79C3C34C52B45572883A05D425EB0F82
National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure
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This file was generated: 2020-12-01 07:35:21
| 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.000009: necessary
p.000009: 5.2.5 When vulnerable populations are involved in research, the necessity of involving them should be
p.000009: clearly demonstrated
p.000009: 5.2.6 Relevant risks and benefits should be clearly and thoroughly spelled out in the documents used in the
p.000009: informed consent process
p.000009:
p.000009: 5.3. Selection of the Research Participants
p.000009: 5.3.1. The system of justice requires that there be fair procedures and outcome in the selection of
p.000009: research participants. Individual justice in the selection of participants requires that researchers exhibit
p.000009: fairness. Thus they should not offer potentially beneficial research only to some who are in their favor or
p.000009: select only „undesirable‟ participants for risky research. Social justice requires that distinction be
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
...
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
p.000014: should have made provisions to compensate the efforts and time of the participants for the purpose of research.
p.000014: The information related to the provision for compensation should have been communicated to the research
p.000014: participant.
p.000014:
p.000015: 15
p.000015:
p.000015: 9. Qualifications and Competence for the Research
p.000015: Principal investigator of any research must have relevant qualifications and competence to conduct research.
p.000015:
p.000015: 10.Equal Distribution
...
Political / political affiliation
Searching for indicator political:
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p.000001: 1790 BC), Agnivesa‟s “Charaka Samhita” (Indian subcontinent 800 BC to 400 AD) and the Hippocratic Oath
p.000001: (Greece 600 BC). Recorded writings on medical ethics are to be found even earlier in the ancient writings of
p.000001: Egyptian, Arabic and Greek scientists and philosophers. More recently, in the west the concept of just moral propriety
p.000001: in medicine was propounded by Thomas Hobbes in 1651 and that of medical humanism by John Gregory in the 18th
p.000001: century. Thomas Percival came up with the concept of bio-ethics and legislative aspects of ethics related
p.000001: behavior.
p.000001:
p.000001: 1
p.000001:
p.000001:
p.000001: In 1946 the International Health Conference meeting in New York adopted the constitutional structure of
p.000001: the World Health Organization (WHO), which formally came into existence in 1948. This constitution
p.000001: reiterated the responsibilities of government and health professionals for promoting and protecting the health of
p.000001: individuals and populations.
p.000001:
p.000001: As the key organization responsible for health within the structure of United Nations, the WHO promotes the
p.000001: Universal Bill of Human Rights which includes Universal Declaration of Human Rights composed in 1948, the
p.000001: International Covenant of Economic, Social and Cultural Rights (1966, ratified in 1976) and the International
p.000001: Covenant of Civil and Political Rights (1966). These three instruments define and describe basic human rights and
p.000001: fundamental freedoms. They form the nucleus of an interlocking set of international conventions, resolutions and
p.000001: declarations intent on promoting the rights and freedoms of persons through law. The Universal Declaration on Human
p.000001: Rights is supported and promoted by Nepal Health Research Council in all its activities.
p.000001:
p.000001: Ethics related to health and biomedical research is a more recent phenomenon. The first international
p.000001: document on this subject is the Nuremberg Code in 1947. This was followed by a series of international
p.000001: declarations, conventions and covenants related to ethics in health, health care and research. The most prominent of
p.000001: these documents are the World Medical Association (WMA) Declaration of Helsinki, the Council of International
p.000001: Organization of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving
p.000001: Human Subjects and the WHO and ICH Guidelines for Good Clinical Practice.
p.000001:
p.000001: The Nepalese national ethical guidelines for health research is cognizant of these declarations, code and
p.000001: guidelines and has followed the spirit in which they are written.
p.000001:
p.000001: 3. Definitions
p.000001: Research: The term research refers to a set of activities designed to develop or to contribute to
p.000001: generalizable knowledge consisting of theories, principles, relationships or the accumulation of information which they
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000001: 5. Application of Ethical Principles in Health Research 6
p.000001: 5.1 Informed Consent 6
p.000001: 5.1.1 Information 6
p.000001: 5.1.2 Comprehension 7
p.000001: 5.1.3 Voluntariness 7
p.000001: 5.1.4 Process and Information Contained in an
p.000001: Informed Consent Form 8
p.000001: 5.2 Assessment of Risks and Benefits 9
p.000001: 5.3 Selection of the Research Participants 10
p.000001: 5.4 Best Research Practices 11
p.000001: 5.5 Externally Sponsored Research 12
p.000001: 5.6 Scientific Merit of a Health Research Proposal 13
p.000001: v
p.000001:
p.000001: Section B
p.000001: Basic Principles of Health Research Involving Human Participants
p.000001: 14-18
p.000001: 1. Essential Research 14
p.000001: 2. Voluntary Participation 14
p.000001: 3. Children in Health Research 15
p.000001: 4. Pregnant Women in Health Research 15
p.000001: 5. Other Vulnerable People in Health Research 15
p.000001: 6. Potential Benefit 15
p.000001: 7. Harm and Risks 15
p.000001: 8. Compensation 15
p.000001: 9. Qualifications and Competence for the Research 16
p.000001: 10. Equal Distribution 16
p.000001: 11. Dissemination of Research Findings 16
p.000001: 12. Institutional Research Arrangements 16
p.000001: 13. Confidentiality and Disclosure 17
p.000001: 14. Professional, Legal and Moral Responsibility 17
p.000001: 15. Transparency and Conflict of Interest 17
p.000001: 16. Research and the Environment 17
p.000001: 17. International and/or Externally Sponsored Research 18
p.000001: 18. Transfer of Biological Samples Outside of Nepal 18
p.000001: 19. Approval Required for all Health Research in Nepal 18
p.000001: vi
p.000001:
p.000001: Section C
p.000001: Standard Operating Procedures for the Ethical Review Board of Nepal Health Research Council
p.000001: 19– 32
p.000001: Introduction 19
p.000001: 1. Function and Duties of ERB 19
p.000001: 2. Membership of ERB 20
p.000001: 3. Independent Consultant(s) to the ERB 22
...
p.000003: autonomy of an individual, beneficence, non malfeasance and the principle of justice. While conducting research
p.000003: at a community level involving humans in groups, all these principles are considered in a composite way.
p.000003: The principle of respect for the environment proposes to ensure respect for the culture of communities,
p.000003: their environment, benefit to the members of the community and not harming them ensuring that the justice is
p.000003: done to them.
p.000003:
p.000003: 4.1. Principle I: Respect for the Autonomy of the Participant The obligation to respect the dignity of
p.000003: participating individuals in all activities of health and biomedical research is the cornerstone of research ethics.
