in the light of existing
p.000003: knowledge, the use of human participants is considered to be essential for the proposed research. This should be duly
p.000003: vetted by an ethics committee (EC) independent of the proposed research.
p.000003: 1.1.2 Principle of voluntariness whereby respect for the right of the participant to agree or not to agree to
p.000003: participate in research, or to withdraw from research at any time, is paramount. The informed consent process
p.000003: ensures that participants’ rights are safeguarded.
p.000003: 1.1.3 Principle of non-exploitation whereby research participants are equitably selected so that the benefits and
p.000003: burdens of the research are distributed fairly and without arbitrariness or discrimination. Sufficient safeguards to
p.000003: protect vulnerable groups should be ensured.
p.000003: 1.1.4 Principle of social responsibility whereby the research is planned and conducted so as to avoid creation or
p.000003: deepening of social and historic divisions or in any way disturb social harmony in community relationships.
...
p.000005: social requirements of the research proposal. The ECs are responsible for ensuring that the research is conducted in
p.000005: accordance with the aforementioned principles.
p.000005: 2.1 Benefit-risk assessment
p.000005: Benefits to the individual, community or society refer to any sort of favourable outcome of the research, whether
p.000005: direct or indirect. The social and scientific value of research should justify the risk, which is the probability of
p.000005: causing discomfort or harm anticipated as physical, psychological, social, economic or legal.
p.000005: 2.1.1 The researcher, sponsor and EC should attempt to maximize benefits and minimize risks to participants so that
p.000005: risks are balanced to lead to potential benefits at individual, societal and/or community levels.
p.000005: 2.1.2 The EC should assess the inherent benefits and risks, ensure a favourable balance of benefits and risks,
p.000005: evaluate plans for minimizing the risk and discomfort and decide on the merit of the research before approving it.
p.000005: 2.1.3 The EC should also assess any altered risks in the study at the time of continuing review.
p.000005: 2.1.4 The type of EC review based on risk involved in the research, is categorized as given in Table 2.1. Also see
p.000005: Table 4.2 for further details.
p.000005: 2.2 Informed consent process
p.000005: Informed consent protects the individual’s autonomy to freely choose whether or not to participate in the research. The
p.000005: process involves three components – providing relevant information to potential participants, ensuring the information
p.000005: is comprehended by them and assuring voluntariness of participation. Informed consent should explain medical
p.000005: terminology in simple terms and be in a language that the participant understands.
p.000005: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000005: 5
p.000006:
p.000006:
p.000006: General Ethical Issues
p.000006: Table 2.1 Categories of Risk
p.000006: Type of risk Definition/description
p.000006:
p.000006: Less than minimal risk
p.000006: Probability of harm or discomfort anticipated in the research is nil or not expected. For example, research on
p.000006: anonymous or non-identified data/samples, data available in the public domain, meta-analysis, etc.
p.000006: Minimal risk Probability of harm or discomfort anticipated in the research is not greater than that ordinarily
p.000006: encountered in routine daily life activities of an average healthy individual or general population or during the
p.000006: performance of routine tests where occurrence of serious harm or an adverse event (AE) is unlikely. Examples include
...
p.000048: certification/accreditation should be kept updated on a continuing basis.
p.000048: 4.15.4 Certification/accreditation are voluntary exercises and help in quality assurance and quality improvement to
p.000048: ensure that ECs follow best practices in protecting the dignity, rights, safety, and well-being of their participants.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 48 INDIAN COUNCIL OF
p.000049: MEDICAL RESEARCH
p.000049:
p.000049: SECTION 5
p.000049:
p.000049: INFORMED CONSENT PROCESS
p.000049:
p.000049: 5.0 The researcher must obtain voluntary written informed consent from the prospective participant for any
p.000049: biomedical and health research involving human participants. This requirement is based on the principle that competent
p.000049: individuals are entitled to choose freely whether or not to participate or continue to participate in the research.
p.000049: Informed consent is a continuous process involving three main components – providing relevant information to potential
p.000049: participants, ensuring competence of the individual, ensuring the information is easily comprehended by the
p.000049: participants and assuring voluntariness of participation. Informed voluntary consent protects the individual’s freedom
p.000049: of choice and respects the individual’s autonomy.
p.000049: 5.1 Requisites
p.000049: 5.1.1 The participant must have the capacity to understand the proposed research, be able to make an informed
p.000049: decision on whether or not to be enrolled and convey her/his decision to the researcher in order to give consent.
p.000049: 5.1.2 The consent should be given voluntarily and not be obtained under duress or coercion of any sort or by offering
p.000049: any undue inducements.
p.000049: 5.1.3 In the case of an individual who is not capable of giving voluntary informed consent, the consent of LAR must
p.000049: be obtained. See section 6 for further details.
p.000049: 5.1.4 It is mandatory for a researcher to administer consent before initiating any study related procedures involving
p.000049: the participant.
p.000049: 5.1.5 It is necessary to maintain privacy and confidentiality of participants at all stages.
p.000049: 5.2 Essential information for prospective research participants
p.000049: 5.2.1 Before requesting an individual’s consent to participate in research, the researcher must provide the
p.000049: individual with detailed information and discuss her/his queries about the research in the language she/he is able to
...
p.000055: requires to be withheld for validation until the completion of the research.
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
p.000056: • incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or
p.000056: permanently, for example people who are unconscious, differently abled;
p.000056: • able to give consent, but whose voluntariness or understanding is compromised due to
p.000056: their situational conditions; or
p.000056: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000056: refusal to participate which may lead them to give consent.
p.000056:
p.000056: The key principle to be followed when research is planned on vulnerable persons is that others will be responsible for
p.000056: protecting their interests because they cannot do so or are in a compromised position to protect their interests on
p.000056: their own. The populations or communities mentioned in Box 6.2 may be vulnerable at some or all times. Please note that
p.000056: this is not an exhaustive list.
p.000056: 6.1 Principles of research among vulnerable populations
p.000056: 6.1.1 Vulnerable populations have an equal right to be included in research so that benefits accruing from the
p.000056: research apply to them as well.
p.000056: 6.1.2 If any vulnerable group is to be solely recruited then the research should answer the health needs of the
p.000056: group.
p.000056: 6.1.3 Participants must be empowered, to the maximum extent possible, to enable them to
p.000056:
...
p.000057: • unduly influenced either by the expectation of benefits or fear of retaliation in case of
p.000057: refusal to participate which may lead them to give consent;
p.000057: • children (up to 18 years);
p.000057: • women in special situations (pregnant or lactating women, or those who have poor
p.000057: decision-making powers/poor access to healthcare);
p.000057: • tribals and marginalized communities;
p.000057: • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster
p.000057: situations;
p.000057: • afflicted with mental illness and cognitively impaired individuals, differently abled –
p.000057: mentally and physically disabled;
p.000057: • terminally ill or are in search of new interventions having exhausted all therapies;
p.000057: • suffering from stigmatizing or rare diseases; or
p.000057: • have diminished autonomy due to dependency or being under a hierarchical system (students, employees,
p.000057: subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and
p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
...
p.000059: populations.
p.000059:
p.000059:
p.000059: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000059: (Contd.)
p.000059: 59
p.000060:
p.000060:
p.000060: Vulnerability
p.000060:
p.000060: Sponsors • The sponsor, whether a government, an institution or a pharmaceutical company,
p.000060: should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their
p.000060: safety.
p.000060: • The sponsor must enable monitoring and ensure that procedures are in
p.000060: place for quality assurance (QA) and quality control (QC).
p.000060: • The sponsor should ensure protection of the participants and research
p.000060: team if the research is on sensitive topics.
p.000060:
p.000060: 6.4 Women in special situations
p.000060: Women have equal rights to participate in research and should not be deprived arbitrarily of the
p.000060: opportunity to benefit from research. Informed consent process for some women can be challenging because of cultural
p.000060: reasons. Hence, the women may consider consulting their husbands or family members, if necessary. Although autonomy of
p.000060: the woman is important, the researcher must follow the requirements of local cultural practices so as not to disturb
p.000060: the harmony in the household/family/community.
p.000060: 6.4.1 Participation of a woman in clinical trials or intervention studies that may expose her to risk is elaborated
p.000060: in Box 6.3. See section 7.18 for more details.
p.000060:
p.000060: Box 6.3 Risks for women participants in clinical trials/intervention studies
p.000060:
p.000060: 1. Researchers must provide the EC with proper justification for inclusion of pregnant and nursing women in
p.000060: clinical trials designed to address the health needs of such women or their foetuses or nursing infants.
p.000060: Some examples of justifiable inclusion are trials designed to test the safety and efficacy of a drug for reducing
p.000060: perinatal transmission of HIV infection from mother to child, trial of a device for detecting foetal abnormalities or
p.000060: trials of therapies for conditions associated with or aggravated by pregnancy, such as nausea, vomiting, hypertension
p.000060: or diabetes.
...
p.000061: limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic
p.000061: Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
p.000061: foetus.
p.000061: 6.4.3 Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence,
p.000061: genetic disorders, rape, etc., confidentiality should be strictly maintained and privacy protected. In risk
p.000061: mitigation strategies, appropriate support systems such as counselling centres, police protection, etc.
p.000061: should be established. At no time should information acquired from a woman participant be unnecessary,
p.000061: hurtful or appear voyeuristic. The EC should be especially vigilant regarding these sensitive issues.
p.000061: 6.5 Children
p.000061: Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are
p.000061: considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully
p.000061: understand the minute details of the study and make decisions. At older ages, although they may attain the
p.000061: cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision
p.000061: regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests
p.000061: of their child/ward. More details are available in ICMR “National Ethical Guidelines for Bio-Medical Research involving
p.000061: Children, 2017”.24
p.000061: Research on children can be carried out in a situation, condition, disorder or diseases as described in Box 6.4.
p.000061: 6.5.1 The EC should do the benefit–risk assessment to determine whether there is a need to put into place additional
p.000061: safeguards/protections for the conduct of research in children. For example, research should be conducted in
p.000061: child-friendly settings, in the presence of parent(s) and where child participants can obtain adequate medical and
p.000061: psychological support.
...
p.000066: • It should be disclosed to the participant that her/his confidentiality may be breached for
p.000066: reporting to family members, police, or other authorities or they may have to be admitted in the hospital upon
p.000066: expression of such thoughts of harm to self or others.
p.000066: • While some interventions, like hospitalization and treatment for suicidality/ homicidal ideas, may
p.000066: be primarily for the participants’ own benefit, they themselves may not perceive these as such and may want to
p.000066: refuse to participate
p.000066:
p.000066: 66 INDIAN COUNCIL OF
p.000067: MEDICAL RESEARCH
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
p.000067: 6.10.3 Benefit-risk assessment should be performed considering perception of benefits and risks by the potential
p.000067: participant.
p.000067:
p.000067: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000067: 67
p.000068:
p.000068:
p.000068: Vulnerability
p.000068:
p.000068: 6.10.4 The EC should carefully review post-trial access to the medication, especially if it is beneficial to the
p.000068: participant.
p.000068: 6.11 Other vulnerable groups
p.000068: Other vulnerable groups include the economically and socially disadvantaged, homeless, refugees, migrants, persons
p.000068: or populations in conflict zones, riot areas or disaster situations. Additional precautions should be taken to
p.000068: avoid exploitation/retaliation/ reward/credits and other inducements when such individuals are to be recruited as
p.000068: research participants.
p.000068: 6.11.1 Autonomy of such individuals is already compromised and researchers have to justify their inclusion.
p.000068: 6.11.2 ECs have to satisfy themselves with the justification provided to include these participants and record the same
p.000068: in the proceedings of the EC meeting.
p.000068: 6.11.3 Additional safety measures suggested earlier in the guidelines should be strictly followed by the ECs.
p.000068: 6.11.4 The informed consent process should be well documented. There should not be any undue coercion or incentive for
p.000068: participation. A person’s refusal to participate should be respected and there should be no penalization.
p.000068: 6.11.5 The EC should also carefully determine the benefits and risks of the study and examine risk minimization
p.000068: strategies.
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: 68 INDIAN COUNCIL OF
p.000069: MEDICAL RESEARCH
p.000069:
p.000069: SECTION 7
p.000069:
p.000069: CLINICAL TRIALS OF DRUGS AND OTHER INTERVENTIONS
p.000069:
p.000069: 7.0 A clinical trial is any research/study that prospectively assigns human participants or groups of humans
p.000069: to one or more health-related intervention(s) to evaluate the effects on health outcomes. The intervention
p.000069: could be drugs, vaccines, biosimilars, biologics, phytopharmaceuticals, radiopharmaceuticals, diagnostic agents,
p.000069: public health interventions, socio-behavioural interventions, technologies, devices, surgical techniques or
...
p.000093: interventions should therefore be conducted through a process of ethical reflection, together with establishment of
p.000093: appropriate protections, oversight procedures and governance mechanisms.
p.000093: Defining boundaries between public health practice and research remains a challenge in public health ethics as the
p.000093: purpose or intent of the investigation may overlap. Public health practice involves data collection through
p.000093: surveillance, vital statistics, disease reporting and registries; investigation of outbreaks including contact
p.000093: tracing, use of preventive interventions and health promotion; monitoring and programme evaluation; and enforcing of
p.000093: mandatory requirements, such as screening, treatment, immunization, notifying diseases and, sometimes, quarantine
p.000093: depending upon the situation. By using epidemiological designs, sampling techniques and analysis, some of these
p.000093: activities could create generalizable knowledge, which is the primary intent of research. Considering these
p.000093: difficulties in clear delineation of boundaries between practice and research, both requiring ethical oversight and
p.000093: governance of public health information, an EC may have to differentiate this to determine its role with more clarity.
p.000093: This section however, highlights the specific ethical issues pertaining to research on public health. The EC will
p.000093: determine if a particular protocol pertains to public health practice or research.
p.000093: 8.1 Principles of public health research ethics
p.000093: • Principle of respect for autonomy, rights and dignity – In public health research, the principle of autonomy
p.000093: is relational, since the interests of an individual as part of
p.000093:
p.000093: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000093: 93
p.000094:
p.000094:
p.000094: Public Health Research
p.000094:
p.000094: a community are relational in nature. Therefore, sometimes individual autonomy may not be appropriate as a stand-alone
p.000094: for application at the community level. While respect for the rights and dignity of all participants need to be
p.000094: considered and ensured, the same should be observed about the community. This can be facilitated by engaging the
p.000094: community in discussion. The conventional method of informed consent from an individual may be replaced with
p.000094: alternative methods after approval by the EC on a case-by-case basis. See section 8.4.2 for further details.
p.000094: • Principle of beneficence – Public health research aims at achieving public good through societal benefit
p.000094: to the maximum possible level as against individual benefit.
p.000094: • Principle of non-maleficence – Maximum efforts should be made to minimize harm done to individuals and
p.000094: others, such as the community, especially while collecting data and its subsequent disclosure. Harm could be in the
p.000094: form of stigma, poverty, and discrimination that affect persons living with diseases like HIV, STD, TB, mental
p.000094: illnesses, etc. Safeguards to maintain confidentiality should be established as there could also be indirect harm to
p.000094: the individual/community/ relationships and loss of benefit.
p.000094: The following principles may overlap with public health service and research.
p.000094: (i) Harm principle – If liberty of an individual or group is rightfully restricted against the person’s will to
p.000094: prevent harm to others, the decision to do so should be backed by strong ethical justification, for example in disease
p.000094: outbreaks.
p.000094: (ii) Principle of least infringement – As far as possible the least restrictive means should be adopted when
p.000094: liberty is curtailed.
p.000094: (iii) Principle of proportionality – This principle requires public health authorities to minimize risks
p.000094: and promote well-being of the public. Breach of autonomy and privacy of individuals should be balanced against
p.000094: probable public benefits and the necessity of such an intervention. It should justify burdens suffered by
p.000094: participants/communities.
p.000094: • Principle of social justice – The benefits and burden of public health research, should be equitably
p.000094: distributed across all study groups. When vulnerable or disadvantaged populations are involved, research that
p.000094: retains or enhances existing inequities should be avoided. Implied as a positive obligation to improve health
p.000094:
p.000094: 94 INDIAN COUNCIL OF
p.000095: MEDICAL RESEARCH
p.000095:
p.000095:
p.000095: Public Health Research
p.000095:
p.000095: of the least advantaged, this principle supports research into the upstream factors among the social determinants of
p.000095: health that influence health equity.
p.000095: • Principle of reciprocity – This principle requires that individuals or communities, who have borne a
p.000095: disproportionate share of burden or risks for the benefit of others be given some form of benefit. The benefit should
p.000095: be context specific such as protection from further exposure, access to food, healthcare, clothing and
p.000095: shelter, communication or compensation for lost income.
p.000095: • Principle of solidarity – Public health research should respect the intra- and inter- dependence among
...
p.000108: advocates. Consent procedures must respect local cultural customs, however, community traditions do not substitute for
p.000108: individual consent unless a waiver has been granted.
p.000108: 2. Participant consent: Researchers must develop culturally appropriate ways to communicate information
p.000108: necessary for adherence to the standard required in the informed consent process.
p.000108: 3. Selective withholding of study information: ECs may permit selective withholding of
p.000108: information/hypothesis of the study in the consent form for achieving overall social and public good, without
p.000108: influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
p.000108: support and conditions for self-respect. Accordingly, concerns about social justice must be central to any
p.000108: adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the
p.000108: vulnerable status of prospective participants during review, for example, a woman asking her husband or family before
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
p.000108: practices. See section 5.7 for further details.
p.000108: 108 INDIAN COUNCIL OF MEDICAL
p.000109: RESEARCH
p.000109:
p.000109: Social and Behavioural Sciences
p.000109: Research for Health
p.000109:
p.000109: 9.2.7 Privacy and confidentiality
p.000109: Privacy and confidentiality of research participants should be considered while selecting sites for data collection,
p.000109: choosing sensitive research areas, specific contexts and settings. In some circumstances participants become more
p.000109: vulnerable in research because of heightened psychological, social, physical or legal risks. Breach of
...
p.000116: if they wish to know the results and must be specified in the ICD. For this, participants’ contact details should be
p.000116: available.
p.000116: 10.7.2 The researcher should work with the local EC to decide on the validity of the research finding and the
p.000116: severity of the potential disease in order to return the results which should be avoided if the logical outcome of the
p.000116: research is expected to be inconclusive and the participants were informed of this in the ICD.
p.000116: 10.7.3 Results cannot be returned for the advantage of participants when the research is done using irreversibly
p.000116: anonymized samples or data, as identifying the individuals is not possible.
p.000116: 10.8 Publication aspects
p.000116:
p.000116:
p.000116: 116 INDIAN COUNCIL OF MEDICAL
p.000117: RESEARCH
p.000117:
p.000117: Human
p.000117: Genetics Testing and Research
p.000117:
p.000117: 10.8.1 Publication of pictures, pedigrees or other identifying information about individuals, families or secondary
p.000117: participant(s) should be done with fresh or re-consent.
p.000117: 10.8.2 Features on the face should be masked to prevent identification. If these features have to be revealed for
p.000117: scientific reasons, this fact should be stated clearly in the informed consent form and fresh consent must be obtained,
p.000117: if not taken earlier.
p.000117: 10.9 Commercialization and COI
p.000117: 10.9.1 Direct to consumer testing (DTC) in laboratories offering a battery of genetic tests is rapidly growing.
p.000117: While this ensures a patient’s autonomy to undergo testing, it is important that the sensitivity and specificity of
p.000117: these investigations and the ability of the laboratory personnel to interpret the result in consultation with treating
p.000117: physician/ clinical geneticist is ensured before arriving at a diagnosis.
p.000117: 10.9.2 When research is conducted by commercial companies‚ steps should be taken to protect researchers and
p.000117: participants from possible coercion or inducement.
p.000117: 10.9.3 Academic or research institutions require a review to probe possible COI between scientific responsibilities
p.000117: of researchers and business interests (for example ownership or part-ownership of the researcher in the company
p.000117: developing a new product).
p.000117: 10.9.4 An EC should determine if the COI could damage the scientific integrity of a proposal or cause harm to
p.000117: research participants and should advise accordingly.
p.000117: 10.9.5 Institutions need self-regulatory processes to monitor, prevent and resolve such COI and assess the need of
p.000117: informing prospective participants.
p.000117: 10.10 Role of the team in genetic testing and research
p.000117: 10.10.1 Adequate awareness should be created by professional societies and universities/ institutions
p.000117: regarding genetic diseases, their prevention, screening and prenatal diagnosis amongst obstetrician,
p.000117: geneticists, paediatricians, neonatologists, radiologists, laboratory professionals and others.
p.000117: 10.10.2 Laboratory personnel, attending physician(s) and counsellors should possess formal qualifications/sufficient
p.000117: experience in genetics.
...
p.000135: 11.7 Special issues related to datasets
p.000135: 11.7.1 With increasing ease of establishing and maintaining large repositories the primary objective of data collection
p.000135: and storage in some of these databases may not be research but with advances in information technology (IT) and
p.000135: decreasing costs, they offer a huge potential for subsequent research as well as commercialization. Whenever such
p.000135: repositories are used for purposes of research or for subsequent commercialization, it must follow the expected
p.000135: requirements of any other health-related research with due
p.000135: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000135: 135
p.000136:
p.000136: Biological Materials,
p.000136: Biobanking and Datasets
p.000136:
p.000136: diligence, including review by an EC.
p.000136: 11.7.2 There is also a proliferation of data mining and other data science tools that can be employed on existing
p.000136: databases for research purposes to reduce costs and health related processes. EC approval is required to establish
p.000136: legitimacy of the purpose for data mining, access control and about the usefulness of information for particular groups
p.000136: (such as rare disease group). Data privacy, data accuracy, data security, and possibility of legal liability should be
p.000136: ensured when the data is outsourced or sold. Auditing could be done to detect misuse.
p.000136: 11.7.3 Health data is increasingly being collected outside of traditional healthcare settings. Data is shared with
p.000136: third parties not only for research, but also for commercial gain. Big data in health research raise a wide spectrum of
p.000136: ethical issues, ranging from risks to individual rights, such as privacy and concerns about autonomy to individuals.
p.000136: There are unique aspects, such as its data sources, scale, and open access provisions. Ethical issues related to data
p.000136: security, sharing, rights, benefit sharing and others surrounding big data need to be closely examined.
p.000136: 11.7.4 Databases maintained in electronic/digital formats, linked by internet or other networks, using cloud
p.000136: computing technologies and those associated with big data initiatives, may pose additional risks to privacy and
p.000136: confidentiality than what is described under biobanks or traditional paper-based data repositories. Hence, in
p.000136: such situations all reasonable measures must be adopted to respect and protect privacy and confidentiality of
p.000136: individuals as given in Box 11.6.
p.000136: Box 11.6 Measures to ensure privacy and confidentiality of individuals
p.000136:
p.000136: 1. Ensure physical safety and security of the involved devices and computer servers
p.000136: 2. Take data security measures such as password protection
p.000136: 3. Provide differential and role-based controlled access to data elements for members of the research team
p.000136: 4. Ensure use of data encryption when data is transferred from one location/device to another
p.000136: 5. Ensure benefit sharing with owners and related legal issues since, unlike some other countries, India
p.000136: does not have a data protection act as yet
p.000136: 11.8 Contingency plan
p.000136: One of the important but often neglected ethical issues related to biorepository is the legacy or
...
p.000152: responsibility for them and to disclose the results in a transparent manner.
p.000152: 2. Adverse event Any untoward medical occurrence in a patient or participant involved in a study
p.000152: which does not necessarily have a causal relationship with the intervention. The adverse event can therefore be
p.000152: any unfavourable or unintended sign or experience, whether or not related to the product under investigation.
p.000152:
p.000152: 3. Appellate
p.000152: authority
p.000152: It decides on the appeal filed against a decision of the lower authority. Its mandate is to ensure
p.000152: that due process of law is followed.
p.000152: 4. Assent To agree or approve after thoughtful consideration an idea or suggestion to
p.000152: participate in research by a young person below the age of 18 years who is old enough to understand the implications of
p.000152: any proposed research but not legally eligible to give consent. The assent has to be corroborated with informed consent
p.000152: of parent/ LAR.
p.000152: 5. Audit A systematic and independent examination of research activities and documents to
p.000152: determine whether the review and approval activities were conducted, data recorded and accurately reported as per
p.000152: applicable guidelines and regulatory requirements.
p.000152: 6. Autonomy The ability and capacity of a rational individual to make an independently
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
p.000152: 152 INDIAN COUNCIL OF MEDICAL
p.000153: RESEARCH
p.000153:
p.000153:
p.000153: Glossary
p.000153:
p.000153:
p.000153: 8. Biomedical and health research
p.000153: Research including studies on basic, applied and operational research designed primarily to increase the
p.000153: scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and
p.000153: evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical
p.000153: research.
p.000153: 9. Beneficence To try to do good or an action which weighs the risks against
p.000153: benefits to prevent, reduce or remove harm for the welfare of the research participant(s) in any type of research.
p.000153: 10. Caregivers A caregiver or carer is an unpaid or paid person who helps another
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
p.000066: a broad range of problems, with different symptoms. They are generally characterized by some combination of abnormal
p.000066: thoughts, emotions, behaviour and relationships with others. According to the Mental Healthcare Act, 2017,26 “mental
p.000066: illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly
p.000066: impairs judgment, behaviour, capacity to recognize reality or ability to meet the ordinary demands of life, mental
p.000066: conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition
p.000066: of arrested or incomplete development of the mind of a person, specially characterized by subnormality of intelligence.
p.000066: Presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed
p.000066: consent.
p.000066: Cognitively affected or impaired: Conscious mental activities such as thinking, understanding, learning and
p.000066: remembering are defined as cognition. Those in whom these activities are not fully functional are regarded as
p.000066: cognitively impaired. Such individuals or groups include people who are without full intellectual potential
p.000066: (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of
p.000066: neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the
p.000066: informed consent process, either temporarily or permanently. Other sources or reasons for cognitive impairment
p.000066: affecting the ability to give informed consent include, but are not limited to, being too young (children do not yet
p.000066: develop the necessary cognitive abilities to give informed consent); being in extreme pain; being under the influence
...
p.000157: Research, particularly psychology studies, can put participants in
p.000157: situations that may make them feel uncomfortable while learning about their reaction to a situation. The result can be
p.000157: psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or
p.000157: depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.
p.000157: 51 Quorum Minimum number and/or kind of EC members required for
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
p.000157: related injury
p.000157: Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which
p.000157: it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the
p.000157: intervention, whenever they occur, as well as any medical injury caused due to procedures.
p.000157: 53 Risk Probability of harm or discomfort to research participants.
p.000157: Acceptable risk differs depending on the conditions inherent in the conduct of research.
p.000157:
p.000157: 54 Serious adverse
p.000157: event (SAE)
p.000157: An adverse event is serious when the research outcome for
p.000157: the participant is death, life-threatening injury requiring hospitalization, prolongation of
p.000157: hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to
p.000157: prevent permanent impairment or damage.
p.000157:
p.000157: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000157: 157
p.000158:
p.000158:
p.000158: Glossary
p.000158:
p.000158: 55 Sexual minorities
p.000158: A group whose sexual identity, orientation or practices differ from majority of the surrounding society.
p.000158: It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex
p.000158: individuals.
p.000158: 56 Social scientist A person who is an expert on societal and social behaviour with
p.000158: specialization/experience in the area.
p.000158:
p.000158: 57 Socio- behavioural research
p.000158: 58 SOP (standard
p.000158: operating procedure)
p.000158: Refers to the socio-behavioural studies on response of individuals, groups, organizations or societies to external or
p.000158: internal stimuli.
p.000158:
p.000158: Detailed written instructions in a certain format describing all activities and actions to be undertaken
p.000158: by an organization to achieve uniformity in performance of a specific function.
p.000158: 59 Sponsor An individual, institution, private company, government or non-
p.000158: governmental organization from within or outside the country who initiates the research and is responsible for
p.000158: its management and funding.
p.000158: 60 Stigmatization Negative perceptions about an individual because of perceived
...