p.000003: This principle is based on the premise that an individual when informed of all aspects of an activity can
p.000003: decide for her/himself a correct course of action. This requires specific attention to the following:
p.000003: 4.1 (a) An individual‟s right to decide what is best for her/him can not be overruled by any consideration
p.000003: of person
p.000003: 4.1 (b) Researchers must actively safeguard the interests of the persons with impaired or diminished
p.000003: autonomy and ensure that the vulnerable people are afforded security against harm, abuse or exploitation
p.000003: 4.1 (c) No researches should take precedence over respect for human rights, fundamental freedom and human dignity,
p.000003: and practices contrary to human dignity should be prohibited.
p.000003:
p.000003: The provisions of respect for autonomy of the human \participants in health research are implemented
p.000003: primarily through the instrument of “informed consent”
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 4.2. Principle II: Beneficence and Non-Malfeasance
p.000004: The principle of beneficence requires that the research activity should benefit the participants directly or
p.000004: indirectly, in the present or in future, individually or through collective benefits. If none of these
p.000004: benefits are obvious, the researcher should ensure that the participation in research does not lead to any
p.000004: harm. All attempts to maximize the benefits and minimize the risks should have been taken by the researcher.
p.000004:
p.000004: This requires that all health and biomedical research activities be preceded by a careful assessment of the potential
p.000004: risks and burdens in comparison to the potential benefits to the prospective research participant and their
p.000004: communities. This does not preclude the participation of healthy volunteers in research. However, in all cases
p.000004: the research should promote the health of the population represented.
p.000004:
p.000004: Beneficence and non malfeasance also requires that the researchers are qualified to carry out proposed
p.000004: research that they are committed to promoting, protecting the health of the participants and their communities.
p.000004: The principle of non malfeasance proscribes those researches which are likely to cause deliberate harm to the
p.000004: participants.
p.000004:
p.000004: 4.3. Principle III: Justice
p.000004: Justice requires that persons in similar circumstances be treated alike and that differences between persons due to
p.000004: circumstances be acknowledged and addressed. In the context of health research, justice requires that persons
p.000004: having similar health complaints or threats be treated equally.
p.000004:
p.000004: Justice also requires the equitable distribution of the burdens and benefits of research. Differences in such
p.000004: distribution are justifiable only if they are based on morally relevant distinctions between persons, for
p.000004: example, in cases where it is necessary to ensure the protection of the rights and welfare of vulnerable
p.000004: persons.
p.000004:
p.000004: The protection of persons in vulnerable situations is of special importance. Persons in vulnerable situations
p.000004: are those who are unable to express or protect fully their own interests owing to such impediments as lack of capacity
p.000004: to consent fully, an inability to obtain alternative means of medical care and or other health necessities, or because
p.000004: they are junior
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: or subordinate member of a hierarchical group. Accordingly, special provisions must be made for the protection
p.000005: of the rights and welfare of all the persons in vulnerable situation.
p.000005:
p.000005: 4.4. Principle IV: Respect for the Environment
p.000005: This principle requires that health research is undertaken within a context of respect for the social, cultural
p.000005: and natural heritage of a society. This fundamental ethical principle is re-enforced by WMA Declaration
p.000005: of Helsinki, which stresses the special precautions that must be exercised for the protection of the environment in
p.000005: the conduct of research. In view of the increasing world movement for the protection of the environment, every
p.000005: researcher is responsible for a moral engagement to protect the social, cultural and natural heritage of
p.000005: communities and societies. This responsibility includes commitment to the following:
p.000005: 4.4 (a) To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical and
p.000005: field research
p.000005: 4.4 (b) To safeguard the cultural, linguistic and religious heritage of communities and individuals
p.000005: 4.4 (c) To treat the biologic and genetic heritage of the people with respect and caution. This requires respecting
p.000005: the principles of informed consent and confidentiality of genetic data
p.000005:
...
p.000008: to something of a positive value related to health or welfare. The most likely types of harm to research
p.000008: participants are physical pain or injury or psychological effects. However, other kinds of harm
p.000008: must not be overlooked which include legal, social, and economic. Benefits may also be of the corresponding types.
p.000008:
p.000008: Making precise judgments about the risk/benefits ratio is difficult in most instances as only rarely can quantitative
p.000008: techniques be available to judge research proposals. Therefore systematic, non-arbitrary analysis of risks
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: and benefits should be adopted as far as possible. For this purpose, through accumulation and assessment
p.000009: of information about all aspects of the research should be done, and alternatives should be considered
p.000009: systematically.
p.000009:
p.000009: In assessing the justifiability of research, consideration of the following is the minimum:
p.000009: 5.2.1 It should be judged whether the use of human participants is in fact necessary at all
p.000009: 5.2.2 Brutal or inhumane treatment of human participants is never justified
p.000009: 5.2.3 Risks should be reduced to those necessary to achieve the research objectives
p.000009: 5.2.4 When research involves significant risk, extra ordinary insistence on the justification of the risk is
p.000009: necessary
p.000009: 5.2.5 When vulnerable populations are involved in research, the necessity of involving them should be
p.000009: clearly demonstrated
p.000009: 5.2.6 Relevant risks and benefits should be clearly and thoroughly spelled out in the documents used in the
p.000009: informed consent process
p.000009:
p.000009: 5.3. Selection of the Research Participants
p.000009: 5.3.1. The system of justice requires that there be fair procedures and outcome in the selection of
p.000009: research participants. Individual justice in the selection of participants requires that researchers exhibit
p.000009: fairness. Thus they should not offer potentially beneficial research only to some who are in their favor or
p.000009: select only „undesirable‟ participants for risky research. Social justice requires that distinction be
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
...
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
p.000014: should have made provisions to compensate the efforts and time of the participants for the purpose of research.
p.000014: The information related to the provision for compensation should have been communicated to the research
p.000014: participant.
p.000014:
p.000015: 15
p.000015:
p.000015: 9. Qualifications and Competence for the Research
...
p.000026: 6.2.1.l Inclusion criteria for the research participants
p.000026: 6.2.1.m Exclusion criteria for the research participants
p.000026: 6.2.1.n Protection of research participants
p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
p.000027: In the following situations the ERB will allow the Member Secretary to expedite the review of the proposal.
p.000027: 6.3.1 If the research is non interventional, based on secondary data, leading to thesis or has
p.000027: received approval from the Institutional Review Committee
p.000027: 6.3.2 If t he r esearch i s carried out under t he circumstances of outbreak, disaster and
p.000027: other emergency conditions
p.000027:
p.000028: 28
p.000028:
p.000028: 6.3.3 If the proposal i s found technically and scientifically sound after reviewing by internal
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.000003: to prevent, control, and or manage health problems and or promote healthy or environment friendly behavior.
p.000003:
p.000003: 4. Ethical Principles
p.000003: The ethical principles which guide the health research and care are the principles of respect for
p.000003: autonomy of an individual, beneficence, non malfeasance and the principle of justice. While conducting research
p.000003: at a community level involving humans in groups, all these principles are considered in a composite way.
p.000003: The principle of respect for the environment proposes to ensure respect for the culture of communities,
p.000003: their environment, benefit to the members of the community and not harming them ensuring that the justice is
p.000003: done to them.
p.000003:
p.000003: 4.1. Principle I: Respect for the Autonomy of the Participant The obligation to respect the dignity of
p.000003: participating individuals in all activities of health and biomedical research is the cornerstone of research ethics.
p.000003: This principle is based on the premise that an individual when informed of all aspects of an activity can
p.000003: decide for her/himself a correct course of action. This requires specific attention to the following:
p.000003: 4.1 (a) An individual‟s right to decide what is best for her/him can not be overruled by any consideration
p.000003: of person
p.000003: 4.1 (b) Researchers must actively safeguard the interests of the persons with impaired or diminished
p.000003: autonomy and ensure that the vulnerable people are afforded security against harm, abuse or exploitation
p.000003: 4.1 (c) No researches should take precedence over respect for human rights, fundamental freedom and human dignity,
p.000003: and practices contrary to human dignity should be prohibited.
p.000003:
p.000003: The provisions of respect for autonomy of the human \participants in health research are implemented
p.000003: primarily through the instrument of “informed consent”
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 4.2. Principle II: Beneficence and Non-Malfeasance
p.000004: The principle of beneficence requires that the research activity should benefit the participants directly or
p.000004: indirectly, in the present or in future, individually or through collective benefits. If none of these
p.000004: benefits are obvious, the researcher should ensure that the participation in research does not lead to any
p.000004: harm. All attempts to maximize the benefits and minimize the risks should have been taken by the researcher.
p.000004:
p.000004: This requires that all health and biomedical research activities be preceded by a careful assessment of the potential
p.000004: risks and burdens in comparison to the potential benefits to the prospective research participant and their
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000009: informed consent process
p.000009:
p.000009: 5.3. Selection of the Research Participants
p.000009: 5.3.1. The system of justice requires that there be fair procedures and outcome in the selection of
p.000009: research participants. Individual justice in the selection of participants requires that researchers exhibit
p.000009: fairness. Thus they should not offer potentially beneficial research only to some who are in their favor or
p.000009: select only „undesirable‟ participants for risky research. Social justice requires that distinction be
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
p.000010: investigators according to a research proposal (protocol) that clearly identifies the purpose, questions,
p.000010: and methodology of the study. The proposal should be scientifically and ethically appraised by one or
p.000010: more suitably and legally constituted review body, independent of the investigators. The
p.000010:
p.000010:
p.000011: 11
p.000011:
...
p.000026: 6.2.1 Scientific Design of Research Proposal and Conduct of Research
p.000026: 6.2.1.a The appropriateness of the study design in relation to the objectives of the study
p.000026: 6.2.1.b Statistical methods: sampling method, sample size and analysis of data
p.000026: 6.2.1.c Justification of predictable risks and inconveniences against the anticipated benefits for the
p.000026: research participants and community by the proposed study
p.000026: 6.2.1.d Justification of the use of control arm (if relevant for the study)
p.000026: 6.2.1.e Criteria for prematurely withdrawing research participants
p.000026: 6.2.1.f Criteria for suspending or terminating the research
p.000026: 6.2.1.g Provisions for data safety monitoring board(DSMB)
p.000026: 6.2.1.h Plan for dissemination or publication of research results
p.000026: 6.2.1.i Infrastructure and other facilities in the institutions conducting the research
p.000026: 6.2.1.j Suitability of researcher‟s qualification and experiences for The proposed research
p.000026: 6.2.1.k Description of the population from which the research participants will be drawn
p.000026: 6.2.1.l Inclusion criteria for the research participants
p.000026: 6.2.1.m Exclusion criteria for the research participants
p.000026: 6.2.1.n Protection of research participants
p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
...
p.000031: 10.10 All written documentation received during the follow-up
p.000031: 10.11 The notification of the completion, premature suspension, or premature termination of a study
p.000031: 10.12 The final summary or final report of the study
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
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p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: APPENDICES
p.000032: Appendix I
p.000032:
p.000032: Checklist for the Ethical Review of Proposals
p.000032: Review of the research proposal for ethical clearance: Title of the research proposal:
p.000032: Date of review:
p.000032: Reviewer:
p.000032:
p.000032: Issue under Consideration
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Consent
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Benefits to the Participants
p.000032:
p.000032:
p.000032: Application of
p.000032: Ethical Principals
p.000032: Questions related to the main Issues Yes No. Remarks
p.000032: Provision for informed consent Clarity of the topics to the subjects. Voluntariness of the consent Inducements to
p.000032: participate, monetary or others
p.000032: Unconditional withdrawal allowed? Mechanism for taking consent from minors and disabled
p.000032: Possibility of tricking participants to participants
p.000032: Possibility of intervention (Vaccine, drug or supplementation) being available to the participant population if found
p.000032: effective.
p.000032: Is the study essential to accomplish the goal?
p.000032: Is there no other way to obtain the information?
p.000032: Do the benefits outweigh the risks? Are the risks reasonable and not excessive?
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Obligations of the sponsors
p.000033: Do the researchers have adequate qualifications and competencies?
p.000033: Assurance of medical services related to research for study participants.
p.000033: Assurance of access to beneficial results to study participants Reasonable mechanisms for care and compensation
p.000033: in case of injury, resulting from research.
p.000033: Provision of mechanism for capacity building of the national research institutions in the host country
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
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p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Appendix II Ethical Questions
p.000034: ETHICALLY DRIVING QUESTIONS FOR CONSIDERATION BY THE ETHICAL REVIEW BOARD
p.000034: 1. What questions does this research answer?
p.000034:
p.000034: 2. Are those questions relevant to the needs of the country?
p.000034:
p.000034: 3. Has/ve such research (es) been already conducted in Nepal? Elsewhere?
p.000034:
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000034:
p.000034: 13. How can the participants opt out of the research once it is started?
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: 14. Is the research" externally sponsored? If yes, what are the responsibilities of the external sponsor?
p.000035:
p.000035: 15. Is there 'any transfer of technology involved during the research process?
p.000035:
p.000035: 16. How are the' sponsors going to strengthen the research capability of the host institution?
p.000035:
p.000035: 17. Is there going to be transfer, of biological materials?
p.000035:
p.000035: 18. Is there provision of Data Safety Monitoring Board (DSMB) for clinical trial study?
p.000035:
p.000035: 19. Is the clinical trial registered elsewhere?