General/Other / Manipulable
Searching for indicator manipulated:
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p.000057: prisoners).
p.000057:
p.000057: decide by themselves whether or not to give assent/consent for participation.
p.000057: 6.1.4 In vulnerable populations, when potential participants lack the ability to consent, a LAR should be involved in
p.000057: decision making.
p.000057: 6.1.5 Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of
p.000057: confidentiality may lead to enhancement of vulnerability.
p.000057: 6.1.6 If vulnerable populations are to be included in research, all stakeholders must ensure that additional
p.000057: protections are in place to safeguard the dignity, rights, safety and well- being of these individuals.
p.000057: 6.2 Additional safeguards/protection mechanisms
p.000057: When vulnerable individuals are to be recruited as research participants additional precaution should be
p.000057: taken to avoid exploitation/retaliation/reward/credits, etc., as they may either feel intimidated and incapable of
p.000057: disagreeing with their caregivers, or feel a desire to please them. In the first case, they may be subjected to undue
p.000057: pressure, while in the second, they may be easily manipulated. If they perceive that their caregivers want
p.000057: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000057: 57
p.000058:
p.000058:
p.000058: Vulnerability
p.000058:
p.000058: them to participate in research, or if the caregiver stands to benefit from the dependant’s participation, the feeling
p.000058: of being pressed to participate may be irresistible which will undermine the potential voluntariness of the consent to
p.000058: participate.
p.000058: 6.2.1 Researchers must justify the inclusion of a vulnerable population in the research.
p.000058: 6.2.2 ECs must satisfy themselves with the justification provided and record the same in the proceedings of the EC
p.000058: meeting.
p.000058: 6.2.3 Additional safety measures should be strictly reviewed and approved by the ECs.
p.000058: 6.2.4 The informed consent process should be well documented. Additional measures such as recording of assent and
p.000058: reconsent, when applicable, should be ensured.
p.000058: 6.2.5 ECs should also carefully determine the benefits and risks of the study and examine the risk minimization
p.000058: strategies.
p.000058: 6.2.6 As potential participants are dependent on others, there should be no coercion, force, duress, undue
p.000058: influence, threat or misrepresentation or incentives for participation during the entire research period.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000094: 10.13 Genetic diagnosis/testing and screening 118
p.000094: 10.14 Gene therapy 122
p.000094: 10.15 Use of newer technologies 123
p.000094: 10.16 Research on human embryos 125
p.000094: 10.17 Foetal autopsy 126
p.000094: Section 11 Biological materials, biobanking and datasets 127
p.000094: 11.1 Biobanking 127
p.000094: 11.2 Storage of biospecimens and data
p.000094: with their personal identifiers 128
p.000094: 11.3 Ethical issues related to donors 130
p.000094: 11.4 Ethical issues related to research 132
p.000094: 11.5 Biological material/data in forensic
p.000094: departments of laboratories 134
p.000094: 11.6 Governance of biobank/biorepository 135
p.000094: 11.7 Special issues related to datasets 135
p.000094: 11.8 Contingency plan 136
p.000094: Section 12 Research during humanitarian emergencies and disasters 137
p.000094: 12.1 Pre-emptive research preparation for
p.000094: humanitarian emergency 138
p.000094: 12.2 Informed consent requirements 138
p.000094: 12.3 Risk-minimization and equitable
p.000094: distribution of benefits and risks 139
p.000094: 12.4 Privacy and confidentiality 139
p.000094: 12.5 Ethics review procedures 140
p.000094: 12.6 Post research benefit 140
p.000094: 12.7 Special considerations 140
p.000094:
p.000094: 12.8 Continuation of ongoing research when
p.000094: a humanitarian emergency occurs 141
p.000094: 12.9 International participation in research 141
p.000094: List of references
p.000143: 143
p.000144: Suggested further reading
p.000146: 146
p.000147: Abbreviations and acronyms
p.000150: 150
p.000151: Glossary
p.000152: 152
p.000153: Annex 1 Standard operating procedures 160
p.000153: Annex 2 List of members of committees involved
p.000153: in revision of guidelines (2015-2017) 161
p.000153: A. Members of Central Ethics Committee
p.000153: on Human Research 161
p.000153: B. Chaipersons of Sub-Committees and
p.000153: Members of Advisory Group 162
p.000153: C. Members of Sub-Committees/Invited Experts 162
p.000153: D. Members – National Consultation, ICMR, New Delhi 164
p.000153: E. Members – Regional Consultation, NCDIR, Bengaluru 167
p.000153: F. Secretariat 170
p.000153: G. Admin and Finance 170
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
...
p.000037: • research with minor increase over minimal risk (see Table 2.1 for further
p.000037: details);
p.000037: • studies involving deception of participants (see section 5.11 for further
p.000037: details);
p.000037: • research proposals that have received exemption from review, or have undergone expedited review/undergone
p.000037: subcommittee review should be ratified by the full committee, which has the right to reverse/or modify any decision
p.000037: taken by the subcommittee or expedited committee;
p.000037: • amendments of proposals/related documents (including but not limited
p.000037: to informed consent documents, investigator’s brochure, advertisements, recruitment methods, etc.) involving an
p.000037: altered risk;
p.000037: • major deviations and violations in the protocol;
p.000037: • any new information that emerges during the course of the research for deciding whether or not to
p.000037: terminate the study in view of the altered benefit–risk assessment;
p.000037: • research during emergencies and disasters either through an expedited
p.000037: review/ scheduled or unscheduled full committee meetings. This may be decided by Member Secretary depending on the
p.000037: urgency and need;
p.000037: • prior approval of research on predictable emergencies or disasters before
p.000037: the actual crisis occurs for implementation later when the actual emergency or disaster occurs.
p.000037:
p.000037: 4.8.2 The Member Secretary/Secretariat shall screen the proposals for their completeness and depending on the risk
p.000037: involved categorize them into three types, namely, exemption from review, expedited review, and full committee
p.000037: review. See Tables 2.1 for risk categorization and 4.2 for further details regarding types of review.
p.000037: 4.8.3 A researcher cannot decide that her/his proposal falls in the exempted, expedited or full review category. All
p.000037: research proposals must be submitted to the EC. The decision on the type of review required rests with the EC and will
p.000037: be decided on a case-to-case basis. Researchers can approach the EC with appropriate justification for the proposal to
p.000037: be considered as exempt, expedited or if waiver of consent is requested.
p.000037: 4.8.4 Expedited review can be conducted by Chairperson, Member Secretary and one or two designated members or as
p.000037: specified in SOPs.
p.000037:
p.000037: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000037: 37
p.000038:
p.000038:
p.000038: Ethical Review Procedures
p.000038:
p.000038: 4.8.5 Approval granted through expedited review and the decisions of the SAE subcommittee must be ratified at the
p.000038: next full committee meeting.
p.000038: 4.8.6 EC members should be given enough time (at least 1 week) to review the proposal and related documents, except
p.000038: in the case of expedited review.
p.000038: 4.8.7 All EC members should review all proposals. However, the EC may adopt different procedures for review of
p.000038: proposals in accordance with their SOPs.
...
p.000052: 5.4.5 The researcher who administers the consent must also sign and date the consent form.
p.000052: 5.4.6 In the case of institutionalized individuals, in addition to individual/LAR consent, permission for
p.000052: conducting the research should be obtained from the head of that institution.
p.000052: 5.4.7 In some types of research, the partner/spouse may be required to give additional consent.
p.000052: 5.4.8 In genetic research, other member of a family may become involved as secondary
p.000052:
p.000052: 52 INDIAN COUNCIL OF
p.000053: MEDICAL RESEARCH
p.000053:
p.000053:
p.000053: Informed Consent Process
p.000053:
p.000053: participants if their details are recorded as a part of the family history. If information about the secondary
p.000053: participants is identifiable then their informed consent will also be required.
p.000053: 5.4.9 Online consent may be obtained, for example, in research involving sensitive data such as unsafe sex, high
p.000053: risk behaviour, use of contraceptives (condoms, oral pills), or emergency contraceptive pills among unmarried females
p.000053: in India etc. Investigators must ensure that privacy of the participant and confidentiality of related data is
p.000053: maintained.
p.000053: 5.5 Electronic consent
p.000053: Electronic media can be used to provide information as in the written informed consent document, which can be
p.000053: administered and documented using electronic informed consent systems. These are electronic processes that use
p.000053: various, and possibly multiple, electronic formats such as text, graphics, audio, video, podcasts or interactive
p.000053: websites to explain information related to a study and to document informed assent/consent from a participant or LAR.
p.000053: 5.5.1 The process, electronic materials, method of documentation (including electronic/ digital
p.000053: signatures), methods used to maintain privacy of participants, confidentiality, and security of the information as well
p.000053: as data use policies at the research site must be reviewed and approved by the EC a priori.
p.000053: 5.5.2 The electronic consent must contain all elements of informed consent in a language understandable by the
p.000053: participant. See Box 5.1 for further details.
p.000053: 5.5.3 The PI or her/his designee must supervise the process.
...
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
p.000086: 86 INDIAN COUNCIL OF
p.000087: MEDICAL RESEARCH
p.000087:
p.000087: Clinical Trials of Drugs and
p.000087: other Interventions
p.000087:
p.000087: auditing, DSMB, etc.
p.000087: 7.16.4 When academic clinical trials are planned for “off-label” use of a drug (when a drug that is marketed is
p.000087: being used for a new indication/new dose/formulation/route) for purely academic purposes and not for commercial use,
p.000087: then such clinical trials designed by researchers/academicians may not currently require regulatory approval. However,
p.000087: an EC has to approve such studies after due consideration of benefits and risks and all other ethical aspects and the
p.000087: licensing authority has to be informed as per GSR 313(e) dated 16.3.2016 issued by CDSCO.
p.000087: 7.16.5 The trials must be registered in CTRI and there should be mechanism for appropriate methods for informed
p.000087: consent, conduct of trial and proper follow-up of patients.
p.000087: 7.16.6 For student conducting clinical trials as part of their academic thesis, the guide and the academic
p.000087: institution should take up the responsibilities of the sponsor.
p.000087: 7.17 Clinical trials on contraceptives
p.000087: Several methods of contraception are available including, barrier methods, hormonal methods, emergency contraception,
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
p.000087: 7.17.5 The educational and socioeconomic level of women participants may be considered to judge whether they will
p.000087: be able to comprehend the use and risks associated with the particular contraceptive.
p.000087: 7.17.6 Participants should be clearly informed about the alternatives available for contraception.
p.000087:
p.000087: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000087: 87
p.000088:
p.000088: Clinical Trials of Drugs and
p.000088: other Interventions
p.000088:
p.000088: 7.17.7 Any pregnancies occurring during a contraceptive trial should be followed up for final outcome to mother and
...
p.000136: confidentiality than what is described under biobanks or traditional paper-based data repositories. Hence, in
p.000136: such situations all reasonable measures must be adopted to respect and protect privacy and confidentiality of
p.000136: individuals as given in Box 11.6.
p.000136: Box 11.6 Measures to ensure privacy and confidentiality of individuals
p.000136:
p.000136: 1. Ensure physical safety and security of the involved devices and computer servers
p.000136: 2. Take data security measures such as password protection
p.000136: 3. Provide differential and role-based controlled access to data elements for members of the research team
p.000136: 4. Ensure use of data encryption when data is transferred from one location/device to another
p.000136: 5. Ensure benefit sharing with owners and related legal issues since, unlike some other countries, India
p.000136: does not have a data protection act as yet
p.000136: 11.8 Contingency plan
p.000136: One of the important but often neglected ethical issues related to biorepository is the legacy or
p.000136: contingency plan. Institutions should develop the contingent plans for sustainability of the biobanks.
p.000136:
p.000136: 136 INDIAN COUNCIL OF MEDICAL
p.000137: RESEARCH
p.000137:
p.000137: SECTION 12
p.000137:
p.000137:
p.000137: RESEARCH DURING HUMANITARIAN EMERGENCIES AND DISASTERS
p.000137:
p.000137: 12.0 A humanitarian emergency or disaster is an event or series of events that represents a critical threat to the
p.000137: health, safety, security or well-being of a community or other large group of people, usually covering a wide
p.000137: land area. For the purpose of these guidelines, humanitarian emergencies and disasters include both man-made and
p.000137: natural ones, some of which occur at periodic frequency. Emergencies, such as an earthquake, flood, mass migration,
p.000137: conflict and outbreak of disease, leading to substantial material damage affecting persons, communities, society
p.000137: and state(s), create an imbalance between capacity and resources to meet the needs of the survivors or the people
p.000137: whose lives are threatened during that period. Research is necessary in such circumstances to enable provision of
p.000137: efficient and appropriate health and humanitarian response during the ongoing emergency and to be able to plan for
p.000137: future emergency situations. Local, national or international responses and preparedness, without interfering with
p.000137: measures to control the crisis or ecology, are the key to reducing morbidity and mortality in such events.
p.000137: Humanitarian emergencies raise complex issues. The health system, communications, research infrastructure, and research
p.000137: governance frameworks may be adversely affected during such situations, which create challenges for the feasibility and
p.000137: oversight of conduct of research. While there may be a need to undertake research quickly, this should not impact
p.000137: scientific validity and the need to uphold ethical requirements. Close attention should be paid to the effect of the
p.000137: emergency on perceptions of ethical questions, altered or increased vulnerabilities, provider–patient and
p.000137: researcher–participant relationships, issues related to integrity of studies and ethical review processes. A unique
p.000137: challenge would be the response to rapidly evolving health needs or priorities of those impacted by the humanitarian
p.000137: emergency when the research cannot be conducted outside the humanitarian emergency situation. Designing or adopting
p.000137: innovative relevant research, based on rapidly evolving scientific and ethical uncertainties, which is expected to
p.000137: yield scientifically valid results is another significant challenge. The other challenges are inadequate time
p.000137: to design a study and lack of infrastructure facilities and resources to
p.000137: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000137: 137
p.000138:
p.000138: Research during Humanitarian Emergencies and
p.000138: Disasters
p.000138:
p.000138: conduct it within a disrupted physical-socio-cultural environment. The role of ECs in such circumstances is very
p.000138: important in reviewing protocols prepared for such emergency situation(s). Responsiveness to the situation,
p.000138: supervision, training and prevention of heightened risk of violence are other factors to be considered and planned.
p.000138: 12.1 Pre-emptive research preparation for future humanitarian emergency
p.000138: A natural disaster of cyclical frequency is an expected phenomenon. The following will be acceptable if a research is
p.000138: planned to study various implications on humans and ecological effects on humans in these circumstances.
p.000138: 12.1.1 Researchers and sponsors could make arrangements about research questions to be addressed in the design,
p.000138: collection of samples and data, and sharing mechanisms much in advance of a future humanitarian emergency.
p.000138: 12.1.2 Researchers could screen available and/or relevant draft research protocols to expedite the review process.
p.000138: 12.1.3 The EC could review proposals prior to the occurrence of the emergency and determine who could be an
p.000138: acceptable LAR in the absence of intended LARs (authorized/ acceptable) in such situations.
p.000138: 12.2 Informed consent requirements
p.000138: 12.2.1 Obtaining valid informed consent in humanitarian emergencies is a challenge as the decisional capacity of the
p.000138: participants would be so low that they may not be able to differentiate between reliefs offered and research
p.000138: components. This should be very clearly distinguished during the informed consent process.
p.000138: 12.2.2 Additional safeguards are required for participants due to their vulnerability, for example,
p.000138: counselling, psychological help, medical advice and process of stakeholder consultation.
p.000138: 12.2.3 The potential research participants might be under duress and traumatized. Researchers should be sensitive to
p.000138: this situation and are obligated to ensure that the informed consent process is conducted in a respectful manner.
p.000138: 12.2.4 Researchers should strive to identify and address barriers to voluntary informed consent and not resort to
p.000138: inducements for research participation.
p.000138: 12.2.5 The different roles of researchers, caregivers and volunteer workers must always be clarified, and potential COI
p.000138: declared.
...
p.000140: Disasters
p.000140:
p.000140: 12.4.3 Efforts should be made to protect the identifying information about individuals and communities, for example,
p.000140: from exploitation by the print and visual media.
p.000140: 12.5 Ethics review procedures
p.000140: 12.5.1 Research during humanitarian emergencies and disasters can be reviewed through an expedited
p.000140: review/scheduled/unscheduled full committee meetings and this may be decided by the Member Secretary on a case-to-case
p.000140: basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as
p.000140: possible.
p.000140: 12.5.2 Meticulous documentation and archiving are required to enable future application in similar situations.
p.000140: 12.5.3 Suggestions to expedite the review process are given below:
p.000140: • Measures such as virtual or tele-conferences should be attempted when face-to-
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
p.000140: data/sample collection that are likely to rapidly deteriorate or perish may be allowed while the review process is
p.000140: underway.
p.000140: • Available protocol templates could be reviewed to expedite the process.
p.000140: • Re-review should be done if the emergency situation changes.
p.000140: • In situations where members of local ECs are unavailable due to the emergency, the ethics review may be
p.000140: conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its
p.000140: meeting. ECs should develop procedures to ensure appropriate and timely review and monitoring of the approved research.
p.000140: On a case-by-case basis, some protocols may require re- review as the emergency situation may change with time and
p.000140: circumstances.
p.000140: 12.5.4 The EC should closely monitor the conduct and outcome of research.
p.000140: 12.6 Post-research benefit
p.000140: Sponsors and researchers should strive to continue to provide beneficial interventions, which were part of the research
p.000140: initiative even after the completion of research and till the local administrative and social support system is
p.000140: restored to provide regular services.
p.000140: 12.7 Special considerations
p.000140: Humanitarian emergencies lead to fragile political environments with disruption of health systems and social
p.000140: situations.
p.000140:
p.000140:
p.000140: 140 INDIAN COUNCIL OF MEDICAL
p.000141: RESEARCH
p.000141:
p.000141: Research during Humanitarian Emergencies and
p.000141: Disasters
p.000141:
p.000141: 12.7.1 The researchers should undertake steps to maintain participant and community trust.
p.000141: 12.7.2 Efforts should be made to engage the community in the conduct of research in a culturally sensitive manner to
p.000141: ensure public trust.
p.000141: • The research team should preferably describe a preliminary community mapping/
p.000141: scoping exercise.
p.000141: • Wherever possible, community representatives or advocates should be involved in conceptualization, review,
p.000141: research and dissemination of research results in such settings.
p.000141: 12.7.3 In case of an outbreak of infectious diseases, monitored emergency use of unregistered and experimental
p.000141: interventions (MEURI) may be approved with the following precautions:
p.000141: • A thorough scientific review should be conducted, followed by an ethics review
p.000141: by a national level EC constituted for this purpose.
p.000141: • Oversight by a local EC is necessary.
p.000141: • Only a product complying with GMP should be used.
p.000141: • Rescue medicines and supportive treatment should be accessible.
p.000141: • Sharing data on safety and efficacy would be beneficial to reduce delay for other
p.000141: researchers.
p.000141: • Consent process is important and must be carried out with care.
p.000141: • Planning should be done for community engagement.
p.000141: • Fair distribution should be ensured when faced with scarce supply.
p.000141: 12.8 Continuation of ongoing research when a humanitarian emergency occurs
p.000141: 12.8.1 The research may have to be suspended and the decision may be taken by researchers with information to EC.
p.000141: 12.8.2 The researchers can go back to the EC for guidance regarding continuation of research or not.
p.000141: 12.8.3 Amendments might be incorporated in the proposal(s) to align to the research needs arising from the emergency
p.000141: including issues related to re-consent from participants.
p.000141: 12.8.4 The EC may decide if more frequent monitoring is required.
p.000141: 12.9 International participation in research
p.000141: 12.9.1 Conduct of research in a humanitarian emergency situation, which involves a foreign researcher/institution, must
p.000141: involve local partner(s).
p.000141: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000141: 141
p.000142:
p.000142: Research during Humanitarian Emergencies and
p.000142: Disasters
p.000142:
p.000142: 12.9.2 Existing guidelines on international collaboration for biological samples, data and intellectual
p.000142: property including publication related issues will be applicable. See section
p.000142: 3.8.3 for further details.
p.000142: 12.9.3 The local EC will monitor the progress of the research and compliance to the various clauses of the
p.000142: international collaboration.
p.000142: 12.9.4 Permission should be obtained from relevant national and local authorities, wherever applicable.
p.000142: 12.9.5 The research should help in developing the capacity of local researchers and sites and provide key learning
p.000142: points to the policy makers and the community.
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
...