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
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p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Bibliography
p.000036: Alberto Pellegrini Filho and Ruth Macklin, Research on Human Subjects: International Experience, First Meeting of
p.000036: the International Advisory Board on Bioethics,Pan American Health Organization, World Health Organization,
p.000036: Washington DC, USA, May 10-12, 1999.
p.000036:
p.000036: Benjamin Freedman, Equipoise and the Ethics of Clinical Research, New England Journal of Medicine, V 01.317, No. 3, pp
p.000036: 141-5, 16 July 1987.
p.000036:
p.000036: David Luban, Lawyers and Justice - An Ethical Study, NewJersey, 1988.
p.000036:
p.000036: Ethical Considerations in HIV Preventive Vaccine Research, UNAIDS Guidance Document, UNAIDS, May, 2000.
p.000036:
p.000036: European Forum for Good Clinical Practice (EFGCP), Guidelines and Recommendations for European Ethics
p.000036: Committees, Revised Edition, 1997.
p.000036:
p.000036: Forum for Ethical Review Committees in Asia & the Western Pacific (FERCAP), Standard Operating Procedure
p.000036: (SOP) Handbook for Ethics Committee, 2005 www.fercap.sidcer.org
p.000036:
p.000036: Forum for Ethical Review Committees in the Asian Western Pacific Region (FERCAP), Terms of Reference, Website:
p.000036: Q:/res/ res/fercap,TORI.
p.000036:
p.000036: Francis P. Crawley, Ethical Review committees: Local, Institutional and International Experiences, Bio-ethics:
p.000036: the Judiciary and Ethics Committees, International Journal of Bio-ethics, VoI.l0, No 5, pp, 25-33, 1999.
p.000036:
p.000036: Francis P. Crawley, Ethics committees and Informed Consent: Locating Responsibility in Clinical Trials, Tokai J
p.000036: Exp Clin Med, VoI.22, No.6, pp, 259-265, 1997.
p.000036:
p.000036: Guidelines for the Conduct of Research in the Intramural Research Programs at NIH, Website:
p.000036: http://www.nih.gov/campus/ irnews
p.000036: / guidelines.htm
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: Guidelines for the conduct of Research Involving Human Subjects at the National Institutes of Health, 3rd printing,
p.000037: February, 2000.
p.000037:
...
Health / Healthy People
Searching for indicator healthy volunteers:
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p.000003: autonomy and ensure that the vulnerable people are afforded security against harm, abuse or exploitation
p.000003: 4.1 (c) No researches should take precedence over respect for human rights, fundamental freedom and human dignity,
p.000003: and practices contrary to human dignity should be prohibited.
p.000003:
p.000003: The provisions of respect for autonomy of the human \participants in health research are implemented
p.000003: primarily through the instrument of “informed consent”
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 4.2. Principle II: Beneficence and Non-Malfeasance
p.000004: The principle of beneficence requires that the research activity should benefit the participants directly or
p.000004: indirectly, in the present or in future, individually or through collective benefits. If none of these
p.000004: benefits are obvious, the researcher should ensure that the participation in research does not lead to any
p.000004: harm. All attempts to maximize the benefits and minimize the risks should have been taken by the researcher.
p.000004:
p.000004: This requires that all health and biomedical research activities be preceded by a careful assessment of the potential
p.000004: risks and burdens in comparison to the potential benefits to the prospective research participant and their
p.000004: communities. This does not preclude the participation of healthy volunteers in research. However, in all cases
p.000004: the research should promote the health of the population represented.
p.000004:
p.000004: Beneficence and non malfeasance also requires that the researchers are qualified to carry out proposed
p.000004: research that they are committed to promoting, protecting the health of the participants and their communities.
p.000004: The principle of non malfeasance proscribes those researches which are likely to cause deliberate harm to the
p.000004: participants.
p.000004:
p.000004: 4.3. Principle III: Justice
p.000004: Justice requires that persons in similar circumstances be treated alike and that differences between persons due to
p.000004: circumstances be acknowledged and addressed. In the context of health research, justice requires that persons
p.000004: having similar health complaints or threats be treated equally.
p.000004:
p.000004: Justice also requires the equitable distribution of the burdens and benefits of research. Differences in such
p.000004: distribution are justifiable only if they are based on morally relevant distinctions between persons, for
p.000004: example, in cases where it is necessary to ensure the protection of the rights and welfare of vulnerable
p.000004: persons.
p.000004:
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
p.000027: In the following situations the ERB will allow the Member Secretary to expedite the review of the proposal.
p.000027: 6.3.1 If the research is non interventional, based on secondary data, leading to thesis or has
p.000027: received approval from the Institutional Review Committee
p.000027: 6.3.2 If t he r esearch i s carried out under t he circumstances of outbreak, disaster and
p.000027: other emergency conditions
p.000027:
p.000028: 28
p.000028:
p.000028: 6.3.3 If the proposal i s found technically and scientifically sound after reviewing by internal
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
p.000028: The ERB will consider the following while making decision about the research proposal
p.000028: 7.1 The ERB will make the decision only if the meeting has met required quorum as noted in 2.18-20
...
p.000031: decision, and follow- up
p.000031: 10.9 A copy of the decision and any advice or requirements sent to an applicant
p.000031: 10.10 All written documentation received during the follow-up
p.000031: 10.11 The notification of the completion, premature suspension, or premature termination of a study
p.000031: 10.12 The final summary or final report of the study
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
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p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: APPENDICES
p.000032: Appendix I
p.000032:
p.000032: Checklist for the Ethical Review of Proposals
p.000032: Review of the research proposal for ethical clearance: Title of the research proposal:
p.000032: Date of review:
p.000032: Reviewer:
p.000032:
p.000032: Issue under Consideration
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Consent
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Benefits to the Participants
p.000032:
p.000032:
p.000032: Application of
p.000032: Ethical Principals
p.000032: Questions related to the main Issues Yes No. Remarks
p.000032: Provision for informed consent Clarity of the topics to the subjects. Voluntariness of the consent Inducements to
p.000032: participate, monetary or others
p.000032: Unconditional withdrawal allowed? Mechanism for taking consent from minors and disabled
p.000032: Possibility of tricking participants to participants
p.000032: Possibility of intervention (Vaccine, drug or supplementation) being available to the participant population if found
p.000032: effective.
p.000032: Is the study essential to accomplish the goal?
p.000032: Is there no other way to obtain the information?
p.000032: Do the benefits outweigh the risks? Are the risks reasonable and not excessive?