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000159: 159
p.000160:
p.000160: ANNEX 1
p.000160:
p.000160: STANDARD OPERATING PROCEDURES (SOPs)
p.000160:
p.000160: S. No. List of SOPs
p.000160: 1 Writing, Reviewing, Distributing and Amending Standard Operating Procedures for ECs
p.000160: 2 Constituting an Ethics Committee
p.000160: 3 Confidentiality Agreements
p.000160: 4 Conflict of Interest Agreements
p.000160: 5 Training Personnel and EC Members
p.000160: 6 Selection of Independent Consultants
p.000160: 7 Procedures for Allowing a Guest or Observer
p.000160: 8 Categorization of Submitted Protocols for Ethics Review
p.000160: a. Initial Full Committee Review of New Research Protocols
p.000160: b. Expedited Review of Research Protocols
p.000160: c. Exemption from Ethics Review of Research Protocols
p.000160: 9 Agenda Preparation, Meeting Procedures and Minutes
p.000160: 10 Review of New Medical Device Studies
p.000160: 11 Review of Resubmitted Protocols
p.000160: 12 Review of Protocol Amendments
p.000160: 13 Continuing Review of Protocols
p.000160: 14 Review of Final Reports
p.000160: 15 Review of Serious Adverse Events (SAE) Reports
p.000160: 16 Review of Study Completion Reports
p.000160: 17 Management of Premature Termination, Suspension, Discontinuation of the Study
p.000160: 18 Waiver of Written or Verbal/oral Informed Consent
p.000160: 19 Site Monitoring Visits
p.000160: 20 Dealing with Participants’ Requests and Complaints
p.000160: 21 Emergency Meetings
p.000160: 22 Communication Records
p.000160: 23 Maintenance of Active Study Files
p.000160: 24 Archive and Retrieval of Documents
p.000160: 25 Maintaining Confidentiality of EC’s Documents
p.000160: 26 Reviewing Proposals involving Vulnerable Populations
p.000160: 27 Review and Inspection of the EC
p.000160: 28 Audio Visual Recording of the Informed Consent Process
p.000160:
p.000160: 160 INDIAN COUNCIL OF MEDICAL
p.000161: RESEARCH
p.000161:
p.000161: ANNEX 2
p.000161:
p.000161: LIST OF MEMBERS OF COMMITTEES INVOLVED IN REVISION OF GUIDELINES (2015-2017)
p.000161:
p.000161: A. Members of Central Ethics Committee on Human Research
p.000161: P. N. Tandon (Chairperson), National Brain Research Centre, Manesar
p.000161: B. N. Dhawan (Late), Formerly at Central Drug Research Institute, Lucknow
p.000161: Sunil K. Pandya, Jaslok Hospital, Mumbai
p.000161: Madhav Menon, Bar Council of Kerala, M.K.Nambyar Academy for Continuing Legal Education, Kochi
p.000161: G. Padmanaban, Indian Institute of Science, Bengaluru
p.000161: Lt. Gen. D. Raghunath, Formerly at Sir Dorabji Tata Centre for Research in Tropical Diseases, Bengaluru
p.000161: K.N. Chaturvedi, Supreme Court, New Delhi
p.000161: P.S.S. Sunder Rao, Formerly at Christian Medical College, Vellore
p.000161: C.A.K. Yesudian, Formerly at Tata Institute of Social Sciences, Mumbai
p.000161: Vinod K. Paul, All India Institute of Medical Sciences, New Delhi
p.000161: Mira Shiva, Initiative for Health & Equity in Society, New Delhi
...
General/Other / Relationship to Authority
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p.000007: 2.3.3 Any publication arising out of research should uphold the privacy of the individuals by ensuring that
p.000007: photographs or other information that may reveal the individual’s identity are not published. A specific re-consent
p.000007: would be required for publication, if this was not previously obtained.
p.000007: 2.3.4 Some information may be sensitive and should be protected to avoid stigmatization and/or discrimination (for
p.000007: example, HIV status; sexual orientation such as lesbian, gay, bisexual, and transgender (LGBT); genetic
p.000007: information; or any other sensitive information).
p.000007: 2.3.5 While conducting research with stored biological samples or medical records/data, coding or anonymization
p.000007: of personal information is important and access to both samples and records should be limited. See section 11 for
p.000007: further details.
p.000007: 2.3.6 Data of individual participants/community may be disclosed in certain circumstances with the permission of the
p.000007: EC such as specific orders of a court of law, threat to a person’s or community’s life, public health risk that would
p.000007: supersede personal rights to privacy, serious adverse events (SAEs) that are required to be communicated to an
p.000007: appropriate regulatory authority etc.
p.000007:
p.000007: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000007: 7
p.000008:
p.000008:
p.000008: General Ethical Issues
p.000008:
p.000008: 2.4 Distributive justice
p.000008: 2.4.1 Efforts must be made to ensure that individuals or communities invited for research are selected in such a way
p.000008: that the benefits and burdens of research are equitably distributed.
p.000008: 2.4.2 Vulnerable individuals/groups should not be included in research to solely benefit others who are better-off
p.000008: than themselves.
p.000008: 2.4.3 Research should not lead to social, racial or ethnic inequalities.
p.000008: 2.4.4 Plans for direct or indirect benefit sharing in all types of research with participants, donors of biological
p.000008: materials or data should be included in the study, especially if there is a potential for commercialization. This
p.000008: should be decided a priori in consultation with the stakeholders and reviewed by the EC.
p.000008: 2.5 Payment for participation
p.000008: 2.5.1 If applicable, participants may be reimbursed for expenses incurred relating to their participation in
p.000008: research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and
p.000008: other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food
p.000008: supplies).
p.000008: 2.5.2 Participants should not be made to pay for any expenses incurred beyond routine clinical care and
p.000008: which are research related including investigations, patient work up, any interventions or associated treatment. This
...
p.000025: regularly monitor the approved research to ensure ethical compliance during the conduct of research. The EC should be
p.000025: competent and independent in its functioning.
p.000025: 4.0.1 The institution is responsible for establishing an EC to ensure an appropriate and sustainable
p.000025: system for quality ethical review and monitoring.
p.000025: 4.0.2 The institution is responsible for providing logistical support, such as infrastructure, staff, space, funds,
p.000025: adequate support and protected time for the Member Secretary to run the EC functions.
p.000025: 4.0.3 The EC is responsible for scientific and ethical review of research proposals. Although ECs may obtain
p.000025: documentation from a prior scientific review, they must determine that the research methods are scientifically sound,
p.000025: and should examine the ethical implications of the chosen research design or strategy.
p.000025: 4.0.4 All types of biomedical and health research (whether clinical, basic science, policy,
p.000025: implementation, epidemiological, behavioural, public health research, etc) must be reviewed by an EC before it
p.000025: is conducted.
p.000025: 4.1 Terms of reference (TOR) for ECs
p.000025: 4.1.1 The TOR for the EC and its members should be clearly specified by the institution in the EC SOPs (Annex 1 for
p.000025: the List of SOPs).
p.000025: 4.1.2 Every EC should have written SOPs according to which the committee should function. The EC can refer to
p.000025: ICMR guidelines in preparing the SOPs for all biomedical and health research and to CDSCO guidelines for drug
p.000025: and device trials under the purview of the licensing authority. The SOPs should be updated periodically to reflect
p.000025: changing requirements. A copy of the latest version of SOPs should be made available to each member and they should be
p.000025: trained on the SOPs. The SOPs must be available in the secretariat of the EC as both hard and soft copies.
p.000025: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000025: 25
p.000026:
p.000026:
p.000026: Ethical Review Procedures
p.000026:
p.000026: 4.1.3 The scope, tenure and renewal policy of the EC should be stated.
p.000026: 4.1.4 Members of the EC should not have any known record of misconduct.
p.000026: 4.1.5 The EC should be registered with the relevant regulatory authorities, for example, ECs approving clinical
p.000026: trials under the ambit of Drugs and Cosmetics Act should be registered with CDSCO.
p.000026: 4.2 Special situations
p.000026: 4.2.1 Institutions can have one or more than one EC. They can have multiple ECs to review large numbers of research
p.000026: proposals. Each EC can function as a stand-alone committee which should follow all the SOPs and TORs of that
p.000026: institution.
p.000026: 4.2.2 An institution that does not have its own EC (user institution) may utilize the services of the EC of another
p.000026: institution (host institution) preferably in the adjoining/nearby area. Relevant requirements must be fulfilled before
p.000026: they do so. See Box 4.1 for further details.
p.000026: Box 4.1 Utilizing the services of an EC of another institution
p.000026:
p.000026: The following requirements must be fulfilled by institutions that use the services of an EC from another institution:
p.000026: • The two institutions (host and user) should enter into an MoU for utilizing the services of the EC of the host
p.000026: institution or the user institution should provide a ‘No Objection Certificate’ and agree to be overseen by the EC of
p.000026: the host institution.
p.000026: • The EC of the host institution should have access to all research records including the source documents and
p.000026: research participants for continuing review of the implemented project, including site visits.
p.000026: • The EC of the host institution can undertake site monitoring and will have all the rights and
p.000026: responsibilities related to ethical review of the projects submitted by the user institutions.
p.000026:
p.000026: 4.2.3 For multicentric biomedical and health research, all participating sites may decide to utilize the services of
p.000026: one common EC from a participating site identified as designated main EC for the purpose of primary review. This EC
p.000026: should be located in India and registered with the relevant authority. However, the local site requirements, such as
p.000026: informed consent process, research implementation and its monitoring, etc. may be performed by the local EC. This would
p.000026: require good communication and coordination between the researchers and EC secretariats of participating sites. For
p.000026: clinical trials under the Drugs and Cosmetics Act, the requirements as stated by CDSCO must be followed. See section
p.000026: 4.10 for further details.
p.000026: 4.2.4 Stem cell proposals should be reviewed and approved by the institutional committee
p.000026: 26 INDIAN COUNCIL OF
p.000027: MEDICAL RESEARCH
p.000027:
p.000027:
p.000027: Ethical Review Procedures
p.000027:
p.000027: for stem cell research (IC-SCR) before being submitted to the EC for consideration, in accordance with the National
p.000027: Guidelines for Stem Cell Research (2017).
p.000027: 4.2.5 Independent ECs (Ind EC) that function outside institutions can be used by researchers who have no
p.000027: institutional attachments. For these committees, the following essential conditions should be met:
p.000027: • The Ind EC must be established as a registered legal entity, governed by individuals who are not
p.000027: members of the proposed EC and who will oversee and monitor the functioning of the Ind EC.
p.000027: • It should function according to SOPs that follow the national guidelines for
p.000027: functioning of ECs.
p.000027: • It should not accept research proposals from investigators affiliated to institutions
p.000027: that have their own ECs unless there is an MoU.
p.000027: • It will have rights and responsibilities related to the projects submitted to it.
...
p.000030: • Serve as a patient/participant/ societal / community representative and bring in ethical and societal
p.000030: concerns.
p.000030:
p.000030:
p.000030:
p.000030: • Ethical review of the proposal, ICD along
p.000030: with translation(s).
p.000030: • Evaluate benefits and risks from the participant’s perspective and opine whether
p.000030: benefits justify the risks.
p.000030: • Serve as a patient/participant/ community representative and bring in ethical and societal concerns.
p.000030: • Assess on societal aspects if any.
p.000030:
p.000030: 4.3.6 The quorum should be as specified in Box 4.2.
p.000030: Box 4.2 Quorum requirements for EC meetings
p.000030: 1. A minimum of five members present in the meeting room.
p.000030: 2. The quorum should include both medical, non medical or technical or/and non-technical members.*
p.000030: 3. Minimum one non-affiliated member should be part of the quorum.
p.000030: 4. Preferably the lay person should be part of the quorum.
p.000030: 5. The quorum for reviewing regulatory clinical trials should be in accordance with current CDSCO requirements.
p.000030: 6. No decision is valid without fulfilment of the quorum.
p.000030:
p.000030: *Medical members are clinicians with appropriate medical qualifications. Technical members are persons with
p.000030: qualifications related to a particular branch in which the study is conducted, for example social sciences.
p.000030: 30 INDIAN COUNCIL OF
p.000031: MEDICAL RESEARCH
p.000031:
p.000031:
p.000031: Ethical Review Procedures
p.000031:
p.000031: 4.3.7 So as to maintain independence, the head of the institution should not be part of the EC but should act as an
p.000031: appellate authority to appoint the committee or to handle disputes.
p.000031: 4.3.8 The Chairperson and Member Secretary could have dual roles in the ethics committee. They could fulfil a role
p.000031: based on their qualifications (such as that of clinician, legal expert, basic scientist, social scientist, lay person
p.000031: etc.) in addition to taking on the role of Chairperson or Member Secretary.
p.000031: 4.3.9 The EC can also have a set of alternate members who can be invited as members with decision-making powers to
p.000031: meet the quorum requirements. These members have the same TORs as regular members and can attend meetings in
p.000031: the absence of regular members.
p.000031: 4.3.10 The EC can maintain a panel of subject experts who are consulted for their subject expertise, for
p.000031: instance, a paediatrician for research in children, a cardiologist for research on heart disorders, etc. They may be
p.000031: invited to attend the meeting to give an expert opinion on a specific proposal but will not have decision making
p.000031: power/voting rights.
p.000031: 4.3.11 The EC may invite subject experts as independent consultants or include a representative from a specific
p.000031: patient group as a member of the EC or special invitee, for opinion on a specific proposal, for example HIV, genetic
p.000031: disorders, or cancer, with appropriate decision making power.
p.000031: 4.3.12 As far as possible a separate scientific committee should priorly also review proposal before it is referred to
...
p.000043:
p.000043: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000043: 43
p.000044:
p.000044:
p.000044: Ethical Review Procedures
p.000044:
p.000044: • If any EC does not grant approval for a study at a site the reasons must be shared
p.000044: with other ECs and deliberated upon.
p.000044: • The EC can suggest site-specific protocols and informed consent modifications
p.000044: as per local needs.
p.000044: • Separate review may be requested for studies with a higher degree of risk, clinical trials or intervention
p.000044: studies where conduct may vary depending on the site or any other reason which requires closer review and attention.
p.000044: 4.10.2 Common review for all participating sites in multicentric research
p.000044: • In order to save time, prevent duplication of effort and streamline the review process, the ECs can decide to
p.000044: have one designated main EC, the decisions of which may be acceptable to other ECs. This is especially important for
p.000044: research involving low or minimal risk, survey or multicentric studies using anonymized samples or data or those that
p.000044: are public health research studies determined to have low or minimal risk.
p.000044: • The meeting of the designated main EC can be attended by nominated members of ECs of the participating centres
p.000044: to discuss their concerns, if any, about ethics or human rights and to seek solutions and communicate the decision of
p.000044: the main EC to their respective ECs.
p.000044: • This EC should be located in India and registered with the relevant authority (if
p.000044: applicable).
p.000044: • Meetings should be organized at the initial and, if required, intermediary stages
p.000044: of the study to ensure uniform procedures at all centres.
p.000044: • The site ECs, however, retain their rights to review any additional site specific requirements, ensure
p.000044: need-based protection of participants or make changes in the informed consent document (ICD), translations and
p.000044: monitoring research as per local requirements.
p.000044: • The protocol may be modified to suit local requirements and should be followed after it is duly approved by the
p.000044: EC of the host institutes/decision of main EC is accepted.
p.000044: • Adherence to protocols, including measures to terminate the participation of the
p.000044: erring local centres, if required should be monitored.
p.000044: • The common review is applicable only for ECs in India. In case of international
p.000044: collaboration for research and approval by a foreign institution, etc., the local
p.000044:
p.000044: 44 INDIAN COUNCIL OF
p.000045: MEDICAL RESEARCH
p.000045:
p.000045:
p.000045: Ethical Review Procedures
p.000045:
p.000045: participating sites would be required to obtain local ethical approval. See section
p.000045: 3.8.3 for further details.
p.000045: • Sponsor/funding agencies should be informed about any site-specific changes
p.000045: being made, and the modified version should only be used by the concerned site.
p.000045: • Plans for manuscript publication and a common final report with contributors
p.000045: from the participating sites should be decided upon before initiation of the study.
p.000045: • Site-specific data may be published only after the appropriate authorities accept
p.000045: the combined report and appropriate permissions are obtained.
p.000045: 4.11 Continuing review
p.000045: 4.11.1 Ongoing research should be reviewed at regular intervals, at least once a year, (or more often, if deemed
p.000045: necessary depending on the level of risk) or as may be specified in the SOP of the EC and at the time of according
p.000045: approval, and as indicated in the communication letter.
p.000045: 4.11.2 The EC should continually evaluate progress of ongoing proposals, review SAE reports from all sites along
p.000045: with protocol deviations/violations and non-compliance, any new information pertaining to the research and assess final
p.000045: reports of all research activities.
p.000045: 4.11.3 Clinical trials under the purview of a licensing authority must comply with all regulations
p.000045: applicable to SAEs. The EC should also ensure compliance by the researcher. For academic and other trials, an
p.000045: institutional policy should be established.
p.000045: 4.11.4 The EC should examine the measures taken for medical management of SAEs. Participants should not
p.000045: have to bear costs for the management of study-related injury whether they are in the intervention arm or the control
p.000045: arm.
p.000045: 4.11.5 Compensation must be given for research-related injuries if applicable, as determined by the EC and as per
p.000045: regulatory requirement (if applicable).
p.000045: 4.11.6 For protocol deviations/violations the EC should examine the corrective actions. If the violations are
p.000045: serious the EC may halt the study. The EC may report to the institutional head/government authorities where there is
p.000045: continuing non-compliance to ethical standards.
p.000045: 4.11.7 Reports of monitoring done by the sponsor and DSMB reports may also be sought.
p.000045: 4.12 Site monitoring
p.000045: 4.12.1 It is recommended that ECs should follow mechanisms described in a SOP to monitor the approved study site
p.000045: until completion of the research to check for compliance or improve the function.
p.000045:
p.000045: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000045: 45
p.000046:
p.000046:
p.000046: Ethical Review Procedures
p.000046:
p.000046: 4.12.2 Monitoring can be routine or “for cause” and must be decided at a full committee meeting. For research that
p.000046: involves higher risk or vulnerable participants or if there is any other reason for concern, the EC at the time of
...
p.000047: • Agenda and minutes
p.000047: • All communications received or made by the EC
p.000047: • SOPs
p.000047: • One hard copy and a soft copy of the initial research proposal and all
p.000047: related documents
p.000047: • Decision letters
p.000047: • Any amendments submitted for review and approval
p.000047: • Regulatory approvals
p.000047: • SAE, AE reports
p.000047: • Protocol deviations/violations
p.000047: • Progress reports, continuing review activities, site monitoring reports
p.000047: • All correspondence between the EC and researchers
p.000047: • Record of notification issued for premature termination of a study with
p.000047: a summary of the reasons
p.000047: • Final report of the study
p.000047: • Publications, if any
p.000047:
p.000047: 4.14 Administration and management
p.000047: 4.14.1 Every institution should have an office for the EC.
p.000047: 4.14.2 The institution should provide space, infrastructure and staff to the EC for maintaining
p.000047:
p.000047: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000047: 47
p.000048:
p.000048:
p.000048: Ethical Review Procedures
p.000048:
p.000048: a full-time secretariat, safe archival of records and conduct of meeting.
p.000048: 4.14.3 Every institution should allocate reasonable funds for smooth functioning of the EC.
p.000048: 4.14.4 A reasonable fee for review may also be charged by the EC to cover the expenses related to optimal
p.000048: functioning in accordance to Institutional policies.
p.000048: 4.15 Registration and accreditation of ECs
p.000048: 4.15.1 ECs must ensure that processes are in place to safeguard the quality of ethical review as well as compliance
p.000048: with national/international and applicable regulations.
p.000048: 4.15.2 ECs should register with the relevant authority as per the regulatory requirements.
p.000048: 4.15.3 Efforts should be made to seek recognition/certification/accreditation from recognized
p.000048: national/international bodies such as Strategic Initiative for Developing Capacity in Ethical Review (SIDCER),
p.000048: Association for the Accreditation of Human Research Protection Programmes (AAHRPP), CDSCO and Quality Council of India
p.000048: through National Accreditation Board for Hospitals and Healthcare Providers (NABH) or any other. Such
p.000048: certification/accreditation should be kept updated on a continuing basis.
p.000048: 4.15.4 Certification/accreditation are voluntary exercises and help in quality assurance and quality improvement to
p.000048: ensure that ECs follow best practices in protecting the dignity, rights, safety, and well-being of their participants.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 48 INDIAN COUNCIL OF
p.000049: MEDICAL RESEARCH
p.000049:
p.000049: SECTION 5
p.000049:
p.000049: INFORMED CONSENT PROCESS
p.000049:
p.000049: 5.0 The researcher must obtain voluntary written informed consent from the prospective participant for any
p.000049: biomedical and health research involving human participants. This requirement is based on the principle that competent
...
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
...
p.000067:
p.000067:
p.000067: Vulnerability
p.000067:
p.000067: in a study if any such interventions are required.
p.000067: • Interventions should be of short duration, as least restrictive as possible and
p.000067: invoked only when necessary, in accordance with relevant laws.
p.000067: • Some research designs may reduce or violate human participant protections/rights or specific requirements of
p.000067: informed consent by resorting to deception in order to achieve the objectives of the research for public good. Types of
p.000067: deception that can be used in a research plan are described in Box 9.5. All such studies should be reviewed by the EC
p.000067: very carefully before approval.
p.000067: 6.9 Individuals who have diminished autonomy due to dependency or being under a hierarchical system
p.000067: While reviewing protocols that include students, employees, subordinates, defence services personnel,
p.000067: healthcare workers, institutionalized individuals, under trials, prisoners, and others the EC must ensure the
p.000067: following:
p.000067: 6.9.1 Enrolling participants as described above is specifically pertinent to the research questions and is
p.000067: not merely a matter of convenience.
p.000067: 6.9.2 Individuals in a hierarchical position may not be in a position to disagree to participate for fear of
p.000067: authority and therefore extra efforts are required to respect their autonomy.
p.000067: 6.9.3 It is possible for the participant to deny consent and/or later withdraw from the study without any negative
p.000067: repercussions on her/his care.
p.000067: 6.9.4 Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the
p.000067: protocol.
p.000067: See Section 5 for informed consent issues.
p.000067: 6.10 Patients who are terminally ill
p.000067: Terminally ill patients or patients who are in search of new interventions having exhausted all available
p.000067: therapies are vulnerable as they are ready to give consent for any intervention that can give them a ray of hope. These
p.000067: studies are approved so that the scientific community or professional groups do not deny such patients the possible
p.000067: benefit of any new intervention that is not yet validated.
p.000067: 6.10.1 Since therapeutic misconception is high there should be appropriate consent procedures and the EC should
p.000067: carefully review such protocols and recruitment procedures.
p.000067: 6.10.2 Additional monitoring should be done to detect any adverse event at the earliest.
...
p.000069: public health interventions, socio-behavioural interventions, technologies, devices, surgical techniques or
p.000069: interventions involving traditional systems of medicine, etc.
p.000069: Clinical trials are usually well-controlled studies. They use a design that allows comparison of
p.000069: participants treated with an investigational product (IP)/any intervention to a control population (receiving placebo
p.000069: or an active comparator), so that the effect of the IP/intervention can be determined and differentiated from effects
p.000069: of other influences, such as spontaneous change, placebo effect, concomitant treatment/intervention or observer
p.000069: expectations.
p.000069: As per the amended Schedule Y (2005) of the Drugs and Cosmetics Rules, 1945, a clinical trial refers to a systematic
p.000069: study of new drugs on human subjects to generate data for discovering and/or verifying the clinical, pharmacological
p.000069: (including pharmacodynamic and pharmacokinetic) and/or adverse effect with the objectives determining safety
p.000069: and/or efficacy of a new drug. The academic clinical trial as per GSR 313 (E) dated 16
p.000069: March 201627 is a clinical trial intended for academic purposes in respect of approved
p.000069: drug formulations for any new indication or new route of administration or new dose or new dosage form. An EC has to
p.000069: approve such studies after due consideration of benefits and risks and all other ethical aspects and the licensing
p.000069: authority has to be informed as per the prescribed procedures.
p.000069: 7.1 General guidelines
p.000069: 7.1.1 All clinical trials must be planned, conducted and reported in a manner that ensures that the dignity, rights,
p.000069: safety and well-being of participants are protected.
p.000069: 7.1.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000069: benefit (direct or indirect) for the individual trial participant and/or society. A trial should be initiated and
p.000069: continued only if the anticipated benefits justify the risks.
p.000069:
p.000069: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000069: 69
p.000070:
p.000070: Clinical Trials of Drugs and
p.000070: other Interventions
p.000070:
p.000070: 7.1.3 All clinical trials must be conducted in accordance with the Indian GCP guidelines, the Declaration of Helsinki
p.000070: (2013 or later versions as applicable), National Guidelines for Biomedical and Health Research Involving Human
p.000070: Participants (2017), the Drugs and Cosmetics Act (1940), and Rules (1945), and applicable amendments (including
p.000070: Schedule Y), and other relevant regulations and guidelines, wherever applicable.
p.000070: 7.1.4 A participant’s right to agree or decline consent to take part in a clinical trial must be respected and
p.000070: her/his refusal should not affect routine care.
p.000070: 7.1.5 At all times, the privacy of a participant must be maintained and any information gathered from
p.000070: the participant be kept strictly confidential.
p.000070: 7.1.6 Therapeutic misconception in potential participants must be avoided (for example, by having a
...
p.000072: regimen, or route of administration. If such studies are intended for ultimate commercial use of the drug, they require
p.000072: regulatory approval. Research on off label use comes under this category. See section 7.16.4 for further details; and
p.000072: d) planned as bridging trials and pivotal trials.
p.000072: Phase IV
p.000072: Phase IV begins after product approval and is related to the use of the intervention for the approved indications.
p.000072: These studies are important for optimizing the use of the product. They may include:
p.000072: a) post-marketing surveillance – the practice of monitoring the safety of a product after it has been released in the
p.000072: market;
p.000072: b) Phase IV clinical trials – a study conducted to assess safety, tolerability and effectiveness of a marketed
p.000072: product when prescribed in the usual manner in accordance with the terms of the marketing authorization, such as the
p.000072: efficacy and safety in special populations.
p.000072: c) outcomes research – which aim to study the effectiveness and efficiency of the intervention after its
p.000072: introduction for human use; and
p.000072: d) registries – which propose to maintain data about patients with certain shared characteristics and who
p.000072: have received a particular intervention (for example a stent) that collects ongoing and supporting data over time on
p.000072: well-defined outcomes of interest.
p.000072: 7.2.2 Ethical considerations
p.000072: All clinical trials should be scientifically and ethically sound. The sponsor of the study, the researcher,
p.000072: institution, EC, and regulatory authority (if applicable) are responsible for ethical conduct of a study. Before any
p.000072: clinical trial is initiated, adequate data from preclinical investigations or previous clinical studies should
p.000072: be generated and be sufficient to indicate that the intervention is acceptably safe for the proposed investigation
p.000072: in humans.
p.000072: The investigator should make an assessment to determine if a clinical trial is under the regulatory ambit and if so, to
p.000072: ensure that all requirements as specified by CDSCO must
p.000072:
p.000072: 72 INDIAN COUNCIL OF
p.000073: MEDICAL RESEARCH
p.000073:
p.000073: Clinical Trials of Drugs and
p.000073: other Interventions
p.000073:
p.000073: also be followed. If required, the EC may provide relevant guidance to the members in deciding the same.
p.000073: • Phase I (for drugs and vaccines) studies
p.000073: m All Phase I trials require EC approval and applicable regulatory approvals. m A Phase I study is a
p.000073: non-therapeutic trial in which there is no anticipated direct clinical benefit to the participant. In general,
p.000073: therefore, it should be conducted
p.000073: in participants who can give voluntary informed consent themselves and who
p.000073: can sign and date the written informed consent forms themselves, unless the therapy under investigation is for diseases
p.000073: specific to those who cannot give consent, such as children, in which case consent of the LAR may be taken.