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Obligations of the sponsors
p.000033: Do the researchers have adequate qualifications and competencies?
p.000033: Assurance of medical services related to research for study participants.
p.000033: Assurance of access to beneficial results to study participants Reasonable mechanisms for care and compensation
p.000033: in case of injury, resulting from research.
p.000033: Provision of mechanism for capacity building of the national research institutions in the host country
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
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p.000033:
p.000033:
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p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Appendix II Ethical Questions
p.000034: ETHICALLY DRIVING QUESTIONS FOR CONSIDERATION BY THE ETHICAL REVIEW BOARD
p.000034: 1. What questions does this research answer?
p.000034:
p.000034: 2. Are those questions relevant to the needs of the country?
p.000034:
...
Searching for indicator mentally:
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p.000009: 5.2.4 When research involves significant risk, extra ordinary insistence on the justification of the risk is
p.000009: necessary
p.000009: 5.2.5 When vulnerable populations are involved in research, the necessity of involving them should be
p.000009: clearly demonstrated
p.000009: 5.2.6 Relevant risks and benefits should be clearly and thoroughly spelled out in the documents used in the
p.000009: informed consent process
p.000009:
p.000009: 5.3. Selection of the Research Participants
p.000009: 5.3.1. The system of justice requires that there be fair procedures and outcome in the selection of
p.000009: research participants. Individual justice in the selection of participants requires that researchers exhibit
p.000009: fairness. Thus they should not offer potentially beneficial research only to some who are in their favor or
p.000009: select only „undesirable‟ participants for risky research. Social justice requires that distinction be
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
p.000010: investigators according to a research proposal (protocol) that clearly identifies the purpose, questions,
p.000010: and methodology of the study. The proposal should be scientifically and ethically appraised by one or
p.000010: more suitably and legally constituted review body, independent of the investigators. The
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: implementation of the research should follow best research practices including internationally accepted Good
p.000011: Clinical Practice Guidelines, Good Laboratory Practice Guidelines, and Good Manufacturing Practice Guidelines.
p.000011: 5.4.2. Data should be handled, processed, and analyzed by competent and qualified persons led by
p.000011: qualified health professionals. Ethical responsibility of managers/handlers of data for safety,
p.000011: confidentiality, and prevention of misuse should be strictly upheld.
p.000011:
p.000011: 5.5. Externally Sponsored Research
p.000011: The following conditions must be considered before externally sponsored research can take place in Nepal:
p.000011: 5.5.1. The research is preferably responsive to the health needs and priorities of Nepal as well as being
...
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
p.000014: should have made provisions to compensate the efforts and time of the participants for the purpose of research.
p.000014: The information related to the provision for compensation should have been communicated to the research
p.000014: participant.
p.000014:
p.000015: 15
p.000015:
p.000015: 9. Qualifications and Competence for the Research
p.000015: Principal investigator of any research must have relevant qualifications and competence to conduct research.
p.000015:
p.000015: 10.Equal Distribution
p.000015: The selection of research participants should be such that there is equal distribution of the burden and
...
Searching for indicator disability:
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p.000007: the following information:
p.000007: 1. The nature of the study-whether investigational, in terms of the use of drugs or procedure, or whether
p.000007: information seeking, or if questionnaires or interviews are to be used
p.000007: 2. The number of participants
p.000007: 3. The purpose/objective of the study
p.000007: 4. The expected duration of the research study and he frequency of the participant‟s involvement
p.000007: 5. The participant‟s responsibility
p.000007: 6. A statement that the participation is voluntary
p.000007: 7. A statement that the participant can withdraw from the study at any time without giving any reason and
p.000007: without fear
p.000007: 8. A statement guaranteeing confidentiality
p.000007: 9. A statement of any re-imbursement/compensation for the research participant
p.000007: 10. A statement on exactly what is expected of the research participant
p.000007: 11. In the case of a clinical trial, the following information should be included
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: a. The Trial treatment and the probability for random assignment to different treatments
p.000008: b. A detailed explanation of the trial procedures including all invasive procedures
p.000008: c. The potential or direct benefits (if any) from participation
p.000008: d. The alternative procedure(s) or treatment(s) that may be available
p.000008: e. The risks,discomforts, and inconveniences associated with the study
p.000008: f. The provisions for management of adverse reaction
p.000008: g. The provision of insurance coverage for any permanent disability death caused directly by the
p.000008: investigational treatment or procedure
p.000008: h. That a study participant will be given information that may be relevant to his/her willingness to
p.000008: continue participation
p.000008: i. The name and address, including telephone numbers, of the person to be contacted in case of adverse events
p.000008: or for any information related to the trial
p.000008: j. Sentence indicating that the participant has understood all the information in the consent form and is
p.000008: willing to volunteer/participate in the research
p.000008: k. Signature space for the research participant, a witness and the date
p.000008:
p.000008: 5.2 Assessment of Risks and Benefits
p.000008: The principle of beneficence requires that the research be justified on the basis of a favorable risk/benefit
p.000008: assessment. The term „risk‟ refers to a possibility that harm may occur. The term „benefit‟ in research refers
p.000008: to something of a positive value related to health or welfare. The most likely types of harm to research
p.000008: participants are physical pain or injury or psychological effects. However, other kinds of harm
p.000008: must not be overlooked which include legal, social, and economic. Benefits may also be of the corresponding types.
p.000008:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000001: 4.3 Principle III: Justice 5
p.000001: 4.4 Principle IV: Respect for the Environment 6
p.000001: 5. Application of Ethical Principles in Health Research 6
p.000001: 5.1 Informed Consent 6
p.000001: 5.1.1 Information 6
p.000001: 5.1.2 Comprehension 7
p.000001: 5.1.3 Voluntariness 7
p.000001: 5.1.4 Process and Information Contained in an
p.000001: Informed Consent Form 8
p.000001: 5.2 Assessment of Risks and Benefits 9
p.000001: 5.3 Selection of the Research Participants 10
p.000001: 5.4 Best Research Practices 11
p.000001: 5.5 Externally Sponsored Research 12
p.000001: 5.6 Scientific Merit of a Health Research Proposal 13
p.000001: v
p.000001:
p.000001: Section B
p.000001: Basic Principles of Health Research Involving Human Participants
p.000001: 14-18
p.000001: 1. Essential Research 14
p.000001: 2. Voluntary Participation 14
p.000001: 3. Children in Health Research 15
p.000001: 4. Pregnant Women in Health Research 15
p.000001: 5. Other Vulnerable People in Health Research 15
p.000001: 6. Potential Benefit 15
p.000001: 7. Harm and Risks 15
p.000001: 8. Compensation 15
p.000001: 9. Qualifications and Competence for the Research 16
p.000001: 10. Equal Distribution 16
p.000001: 11. Dissemination of Research Findings 16
p.000001: 12. Institutional Research Arrangements 16
p.000001: 13. Confidentiality and Disclosure 17
p.000001: 14. Professional, Legal and Moral Responsibility 17
p.000001: 15. Transparency and Conflict of Interest 17
p.000001: 16. Research and the Environment 17
p.000001: 17. International and/or Externally Sponsored Research 18
p.000001: 18. Transfer of Biological Samples Outside of Nepal 18
p.000001: 19. Approval Required for all Health Research in Nepal 18
p.000001: vi
p.000001:
p.000001: Section C
p.000001: Standard Operating Procedures for the Ethical Review Board of Nepal Health Research Council
p.000001: 19– 32
p.000001: Introduction 19
...