...
p.000082: drug administration (MDA) trials, fortification of food, etc. Such studies typically involve the whole community. The
p.000082: study unit could be a group, area, institution, village, block, district, etc. and the whole population is expected to
p.000082: participate in the study. In such studies, different communities are randomized and allocated to different arms (see
p.000082: section 8 for further details).
p.000082: 7.12 Clinical trials of interventions in HIV/AIDS
p.000082: Clinical trials in HIV positive patients could be for the evaluation of new drugs, vaccines, other
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
p.000082: 7.12.1 Global studies in HIV/AIDS in specific communities should receive approval from the relevant national
p.000082: authority and any other relevant authority, such as the HMSC, where applicable, in addition to approval from the EC.
p.000082: 7.12.2 When testing for HIV is done, consent and pre-test- and post-test counselling should be done as per National
p.000082: AIDS Control Organization (NACO) guidelines.
p.000082: 7.12.3 Issues that may arise because of discordant couples should be addressed before initiating any
p.000082: study in people living with HIV/AIDS.
p.000082: 7.12.4 As HIV is a sexually transmitted disease and is potentially life-threatening, the right to life of the
p.000082: sexual partner must be respected over the right to privacy of the HIV positive individual.
p.000082: 7.12.5 Phase I studies are permissible in patients with HIV/AIDS if the drug under study cannot be tested in
p.000082: healthy participants due to expected toxicity of the IP.
p.000082:
p.000082: 82 INDIAN COUNCIL OF
p.000083: MEDICAL RESEARCH
p.000083:
p.000083: Clinical Trials of Drugs and
p.000083: other Interventions
p.000083:
p.000083: 7.12.6 A combined Phase I/II or Phase II study can be conducted in this population when other therapeutic options
p.000083: have been exhausted.
p.000083: 7.12.7 When a trial with a preventive HIV vaccine is conducted, it can result in positive serology. This does
...
p.000085: subjective evaluation criteria, for example, skin changes in a skin prick test or for the assessment of
p.000085: tolerability. There have to be clear justifications in the protocol for the use of a placebo and no irreversible harm
p.000085: should occur to the participant. Post-trial access to the standard of care diagnostic test must be assured.
p.000085: 7.14.5 Safety follow-up of patients in these trials should not be limited to the duration of the diagnostic
p.000085: procedure but may be extended for a longer period according to the pharmacokinetic and pharmacodynamic properties of
p.000085: the diagnostic agent.
p.000085: 7.14.6 Long-term safety (when appropriate) should be assessed especially for agents accumulating in the
p.000085: body, such as deposits of gadolinium in bones and skin.
p.000085: 7.15 Radioactive materials and X-rays
p.000085: Radioactive substances contain a radioactive isotope, and may be used for therapeutic or diagnostic purposes. If the
p.000085: radioactive substance is to be tested as a drug then all the ethical considerations described in previous sections will
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
p.000086: 7.15.1 The investigating site should have a license from the competent authority to store, handle and dispense the
p.000086: radioactive substance.
p.000086: 7.15.2 The investigator and clinical trial team must be competent and should have received appropriate training in
p.000086: handling radioactive substances and X-rays.
p.000086: 7.15.3 The protocol and ICD should clearly state the potential radiation exposure to which participants are likely
p.000086: to be exposed in quantitative terms to the whole body or per organ. This exposure must be within acceptable limits.
p.000086: 7.15.4 The EC may co-opt relevant expertise to review such protocols.
p.000086: 7.15.5 When a trial involving radioactive substances is planned in healthy participants, they should preferably
p.000086: have completed their family and receive radiation in a dose as low as permitted.
p.000086: 7.15.6 Women of childbearing age, children, radiation workers or any individual who has received more than the
p.000086: permissible amount of radiation in the past 12 months should be excluded from trials involving radioactive materials or
p.000086: X-rays.
p.000086: 7.15.7 In the event of death of a participant with a radiological implant, due precautions must be taken as per the
p.000086: prescribed radiation guidelines so as to ensure that relatives or close co-habitants are not exposed to radiation.
p.000086: 7.15.8 The protocol should make adequate provisions for detecting pregnancies to avoid risks of exposure to the
p.000086: embryo. Information must be given to the participant in the ICD about possible genetic damage to the offspring.
p.000086: 7.16 Investigator initiated clinical trials
p.000086: Academic institutions routinely carry out investigator initiated clinical trials.
p.000086: 7.16.1 In such trials, the investigator has the dual responsibility of being an investigator as well as the
p.000086: sponsor.
p.000086: 7.16.2 Financial arrangements must be made by the institution/investigator for the conduct of the study as
p.000086: well as to pay for free management of research-related injury and compensation, if applicable. Funds should be
p.000086: made available or appropriate mechanisms be established.
p.000086: 7.16.3 The institution must have or introduce policies that establish mechanisms to ensure quality of the data
p.000086: generated and safety of the intervention, such as monitoring,
p.000086:
p.000086: 86 INDIAN COUNCIL OF
p.000087: MEDICAL RESEARCH
p.000087:
p.000087: Clinical Trials of Drugs and
p.000087: other Interventions
p.000087:
p.000087: auditing, DSMB, etc.
p.000087: 7.16.4 When academic clinical trials are planned for “off-label” use of a drug (when a drug that is marketed is
p.000087: being used for a new indication/new dose/formulation/route) for purely academic purposes and not for commercial use,
p.000087: then such clinical trials designed by researchers/academicians may not currently require regulatory approval. However,
p.000087: an EC has to approve such studies after due consideration of benefits and risks and all other ethical aspects and the
p.000087: licensing authority has to be informed as per GSR 313(e) dated 16.3.2016 issued by CDSCO.
p.000087: 7.16.5 The trials must be registered in CTRI and there should be mechanism for appropriate methods for informed
p.000087: consent, conduct of trial and proper follow-up of patients.
p.000087: 7.16.6 For student conducting clinical trials as part of their academic thesis, the guide and the academic
p.000087: institution should take up the responsibilities of the sponsor.
p.000087: 7.17 Clinical trials on contraceptives
p.000087: Several methods of contraception are available including, barrier methods, hormonal methods, emergency contraception,
p.000087: intra-uterine and surgical methods. Since these studies are conducted in healthy participants, all efforts to minimize
p.000087: risks must be in place and the proposed benefits must justify the foreseeable risks. The following issues must be
p.000087: addressed while undertaking research on contraceptives whether they be drugs, devices or surgeries:
p.000087: 7.17.1 All procedures for clinical trials will be applicable.
p.000087: 7.17.2 For a new contraceptive method, non-comparative studies can be accepted. However, a sufficient number of
p.000087: cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
p.000087: 7.17.3 The comparator should, whenever possible, be chosen from among marketed products with a similar mechanism of
p.000087: action and schedule of use.
p.000087: 7.17.4 In women where a non-biodegradable implant has been used, a proper follow-up for removal of the implant
p.000087: should be done after the trial is over or the participant has withdrawn from the trial.
...
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
p.000090: 7.19.8 A post-trial access plan must be in place for patients who show benefit from an IP. In case it is a placebo
p.000090: controlled trial, those participants who have been in the placebo group may be offered post-trial access to the IP if
p.000090: found effective in other patients.
p.000090: 7.20 Clinical trials of products using any new technology
p.000090: If any product using new technologies (such as nanotechnology) is developed for human use and is to be evaluated in
p.000090: human beings, the following ethical issues have to be taken into consideration in addition to all the general ethical
p.000090: guidelines for clinical trials as elaborated in the guidelines.
p.000090: 7.20.1 Compliance with GLP, GMP, and GCP norms should be observed in research using new technology products.
p.000090: 7.20.2 Before the use of a new technology product in a human being, preclinical studies should be carried out and
p.000090: all applicable regulatory requirements fulfilled.
p.000090: 7.20.3 The new technology-based products should be contained and released into the environment in a
p.000090: step-wise manner after clearance from the appropriate authority regarding environmental safety.
p.000090: 7.20.4 Differing process based technologies can result in similarly functioning biological products which can
p.000090: give rise to IPR issues.
p.000090: 7.20.5 The research on new technologies should have a well-established mechanism or system for assessing the risk,
p.000090: both in terms of severity and temporality. The unpredictable
p.000090:
p.000090: 90 INDIAN COUNCIL OF
p.000091: MEDICAL RESEARCH
p.000091:
p.000091: Clinical Trials of Drugs and
p.000091: other Interventions
p.000091:
p.000091: metabolic behaviour in a human system during clinical trial cannot exclude long-term side effects which may manifest
p.000091: later, leading to compensation issues.
p.000091: 7.20.6 Training of all stakeholders should address issues regarding safe research, handling of products,
p.000091: environmental safety and community misconceptions.
p.000091: 7.21 Synthetic biology
p.000091: Synthetic biology is the application of science, technology and engineering to “facilitate and accelerate the design,
p.000091: manufacture and/or modification of genetic material of living organisms”.33 The ethical, legal and social issues
p.000091: pertain to the impact of this science on society, biosafety, biosecurity, IPRs, governance of such research, and socio-
p.000091: economics. Creation of organisms, molecular compounds and biological systems by manipulating biology through
p.000091: standardized engineering techniques has led to the rise of the biotechnology industry which includes genetically
p.000091: modified organisms, stem cells, cloning, artificial life forms like biofuels, bioweapons, vaccines,
p.000091: diagnostics, etc. Software and bioinformatics as design tools, along with constructional and diagnostic
p.000091: tools, play a major role in the synthesis. EC review, pre-market approval and registration should be aimed at
p.000091: protection of human beings and the environment.
p.000091: 7.21.1 Special considerations
p.000091: • Precautionary principle: This applies to the prevention of harm to humans, environment and ecosystem because
p.000091: development of a new technology may emit hazardous elements like X-ray radiation, electro-magnetic currents and
p.000091: non-ionizing magnetic waves in the environment, which may manifest only later. Safety measures should be followed as
p.000091: per the Environmental Protection Act, 1986, Atomic Energy Act34, Biomedical Waste Management Rules35, and other
p.000091: relevant laws.
p.000091: • Biosecurity: Sometimes, the product can have dual use, that is, one beneficial use for a particular
p.000091: purpose and the other for harmful use which could be unintentional or intentional, for example, use as a
p.000091: biological weapon. Therefore, to maintain security, the ICMR code of conduct for researchers involved in life sciences
p.000091: should be followed along with creation of a system for reporting and maintaining vigilance to prevent misuse. There
p.000091: should be effective partnership between researchers and policy makers to create a secure system.
p.000091: • GLP, GMP and GCP should be observed when conducting clinical trials.
p.000091: • Products should be contained and released into the environment in a step-wise
p.000091: manner after clearance from the appropriate authority regarding its safety.
p.000091:
p.000091: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000091: 91
p.000092:
p.000092: Clinical Trials of Drugs and
p.000092: other Interventions
p.000092:
p.000092: • Training should be given for safe handling of the product and conduct of research
p.000092: and should address community misconceptions.
p.000092: • Testing of biomaterials and biocompatibility should be as per relevant Indian regulatory standards or
p.000092: American Society for Testing and Materials (ASTM)36 international standards until Indian standards for biomaterials are
p.000092: in place. The testing of such standards shall be done in a laboratory certified by the National Accreditation Board for
p.000092: Testing and Calibration Laboratories (NABL).
p.000092: • Appropriate training for safety of healthcare workers should be given and they should be provided periodic
p.000092: health check-ups due to exposure to occupational risks.
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: 92 INDIAN COUNCIL OF
p.000093: MEDICAL RESEARCH
p.000093:
p.000093: SECTION 8
p.000093:
p.000093: PUBLIC HEALTH RESEARCH
p.000093:
p.000093: 8.0 Public health raises a complex relationship between the state, its policies and society involving individuals
p.000093: and organizations with a precautionary approach. Ethics in public health apply to both practice and research,
...
p.000097: health-related policy and practice. They can also help define a relevant research and development agenda.
p.000097: • Prior approval from competent state/national authorities and from the community leadership is required to
p.000097: set-up the demographic surveillance sites, with or without the use of geographic information system (GIS) facilities.
p.000097: Setting-up such sites need not be subject to prior review and approval by an EC.
p.000097: • Strategies for research studies to be undertaken at these sites including data-set collection and its
p.000097: storage, with plans to maintain confidentiality, will have to undergo appropriate EC review. To safeguard the
p.000097: confidentiality of personally identifiable records, the collected data at demographic sites must be stored in an
p.000097: encrypted format with primary identifiers accessible only to restricted designated individuals who are bound by a
p.000097: confidentiality agreement.
p.000097: • Spatial epidemiology, including use of GIS technology, in health is an evolving area and the related
p.000097: ethical issues that may emerge need to be addressed as experience grows.
p.000097: • Registries are a systematic collection of data concerning a particular diseases and/ or health conditions at
p.000097: one or more places. For registries that are established as part of research projects or if the data emerging from these
p.000097: registries is proposed to be used for research, prior approval of the EC is required.
p.000097: • On the other hand, registries that are set-up as part of public health programmes by a national authority may
p.000097: be exempted from the ethical review process if the data is de-identified, but are subject to governance processes and a
p.000097: certificate
p.000097:
p.000097: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000097: 97
p.000098:
p.000098:
p.000098: Public Health Research
p.000098:
p.000098: from an EC for exemption for ethics review and if required for waiver of informed consent.
p.000098: • The ethical concerns for EC approval are similar to those mentioned in section
p.000098: 8.3.
p.000098: 8.2.4 Implementation research
p.000098: At local, national and global levels, a persistent challenge is to effectively implement and scale-up policies,
p.000098: programmes and interventions that can save lives and improve health. A new approach to achieving these goals is through
p.000098: implementation research (IR), which facilitates informed decisions about health policies, programmes and clinical
p.000098: practices. IR is a type of health policy and systems research that draws on many traditions and disciplines of research
p.000098: and practice. It builds on operations research, participatory action research, management science, quality improvement,
p.000098: implementation science and impact evaluation. For research to be relevant to public health it is co-designed and
p.000098: co-implemented with implementers and end users to understand and encourage uptake of a piloted or completed research or
p.000098: programme. This requires a long-term mutually advantageous relationship between researchers, other stakeholders and the
p.000098: community from the inception stage of the research project involving issues such as framing of questions, research
p.000098: design and delivery of strategy for influencing implementation and wider dissemination as part of its design. IR
...
p.000100: • Partnership between the researcher(s) and the representation from the department or the organization from
p.000100: where data is sourced is considered an important strategy to take care of some of these concerns.
p.000100: • ECs should ensure that research using administrative data does not violate any
p.000100: principles of public health research ethics.
p.000100: 8.4 Informed consent
p.000100: 8.4.1 Obtaining informed consent – Several public health research studies, such as cluster
p.000100:
p.000100: 100 INDIAN COUNCIL OF MEDICAL
p.000101: RESEARCH
p.000101:
p.000101:
p.000101: Public Health Research
p.000101:
p.000101: randomized field trials or IR, have participants who cannot avoid interventions. This implies that
p.000101: participant’s informed consent refers only to data collection, not administration of an intervention.
p.000101: Occasionally, complete participant information may be a source of selection bias, which then raises methodological
p.000101: concerns. Participant informed consent in such types of research protocols should therefore be differently reviewed by
p.000101: an EC than in individually randomized trials because of methodological consequences.
p.000101: 8.4.2 The hierarchical structure of such trials imply consideration of two levels of consent. The first level is the
p.000101: gatekeeper(s) who could be the guardian or local authority normally responsible for participants’ well-being; who
p.000101: give permission for participation and randomization of individual participation. The other level is individual
p.000101: participants, consent from whom can cover different aspects:
p.000101: • consent that routinely held data on individuals be collected;
p.000101: • consent regarding the collection of supplementary data;
p.000101: • consent for active participation;
p.000101: • Field trials which involve new pharmaceutical agents require individual consent
p.000101: for both intervention and collection of data.
p.000101: 8.4.3 Types of consent
p.000101: Written voluntary informed consent is the norm for research. However, for specific research the following types of
p.000101: consent may be considered by the EC.
p.000101: Box 8.2 Types of Consent
p.000101: • Verbal/oral consent: For research on sensitive topics, verbal/oral consent or pseudonyms
p.000101: may be suitable with appropriate approval of the EC and with proper documentation.
p.000101: • Broad consent: Providing an individual opt-out option, consultation may be held with
...
p.000115: may have explanations/details on the following elements:
p.000115: • the nature and complexity of information that would be generated;
p.000115: • the nature and consequences of return of results and choice offered to the participant whether to
p.000115: receive that information or not and incidental findings, if any;
p.000115: • direct/indirect benefits and their implications including if there are no direct
p.000115: benefits to the participants;
p.000115: • how the data/samples will be stored, for how long, and procedures involved in
p.000115: anonymisation, sharing , etc. See section 11 for further details;
p.000115: • choice to opt out of testing/withdraw from research at any time;
p.000115: • whether the affected individual or the proband would like to share her/his genetic
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
p.000115: • In case of population or community based studies, it may be noted that the genetic research may generate
p.000115: information applicable to the community/populations from which the participants were drawn, and therefore, group
p.000115: consent must be taken from the community head and/or the culturally appropriate authority.
p.000115: • Even if group consent is taken, it will not be a replacement for individual consent
p.000115: as individual consent is important. See section 5 for further details.
p.000115: • Researchers should be aware of potential stigmatization of the entire group and must explain ways to
p.000115: avoid the same during the conduct of research and publication of research results.
p.000115: 10.5 Culturally sensitive issues
p.000115: 10.5.1 Transmission of a genetic abnormality from parents, especially the mother to the foetus, could be
p.000115: a very sensitive cultural issue. Such possibility arises when during routine testing or prenatal diagnosis it is
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
p.000115: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000115: 115
p.000116:
p.000116: Human
p.000116: Genetics Testing and Research
p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
...
p.000151: NABH National Accreditation Board for Hospitals and Healthcare Providers NABL National
p.000151: Accreditation Board for Testing and Calibration Laboratories NACO National AIDS Control Organization
p.000151: NAC-SCRT National Apex Committee for Stem Cell Research and Therapy
p.000151: PGD/ PGS pre-implantation genetic diagnosis/screening
p.000151: PIS participant information sheet
p.000151: RCR responsible conduct of research
p.000151: SAE serious adverse events
p.000151: SIDCER Strategic Initiative for Developing Capacity in Ethical Review
p.000151: SOP standard operating procedure
p.000151: TM traditional medicines
p.000151: TOR terms of reference
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000151: 151
p.000152:
p.000152: GLOSSARY
p.000152: 1. Accountability The obligation of an individual or organization to account for its activities, accept
p.000152: responsibility for them and to disclose the results in a transparent manner.
p.000152: 2. Adverse event Any untoward medical occurrence in a patient or participant involved in a study
p.000152: which does not necessarily have a causal relationship with the intervention. The adverse event can therefore be
p.000152: any unfavourable or unintended sign or experience, whether or not related to the product under investigation.
p.000152:
p.000152: 3. Appellate
p.000152: authority
p.000152: It decides on the appeal filed against a decision of the lower authority. Its mandate is to ensure
p.000152: that due process of law is followed.
p.000152: 4. Assent To agree or approve after thoughtful consideration an idea or suggestion to
p.000152: participate in research by a young person below the age of 18 years who is old enough to understand the implications of
p.000152: any proposed research but not legally eligible to give consent. The assent has to be corroborated with informed consent
p.000152: of parent/ LAR.
p.000152: 5. Audit A systematic and independent examination of research activities and documents to
p.000152: determine whether the review and approval activities were conducted, data recorded and accurately reported as per
p.000152: applicable guidelines and regulatory requirements.
p.000152: 6. Autonomy The ability and capacity of a rational individual to make an independently
p.000152: informed decision to volunteer as a research participant.
p.000152:
p.000152: 7. AYUSH intervention
p.000152: Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized
p.000152: traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani,
p.000152: Siddha, Homoeopathy, SOWA- RIGPA).
p.000152:
...
p.000155:
p.000155: 33 Informed
p.000155: consent document (ICD)
p.000155: Written signed and dated paper confirming a participant’s
p.000155: willingness to voluntarily participate in a particular research, after having been informed of all aspects of
p.000155: the research that are relevant for the participant’s decision to participate.
p.000155: 34 Justice Pertains to fairness in the way people are dealt with, indicating fair
p.000155: selection and distribution of benefits and risks to participants who should be fully apprised about them.
p.000155: 35 Lay person A literate person who has not pursued a medical science/health-
p.000155: related career in the last 5 years and is aware of the local language, cultural and moral values of the community.
p.000155: 36 Legal expert A person with a basic degree in law from a recognized university,
p.000155: with experience.
p.000155:
p.000155: 37 Legally acceptable representative (LAR)
p.000155:
p.000155: 38 Legally authorized representative (LAR)
p.000155: A person who will give consent on behalf of a prospective participant who, for either legal or medical
p.000155: reasons, is unable to give consent herself/himself to participate in research or to undergo a diagnostic,
p.000155: therapeutic or preventive procedure as per research protocol, duly approved by the EC.
p.000155: A person who, under applicable law or judicial authority, can give
p.000155: consent on behalf of a prospective participant who, for either legal or medical reasons, is unable to give
p.000155: consent herself/himself to participate in research or to undergo a diagnostic, therapeutic or preventive procedure as
p.000155: per research protocol, duly approved by the ethics committee.
p.000155: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000155: 155
p.000156:
p.000156:
p.000156: Glossary
p.000156: 39 Maleficence The act of committing harm or a harmful act.
p.000156:
p.000156: 40 Marginalized communities
p.000156: A group of people actively separated or excluded from the rest of society.
p.000156: 41 Minimal risk Probability of harm or discomfort anticipated in the research is
p.000156: not greater than that ordinarily encountered in routine daily life activities of a healthy individual or general
p.000156: population or during the performance of routine physical or psychological examinations or tests. However, in some
p.000156: cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but
p.000156: this may be within the range of minimal risk for the research participant since it would be undertaken as
p.000156: part of current everyday life.
p.000156:
p.000156: 42 Non-
p.000156: therapeutic trial
p.000156: A trial which is unlikely to produce any direct benefit to the
...
p.000156: conversation, privileges, etc.
p.000156:
p.000156: 44 Particularly vulnerable tribal group (PVTG)
p.000156: These are a special class of tribal groups, classified as such by the Government of India, due to their
p.000156: especially low development indices when compared to other local tribes. These were classified under the Dhebar
p.000156: Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national
p.000156: scale, and help them to get included in mainstream development, while using their indigenous knowledge. They have a
p.000156: pre-agricultural system of existence as mainly hunters with zero or negative population growth, extremely low
p.000156: level of literacy and no written language.