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
...
p.000013:
p.000013: 1. Essential Research
p.000013: Research involving human participants should have been considered essential for the understanding of a
p.000013: problem or disease process, or to identify a better diagnostic, therapeutic or preventive approach to a
p.000013: disease.
p.000013:
p.000013: 2. Voluntary Participation
p.000013: The human participation in research must have been ensured voluntarily. The voluntary participation should be
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
p.000014: should have made provisions to compensate the efforts and time of the participants for the purpose of research.
p.000014: The information related to the provision for compensation should have been communicated to the research
p.000014: participant.
p.000014:
p.000015: 15
p.000015:
p.000015: 9. Qualifications and Competence for the Research
p.000015: Principal investigator of any research must have relevant qualifications and competence to conduct research.
p.000015:
p.000015: 10.Equal Distribution
p.000015: The selection of research participants should be such that there is equal distribution of the burden and
p.000015: benefits of participation among population groups of different geographical regions or ethnicity or
p.000015: socioeconomic
...
Social / Access to Social Goods
Searching for indicator necessities:
(return to top)
p.000004:
p.000004: 4.3. Principle III: Justice
p.000004: Justice requires that persons in similar circumstances be treated alike and that differences between persons due to
p.000004: circumstances be acknowledged and addressed. In the context of health research, justice requires that persons
p.000004: having similar health complaints or threats be treated equally.
p.000004:
p.000004: Justice also requires the equitable distribution of the burdens and benefits of research. Differences in such
p.000004: distribution are justifiable only if they are based on morally relevant distinctions between persons, for
p.000004: example, in cases where it is necessary to ensure the protection of the rights and welfare of vulnerable
p.000004: persons.
p.000004:
p.000004: The protection of persons in vulnerable situations is of special importance. Persons in vulnerable situations
p.000004: are those who are unable to express or protect fully their own interests owing to such impediments as lack of capacity
p.000004: to consent fully, an inability to obtain alternative means of medical care and or other health necessities, or because
p.000004: they are junior
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: or subordinate member of a hierarchical group. Accordingly, special provisions must be made for the protection
p.000005: of the rights and welfare of all the persons in vulnerable situation.
p.000005:
p.000005: 4.4. Principle IV: Respect for the Environment
p.000005: This principle requires that health research is undertaken within a context of respect for the social, cultural
p.000005: and natural heritage of a society. This fundamental ethical principle is re-enforced by WMA Declaration
p.000005: of Helsinki, which stresses the special precautions that must be exercised for the protection of the environment in
p.000005: the conduct of research. In view of the increasing world movement for the protection of the environment, every
p.000005: researcher is responsible for a moral engagement to protect the social, cultural and natural heritage of
p.000005: communities and societies. This responsibility includes commitment to the following:
p.000005: 4.4 (a) To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical and
p.000005: field research
...
Searching for indicator access:
(return to top)
p.000026: by the external reviewers.
p.000026:
p.000026: Ethical Review: Those applications which qualify are then submitted to the Member-Secretary of the Ethical Review
p.000026: Board and then discussed in full board ERB meeting for ethical review.
p.000026: 6.2.1 Scientific Design of Research Proposal and Conduct of Research
p.000026: 6.2.1.a The appropriateness of the study design in relation to the objectives of the study
p.000026: 6.2.1.b Statistical methods: sampling method, sample size and analysis of data
p.000026: 6.2.1.c Justification of predictable risks and inconveniences against the anticipated benefits for the
p.000026: research participants and community by the proposed study
p.000026: 6.2.1.d Justification of the use of control arm (if relevant for the study)
p.000026: 6.2.1.e Criteria for prematurely withdrawing research participants
p.000026: 6.2.1.f Criteria for suspending or terminating the research
p.000026: 6.2.1.g Provisions for data safety monitoring board(DSMB)
p.000026: 6.2.1.h Plan for dissemination or publication of research results
p.000026: 6.2.1.i Infrastructure and other facilities in the institutions conducting the research
p.000026: 6.2.1.j Suitability of researcher‟s qualification and experiences for The proposed research
p.000026: 6.2.1.k Description of the population from which the research participants will be drawn
p.000026: 6.2.1.l Inclusion criteria for the research participants
p.000026: 6.2.1.m Exclusion criteria for the research participants
p.000026: 6.2.1.n Protection of research participants
p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
...
p.000030: 9.1 The follow-up review intervals will be determined by the nature and the events of research
p.000030: projects, though each protocol should undergo a follow-up review at least once a year
p.000030: 9.2 The following instances or events require the follow-up review of a study
p.000030: 9.2.1 Any protocol amendment
p.000030: 9.2.2 Serious and unexpected adverse events related to the conduct of the study or study product, and
p.000030: the response taken by investigators, sponsors, and regulatory agencies
p.000030: 9.2.3 Any event or new information that may affect the benefit/ risk ratio of the study
p.000030: 9.3 A decision of a follow-up review will be issued and communicated to the applicant, indicating
p.000030: a modification, suspension, or termination of the ERB‟s original decision or confirmation that the decision is still
p.000030: valid
p.000030: 9.4 In the case of the premature suspension/termination of a study, the applicant should notify the ERB
p.000030: of the reasons for suspension/termination; a summary of results obtained in a study prematurely
p.000030: suspended/terminated should be submitted to the ERB
p.000030: 9.5 The applicant will inform the ERB at the time of the completion of a study
p.000030: 9.6 The applicant will submit to the ERB a copy of the final summary or final report of a study
p.000030: 9.7 The ERB can issue an approval letter for publication as per need
p.000030: 10. Documentation and Archiving
p.000030: All documentation and communication of ERB will be dated, filed, and archived according to written procedures.
p.000030: A statement is required defining the access and retrieval procedure (including authorized persons) for the various
p.000030: documents, files, and archives. The documents will be archived for a minimum period of 5 years following the
p.000030: completion of a study.
p.000030:
p.000030: Documents that should be filed and archived include
p.000030: 10.1 The Constitution, written standard operating procedures of the ERB, and regular (annual) reports
p.000030:
p.000031: 31
p.000031:
p.000031: 10.2 The curriculum vitae of all ERB members
p.000031: 10.3 A record of all income and expenses of the ERB, including allowances and reimbursements made to the
p.000031: secretariat and ERB members
p.000031: 10.4 The published guidelines for submission established by the ERB
p.000031: 10.5 The agenda of the ERB meetings
p.000031: 10.6 The minutes of the ERB meetings
p.000031: 10.7 All materials submitted by an applicant
p.000031: 10.8 The correspondence by ERB members with applicants or concerned parties regarding application,
p.000031: decision, and follow- up
p.000031: 10.9 A copy of the decision and any advice or requirements sent to an applicant
p.000031: 10.10 All written documentation received during the follow-up
p.000031: 10.11 The notification of the completion, premature suspension, or premature termination of a study
p.000031: 10.12 The final summary or final report of the study
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: APPENDICES
p.000032: Appendix I
p.000032:
p.000032: Checklist for the Ethical Review of Proposals
p.000032: Review of the research proposal for ethical clearance: Title of the research proposal:
p.000032: Date of review:
p.000032: Reviewer:
p.000032:
p.000032: Issue under Consideration
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Consent
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Benefits to the Participants
p.000032:
p.000032:
p.000032: Application of
p.000032: Ethical Principals
p.000032: Questions related to the main Issues Yes No. Remarks
p.000032: Provision for informed consent Clarity of the topics to the subjects. Voluntariness of the consent Inducements to
p.000032: participate, monetary or others
p.000032: Unconditional withdrawal allowed? Mechanism for taking consent from minors and disabled
p.000032: Possibility of tricking participants to participants
p.000032: Possibility of intervention (Vaccine, drug or supplementation) being available to the participant population if found
p.000032: effective.
p.000032: Is the study essential to accomplish the goal?
p.000032: Is there no other way to obtain the information?
p.000032: Do the benefits outweigh the risks? Are the risks reasonable and not excessive?
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Obligations of the sponsors
p.000033: Do the researchers have adequate qualifications and competencies?
p.000033: Assurance of medical services related to research for study participants.
p.000033: Assurance of access to beneficial results to study participants Reasonable mechanisms for care and compensation
p.000033: in case of injury, resulting from research.
p.000033: Provision of mechanism for capacity building of the national research institutions in the host country
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Appendix II Ethical Questions
p.000034: ETHICALLY DRIVING QUESTIONS FOR CONSIDERATION BY THE ETHICAL REVIEW BOARD
p.000034: 1. What questions does this research answer?
p.000034:
p.000034: 2. Are those questions relevant to the needs of the country?
p.000034:
p.000034: 3. Has/ve such research (es) been already conducted in Nepal? Elsewhere?
p.000034:
p.000034: 4. Has another ERB reviewed this proposed research? If yes, what was their decision?
p.000034:
p.000034: 5. Is it necessary to involve human subjects for the research?
p.000034:
p.000034: 6. Whom does the research put at risk?
p.000034:
p.000034: 7. What are risks? Identify them.
p.000034:
p.000034: 8. Whom does the research benefit?
p.000034:
p.000034: 9. Do the participants benefit at all from the study?
p.000034:
p.000034: 10. Do the participants have any risk from participating in the study ? If so, what are those risks?
p.000034:
p.000034: 11. Do the benefits outweigh any risks?
p.000034:
...
Social / Child
Searching for indicator child:
(return to top)
p.000006: incompetent, the proxy consent of a properly authorized representative is necessary.
p.000006:
p.000006: It is necessary to adapt the presentation of the information to the participants‟ capacities in a language
p.000006: the participant can understand. necessary attention and sensitivity should be given to cultural
p.000006: particularities.
p.000006:
p.000006: 5.1.3 Voluntariness
p.000006: Informed consent is valid only if it is given voluntarily. Therefore there should be no coercion in the
p.000006: form of any threat or undue influence in the form of excessive, unwarranted, inappropriate or improper
p.000006: award.
p.000006:
p.000006: When the research design involves no more than minimal risk, that is, risk that is no more likely and not
p.000006: greater that attached to routine medical or psychological examination, and it is not practical to obtain informed
p.000006: consent from each participant, the Ethical Review Board may waive some or all of the elements of informed
p.000006: consent.
p.000006:
p.000006: Even though the legal guardian of a child or a person with a mental disorder gives the actual consent for
p.000006: participation in research, whenever possible, the assent of the child or the person with a mental disorder, to the
p.000006: extent possible, has to be obtained.
p.000006:
p.000007: 7
p.000007:
p.000007: 5.1.4 Process and Information Contained in an Informed Consent Form
p.000007:
p.000007: 5.1.4 (a) Obtaining consent from the participants
p.000007: It is important to know who will explain the research questions, and who will receive the informed consent
p.000007: from the participant. Consider how much time is essential for this important matter.
p.000007:
p.000007: 5.1.4 (b) Is there any coercion or deception?
p.000007: The consent form must clearly indicate that the participants volunteer of their own free will for the research.
p.000007: There should be no coercion or deception during the process of obtaining consent.
p.000007:
p.000007: 5.1.4 (c) The consent form should be prepared in English as well as the relevant local language and should include
p.000007: the following information:
p.000007: 1. The nature of the study-whether investigational, in terms of the use of drugs or procedure, or whether
p.000007: information seeking, or if questionnaires or interviews are to be used
p.000007: 2. The number of participants
p.000007: 3. The purpose/objective of the study
...
p.000013: problem or disease process, or to identify a better diagnostic, therapeutic or preventive approach to a
p.000013: disease.
p.000013:
p.000013: 2. Voluntary Participation
p.000013: The human participation in research must have been ensured voluntarily. The voluntary participation should be
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
...