p.000156: 45 Pilot studies A pilot study, project or experiment is a small-scale preliminary
p.000156: study conducted in order to evaluate feasibility, time, cost, adverse events and effect size (statistical
p.000156: variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to
p.000156: performance of a full-scale research project.
p.000156:
p.000156:
p.000156:
p.000156:
p.000156: 156 INDIAN COUNCIL OF MEDICAL
p.000157: RESEARCH
p.000157:
p.000157: Glossary
p.000157:
p.000157: 46 Pivotal trial A clinical trial or study intended to provide evidence for drug marketing
p.000157: approval from the licensing authority; usually a Phase III study which presents the data that the licensing authority
p.000157: uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of
p.000157: adequate size, and whenever possible, double-blind.
p.000157:
p.000157: 47 Post-marketing
p.000157: surveillance
p.000157:
p.000157: 48 Professional competence
p.000157: 49 Principal
p.000157: investigator
p.000157:
p.000157:
p.000157: 50 Psychosocial harm
p.000157: The practice of monitoring the safety of a pharmaceutical drug or
p.000157: medical device after it has been released on the market. This is an important part of the science of pharmacovigilance.
p.000157: The broad professional knowledge, attitude and skills required in
p.000157: order to work in a specialized area or profession.
p.000157: An individual or the leader of a group of individuals who initiates and takes full responsibility for the conduct of
p.000157: biomedical health research; if there is more than one such individual, they may be called co-principal investigators/
p.000157: co-investigators.
p.000157: Research, particularly psychology studies, can put participants in
p.000157: situations that may make them feel uncomfortable while learning about their reaction to a situation. The result can be
p.000157: psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or
p.000157: depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.
p.000157: 51 Quorum Minimum number and/or kind of EC members required for
p.000157: decision making during a meeting.
p.000157:
p.000157: 52 Research-
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000055: members ordinarily required to conduct a meeting must be present while giving consent. Individual consent is important
p.000055: and required even if the community gives permission.
p.000055: 5.10.3 Consent from vulnerable groups
p.000055: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own interests
p.000055: and providing valid informed consent. The list of vulnerable populations/communities is given in Box 6.2.
p.000055: 5.11 Consent for studies using deception
p.000055: Some types of research studies require deception due to nature of research design. A true informed consent may lead to
p.000055: modification and may defeat the purpose of research. Such research may be carefully reviewed by the EC before
p.000055: implementation.
p.000055: 5.11.1 True informed consent in studies involving deception is difficult due to the nature of research. A two-step
p.000055: procedure may be required comprising an initial consent and a debriefing after participation.
p.000055: 5.11.2 The possibility of unjustified deception, undue influence and intimidation should be avoided at all costs.
p.000055: Although deception is not permissible, approval may be taken from the EC in circumstances where some information
p.000055: requires to be withheld for validation until the completion of the research.
p.000055: 5.11.3 In such instances, an attempt should be made to debrief the participants/communities after completion of the
p.000055: research.
p.000055:
p.000055: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000055: 55
p.000056:
p.000056: VULNERABILITY
p.000056: SECTION 6
p.000056: 6.0 The word vulnerability is derived from the Latin word vulnarere which means ‘to wound’.
p.000056: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own
p.000056: interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or
p.000056: ability to communicate or are in a situation that prevents them from doing so. These vulnerable persons have some
p.000056: common characteristics which are listed in Box 6.1.
p.000056: Box 6.1 Characteristics of vulnerable individuals/populations/group
p.000056:
p.000056: Individuals may be considered to be vulnerable if they are:
p.000056: • socially, economically or politically disadvantaged and therefore susceptible to being
p.000056: exploited;
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p. xv: the society. The Indian Council of Medical Research (ICMR) issued the Policy Statement on Ethical Considerations
p. xv: Involved in Research on Human Subjects in 1980.1 Due to rapid advances in biomedical science and technology, new
p. xv: ethical dimensions emerged which necessitated further updation of these guidelines. Subsequently the Ethical Guidelines
p. xv: for Biomedical Research on Human Subjects was released in 2000,2 followed by the revised Ethical Guidelines for
p. xv: Biomedical Research on Human Participants in 2006.3 In the meantime, the Central Drugs Standard Control Organization
p. xv: (CDSCO) also released the Indian Good Clinical Practice Guidelines (2001)4 for clinical trials and revised Schedule Y
p. xv: of the Drugs and Cosmetics Act, 1940, in the year 20055 with several amendments in the Rules under Drugs and Cosmetics
p. xv: Act in the year 2013. ICMR and the Department of Biotechnology (DBT) jointly brought out Guidelines for Stem Cell
p. xv: Research and Therapy in 2007 and a further revision in 2013 which is now revised as National Guidelines for Stem Cell
p. xv: Research, 2017.6
p. xv: The Nuremberg Code of 1947 7was the first international treatise on the ethics of research involving human beings
p. xv: and highlighted the essentiality of obtaining voluntary consent. In 1964, the World Medical Association
p. xv: formulated guidelines on conducting research on humans, known as the Declaration of Helsinki. This has undergone
p. xv: seven revisions with the latest version being issued in October 2013 at Fortaleza, Brazil.8
p. xv: In 1979, the Belmont Report released by the National Commission for the Protection of Human Subjects of Biomedical and
p. xv: Behavioural Research in the United States of America (USA), for the first time enunciated the three basic ethical
p. xv: principles for research involving human subjects: respect for persons, beneficence and justice.9 The Department of
p. xv: Health and Human Services (DHHS), USA, released the Federal Policy for the Protection of Human Subjects as the ‘Common
p. xv: Rule’ in 1991 (revised in 2017).10 The International Conference on Harmonization (ICH) brought out the Good Clinical
p. xv: Practice Guidelines E6 (R1) in 199611 revised as E6 (R2) in 2016.12 The National Bioethics Advisory Commission, USA
p. xv: (2001),13 the Council for International Organizations of Medical Sciences (CIOMS), Geneva (2002 revised in 2016),14,15
p. xv: and the Nuffield Council of Bioethics, United Kingdom (2002)16 released recommendations/guidelines relevant
p. xv:
p. xv: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000001: 1
p.000002:
p.000002:
p.000002: Introduction
p.000002: to research in developing countries. UNESCO’s Universal Declaration on Bioethics and Human Rights (2005)17 and
p.000002: other international instruments on human rights further defined the Universal Codes of Ethics to be adopted by
p.000002: the member countries. The revised ICMR ethical guidelines have adapted important guidance points from these
...
p.000143: 1. Policy statement on ethical considerations involved in research on human subjects. New Delhi: Indian Council
p.000143: of Medical Research; 1980.
p.000143: 2. Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research;
p.000143: 2000.
p.000143: 3. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical
p.000143: Research; 2006.
p.000143: 4. Good clinical practice. New Delhi: Central Drugs Standard Control Organization; 2004. Available from:
p.000143: http://www.cdsco.nic.in/html/gcp1.html (accessed 31 Aug 2017).
p.000143: 5. Schedule Y of the Drugs and Cosmetics Act, 1940, amended on June 2005, India [statute on the
p.000143: Internet]. Available from: http://cdsco.nic.in/writereaddata/ Drugs&CosmeticAct.pdf (accessed 06 Aug 2017).
p.000143: 6. National guidelines for stem cell research. New Delhi: Indian Council of Medical Research and Department of
p.000143: Biotechnology; 2017.
p.000143: 7. The Nuremberg Code, 1947. In: Trials of war criminals before the Nuremberg Military Tribunals under Control
p.000143: Council Law No. 10. Washington DC: US Government Printing Office; 1949; 2:181-182.
p.000143: 8. Declaration of Helsinki: ethical principles for medical research involving human subjects.
p.000143: Fortaleza: World Medical Association. 2013; Available from: https://www.
p.000143: wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf (accessed 08 Sept 2017).
p.000143: 9. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The
p.000143: Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC:
p.000143: Department of Health, Education and Welfare; 1979.
p.000143: 10. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human
p.000143: Services; (1991); 2001, 2017.
p.000143: 11. Good clinical practice guidelines E6 (R1). The International Conference on Harmonization; 1996.
p.000143: Available from: https://www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
p.000143: (accessed 02 Sept 2017).
p.000143: 12. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Available from:
p.000143: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E6/E6_R2 Step_4.pdf (accessed 02 Sep
p.000143: 2017).
p.000143:
p.000143: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000143: 143
p.000144:
p.000144:
p.000144: List of references
p.000144:
p.000144: 13. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda: The National
p.000144: Bioethics Advisory Commission; August, 2001.
p.000144: 14. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2002.
p.000144: 15. International ethical guidelines for health-related research involving humans. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2016.
p.000144: 16. Nuffield Council on Bioethics; 2007.
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p. xv: Research and Therapy in 2007 and a further revision in 2013 which is now revised as National Guidelines for Stem Cell
p. xv: Research, 2017.6
p. xv: The Nuremberg Code of 1947 7was the first international treatise on the ethics of research involving human beings
p. xv: and highlighted the essentiality of obtaining voluntary consent. In 1964, the World Medical Association
p. xv: formulated guidelines on conducting research on humans, known as the Declaration of Helsinki. This has undergone
p. xv: seven revisions with the latest version being issued in October 2013 at Fortaleza, Brazil.8
p. xv: In 1979, the Belmont Report released by the National Commission for the Protection of Human Subjects of Biomedical and
p. xv: Behavioural Research in the United States of America (USA), for the first time enunciated the three basic ethical
p. xv: principles for research involving human subjects: respect for persons, beneficence and justice.9 The Department of
p. xv: Health and Human Services (DHHS), USA, released the Federal Policy for the Protection of Human Subjects as the ‘Common
p. xv: Rule’ in 1991 (revised in 2017).10 The International Conference on Harmonization (ICH) brought out the Good Clinical
p. xv: Practice Guidelines E6 (R1) in 199611 revised as E6 (R2) in 2016.12 The National Bioethics Advisory Commission, USA
p. xv: (2001),13 the Council for International Organizations of Medical Sciences (CIOMS), Geneva (2002 revised in 2016),14,15
p. xv: and the Nuffield Council of Bioethics, United Kingdom (2002)16 released recommendations/guidelines relevant
p. xv:
p. xv: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000001: 1
p.000002:
p.000002:
p.000002: Introduction
p.000002: to research in developing countries. UNESCO’s Universal Declaration on Bioethics and Human Rights (2005)17 and
p.000002: other international instruments on human rights further defined the Universal Codes of Ethics to be adopted by
p.000002: the member countries. The revised ICMR ethical guidelines have adapted important guidance points from these
p.000002: international guidelines keeping in mind the diverse socio-cultural milieu of our country.
p.000002: The socio-cultural ethos in India and its varying standards of healthcare pose unique challenges to the application of
p.000002: universal ethical principles to biomedical and health research. The last decade has seen emerging ethical issues
p.000002: necessitating further revision of the earlier guidelines and preparation of the current National Ethical Guidelines for
p.000002: Biomedical and Health Research Involving Human Participants, 2017. These guidelines have covered some newer areas like
p.000002: public health research, social and behavioural sciences research for health and responsible conduct of research, and
p.000002: research during humanitarian emergencies and disasters while a few other specialized areas like informed consent
...
General/Other / common rule
Searching for indicator commonXrule:
(return to top)
p.000143: http://www.cdsco.nic.in/html/gcp1.html (accessed 31 Aug 2017).
p.000143: 5. Schedule Y of the Drugs and Cosmetics Act, 1940, amended on June 2005, India [statute on the
p.000143: Internet]. Available from: http://cdsco.nic.in/writereaddata/ Drugs&CosmeticAct.pdf (accessed 06 Aug 2017).
p.000143: 6. National guidelines for stem cell research. New Delhi: Indian Council of Medical Research and Department of
p.000143: Biotechnology; 2017.
p.000143: 7. The Nuremberg Code, 1947. In: Trials of war criminals before the Nuremberg Military Tribunals under Control
p.000143: Council Law No. 10. Washington DC: US Government Printing Office; 1949; 2:181-182.
p.000143: 8. Declaration of Helsinki: ethical principles for medical research involving human subjects.
p.000143: Fortaleza: World Medical Association. 2013; Available from: https://www.
p.000143: wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf (accessed 08 Sept 2017).
p.000143: 9. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The
p.000143: Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC:
p.000143: Department of Health, Education and Welfare; 1979.
p.000143: 10. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human
p.000143: Services; (1991); 2001, 2017.
p.000143: 11. Good clinical practice guidelines E6 (R1). The International Conference on Harmonization; 1996.
p.000143: Available from: https://www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
p.000143: (accessed 02 Sept 2017).
p.000143: 12. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Available from:
p.000143: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E6/E6_R2 Step_4.pdf (accessed 02 Sep
p.000143: 2017).
p.000143:
p.000143: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000143: 143
p.000144:
p.000144:
p.000144: List of references
p.000144:
p.000144: 13. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda: The National
p.000144: Bioethics Advisory Commission; August, 2001.
p.000144: 14. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2002.
p.000144: 15. International ethical guidelines for health-related research involving humans. Geneva: Council for
p.000144: International Organizations of Medical Sciences; 2016.
p.000144: 16. Nuffield Council on Bioethics; 2007.
p.000144: 17. Universal Declaration on Bioethics and Human Rights. Paris: Adopted by United Nations Educational, Scientific
p.000144: and Cultural Organization’s General Conference; 2005.
p.000144: 18. Guidelines for laboratory animal facilities. Committee for the Purpose of Control and Supervision of
p.000144: Experiments on Animals; 2003.
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.000094: 8.2 Ethical issues of epidemiological and
p.000094: public health research study designs 96
p.000094: 8.3 Use of administrative and other data sources for research 100
p.000094: 8.4 Informed consent 100
p.000094: 8.5 Role of EC 102
p.000094: 8.6 Protecting participants and communities 103
p.000094: 8.7 Stakeholders in public health research 103
p.000094: Section 9 Social and behavioural sciences research for health 104
p.000094: 9.1 Some key features 104
p.000094: 9.2 Addressing the ethical challenges 105
p.000094: Section 10 Human genetics testing and research 112
p.000094: 10.1 General issues 112
p.000094: 10.2 Genetic counselling 113
p.000094: 10.3 Privacy and confidentiality 113
p.000094: 10.4 Informed consent 114
p.000094: 10.5 Culturally sensitive issues 115
p.000094: 10.6 Storage of samples for future genetic research 116
p.000094: 10.7 Results of genetic testing 116
p.000094: 10.8 Publication aspects 116
p.000094:
p.000094: 10.9 Commercialization and COI 117
p.000094: 10.10 Role of the team in genetic testing and research 117
p.000094: 10.11 Quality standards of the laboratory 117
p.000094: 10.12 Misuse of genetic technology 118
p.000094: 10.13 Genetic diagnosis/testing and screening 118
p.000094: 10.14 Gene therapy 122
p.000094: 10.15 Use of newer technologies 123
p.000094: 10.16 Research on human embryos 125
p.000094: 10.17 Foetal autopsy 126
p.000094: Section 11 Biological materials, biobanking and datasets 127
p.000094: 11.1 Biobanking 127
p.000094: 11.2 Storage of biospecimens and data
p.000094: with their personal identifiers 128
...
p.000011: including but not limited to being economically or socially disadvantaged, (for example, certain ethnic or religious
p.000011: groups, individuals/communities which have hierarchical relationships, institutionalized persons, humanitarian
p.000011: emergencies, language barriers and cultural differences).
p.000011: 2.9.2 In general, such participants should be included in research only when the research is directly answering the
p.000011: health needs or requirements of the group. On the other hand, vulnerable populations also have an equal right to be
p.000011: included in research so that benefits accruing from the research apply to them as well. This needs careful
p.000011: consideration by researchers as well as the EC.
p.000011: 2.9.3 The EC should determine vulnerability and ensure that additional safeguards and monitoring mechanisms
p.000011: are established. It should also advise the researcher in this regard. See section 6 for further details.
p.000011: 2.10 Community engagement
p.000011: Community can be defined as a social group of people of any size sharing the same geographical location, beliefs,
p.000011: culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during
p.000011: and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs
p.000011: and requirements.
p.000011: 2.10.1 The community can be engaged in many ways and can provide valuable opinions. The degree of community engagement
p.000011: should depend on the type of research that is being conducted.
p.000011: 2.10.2 Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants
p.000011: are to be drawn), the researchers and the concerned EC. Members of the CAB should be such that they do not coerce the
p.000011: members of the community to participate in the research and also protect the rights and serve the
p.000011: requirements of the group.
p.000011: 2.10.3 Members of the community can also be represented in the EC either as members or special invitees.
p.000011: 2.10.4 Community engagement does not replace individual informed consent. It ensures that the community’s
p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
p.000012: General Ethical Issues
p.000012:
p.000012: representative, local institution or the government department from where the data was collected to help in
...
p.000054: • research requires a long-term follow-up or requires extension;
p.000054: • there is a change in treatment modality, procedures, site visits, data collection methods or tenure of
p.000054: participation which may impact the participant’s decision to continue in the research; and
p.000054: • there is possibility of disclosure of identity through data presentation or photographs (this
p.000054: should be camouflaged adequately) in an upcoming publication.
p.000054: • the partner/spouse may also be required to give additional re-consent in some
p.000054: of the above cases.
p.000054: 5.9 Procedures after the consent process
p.000054: 5.9.1 After consent is obtained, the participant should be given a copy of the PIS and signed ICF unless the
p.000054: participant is unwilling to take these documents. Such reluctance should be recorded.
p.000054: 5.9.2 The researcher has an obligation to convey details of how confidentiality will be maintained to
p.000054: the participant.
p.000054: 54 INDIAN COUNCIL OF
p.000055: MEDICAL RESEARCH
p.000055:
p.000055:
p.000055: Informed Consent Process
p.000055:
p.000055: 5.9.3 The original PIS and ICF should be archived as per the requirements given in the guidelines and regulations.
p.000055: 5.10 Special situations
p.000055: 5.10.1 Gatekeepers
p.000055: Permission of the gatekeepers, that is, the head/leader of the group or culturally appropriate authorities,
p.000055: may be obtained in writing or audio/video recorded on behalf of the group and should be witnessed.
p.000055: 5.10.2 Community consent
p.000055: In certain populations, the community plays an important role in the consent process. Some participants may not
p.000055: participate in the research unless the community’s consent is available. There may be situations when individual
p.000055: consent cannot be obtained as it will change the behaviour of the individual (see section 8 for further details). In
p.000055: such situations community consent is required. When permission is obtained from an organization that represents the
p.000055: community, the quorum required for such a committee must be met. For example, in a village panchayat the number of
p.000055: members ordinarily required to conduct a meeting must be present while giving consent. Individual consent is important
p.000055: and required even if the community gives permission.
p.000055: 5.10.3 Consent from vulnerable groups
p.000055: Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own interests
...
p.000065: transgender (LGBT) community as a special invitee/member to participate in the meeting of the EC if
p.000065: there is a research proposal involving these participants.
p.000065: 6.6.3 The EC can suggest setting up of a community advisory board to act as an interface between the researcher(s)
p.000065: and the community.
p.000065: 6.6.4 Among the LGBT community there are inhibitions between the different groups, so details of the research should
p.000065: be explained to each group separately.
p.000065: 6.6.5 Peer educators or champions among the LGBT community could be educated and sensitized first. They
p.000065: would in turn explain the details to the potential participants from the community who would then understand them
p.000065: better.
p.000065: 6.7 Research among tribal population
p.000065: 6.7.1 Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and
p.000065: preventive nature with appropriate benefits to the tribal population.
p.000065: 6.7.2 Due approval from competent administrative authorities, like the tribal welfare commissioner or
p.000065: district collector, should be taken before entering tribal areas.
p.000065: 6.7.3 Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who
p.000065: work closely with the tribal groups and have their confidence.
p.000065: 6.7.4 Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the
p.000065: person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact
p.000065: should be sought.
p.000065: 6.7.5 Informed consent should be taken in consultation with community elders and persons who know the local
p.000065: language/dialect of the tribal population and in the presence of appropriate witnesses.
p.000065: 6.7.6 Even with permission of the gatekeeper, consent from the individual participant must be sought.
p.000065: 6.7.7 Additional precautions should be taken to avoid inclusion of children, pregnant women and elderly people
p.000065: belonging to particularly vulnerable tribal groups (PVTG).25
p.000065: 6.7.8 Benefit sharing with the tribal group should be ensured for any research done using tribal knowledge that may
p.000065: have potential for commercialization.
p.000065: 6.8 Research involving individuals with mental illness or cognitively impaired/affected individuals
p.000065: Mental illness: According to the World Health Organization, mental disorders comprise
p.000065:
p.000065: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000065: 65
p.000066:
p.000066:
p.000066: Vulnerability
...
p.000082: Box 7.6 Conditions for sham surgery
p.000082: 1. There has to be a clear description of the justifications to include a sham surgery group in the protocol, which
p.000082: must be assessed by the EC.
p.000082: 2. There should be no serious harm caused by the sham surgery.
p.000082: 3. The participant must get access to appropriate, relevant intervention at the end of the trial.
p.000082:
p.000082: 7.11 Community trials (public health interventions)
p.000082: Community trials are studies involving whole communities and are conducted to evaluate preventive strategies like mass
p.000082: drug administration (MDA) trials, fortification of food, etc. Such studies typically involve the whole community. The
p.000082: study unit could be a group, area, institution, village, block, district, etc. and the whole population is expected to
p.000082: participate in the study. In such studies, different communities are randomized and allocated to different arms (see
p.000082: section 8 for further details).
p.000082: 7.12 Clinical trials of interventions in HIV/AIDS
p.000082: Clinical trials in HIV positive patients could be for the evaluation of new drugs, vaccines, other
p.000082: preventive measures and diagnostic tests. Apart from the general ethical principles that apply to all clinical trials,
p.000082: some special issues need to be addressed when clinical trials are planned in patients with HIV/AIDS. Social stigma,
p.000082: culturally embedded myths about HIV, marginalization, lack of legal status or criminalization of some communities that
p.000082: are susceptible to HIV or the disparity in standards of care in different parts of the world are examples of special
p.000082: issues.
p.000082: 7.12.1 Global studies in HIV/AIDS in specific communities should receive approval from the relevant national
p.000082: authority and any other relevant authority, such as the HMSC, where applicable, in addition to approval from the EC.
p.000082: 7.12.2 When testing for HIV is done, consent and pre-test- and post-test counselling should be done as per National
p.000082: AIDS Control Organization (NACO) guidelines.
p.000082: 7.12.3 Issues that may arise because of discordant couples should be addressed before initiating any
p.000082: study in people living with HIV/AIDS.
p.000082: 7.12.4 As HIV is a sexually transmitted disease and is potentially life-threatening, the right to life of the
p.000082: sexual partner must be respected over the right to privacy of the HIV positive individual.
p.000082: 7.12.5 Phase I studies are permissible in patients with HIV/AIDS if the drug under study cannot be tested in
...
p.000107: research is undertaken.
p.000107: 9.2.5 Community engagement
p.000107: While devising methods and interpreting observations, researchers should engage potential participants and
p.000107: communities in a meaningful participatory process
p.000107:
p.000107: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000107: 107
p.000108:
p.000108: Social and Behavioural Sciences
p.000108: Research for Health
p.000108:
p.000108: that involves them in an early and sustained manner in the design, development, implementation and
p.000108: monitoring of research, and in the dissemination of its results.
p.000108: 9.2.6 Informed consent
p.000108: Human participants in a proposed research study must be informed about the nature of the research project, and
p.000108: researchers/research teams must obtain their voluntary consent prior to their participation in the study. The different
p.000108: types of informed consent processes in social and behavioural sciences research are provided in Box 9.4.
p.000108: Box 9.4 Informed consent in social and behavioural sciences research on health
p.000108: 1. Community consent/gatekeeper consent/individual consent: Individual informed consent has to be taken after
p.000108: obtaining the permission of gatekeepers, such as community heads or leaders/ culturally appropriate local
p.000108: authorities/healthcare providers/institutions or organizations responsible for community welfare or their appointed
p.000108: advocates. Consent procedures must respect local cultural customs, however, community traditions do not substitute for
p.000108: individual consent unless a waiver has been granted.
p.000108: 2. Participant consent: Researchers must develop culturally appropriate ways to communicate information
p.000108: necessary for adherence to the standard required in the informed consent process.
p.000108: 3. Selective withholding of study information: ECs may permit selective withholding of
p.000108: information/hypothesis of the study in the consent form for achieving overall social and public good, without
p.000108: influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if
p.000108: applicable. Authorized deception as described in section 5.11 is also applicable here.
p.000108: 4. Participant refusal: Often the power differences between participants and researchers in India make it difficult
p.000108: for people to explicitly refuse to participate. Researchers should be alert to cultural symbols of refusal,
p.000108: such as body language, silence, monosyllabic replies, or restlessness that communicate discomfort. They must not
p.000108: persist with the research under these circumstances.
p.000108: 5. Relational autonomy: Individuals are socially embedded wherein the person’s identity is shaped by social
p.000108: determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision
p.000108: making. Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social
...
p.000108: giving consent.
p.000108: 6. Waiver of informed consent: If the research has important social and public health value and poses no more than
p.000108: minimal risks to participants, the EC may waive the requirement for individual informed consent if it is convinced that
p.000108: the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful
p.000108: practices. See section 5.7 for further details.
p.000108: 108 INDIAN COUNCIL OF MEDICAL
p.000109: RESEARCH
p.000109:
p.000109: Social and Behavioural Sciences
p.000109: Research for Health
p.000109:
p.000109: 9.2.7 Privacy and confidentiality
p.000109: Privacy and confidentiality of research participants should be considered while selecting sites for data collection,
p.000109: choosing sensitive research areas, specific contexts and settings. In some circumstances participants become more
p.000109: vulnerable in research because of heightened psychological, social, physical or legal risks. Breach of
p.000109: confidentiality in these types of research may cause serious harm to vulnerable participants. It is important to
p.000109: protect study participants from potential future risks and harm by establishing culturally sensitive and context
p.000109: specific safeguards.
p.000109: 9.2.8 Duty to disclose sensitive information
p.000109: As mentioned in Box 9.1, researcher(s) may come across certain facts detrimental to a participant’s self or others,
p.000109: such as suicidal tendency/ideation, notifiable diseases. In such a situation, researchers have a responsibility to
p.000109: disclose this information to relevant persons/authorities to save life or prevent damage contemplated by the
p.000109: participant. Measures to be taken in such instances are given below:
p.000109: • If there is a high likelihood of getting sensitive incidental findings during the research
p.000109: process, then the ways to handle these at individual, family and community levels should be discussed and mentioned in
p.000109: the protocol.
p.000109: • Researchers and the EC should have a basic understanding of the legal provisions in the related area. Persons
p.000109: with the necessary domain knowledge and experience can be special invitees to EC meetings.
p.000109: 9.2.9 Studies Using Deception
p.000109: Deception occurs when researchers provide false or incomplete information to participants for the purpose of
p.000109: misleading them so as to achieve the study objectives and for larger public good. Research employing any type of
p.000109: deception should undergo full committee review.
p.000109: Research involving any kind of deception should:
p.000109: • pose no more than minimal risk;
p.000109: • not adversely affect the welfare and safety of the participants;
...
p.000115: 10.4.5 In addition to the general contents specified in section 5, the consent form for genetic testing for research
p.000115: may have explanations/details on the following elements:
p.000115: • the nature and complexity of information that would be generated;
p.000115: • the nature and consequences of return of results and choice offered to the participant whether to
p.000115: receive that information or not and incidental findings, if any;
p.000115: • direct/indirect benefits and their implications including if there are no direct
p.000115: benefits to the participants;
p.000115: • how the data/samples will be stored, for how long, and procedures involved in
p.000115: anonymisation, sharing , etc. See section 11 for further details;
p.000115: • choice to opt out of testing/withdraw from research at any time;
p.000115: • whether the affected individual or the proband would like to share her/his genetic
p.000115: information with family members who may benefit from it; and
p.000115: • issues related to ownership rights, IPR concerns, commercialization aspects,
p.000115: benefit sharing,. See section 11 for further details.
p.000115: 10.4.6 Group consent/community consent
p.000115: • In case of population or community based studies, it may be noted that the genetic research may generate
p.000115: information applicable to the community/populations from which the participants were drawn, and therefore, group
p.000115: consent must be taken from the community head and/or the culturally appropriate authority.
p.000115: • Even if group consent is taken, it will not be a replacement for individual consent
p.000115: as individual consent is important. See section 5 for further details.
p.000115: • Researchers should be aware of potential stigmatization of the entire group and must explain ways to
p.000115: avoid the same during the conduct of research and publication of research results.
p.000115: 10.5 Culturally sensitive issues
p.000115: 10.5.1 Transmission of a genetic abnormality from parents, especially the mother to the foetus, could be
p.000115: a very sensitive cultural issue. Such possibility arises when during routine testing or prenatal diagnosis it is
p.000115: revealed that the wife is a carrier of X-linked or recessive disease affecting the foetus or making it a carrier of
p.000115: fatal or late onset disease conditions, such as haemophilia, huntington’s disease, non-syndromic deafness
p.000115: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000115: 115
p.000116:
p.000116: Human
p.000116: Genetics Testing and Research
p.000116:
p.000116: and mitochondrial conditions where a female foetus could transmit the abnormality to the next progeny, etc. If
p.000116: information is revealed to the husband or other members of the family, it may cause marital discord despite the fact
p.000116: that the husband himself is a carrier of the autosomal recessive disorder. Appropriate counselling should be part of
p.000116: the testing process.
p.000116: 10.5.2 Consanguineous marriages are common in some communities. If there are inherited diseases detected in the
p.000116: family, it is the responsibility of the health professionals/ researchers to inform participants regarding the possible
p.000116: implications that may arise due to consanguinity. Appropriate pedigrees need to be prepared and stored, as these can
...
p.000134: sets, should be reviewed by the EC, either an institutional one or that of the biorepository.
p.000134: 11.5 Biological material/data in forensic departments of laboratories
p.000134: Specimens collected for forensic purposes and related or unrelated data (DNA profiling) offer a good source for
p.000134: academic research after the initial purpose has been served. Data sharing with researchers across the globe is a common
p.000134: practice for refining techniques to develop biomarkers, which could identify missing persons in most difficult
p.000134: circumstances (for example, highly decomposed bodies, disaster situations). In academic institutions, there is a demand
p.000134: for organs and tissues for education, training and research purposes.
p.000134: 11.5.1 Informed consent: If there is no written consent by the deceased person permitting use of organs or tissues, the
p.000134: family can be approached for consent for use of left-over organs or tissues.
p.000134: 11.5.2 No consent would be required if sample or data is anonymized.
p.000134: 11.5.3 If the deceased has no claimant then forensic officials will be authorized to give permission for
p.000134: use of material/data from its sources and be responsible for use of unclaimed cadavers.
p.000134: 11.5.4 The quantity of tissue taken should ideally be minimal, particularly if it is seen externally on the body in
p.000134: order to preserve the dignity of the dead and be culturally acceptable by
p.000134:
p.000134: 134 INDIAN COUNCIL OF MEDICAL
p.000135: RESEARCH
p.000135:
p.000135: Biological Materials,
p.000135: Biobanking and Datasets
p.000135:
p.000135: the next of kin or closest relative or friend.
p.000135: 11.5.5 The information in the informed consent document should state what tissue/organ will be retained, who will be
p.000135: the custodian, duration of storage of sample, what type of research would be conducted and method for disposal of the
p.000135: remains.
p.000135: 11.5.6 Genetic research or revelation of any other stigmatizing factors like HIV, etc. in the deceased may have
p.000135: implications for family members. In such instances, all ethical requirements as in the case of live
p.000135: participants should be followed.
p.000135: 11.5.7 The role of the EC is to review and approve the type of consent – broad, tiered with or without option to
p.000135: opt-out or specific and to assess from whom it would be taken – the family, closest relative or friend – or whether
p.000135: sample anonymization should be done.
p.000135: 11.6 Governance of biobank/biorepository
p.000135: Institutions where data are collected and archived must have an established governance structure with the following
p.000135: requirements for regulation.
p.000135: 11.6.1 Each biorepository should have its own technical authorization committee with representation of both
...
p.000139: 12.3.1 Considerations for fair selection of participants are described in Box 12.1.
p.000139:
p.000139: Box 12.1 Considerations for fair selection of participants
p.000139:
p.000139: 1. The overall effort is not to over-sample, particularly vulnerable segments of the population.
p.000139: 2. Explicit selection criteria or prioritization of participants with proper justification should be provided in the
p.000139: protocol.
p.000139: 3. Efforts should be taken to ensure that research participants are not exploited during the research project by
p.000139: imposing additional burdens on them.
p.000139: 4. It is desirable to set up a DSMB to frequently review the data to check on risk quantum.
p.000139:
p.000139: 12.3.2 Efforts should be made to see that the positive results of a specific research are applicable to future similar
p.000139: disaster situations.
p.000139: 12.3.3 Whenever possible, a priori agreement could be reached between researcher(s) and disaster affected communities
p.000139: for benefit sharing, which could be extended to future disaster affected communities wherever applicable.
p.000139: 12.4 Privacy and confidentiality
p.000139: 12.4.1 Disruption of governance, infrastructure and communication networks and inflow of visitors during emergencies
p.000139: can lead to a breach of privacy and confidentiality. In some situations, there can be stigmatization and discrimination
p.000139: which should be minimized at all stages of research.
p.000139: 12.4.2 Special efforts (culturally appropriate and scientifically valid) are required to maintain dignity, privacy and
p.000139: confidentiality of individuals and the communities.
p.000139:
p.000139: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000139: 139
p.000140:
p.000140: Research during Humanitarian Emergencies and
p.000140: Disasters
p.000140:
p.000140: 12.4.3 Efforts should be made to protect the identifying information about individuals and communities, for example,
p.000140: from exploitation by the print and visual media.
p.000140: 12.5 Ethics review procedures
p.000140: 12.5.1 Research during humanitarian emergencies and disasters can be reviewed through an expedited
p.000140: review/scheduled/unscheduled full committee meetings and this may be decided by the Member Secretary on a case-to-case
p.000140: basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as
p.000140: possible.
p.000140: 12.5.2 Meticulous documentation and archiving are required to enable future application in similar situations.
p.000140: 12.5.3 Suggestions to expedite the review process are given below:
p.000140: • Measures such as virtual or tele-conferences should be attempted when face-to-
p.000140: face meetings are not possible.
p.000140: • In exceptional situations, preliminary research procedures including but not restricted to
p.000140: data/sample collection that are likely to rapidly deteriorate or perish may be allowed while the review process is
p.000140: underway.
p.000140: • Available protocol templates could be reviewed to expedite the process.
...
p.000140: conducted by any other recognized EC within India for initiating the study, until the local EC is able to convene its
p.000140: meeting. ECs should develop procedures to ensure appropriate and timely review and monitoring of the approved research.
p.000140: On a case-by-case basis, some protocols may require re- review as the emergency situation may change with time and
p.000140: circumstances.
p.000140: 12.5.4 The EC should closely monitor the conduct and outcome of research.
p.000140: 12.6 Post-research benefit
p.000140: Sponsors and researchers should strive to continue to provide beneficial interventions, which were part of the research
p.000140: initiative even after the completion of research and till the local administrative and social support system is
p.000140: restored to provide regular services.
p.000140: 12.7 Special considerations
p.000140: Humanitarian emergencies lead to fragile political environments with disruption of health systems and social
p.000140: situations.
p.000140:
p.000140:
p.000140: 140 INDIAN COUNCIL OF MEDICAL
p.000141: RESEARCH
p.000141:
p.000141: Research during Humanitarian Emergencies and
p.000141: Disasters
p.000141:
p.000141: 12.7.1 The researchers should undertake steps to maintain participant and community trust.
p.000141: 12.7.2 Efforts should be made to engage the community in the conduct of research in a culturally sensitive manner to
p.000141: ensure public trust.
p.000141: • The research team should preferably describe a preliminary community mapping/
p.000141: scoping exercise.
p.000141: • Wherever possible, community representatives or advocates should be involved in conceptualization, review,
p.000141: research and dissemination of research results in such settings.
p.000141: 12.7.3 In case of an outbreak of infectious diseases, monitored emergency use of unregistered and experimental
p.000141: interventions (MEURI) may be approved with the following precautions:
p.000141: • A thorough scientific review should be conducted, followed by an ethics review
p.000141: by a national level EC constituted for this purpose.
p.000141: • Oversight by a local EC is necessary.
p.000141: • Only a product complying with GMP should be used.
p.000141: • Rescue medicines and supportive treatment should be accessible.
p.000141: • Sharing data on safety and efficacy would be beneficial to reduce delay for other
p.000141: researchers.
p.000141: • Consent process is important and must be carried out with care.
p.000141: • Planning should be done for community engagement.
p.000141: • Fair distribution should be ensured when faced with scarce supply.
p.000141: 12.8 Continuation of ongoing research when a humanitarian emergency occurs
p.000141: 12.8.1 The research may have to be suspended and the decision may be taken by researchers with information to EC.
p.000141: 12.8.2 The researchers can go back to the EC for guidance regarding continuation of research or not.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
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p. xv: underlying universal principle besides other principles applicable to the prevalent culture and the class systems of
p. xv: the society. The Indian Council of Medical Research (ICMR) issued the Policy Statement on Ethical Considerations
p. xv: Involved in Research on Human Subjects in 1980.1 Due to rapid advances in biomedical science and technology, new
p. xv: ethical dimensions emerged which necessitated further updation of these guidelines. Subsequently the Ethical Guidelines
p. xv: for Biomedical Research on Human Subjects was released in 2000,2 followed by the revised Ethical Guidelines for
p. xv: Biomedical Research on Human Participants in 2006.3 In the meantime, the Central Drugs Standard Control Organization
p. xv: (CDSCO) also released the Indian Good Clinical Practice Guidelines (2001)4 for clinical trials and revised Schedule Y
p. xv: of the Drugs and Cosmetics Act, 1940, in the year 20055 with several amendments in the Rules under Drugs and Cosmetics
p. xv: Act in the year 2013. ICMR and the Department of Biotechnology (DBT) jointly brought out Guidelines for Stem Cell
p. xv: Research and Therapy in 2007 and a further revision in 2013 which is now revised as National Guidelines for Stem Cell
p. xv: Research, 2017.6
p. xv: The Nuremberg Code of 1947 7was the first international treatise on the ethics of research involving human beings
p. xv: and highlighted the essentiality of obtaining voluntary consent. In 1964, the World Medical Association
p. xv: formulated guidelines on conducting research on humans, known as the Declaration of Helsinki. This has undergone
p. xv: seven revisions with the latest version being issued in October 2013 at Fortaleza, Brazil.8
p. xv: In 1979, the Belmont Report released by the National Commission for the Protection of Human Subjects of Biomedical and
p. xv: Behavioural Research in the United States of America (USA), for the first time enunciated the three basic ethical
p. xv: principles for research involving human subjects: respect for persons, beneficence and justice.9 The Department of
p. xv: Health and Human Services (DHHS), USA, released the Federal Policy for the Protection of Human Subjects as the ‘Common
p. xv: Rule’ in 1991 (revised in 2017).10 The International Conference on Harmonization (ICH) brought out the Good Clinical
p. xv: Practice Guidelines E6 (R1) in 199611 revised as E6 (R2) in 2016.12 The National Bioethics Advisory Commission, USA
p. xv: (2001),13 the Council for International Organizations of Medical Sciences (CIOMS), Geneva (2002 revised in 2016),14,15
p. xv: and the Nuffield Council of Bioethics, United Kingdom (2002)16 released recommendations/guidelines relevant
p. xv:
p. xv: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000001: 1
p.000002:
p.000002:
p.000002: Introduction
p.000002: to research in developing countries. UNESCO’s Universal Declaration on Bioethics and Human Rights (2005)17 and
p.000002: other international instruments on human rights further defined the Universal Codes of Ethics to be adopted by
...
p.000020: or results without scientific or statistical justification, such that the research is not accurately represented in the
p.000020: research record.
p.000020: • Plagiarism is the “wrongful appropriation” and “stealing and publication” of another paper or another author’s
p.000020: “language, thoughts, ideas, or expressions” and the representation of them as one’s own original work or
p.000020: duplicating one’s own publication (self plagiarism).
p.000020:
p.000020: confidential until the enquiry is complete.
p.000020: 3.6.4 Simultaneous submission of the same grant application to different funding agencies or submitting
p.000020: papers/overlapping publications to journals is not acceptable, as this could lead to unnecessary duplication in review
p.000020: process or in meta analysis. .
p.000020: 3.7 Registration with Clinical Trials Registry–India
p.000020: The Clinical Trials Registry–India, linked to WHO registry, was launched on 20 July 2007 by ICMR, as a free and online
p.000020: public record system for registration of clinical trials, PG thesis and other biomedical research being conducted in
p.000020: the country. Trial registration in the CTRI was made mandatory by CDSCO on 15 June 2009 for clinical trials that are
p.000020: registered under the Drugs and Cosmetics Act and its Rules. Registration with CTRI is voluntary for other
p.000020: biomedical and health research. In addition, editors of major biomedical journals of India declared that only
p.000020: trials on any of the public databases would be considered for publication in journals. According to 64th WMA
p.000020: General Assembly, held at Fortaleza, Brazil, in October 2013, the Declaration of Helsinki clearly states that “Every
p.000020: research study involving human subjects must be registered in a publicly accessible database before recruitment of the
p.000020: first subject.” Under the aegis of WHO, a joint statement on public disclosure of results from all international trials
p.000020: was signed by ICMR and others in May 2017.
p.000020: 3.7.1 All clinical research involving human participants including any intervention such as drugs, surgical
p.000020: procedures, devices, biomedical, educational or behavioural research, public health intervention studies, observational
p.000020: studies, implementation research and preclinical studies of experimental therapeutics and preventives or AYUSH studies
p.000020: may be registered prospectively with the CTRI.
p.000020: 20 INDIAN COUNCIL OF
p.000021: MEDICAL RESEARCH
p.000021:
p.000021:
p.000021: Responsible Conduct of Research
p.000021:
p.000021: 3.7.2 Trial registration involves providing information regarding the study, investigators, sites, sponsor, ethics
p.000021: committees, regulatory clearances, disease/condition, types of study, methodologies, outcomes, etc.
p.000021: 3.7.3 Registration of research in CTRI ensures that more complete, authenticated, readily available data on
p.000021: research is available publicly. This improves transparency, accountability and accessibility.
p.000021: 3.8 Collaborative research
p.000021: Researchers are increasingly collaborating with colleagues who have the expertise and/or for resources needed to carry
p.000021: out particular research. This could be inter-departmental/ inter-institutional or international and also multicentre
...
p.000069: study of new drugs on human subjects to generate data for discovering and/or verifying the clinical, pharmacological
p.000069: (including pharmacodynamic and pharmacokinetic) and/or adverse effect with the objectives determining safety
p.000069: and/or efficacy of a new drug. The academic clinical trial as per GSR 313 (E) dated 16
p.000069: March 201627 is a clinical trial intended for academic purposes in respect of approved
p.000069: drug formulations for any new indication or new route of administration or new dose or new dosage form. An EC has to
p.000069: approve such studies after due consideration of benefits and risks and all other ethical aspects and the licensing
p.000069: authority has to be informed as per the prescribed procedures.
p.000069: 7.1 General guidelines
p.000069: 7.1.1 All clinical trials must be planned, conducted and reported in a manner that ensures that the dignity, rights,
p.000069: safety and well-being of participants are protected.
p.000069: 7.1.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000069: benefit (direct or indirect) for the individual trial participant and/or society. A trial should be initiated and
p.000069: continued only if the anticipated benefits justify the risks.
p.000069:
p.000069: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000069: 69
p.000070:
p.000070: Clinical Trials of Drugs and
p.000070: other Interventions
p.000070:
p.000070: 7.1.3 All clinical trials must be conducted in accordance with the Indian GCP guidelines, the Declaration of Helsinki
p.000070: (2013 or later versions as applicable), National Guidelines for Biomedical and Health Research Involving Human
p.000070: Participants (2017), the Drugs and Cosmetics Act (1940), and Rules (1945), and applicable amendments (including
p.000070: Schedule Y), and other relevant regulations and guidelines, wherever applicable.
p.000070: 7.1.4 A participant’s right to agree or decline consent to take part in a clinical trial must be respected and
p.000070: her/his refusal should not affect routine care.
p.000070: 7.1.5 At all times, the privacy of a participant must be maintained and any information gathered from
p.000070: the participant be kept strictly confidential.
p.000070: 7.1.6 Therapeutic misconception in potential participants must be avoided (for example, by having a
p.000070: co-investigator who is not the primary treating physician administer the consent).
p.000070: 7.1.7 At least one member of the research team must have the qualifications and adequate research experience in the
p.000070: subject on which the trial is planned.
p.000070: 7.1.8 All clinical trials must be approved by an EC that is constituted and functions in accordance
p.000070: with these guidelines and applicable regulations.
p.000070: 7.1.9 Applicable regulatory approvals must be taken (if required).
p.000070: 7.1.10 All clinical trials must be registered with the Clinical Trial Registry -India (CTRI).28
p.000070: 7.1.11 Written informed consent must be obtained from each participant before any research related procedure is
p.000070: performed.
...
p.000131: of consent.
p.000131: 6. Withdrawal of consent or destruction of sample: The donor has the right to ask for destruction of her/his
p.000131: collected sample(s) and discontinuation/withdrawal from participation in the research. In longitudinal studies, a
p.000131: participant may withdraw from one component of the study, like continued follow-up/data collection when withdrawal may
p.000131: be referred to as partial.
p.000131: 7. Waiver of consent: While using anonymized (de-identified) samples/data, researchers should seek the approval of
p.000131: the EC of the institution or the repository for waiver of consent from donors.
p.000131: 8. Re-consent
p.000131: • Secondary or extended uses of stored samples/dataset: In such an instance, one of the preliminary considerations
p.000131: for ECs must be to identify the circumstances under which the research requires re-use of collected identifiable
p.000131: biological material to generate the data or utilize the pre-existing identifiable dataset. This must also include
p.000131: review of the informed consent obtained originally to see if re-consent is warranted. There may be situations where
p.000131: consent would be impossible or impracticable to obtain for such research, in which case the research may be done only
p.000131: after independent evaluation by an EC (Declaration of Helsinki, October 2013).
p.000131:
p.000131:
p.000131: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000131: (Contd.)
p.000131: 131
p.000132:
p.000132: Biological Materials,
p.000132: Biobanking and Datasets
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: • Paediatric donors: In longitudinal studies once the child donor attains the legal age of consent a re-consent
p.000132: should be sought for the storage and use of her/his tissue or sample. In paediatric biobanks or biobanks with
p.000132: paediatric samples it is important to address the issue of children reaching legal age of consent. Sometimes re-contact
p.000132: may lead to withdrawal, resulting in limited data analysis. This may lead to bias or it could evoke emotional distress
p.000132: about past research. On the other hand, re-consent may give the participant the power to agree. A biobank should decide
p.000132: the policy it would like to adopt for re-contact.
p.000132:
p.000132: 11.4 Ethical issues related to research
p.000132: Biobanks can use the stored material/data for doing research themselves or they can outsource or supply such
p.000132: material/data to other researchers or institutions on a non- profit basis.
p.000132: 11.4.1 Ownership of the biological samples and data: The participant owns the biological sample and data collected
p.000132: from her/him and therefore, could withdraw both the biological material donated to the biobank and the
...
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142:
p.000142: 142 INDIAN COUNCIL OF MEDICAL
p.000143: RESEARCH
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: LIST OF REFERENCES
p.000143: 1. Policy statement on ethical considerations involved in research on human subjects. New Delhi: Indian Council
p.000143: of Medical Research; 1980.
p.000143: 2. Ethical guidelines for biomedical research on human subjects. New Delhi: Indian Council of Medical Research;
p.000143: 2000.
p.000143: 3. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical
p.000143: Research; 2006.
p.000143: 4. Good clinical practice. New Delhi: Central Drugs Standard Control Organization; 2004. Available from:
p.000143: http://www.cdsco.nic.in/html/gcp1.html (accessed 31 Aug 2017).
p.000143: 5. Schedule Y of the Drugs and Cosmetics Act, 1940, amended on June 2005, India [statute on the
p.000143: Internet]. Available from: http://cdsco.nic.in/writereaddata/ Drugs&CosmeticAct.pdf (accessed 06 Aug 2017).
p.000143: 6. National guidelines for stem cell research. New Delhi: Indian Council of Medical Research and Department of
p.000143: Biotechnology; 2017.
p.000143: 7. The Nuremberg Code, 1947. In: Trials of war criminals before the Nuremberg Military Tribunals under Control
p.000143: Council Law No. 10. Washington DC: US Government Printing Office; 1949; 2:181-182.
p.000143: 8. Declaration of Helsinki: ethical principles for medical research involving human subjects.
p.000143: Fortaleza: World Medical Association. 2013; Available from: https://www.
p.000143: wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf (accessed 08 Sept 2017).
p.000143: 9. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The
p.000143: Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington DC:
p.000143: Department of Health, Education and Welfare; 1979.
p.000143: 10. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human
p.000143: Services; (1991); 2001, 2017.
p.000143: 11. Good clinical practice guidelines E6 (R1). The International Conference on Harmonization; 1996.
p.000143: Available from: https://www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
p.000143: (accessed 02 Sept 2017).
p.000143: 12. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Available from:
p.000143: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E6/E6_R2 Step_4.pdf (accessed 02 Sep
p.000143: 2017).
p.000143:
p.000143: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000143: 143
p.000144:
p.000144:
p.000144: List of references
p.000144:
p.000144: 13. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda: The National
...
General/Other / participants in a control group
Searching for indicator control group:
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p.000011: health needs and expectations are addressed, informed consent is appropriate, and access to research benefits are
p.000011: provided through research that is designed and implemented in the best interests of science and the community.
p.000011: 2.10.5 After the study is completed, the researcher may communicate with the community
p.000011:
p.000011: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000011: 11
p.000012:
p.000012:
p.000012: General Ethical Issues
p.000012:
p.000012: representative, local institution or the government department from where the data was collected to help in
p.000012: dissemination of the results to the entire community.
p.000012: See sections 8 and 9 for further details.
p.000012: 2.11 Post research access and benefit sharing
p.000012: The benefits accruing from research should be made accessible to individuals, communities and populations
p.000012: whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in
p.000012: an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and
p.000012: providing education on good health practices.
p.000012: 2.11.1 Efforts should be made to communicate the findings of the research study to the
p.000012: individuals/communities wherever relevant.
p.000012: 2.11.2 The research team should make plans wherever applicable for post-research access and sharing of academic or
p.000012: intervention benefits with the participants, including those in the control group.
p.000012: 2.11.3 Post-research access arrangements or other care must be described in the study protocol so that the EC may
p.000012: consider such arrangements during its review.
p.000012: 2.11.4 If an investigational drug is to be given to a participant post-trial, appropriate regulatory approvals should
p.000012: be in place.
p.000012: 2.11.5 The EC should consider the need for an a priori agreement between the researchers and sponsors regarding all the
p.000012: points mentioned above (from 2.11.1 to 2.11.3).
p.000012: 2.11.6 In studies with restricted scope, such as student projects, post study benefit to the participants
p.000012: may not be feasible, but conscious efforts should be made by the institution to take steps to continue to support and
p.000012: give better care to the participants.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: 12 INDIAN COUNCIL OF
p.000013: MEDICAL RESEARCH
p.000013:
p.000013: SECTION 3
p.000013:
p.000013: RESPONSIBLE CONDUCT OF RESEARCH
p.000013:
p.000013: 3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a
p.000013: significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide
p.000013: by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members
...
p.000075: m Combination vaccines – The main goal in efficacy trial design of such vaccines is to evaluate the efficacy of each
p.000075: antigenic component. Non-inferiority trials should be conducted to demonstrate that the combination vaccine is
p.000075: not inferior in terms of immunogenicity or efficacy to vaccines with individual components.
p.000075: m Vaccines administered simultaneously with combination vaccines – Immunogenicity and safety data should be
p.000075: obtained in Phase III (pre-licensure) studies to support the simultaneous administration of a new vaccine with already
p.000075: licensed vaccines that would be given to the same target population using the same (or overlapping) schedule. Types of
p.000075: vaccines are listed in Box 7.3.
p.000075: Box 7.3 Types of vaccines
p.000075: • Live and attenuated vaccines (measles, mumps, rubella and chickenpox)
p.000075: • Inactivated vaccine (flu vaccine)
p.000075: • Toxoid vaccines (diphtheria and tetanus vaccines)
p.000075: • DNA vaccines
p.000075: • Recombinant vector vaccines
p.000075:
p.000075: m Some vaccines that contain active or live (attenuated) micro-organisms can possibly possess a small risk of
p.000075: producing that particular infection. The participant to be vaccinated should be informed of this.
p.000075: m The participants in control groups, or when subjected to ineffective vaccines, run a risk of contracting the
p.000075: disease. In such an event, provisions be made to provide free treatment for the disease.
p.000075: m For recombinant DNA vaccines and products, applicable governmental guidelines and regulations should be
p.000075: followed.
p.000075: m Post-trial, the control group should receive the complete dose of an effective vaccine (either one that is already
p.000075: available or the investigational vaccine).
p.000075: 7.3 Bioavailability/bioequivalence study
p.000075: Bioavailability (BA) is the measurement of the proportion of the total administered dose of a therapeutically active
p.000075: drug that reaches the systemic circulation and is therefore available at the site of action.
p.000075: Bioequivalence (BE) is a term used in pharmacokinetics when there are two or more
p.000075:
p.000075: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000075: 75
p.000076:
p.000076: Clinical Trials of Drugs and
p.000076: other Interventions
p.000076:
p.000076: medicinal products (proprietary preparations of a drug), containing the same active substance that need to be compared
p.000076: in vivo for biological equivalence. These comparative studies are used to assess if the new version (generic) produces
p.000076: the same concentration in the systemic circulation when given to human participants. If two products are
p.000076: said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
p.000076: BE studies are used as surrogates for clinical effectiveness data for generic drugs where no clinical difference is
p.000076: anticipated between the two products.
p.000076: 7.3.1 Ethical issues
p.000076: • All BA/BE studies should be scientifically sound and conducted in compliance with principles of ethical
p.000076: conduct described earlier for a Phase I study.
p.000076: • Ethical conduct of BA/BE study requires evaluation of the benefit–risk profile of:
...
Searching for indicator placebo:
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p.000006: encountered in routine daily life activities of an average healthy individual or general population or during the
p.000006: performance of routine tests where occurrence of serious harm or an adverse event (AE) is unlikely. Examples include
p.000006: research involving routine questioning or history taking, observing, physical examination, chest X-ray,
p.000006: obtaining body fluids without invasive intervention, such as hair, saliva or urine samples, etc.
p.000006:
p.000006: Minor increase over minimal risk or Low risk
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: More than minimal risk or High risk
p.000006: Increment in probability of harm or discomfort is only a little more than the minimal risk threshold. This
p.000006: may present in situations such as routine research on children and adolescents; research on persons incapable
p.000006: of giving consent; delaying or withholding a proven intervention or standard of care in a control or placebo group
p.000006: during randomized trials; use of minimally invasive procedures that might cause no more than brief pain or
p.000006: tenderness, small bruises or scars, or very slight, temporary distress, such as drawing a small sample of blood for
p.000006: testing; trying a new diagnostic technique in pregnant and breastfeeding women, etc. Such research should have a social
p.000006: value. Use of personal identifiable data in research also imposes indirect risks. Social risks, psychological
p.000006: harm and discomfort may also fall in this category.
p.000006: Probability of harm or discomfort anticipated in the research is invasive and greater than minimal risk. Examples
p.000006: include research involving any interventional study using a drug, device or invasive procedure such as lumbar puncture,
p.000006: lung or liver biopsy, endoscopic procedure, intravenous sedation for diagnostic procedures, etc.
p.000006: 2.2.1 The informed consent document (ICD), which includes patient/participant information sheet (PIS) and informed
p.000006: consent form (ICF) should have the required elements (see Box
p.000006: 5.1 for further details) and should be reviewed and approved by the EC before enrolment of participants. For all
p.000006: biomedical and health research involving human participants, it is the primary responsibility of the researcher to
...
p.000035: participants indicating conditions of coverage, date of commencement and date of expiry of coverage of risk (if
p.000035: applicable)
p.000035: 23. Indemnity policy, clearly indicating the conditions of coverage, date of commencement and date of
p.000035: expiry of coverage of risk (if applicable)
p.000035: 24. Any additional document(s), as required by EC (such as other EC clearances for multicentric studies)
p.000035: 25. Protocol
p.000035:
p.000035: Box 4.4 (b) Details of documents to be included in the protocol
p.000035:
p.000035: The protocol should including the following:
p.000035: 1. the face page carrying the title of the proposal with signatures of the investigators;
p.000035: 2. brief summary/ lay summary;
p.000035: 3. background with rationale of why a human study is needed to answer the research question;
p.000035: 4. justification of inclusion/exclusion of vulnerable populations;
p.000035: 5. clear research objectives and end points (if applicable);
p.000035: 6. eligibility criteria and participant recruitment procedures;
p.000035: 7. detailed description of the methodology of the proposed research, including sample size (with
p.000035: justification), type of study design (observational, experimental, pilot, randomized, blinded, etc.), types of
p.000035: data collection, intended intervention, dosages of drugs, route of administration, duration of treatment and
p.000035: details of invasive procedures, if any;
p.000035: 8. duration of the study;
p.000035: 9. justification for placebo, benefit–risk assessment, plans to withdraw. If standard therapies are to be
p.000035: withheld,
p.000035: justification for the same;
p.000035: 10. procedure for seeking and obtaining informed consent with a sample of the patient/participant information
p.000035: sheet and informed consent forms in English and local languages. AV recording if applicable; informed consent for
p.000035: stored samples;
p.000035: 11. plan for statistical analysis of the study;
p.000035: 12. plan to maintain the privacy and confidentiality of the study participants;
p.000035: 13. for research involving more than minimal risk, an account of management of risk or injury;
p.000035: 14. proposed compensation, reimbursement of incidental expenses and management of research related injury/illness
p.000035: during and after research period;
p.000035: 15. provision of ancillary care for unrelated illness during the duration of research;
p.000035: 16. an account of storage and maintenance of all data collected during the trial; and
p.000035: 17. plans for publication of results – positive or negative – while maintaining confidentiality of personal
p.000035: information/ identity.
p.000035: 18. ethical considerations and safeguards for protection of participants.
p.000035:
p.000035: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000035: 35
p.000036:
p.000036:
p.000036: Ethical Review Procedures
p.000036:
...
p.000068: 6.11.4 The informed consent process should be well documented. There should not be any undue coercion or incentive for
p.000068: participation. A person’s refusal to participate should be respected and there should be no penalization.
p.000068: 6.11.5 The EC should also carefully determine the benefits and risks of the study and examine risk minimization
p.000068: strategies.
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: 68 INDIAN COUNCIL OF
p.000069: MEDICAL RESEARCH
p.000069:
p.000069: SECTION 7
p.000069:
p.000069: CLINICAL TRIALS OF DRUGS AND OTHER INTERVENTIONS
p.000069:
p.000069: 7.0 A clinical trial is any research/study that prospectively assigns human participants or groups of humans
p.000069: to one or more health-related intervention(s) to evaluate the effects on health outcomes. The intervention
p.000069: could be drugs, vaccines, biosimilars, biologics, phytopharmaceuticals, radiopharmaceuticals, diagnostic agents,
p.000069: public health interventions, socio-behavioural interventions, technologies, devices, surgical techniques or
p.000069: interventions involving traditional systems of medicine, etc.
p.000069: Clinical trials are usually well-controlled studies. They use a design that allows comparison of
p.000069: participants treated with an investigational product (IP)/any intervention to a control population (receiving placebo
p.000069: or an active comparator), so that the effect of the IP/intervention can be determined and differentiated from effects
p.000069: of other influences, such as spontaneous change, placebo effect, concomitant treatment/intervention or observer
p.000069: expectations.
p.000069: As per the amended Schedule Y (2005) of the Drugs and Cosmetics Rules, 1945, a clinical trial refers to a systematic
p.000069: study of new drugs on human subjects to generate data for discovering and/or verifying the clinical, pharmacological
p.000069: (including pharmacodynamic and pharmacokinetic) and/or adverse effect with the objectives determining safety
p.000069: and/or efficacy of a new drug. The academic clinical trial as per GSR 313 (E) dated 16
p.000069: March 201627 is a clinical trial intended for academic purposes in respect of approved
p.000069: drug formulations for any new indication or new route of administration or new dose or new dosage form. An EC has to
p.000069: approve such studies after due consideration of benefits and risks and all other ethical aspects and the licensing
p.000069: authority has to be informed as per the prescribed procedures.
p.000069: 7.1 General guidelines
p.000069: 7.1.1 All clinical trials must be planned, conducted and reported in a manner that ensures that the dignity, rights,
p.000069: safety and well-being of participants are protected.
p.000069: 7.1.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000069: benefit (direct or indirect) for the individual trial participant and/or society. A trial should be initiated and
p.000069: continued only if the anticipated benefits justify the risks.
p.000069:
p.000069: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000069: 69
p.000070:
p.000070: Clinical Trials of Drugs and
p.000070: other Interventions
p.000070:
...
p.000076: Volunteers often regularly participate in such studies at the cost of their health and care should be taken that taking
p.000076: part in multiple trials is avoided by maintaining volunteer registries, biometry, follow up, etc. Care must be taken to
p.000076: maintain confidentiality of biometric data.
p.000076: • The amount of blood drawn for a BA/BE study should be within physiological limits irrespective of study
p.000076: design and the EC should take specific note on the amount of blood drawn depending on whether the individual is a
p.000076: healthy adult or a child or a patient.
p.000076: 7.4 Ethical implications of study designs
p.000076: Clinical trials have a wide range of methodological approaches. ECs need to look into the details of the ethical
p.000076: concerns involved.
p.000076: 7.4.1 If a SAE occurs in a blinded study, and it is imperative, in the interest of managing the event to know what
p.000076: the patient was receiving, unblinding mechanisms should be available to the researcher.
p.000076:
p.000076: 76 INDIAN COUNCIL OF
p.000077: MEDICAL RESEARCH
p.000077:
p.000077: Clinical Trials of Drugs and
p.000077: other Interventions
p.000077:
p.000077: 7.4.2 When an available therapy is effective in preventing serious harm, such as death or irreversible morbidity in
p.000077: the clinical trial population, it is inappropriate to use a placebo control.
p.000077: 7.4.3 Placebo may be used as a comparator under the conditions given in Box 7.4.
p.000077: Box 7.4 Conditions where a placebo may be used
p.000077: A placebo may be used when:
p.000077: • there is no established effective therapy available;
p.000077: • withholding an established effective therapy would not expose participants to serious
p.000077: harm, but may cause temporary discomfort or delay in relief of symptoms;
p.000077: • if the disease is self-limited; or
p.000077: • the use of an established effective therapy as a comparator would not yield scientifically reliable
p.000077: results and the use of placebo would not add any additional risk of serious or irreversible harm to the participants.
p.000077: 7.4.4 If a placebo must be used for scientific reasons, then certain precautions must be exercised. These should be
p.000077: reviewed and approved by the EC. See Box 7.5 for further details.
p.000077: Box 7.5 Precautions to be taken when a placebo is used
p.000077: 1. The protocol must have added safeguards to protect participants from harm, such as but not restricted to
p.000077: having clear-cut withdrawal criteria, intensive monitoring and rescue medications.
p.000077: 2. Use an add-on trial design where the IP or placebo are added to standard of care.
p.000077: 3. Expose fewer patients to placebo groups, for example by having 2:1 randomization with 2 participants
p.000077: receiving IP against 1 getting placebo (unbalanced randomization).
p.000077: 4. An active comparator as an additional arm may also be included in such trials where randomization can be,
p.000077: for example, 2:2:1 (IP: active comparator: placebo).
p.000077: 5. Ensure transition to standard of care/active medicine for study participants after research is completed,
p.000077: including post-trial arrangements for implementing any positive trial results.
p.000077:
p.000077: 7.5 Multicentric trials
p.000077: Multicentric trials are carried out with a primary aim of providing a sound basis for the subsequent generalization of
p.000077: its results.
p.000077: 7.5.1 ECs of all sites should follow all applicable regulatory guidelines, including registration with regulating
p.000077: bodies.
p.000077:
p.000077: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000077: 77
p.000078:
p.000078: Clinical Trials of Drugs and
p.000078: other Interventions
p.000078:
p.000078: 7.5.2 The ethical review procedure for common review of multicentric research is given in section 4.10. Not
p.000078: applicable for clinical trials under Drugs and Cosmetic Act.
p.000078: 7.6 Phytopharmaceutical drugs
p.000078: The Drugs and Cosmetics Rules, 8th Amendment, 2015,29 defines a new class of drugs called phytopharmaceutical drug as
p.000078: “purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and
p.000078: quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings
p.000078: or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include
p.000078: administration by parenteral route”. All details described in 7.2 also apply to this group of drugs.
p.000078: 7.7 Device trials
p.000078: 7.7.1 A medical device is defined as a medical tool which does not achieve its primary intended action in or on
p.000078: the human body by pharmacological, immunological, or metabolic means but which may be assisted in its intended
...
p.000084: Diagnostic agents
p.000084:
p.000084: 84 INDIAN COUNCIL OF
p.000085: MEDICAL RESEARCH
p.000085:
p.000085: Clinical Trials of Drugs and
p.000085: other Interventions
p.000085:
p.000085: must be considered as new drugs and therefore clinical trials involving diagnostic agents should be conducted in
p.000085: accordance with all the ethical principles described in these guidelines, Indian GCP guidelines, as well as applicable
p.000085: regulations of the country.
p.000085: 7.14.1 Benefit-risk assessment involving diagnostic agents additionally includes the assessment of benefits,
p.000085: such as technical performance, diagnostic performance, impact on diagnostic thinking and impact on patient
p.000085: management/outcome, and the risks related to the agent itself, such as immunogenicity, allergic reactions, but also
p.000085: risks related to incorrect handling of test procedures or incorrect diagnosis induced by its use.
p.000085: 7.14.2 The EC must review the pharmacology, toxicology, pharmacokinetics and safety data (preclinical and clinical
p.000085: data as applicable) especially for diagnostic agents which come in contact with skin or mucosal surfaces in the human
p.000085: body (in vivo use). Special expertise may be co-opted in the EC for review of such products.
p.000085: 7.14.3 These trials are usually comparative, the comparator being the reference/gold standard test to diagnose the
p.000085: disease. Hence, the protocol must state clearly the choice of the reference with justification. Likewise, omission of a
p.000085: reference standard as comparator must also be justified.
p.000085: 7.14.4 A placebo may be used as comparator when the response to a diagnostic test is being assessed using
p.000085: subjective evaluation criteria, for example, skin changes in a skin prick test or for the assessment of
p.000085: tolerability. There have to be clear justifications in the protocol for the use of a placebo and no irreversible harm
p.000085: should occur to the participant. Post-trial access to the standard of care diagnostic test must be assured.
p.000085: 7.14.5 Safety follow-up of patients in these trials should not be limited to the duration of the diagnostic
p.000085: procedure but may be extended for a longer period according to the pharmacokinetic and pharmacodynamic properties of
p.000085: the diagnostic agent.
p.000085: 7.14.6 Long-term safety (when appropriate) should be assessed especially for agents accumulating in the
p.000085: body, such as deposits of gadolinium in bones and skin.
p.000085: 7.15 Radioactive materials and X-rays
p.000085: Radioactive substances contain a radioactive isotope, and may be used for therapeutic or diagnostic purposes. If the
p.000085: radioactive substance is to be tested as a drug then all the ethical considerations described in previous sections will
p.000085: apply. However, if it is to be evaluated as a diagnostic agent then section 7.15 applies. The permissible radiation
p.000085: limits when radioactive materials and X-rays are being evaluated must comply
p.000085: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000085: 85
p.000086:
p.000086: Clinical Trials of Drugs and
p.000086: other Interventions
p.000086:
p.000086: with regulatory authority guidelines. In India, the agency that regulates radioactive materials is the Bhabha Atomic
p.000086: Research Centre (BARC), Mumbai. Additionally, the following considerations must be applied:
...
p.000089: motivate participation in oncology clinical trials: hope for a cure; altruism that even if the patient does not
p.000089: benefit, it may ultimately help others; and trust that the physician would not recommend a treatment (the
p.000089: investigational drug) unless she/ he thought it might be helpful.
p.000089: All criteria described in section 7.1 and stated in drug trials, biologics and radioactive substances, apply to
p.000089: oncology clinical trials. In addition, while reviewing oncology studies, the following should be kept in mind:
p.000089: 7.19.1 Phase I studies with oncology drugs are conducted in patients. However, there may or may not be any benefit
p.000089: and there may be a high degree of therapeutic misconception. Further, there will be foreseeable and unforeseeable risks
p.000089: that need to be considered before a protocol is approved.
p.000089: 7.19.2 The patient population may be vulnerable as they are often terminally ill. Economically
p.000089:
p.000089: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000089: 89
p.000090:
p.000090: Clinical Trials of Drugs and
p.000090: other Interventions
p.000090:
p.000090: disadvantaged populations may participate in the research to gain free access to an intervention. It is important to
p.000090: ensure that the participant has understood that this is research and the benefits expected may be small or they may not
p.000090: occur at all.
p.000090: 7.19.3 Participants must be made to understand that they may be randomized to a placebo group and therefore receive
p.000090: an inert drug, in case of a placebo-controlled study.
p.000090: 7.19.4 If the trial is a placebo- or active-controlled trial, all the groups must be given the current standard of
p.000090: care to which the IP, placebo or active control is added.
p.000090: 7.19.5 Perceptions of benefits and risks may be different for patients, healthcare workers and EC members. All
p.000090: these perspectives must be taken into consideration while reviewing the protocol.
p.000090: 7.19.6 Undue inducement must be avoided.
p.000090: 7.19.7 Patients should not be charged for any intervention including standard of care in the control arm. If the
p.000090: trial is an add-on design, the background standard of care may not be given free. The EC should review this carefully.
p.000090: 7.19.8 A post-trial access plan must be in place for patients who show benefit from an IP. In case it is a placebo
p.000090: controlled trial, those participants who have been in the placebo group may be offered post-trial access to the IP if
p.000090: found effective in other patients.
p.000090: 7.20 Clinical trials of products using any new technology
p.000090: If any product using new technologies (such as nanotechnology) is developed for human use and is to be evaluated in
p.000090: human beings, the following ethical issues have to be taken into consideration in addition to all the general ethical
p.000090: guidelines for clinical trials as elaborated in the guidelines.
p.000090: 7.20.1 Compliance with GLP, GMP, and GCP norms should be observed in research using new technology products.
p.000090: 7.20.2 Before the use of a new technology product in a human being, preclinical studies should be carried out and
p.000090: all applicable regulatory requirements fulfilled.
p.000090: 7.20.3 The new technology-based products should be contained and released into the environment in a
p.000090: step-wise manner after clearance from the appropriate authority regarding environmental safety.
p.000090: 7.20.4 Differing process based technologies can result in similarly functioning biological products which can
p.000090: give rise to IPR issues.
p.000090: 7.20.5 The research on new technologies should have a well-established mechanism or system for assessing the risk,
p.000090: both in terms of severity and temporality. The unpredictable
p.000090:
p.000090: 90 INDIAN COUNCIL OF
p.000091: MEDICAL RESEARCH
p.000091:
p.000091: Clinical Trials of Drugs and
p.000091: other Interventions
p.000091:
...
Orphaned Trigger Words
p.000004: 1.1.7 Principle of professional competence whereby the research is planned, conducted, evaluated and monitored
p.000004: throughout by persons who are competent and have the appropriate and relevant qualification, experience and/or
p.000004: training.
p.000004: 1.1.8 Principle of maximization of benefit whereby due care is taken to design and conduct the research in such a way
p.000004: as to directly or indirectly maximize the benefits to the research participants and/or to the society.
p.000004: 1.1.9 Principle of institutional arrangements whereby institutions where the research is being conducted, have
p.000004: policies for appropriate research governance and take the responsibility to facilitate research by providing required
p.000004: infrastructure, manpower, funds and training opportunities.
p.000004: 1.1.10 Principle of transparency and accountability whereby the research plan and outcomes emanating from the research
p.000004: are brought into the public domain through registries, reports and scientific and other publications while safeguarding
p.000004: the right to privacy of the participants. Stakeholders involved in research should disclose any existing conflict of
p.000004: interest and manage it appropriately. The research should be conducted in a fair, honest, impartial and transparent
p.000004: manner to guarantee accountability. Related records, data and notes should be retained for the required period for
p.000004: possible external scrutiny/ audit.
p.000004: 1.1.11 Principle of totality of responsibility whereby all stakeholders involved in research are responsible for their
p.000004: actions. The professional, social and moral responsibilities compliant with ethical guidelines and related regulations
p.000004: are binding on all stakeholders directly or indirectly.
p.000004: 1.1.12 Principle of environmental protection whereby researchers are accountable for ensuring protection of the
p.000004: environment and resources at all stages of the research, in compliance with existing guidelines and regulations.
p.000004:
p.000004: 4 INDIAN COUNCIL OF
p.000005: MEDICAL RESEARCH
p.000005:
p.000005: SECTION 2
p.000005:
p.000005:
p.000005: GENERAL ETHICAL ISSUES
p.000005:
p.000005: 2.0 All research involving human participants should be conducted in accordance with the basic and general ethical
p.000005: principles as outlined in section 1. The researcher and the team are responsible for protecting the dignity, rights,
p.000005: safety and well-being of the participants enrolled in the study. They should have the appropriate qualifications and
p.000005: competence in research methodology and should be aware of and comply with the scientific, medical, ethical, legal and
p.000005: social requirements of the research proposal. The ECs are responsible for ensuring that the research is conducted in
p.000005: accordance with the aforementioned principles.
p.000005: 2.1 Benefit-risk assessment
p.000005: Benefits to the individual, community or society refer to any sort of favourable outcome of the research, whether
p.000005: direct or indirect. The social and scientific value of research should justify the risk, which is the probability of
p.000005: causing discomfort or harm anticipated as physical, psychological, social, economic or legal.
p.000005: 2.1.1 The researcher, sponsor and EC should attempt to maximize benefits and minimize risks to participants so that
p.000005: risks are balanced to lead to potential benefits at individual, societal and/or community levels.
...
p.000016: • Institutes hosting/implementing the research are the custodians of the data/
p.000016: samples.
p.000016: • Research must be conducted using appropriate and reliable methods to provide reliable data. The use of
p.000016: inappropriate methods in research compromises the integrity of research data and should be avoided.
p.000016: • Quality research requires attention to detail at every step. Proper protocols need
p.000016:
p.000016: 16 INDIAN COUNCIL OF
p.000017: MEDICAL RESEARCH
p.000017:
p.000017:
p.000017: Responsible Conduct of Research
p.000017:
p.000017: to be established and the results accurately recorded, interpreted and published. Implementation of poorly designed
p.000017: research wastes resources and should be avoided.
p.000017: In some cases, authorization is needed prior to data collection. Researchers are responsible for knowing when
p.000017: permission is needed to collect or use specific data in their research.
p.000017: See Box 3.2 for further details.
p.000017: Box 3.2 Research requiring authorization prior to data collection
p.000017:
p.000017: Data for the following types of research cannot be collected without getting prior authorization:
p.000017: 1. human participants and animals in research;
p.000017: 2. information posted on some websites;
p.000017: 3. hazardous materials and biological agents;
p.000017: 4. biological sample storage and future testing;
p.000017: 5. information from some libraries, databases and archives;
p.000017: 6. published photographs and other published information; and
p.000017: 7. other copyrighted or patented processes or materials.
p.000017:
p.000017: • Data protection and storage is important and once collected, data must be properly protected, as it may be
p.000017: needed at a later stage to confirm research findings, establish priority, or be re-analysed by other researchers.
p.000017: Responsible data handling begins with proper storage and protection from accidental damage, loss or theft. Care should
p.000017: be taken to reduce the risk of fire, flood and other catastrophic events. Computer files should be backed-up and the
p.000017: back-up data saved in a secure place at a site that is different from the original data storage site.
p.000017: • Data sharing is important as research data is valuable and needs to be shared, but deciding when and with
p.000017: whom to share may raise difficult questions. Once a researcher has published the results of an experiment, it is
p.000017: generally expected that all the information about that experiment, including the final data, should be freely available
p.000017: for other researchers to check and use. Data should be shared or placed in a public domain in a
p.000017: de-identified/anonymized form, unless required otherwise, for which applicable permissions/re-consent should be sought
p.000017: unless obtained beforehand.
p.000017: 3.4 Reviewing and reporting research
p.000017: The public’s trust in published research is an essential component of ethical and responsible research.
p.000017:
p.000017: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000017: 17
p.000018:
p.000018:
p.000018: Responsible Conduct of Research
p.000018:
p.000018: 3.4.1 The basic premise of all reviewers and editors evaluating research is that the work has been performed
p.000018: honestly, its reporting is transparent and truthful and the researchers’ integrity is beyond doubt.
p.000018: 3.4.2 Transparency pertains to both the research site and the researcher(s). This would require disclosure of the
p.000018: location of the research as well as the collaborating sites/institutions and the authors of that research.
...
p.000023: The types of international collaborations are mentioned in Box 3.5
p.000023:
p.000023: Box 3.5 Types of international collaboration
p.000023:
p.000023: International collaboration can include all or any of the following elements:
p.000023: • funding by international agencies, such as UN Agencies, NIH, WHO, Wellcome Trust,
p.000023: World Bank and others;
p.000023: • academic collaborations with foreign institutions, universities, organizations,
p.000023: foundations with or without external funding; and
p.000023: • formal government inter-country bilateral/multilateral collaborative arrangements between Indian research
p.000023: bodies/institutions and similar bodies/institutions of other countries.
p.000023:
p.000023: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000023: 23
p.000024:
p.000024:
p.000024: Responsible Conduct of Research
p.000024: • All biomedical and health research proposals involving foreign assistance and/or collaboration should be
p.000024: submitted to the Health Ministry’s Screening Committee (HMSC) for consideration and approval before initiation.19 The
p.000024: secretariat for HMSC is located at the ICMR Headquarters, New Delhi. As per the requirements of HMSC, all research
p.000024: involving international collaboration – either technical, financial, laboratory or data management must be submitted to
p.000024: HMSC.
p.000024: • The exchange of material envisaged as part of a collaborative research proposal must be routed through
p.000024: appropriate authorities. While ethical review and approvals are subject to the national regulatory
p.000024: framework, international collaborations are subject to appropriate considerations of universal ethical
p.000024: principles. The finer specifics recommended in the Indian context may vary from other countries and agencies with
p.000024: respect to socio-cultural norms and needs of the country.
p.000024: • Export of all biological materials will be covered under the existing Government of India (GOI) guidelines
p.000024: for transfer of human biological materials. Research proposals requiring biological material transfer may be considered
p.000024: by the EC on a case-to-case basis. Collaborators should obtain applicable regulatory clearances as mandated by laws
p.000024: such as the Environmental Protection Act, 198620, the Biological Diversity Act, 200221, of Ministry of
p.000024: Environment and Forests, Drugs and Cosmetics Act, 1940, and Rules, 1945, and the relevant amendments. Such exchange of
p.000024: material from and to WHO Collaborating Centres/reference centres for specific purposes, and for individual cases of
p.000024: diagnosis or therapeutic purposes, may not require permission.
p.000024: • Indian participating centre(s) must have appropriate regulatory approval and
p.000024: registration to receive foreign funds for research.22
p.000024: • Any research involving exchange of biological material/specimens with collaborating institution(s)
p.000024: outside India must sign an MTA justifying the purpose and quantity of the sample being collected and addressing
p.000024: issues related to confidentiality, sharing of data, joint publication policy, IPR and benefit sharing, post analysis
p.000024: handling of the leftover biological materials, safety norms, etc.
p.000024: • The guidelines, regulations and cultural sensitivities of all countries participating in collaborative
p.000024: research proposals should be respected by researchers in India and the sponsor country. An appropriate MoU should be in
p.000024: place to safeguard mutual interests and ensure compliance.
p.000024:
p.000024: 24 INDIAN COUNCIL OF
p.000025: MEDICAL RESEARCH
p.000025:
p.000025: SECTION 4
p.000025:
p.000025: ETHICAL REVIEW PROCEDURES
p.000025: 4.0 It is necessary for all research proposals on biomedical, social and behavioural science research for health
p.000025: involving human participants, their biological material and data to be reviewed and approved by an appropriately
p.000025: constituted EC to safeguard the dignity, rights, safety and well-being of all research participants. ECs are entrusted
p.000025: with the initial review of research proposals prior to their initiation, and also have a continuing responsibility to
p.000025: regularly monitor the approved research to ensure ethical compliance during the conduct of research. The EC should be
p.000025: competent and independent in its functioning.
p.000025: 4.0.1 The institution is responsible for establishing an EC to ensure an appropriate and sustainable
p.000025: system for quality ethical review and monitoring.
p.000025: 4.0.2 The institution is responsible for providing logistical support, such as infrastructure, staff, space, funds,
p.000025: adequate support and protected time for the Member Secretary to run the EC functions.
p.000025: 4.0.3 The EC is responsible for scientific and ethical review of research proposals. Although ECs may obtain
p.000025: documentation from a prior scientific review, they must determine that the research methods are scientifically sound,
...
p.000031: disorders, or cancer, with appropriate decision making power.
p.000031: 4.3.12 As far as possible a separate scientific committee should priorly also review proposal before it is referred to
p.000031: EC. EC can raise scientific queries besides ethical ones as both good science and ethics are important to ensure
p.000031: quality of research and participant protection.
p.000031: 4.4 Terms of reference for EC members
p.000031: 4.4.1 The head of the institution should appoint all EC members, including the Chairperson.
p.000031: 4.4.2 The appointment letter issued to all members should specify the TORs. The letter issued by the head of the
p.000031: institution should include, at the minimum, the following:
p.000031: • Role and responsibility of the member in the committee
p.000031: • Duration of appointment
p.000031: • Conditions of appointment
p.000031: 4.4.3 Generally, the term of EC membership may be 2–3 years. The duration could be extended as specified in the SOPs.
p.000031: A defined percentage of EC members could be changed on a regular basis.
p.000031: 4.4.4 EC members may be given a reasonable honorarium for attendance at the meeting.
p.000031:
p.000031: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000031: 31
p.000032:
p.000032:
p.000032: Ethical Review Procedures
p.000032: 4.4.5 Members to be appointed on the EC should be willing to fulfil the EC requirements as given in Box 4.3.
p.000032: Box 4.3 Requirements for EC members
p.000032:
p.000032: Every EC member must:
p.000032: 1. provide a recent signed CV and training certificates on human research protection and good clinical practice (GCP)
p.000032: guidelines, if applicable;
p.000032: 2. either be trained in human research protection and/or GCP at the time of induction into the EC, or must undergo
p.000032: training and submit training certificates within 6 months of appointment (or as per institutional policy);
p.000032: 3. be willing to undergo training or update their skills/knowledge during their tenure as an EC member;
p.000032: 4. be aware of relevant guidelines and regulations;
p.000032: 5. read, understand, accept and follow the COI policy of the EC and declare it, if applicable, at the
p.000032: appropriate time;
p.000032: 6. sign a confidentiality and conflict of interest agreement/s;
p.000032: 7. be willing to place her/his full name, profession and affiliation to the EC in the public domain; and
p.000032: 8. be committed and understanding to the need for research and for imparting protection to research participants in
p.000032: research.
p.000032:
p.000032: 4.5 Criteria for selection of members of an EC
p.000032: 4.5.1 Members should be selected in their personal capacities based on their qualifications, experience, interest,
p.000032: commitment and willingness to volunteer the required time and effort for the EC. See Table 4.1 for further details.
p.000032: 4.5.2 Members are appointed to the EC for a particular role. They cannot substitute for the role of any
p.000032: other member who is absent for a meeting. The role of Chairperson/ Member Secretary is an additional activity to their
p.000032: primary responsibility based on their qualifications. Hence, if the Chairperson is a lawyer, she or he can serve as
p.000032: both the lawyer and the Chairperson.
p.000032: 4.5.3 These criteria should be specified in SOPs.
p.000032: 4.6 Training
p.000032: 4.6.1 Members should be trained in human research protection, EC functions and SOPs, and should be conversant with
p.000032: ethical guidelines, GCP guidelines (if applicable) and relevant regulations of the country.
p.000032: 32 INDIAN COUNCIL OF
p.000033: MEDICAL RESEARCH
p.000033:
p.000033:
p.000033: Ethical Review Procedures
p.000033:
p.000033: 4.6.2 EC members should undergo initial and continuing training in human research protection, applicable EC
p.000033: SOPs and related regulatory requirements. All trainings should be documented.
p.000033: 4.6.3 Any change in the relevant guidelines or regulatory requirements should be brought to the attention of all EC
p.000033: members.
p.000033: 4.6.4 EC members should be aware of local, social and cultural norms and emerging ethical issues.
p.000033: 4.7 Roles and responsibilities of the EC
p.000033: 4.7.1 The basic responsibility of an EC is to ensure protection of the dignity, rights, safety and well-being of the
p.000033: research participants.
p.000033: 4.7.2 The EC must ensure ethical conduct of research by the investigator team.
p.000033: 4.7.3 The EC is responsible for declaration of conflicts of interest to the Chairperson, if any, at each meeting and
p.000033: ensuring these are recorded in the minutes.
p.000033: 4.7.4 The EC should perform its function through competent initial and continuing review of all scientific, ethical,
p.000033: medical and social aspects of research proposals received by it in an objective, timely and independent manner by
p.000033: attending meetings, participation in discussion and deliberations.
...
p.000098: may involve simple methods or more sophisticated research designs and often uses mixed, quantitative and
p.000098: qualitative, methods. Analyses is done with the intention to reach, rather than the intention to treat, for equitable
p.000098: population health impact. Specialized analyses may also be used to explain how and why a policy works, how best to
p.000098: scale an intervention, or how to introduce and expand an innovation. To account for the changing contexts and
p.000098: interventions during the period concerned, a detailed pre-specification of interventions and outcome measures may not
p.000098: be feasible in many projects. IR is essentially adaptive in nature and is different from protocols that require precise
p.000098: pre-definition of interventions, mode of delivery, outcome measurement and the role of study participants.
p.000098: • ECs should, therefore, understand this requirement of flexibility or resilience
p.000098: while reviewing IR projects.
p.000098: • The IR process attempts to distribute roles and responsibilities between researchers
p.000098: and other stakeholders including those researched, at least to a certain extent.
p.000098: • ECs should acknowledge these aspects of good participatory practice in IR and
p.000098: delivery sciences – both formally (by undergoing training) and informally (by
p.000098:
p.000098: 98 INDIAN COUNCIL OF
p.000099: MEDICAL RESEARCH
p.000099:
p.000099:
p.000099: Public Health Research
p.000099:
p.000099: encouraging discussion and debate).
p.000099: • The theoretical core of a complex intervention must be kept constant while allowing and accepting
p.000099: the unique flexibility and resilience of the study design. The ethics of IR is an emerging area and will keep growing
p.000099: as more experience accumulates.
p.000099: • There is a critical role of governance and accountability of all stakeholders due to the asymmetry
p.000099: of knowledge and power relationships which should be considered.
p.000099: 8.2.5 Demonstration projects
p.000099: A demonstration project tests the effects of a new policy approach on the health system in a real-world situation. By
p.000099: their very nature, such projects change the status quo of existing public programmes, affecting communities,
p.000099: users/beneficiaries, providers, and expenditures. They help policymakers to learn about the potential impact
p.000099: and operational challenges of a new policy/programme or modification of the existing policy to a public health system,
p.000099: but in a more controlled environment and on a limited basis. Demonstration projects affect a large population – a
p.000099: district or cluster of districts or a state, thus involving hundreds of thousands of people (users and health
p.000099: providers) with substantial resource investment.
p.000099: • A number of key issues must be considered in designing, implementing and evaluating demonstration
p.000099: projects. This most often requires some level of research for cultural and geographical appropriateness (formative
p.000099: research) to support their development and evaluation to report to the policy makers on recommendations regarding the
p.000099: proposed approach.
p.000099: • All demonstration projects should be subject to ethical scrutiny.
p.000099: Some of the key questions that the EC should raise are:
p.000099: • Why is the demonstration project being undertaken?
p.000099: • How is this designed/being initiated/implemented?
...
p.000101: give permission for participation and randomization of individual participation. The other level is individual
p.000101: participants, consent from whom can cover different aspects:
p.000101: • consent that routinely held data on individuals be collected;
p.000101: • consent regarding the collection of supplementary data;
p.000101: • consent for active participation;
p.000101: • Field trials which involve new pharmaceutical agents require individual consent
p.000101: for both intervention and collection of data.
p.000101: 8.4.3 Types of consent
p.000101: Written voluntary informed consent is the norm for research. However, for specific research the following types of
p.000101: consent may be considered by the EC.
p.000101: Box 8.2 Types of Consent
p.000101: • Verbal/oral consent: For research on sensitive topics, verbal/oral consent or pseudonyms
p.000101: may be suitable with appropriate approval of the EC and with proper documentation.
p.000101: • Broad consent: Providing an individual opt-out option, consultation may be held with
p.000101: only a small representative group of the population of interest.
p.000101: • Group consent: Cluster randomized trials (CRT), IR, and demonstration projects are examples where ECs
p.000101: have to decide on the complex issues of feasibility and type of consent to be obtained from the participants.
p.000101: The process of obtaining such forms of consent and the associated documentation should be approved by the EC.
p.000101: 8.4.4 Waiver of consent – Most epidemiological and public health research would follow standard informed consent
p.000101: guidelines. However, the EC can consider consent waiver in the following conditions, as given in Box 8.3.
p.000101:
p.000101: INDIAN COUNCIL OF MEDICAL RESEARCH
p.000101: 101
p.000102:
p.000102:
p.000102: Public Health Research
p.000102:
p.000102: Box 8.3 Waiver of consent in public health research
p.000102: Consent in public health research may be waived:
p.000102: • on routinely collected data under programme conditions, including research involving linkage to large
p.000102: anonymous databases of information that has been routinely collected such as administrative data and through
p.000102: surveillance activities. However, at the time of collection people concerned may have been told that the data would be
p.000102: used for other purposes, including research;
p.000102: • in circumstances where obtaining consent is impractical, such as for stored anonymous data/ biological samples,
p.000102: surveillance and administrative data or personal non-identifiable data/ material available from public health
p.000102: programmes;
p.000102: • for studies performed within the scope of regulatory and public health authorities, such as process and impact
p.000102: evaluations of national policies and programmes, including neonatal screening programmes or diabetes screening
p.000102: as part of national programme activities may be exempt from the requirement for informed consent;
p.000102: • when the primary purpose is refinement and improvement of the public health programmes;
p.000102: • for studies using health-related registries that are authorized under national regulations; or
p.000102: • when it is not practical or meaningful to obtain consent in large geographical clusters in cluster
p.000102: randomization trials and several IRs.
p.000102:
p.000102: 8.4.5 Re-consenting in longitudinal studies: There is need for re-consenting when there is a change in protocol, new
...
p.000132: the policy it would like to adopt for re-contact.
p.000132:
p.000132: 11.4 Ethical issues related to research
p.000132: Biobanks can use the stored material/data for doing research themselves or they can outsource or supply such
p.000132: material/data to other researchers or institutions on a non- profit basis.
p.000132: 11.4.1 Ownership of the biological samples and data: The participant owns the biological sample and data collected
p.000132: from her/him and therefore, could withdraw both the biological material donated to the biobank and the
p.000132: related data unless the latter is required for outcome measurement and is so mentioned in the initial informed
p.000132: consent document. Complete anonymization would practically make the original donor lose the right of ownership.
p.000132: Biobanks/institutes are the custodians or trustees of the samples and data through their ECs as their present and
p.000132: future use would be done under supervision of the respective ECs. Researchers have no claim for either ownership or
p.000132: custodianship.
p.000132: 11.4.2 Transfer of biospecimens: An MTA should be executed if the biospecimens are likely to be shipped from the host
p.000132: institution to collaborating institutions within the country or abroad. The EC should oversee the process of
p.000132: the in-country and international material transfer. Mandatory regulatory clearances with appropriate MoU are
p.000132: required if biospecimens are to be sent overseas. See section 3.8.3 for further details. Directorate General of Foreign
p.000132: Trade (DGFT) has issued a notification related to transfer of human
p.000132: biological material for commercial purposes.38
p.000132: 11.4.3 Secondary or extended uses of stored samples/re-consent: The EC will examine circumstances under which
p.000132: the biological material or the data were originally collected and informed consent obtained. The decision about
p.000132: anonymization/informed consent waiver or re-consent will be made on a case-by-case basis as provided in Box 11.4
p.000132:
p.000132: 132 INDIAN COUNCIL OF MEDICAL
p.000133: RESEARCH
p.000133:
p.000133: Biological Materials,
p.000133: Biobanking and Datasets
p.000133:
p.000133:
p.000133: Box 11.4 Use of stored samples
p.000133:
p.000133: The following must be considered when stored samples are to be used:
p.000133: 1. whether the proposed use is aligned with the original consent given for the earlier research and scrutinize the
p.000133: validity of the objectives of the new research;
p.000133: 2. whether provisions for ensuring anonymity of the samples for secondary use are stated;
p.000133: 3. whether the permission of LAR is obtained for post-mortem uses of samples;
p.000133: 4. whether the consent form mentions retention and various possible future uses of tissues in the form of a tiered
p.000133: consent; and
p.000133: 5. Whether provisions have been made for allowance of waiver of consent if the donor is not traceable or the
p.000133: sample/data is anonymized or it is impractical to conduct the research.
p.000133:
p.000133: 11.4.4 Return of research results to individual/groups
p.000133: There are several possibilities which may be appropriate for a particular research and, according to the suitability,
p.000133: could be included in the participant information sheet/ informed consent document for biobanking.
p.000133: • Results of the study should be communicated back to the providers of samples/
p.000133: data.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| LGBT | LGBTQ+ Status |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to healthcare | access to healthcare |
| access to information | Access to information |
| age | Age |
| arrested | person under arrest |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| blind | visual impairment |
| blinded | visual impairment |
| breastfeeding | breastfeeding |
| cadavers | Cadavers |
| child | Child |
| childbearing age | of childbearing age/fertile |
| children | Child |
| cioms | cioms guidelines |
| coerce | Presence of Coercion |
| coerced | Presence of Coercion |
| cognitive | Cognitive Impairment |
| commonXrule | common rule |
| control group | participants in a control group |
| culturally | cultural difference |
| dependence | Drug Dependence |
| dependency | Drug Dependence |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| ethnic | Ethnicity |
| ethnicity | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| gender | gender |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| home | Property Ownership |
| homeless | Homeless Persons |
| ill | ill |
| illiterate | Literacy |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| indigenous | Indigenous |
| infant | Infant |
| influence | Drug Usage |
| institutionalized | Institutionalized |
| job | Occupation |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| literacy | Literacy |
| literate | Literacy |
| manipulated | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| minority | Racial Minority |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| physically | Physically Disabled |
| placebo | participants in a control group |
| police | Police Officer |
| political | political affiliation |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| race | Racial Minority |
| racial | Racial Minority |
| religious | Religion |
| restricted | Incarcerated |
| schooling | education |
| sex workers | sex worker |
| sexually transmitted | sexually transmitted disases |
| single | Marital Status |
| std | sexually transmitted disases |
| stem cells | stem cells |
| stigma | Threat of Stigma |
| stigmatization | Threat of Stigma |
| student | Student |
| substance | Drug Usage |
| terminally | Terminally Ill |
| threat | Threat of Stigma |
| trauma | Victim of Abuse |
| unconscious | Unconscious People |
| undue influence | Undue Influence |
| unemployed | Unemployment |
| union | Trade Union Membership |
| unmarried | Marital Status |
| violence | Threat of Violence |
| visually impaired | visual impairment |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| abuse | ['trauma'] |
| blind | ['blinded', 'visuallyXimpaired'] |
| blinded | ['blind', 'visuallyXimpaired'] |
| child | ['children'] |
| children | ['child'] |
| coerce | ['coerced'] |
| coerced | ['coerce'] |
| cognitive | ['impaired', 'impairment'] |
| control group | ['placebo'] |
| dependence | ['dependency'] |
| dependency | ['dependence'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| drug | ['influence', 'substance'] |
| education | ['educational', 'schooling'] |
| educational | ['education', 'schooling'] |
| emergencies | ['emergencyXsituation'] |
| emergency situation | ['emergencies'] |
| ethnic | ['ethnicity'] |
| ethnicity | ['ethnic'] |
| faith | ['religious'] |
| fetus | ['foetus', 'foetuses'] |
| foetus | ['fetus', 'foetuses'] |
| foetuses | ['fetus', 'foetus'] |
| healthy volunteers | ['volunteers'] |
| hiv/aids | ['HIV'] |
| home | ['property'] |
| illiterate | ['literacy', 'literate'] |
| illness | ['physically'] |
| impaired | ['cognitive', 'impairment'] |
| impairment | ['cognitive', 'impaired'] |
| influence | ['drug', 'substance'] |
| liberty | ['restricted'] |
| literacy | ['illiterate', 'literate'] |
| literate | ['illiterate', 'literacy'] |
| mentally | ['disabled', 'disability'] |
| minority | ['race', 'racial'] |
| opinion | ['philosophy'] |
| parent | ['parents'] |
| parents | ['parent'] |
| party | ['political'] |
| philosophy | ['opinion'] |
| physically | ['illness'] |
| placebo | ['controlXgroup'] |
| political | ['party'] |
| poor | ['poverty'] |
| poverty | ['poor'] |
| property | ['home'] |
| race | ['minority', 'racial'] |
| racial | ['minority', 'race'] |
| religious | ['faith'] |
| restricted | ['liberty'] |
| schooling | ['education', 'educational'] |
| sexually transmitted | ['std'] |
| single | ['unmarried'] |
| std | ['sexuallyXtransmitted'] |
| stigma | ['threat', 'stigmatization'] |
| stigmatization | ['stigma', 'threat'] |
| substance | ['drug', 'influence'] |
| threat | ['stigma', 'stigmatization'] |
| trauma | ['abuse'] |
| unmarried | ['single'] |
| visually impaired | ['blind', 'blinded'] |
| volunteers | ['healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
compromised position
consent
cultural
developing
ethics
exploit
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input