Searching for indicator children:
(return to top)
p.000001: 4.2 Principle II: Beneficence and Non-Malfeasance 5
p.000001: 4.3 Principle III: Justice 5
p.000001: 4.4 Principle IV: Respect for the Environment 6
p.000001: 5. Application of Ethical Principles in Health Research 6
p.000001: 5.1 Informed Consent 6
p.000001: 5.1.1 Information 6
p.000001: 5.1.2 Comprehension 7
p.000001: 5.1.3 Voluntariness 7
p.000001: 5.1.4 Process and Information Contained in an
p.000001: Informed Consent Form 8
p.000001: 5.2 Assessment of Risks and Benefits 9
p.000001: 5.3 Selection of the Research Participants 10
p.000001: 5.4 Best Research Practices 11
p.000001: 5.5 Externally Sponsored Research 12
p.000001: 5.6 Scientific Merit of a Health Research Proposal 13
p.000001: v
p.000001:
p.000001: Section B
p.000001: Basic Principles of Health Research Involving Human Participants
p.000001: 14-18
p.000001: 1. Essential Research 14
p.000001: 2. Voluntary Participation 14
p.000001: 3. Children in Health Research 15
p.000001: 4. Pregnant Women in Health Research 15
p.000001: 5. Other Vulnerable People in Health Research 15
p.000001: 6. Potential Benefit 15
p.000001: 7. Harm and Risks 15
p.000001: 8. Compensation 15
p.000001: 9. Qualifications and Competence for the Research 16
p.000001: 10. Equal Distribution 16
p.000001: 11. Dissemination of Research Findings 16
p.000001: 12. Institutional Research Arrangements 16
p.000001: 13. Confidentiality and Disclosure 17
p.000001: 14. Professional, Legal and Moral Responsibility 17
p.000001: 15. Transparency and Conflict of Interest 17
p.000001: 16. Research and the Environment 17
p.000001: 17. International and/or Externally Sponsored Research 18
p.000001: 18. Transfer of Biological Samples Outside of Nepal 18
p.000001: 19. Approval Required for all Health Research in Nepal 18
p.000001: vi
p.000001:
p.000001: Section C
p.000001: Standard Operating Procedures for the Ethical Review Board of Nepal Health Research Council
p.000001: 19– 32
...
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
p.000010: investigators according to a research proposal (protocol) that clearly identifies the purpose, questions,
p.000010: and methodology of the study. The proposal should be scientifically and ethically appraised by one or
p.000010: more suitably and legally constituted review body, independent of the investigators. The
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: implementation of the research should follow best research practices including internationally accepted Good
p.000011: Clinical Practice Guidelines, Good Laboratory Practice Guidelines, and Good Manufacturing Practice Guidelines.
p.000011: 5.4.2. Data should be handled, processed, and analyzed by competent and qualified persons led by
p.000011: qualified health professionals. Ethical responsibility of managers/handlers of data for safety,
p.000011: confidentiality, and prevention of misuse should be strictly upheld.
p.000011:
p.000011: 5.5. Externally Sponsored Research
p.000011: The following conditions must be considered before externally sponsored research can take place in Nepal:
...
p.000012:
p.000013: 13
p.000013:
p.000013: Section B
p.000013: BASIC PRINCIPLES OF
p.000013: HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS
p.000013: All health research conducted in Nepal must have the approval of the Ethical Review Board (ERB) of the
p.000013: Nepal Health Research Council (NHRC) or a similar body authorized by NHRC.
p.000013:
p.000013: The approval for research is granted after a meticulous review. The review process is guided mainly by the
p.000013: principle of protection of the research articipants, creation of generalizable and scientifically valid
p.000013: knowledge
p.000013: and equitable utilization of such knowledge.
p.000013:
p.000013: In order to achieve these aims the following ethical guiding principles are to be followed:
p.000013:
p.000013: 1. Essential Research
p.000013: Research involving human participants should have been considered essential for the understanding of a
p.000013: problem or disease process, or to identify a better diagnostic, therapeutic or preventive approach to a
p.000013: disease.
p.000013:
p.000013: 2. Voluntary Participation
p.000013: The human participation in research must have been ensured voluntarily. The voluntary participation should be
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
...
p.000026: 6.2.1.m Exclusion criteria for the research participants
p.000026: 6.2.1.n Protection of research participants
p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
p.000027: In the following situations the ERB will allow the Member Secretary to expedite the review of the proposal.
p.000027: 6.3.1 If the research is non interventional, based on secondary data, leading to thesis or has
p.000027: received approval from the Institutional Review Committee
p.000027: 6.3.2 If t he r esearch i s carried out under t he circumstances of outbreak, disaster and
p.000027: other emergency conditions
p.000027:
p.000028: 28
p.000028:
p.000028: 6.3.3 If the proposal i s found technically and scientifically sound after reviewing by internal
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
p.000028: The ERB will consider the following while making decision about the research proposal
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000026: 6.2.1.n Protection of research participants
p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
p.000027: In the following situations the ERB will allow the Member Secretary to expedite the review of the proposal.
p.000027: 6.3.1 If the research is non interventional, based on secondary data, leading to thesis or has
p.000027: received approval from the Institutional Review Committee
p.000027: 6.3.2 If t he r esearch i s carried out under t he circumstances of outbreak, disaster and
p.000027: other emergency conditions
p.000027:
p.000028: 28
p.000028:
p.000028: 6.3.3 If the proposal i s found technically and scientifically sound after reviewing by internal
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
p.000028: The ERB will consider the following while making decision about the research proposal
p.000028: 7.1 The ERB will make the decision only if the meeting has met required quorum as noted in 2.18-20
...
Social / Ethnicity
Searching for indicator ethnicity:
(return to top)
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
p.000014: should have made provisions to compensate the efforts and time of the participants for the purpose of research.
p.000014: The information related to the provision for compensation should have been communicated to the research
p.000014: participant.
p.000014:
p.000015: 15
p.000015:
p.000015: 9. Qualifications and Competence for the Research
p.000015: Principal investigator of any research must have relevant qualifications and competence to conduct research.
p.000015:
p.000015: 10.Equal Distribution
p.000015: The selection of research participants should be such that there is equal distribution of the burden and
p.000015: benefits of participation among population groups of different geographical regions or ethnicity or
p.000015: socioeconomic
p.000015: status as far as possible.
p.000015:
p.000015: 11.Dissemination of Research Findings
p.000015: The research findings and their application or any further research emanating from such research should be
p.000015: brought into the public domain through scientific and other publications. The research findings should be shared with
p.000015: the local stakeholders preferably through publication in local scientific journals. In case the researcher plans
p.000015: to publish the scientific paper in an internationally acclaimed indexed journal, a summary from such a
p.000015: publication must be published in the local scientific publication. Publications resulting from the research
p.000015: should be subject to such rights as are available to the researcher and her/his associates as determined by the
p.000015: law(s) in force at that time.
p.000015:
p.000015: 12.Institutional Research Arrangements
p.000015: The research activity should be carried out only after making necessary institutional arrangements required
p.000015: to conduct the research. Such institutional arrangements should include involvement of competent researchers
p.000015: and support staff, organizational set up conducive to research, ensuring safety and confidentiality of data and
p.000015: disseminating the research findings. Institutional arrangements for preservation and archiving of research
p.000015: materials, data and reports also must be in place. The research conducted in any institution should have
p.000015: received approval from the institutional chief and other related authorities.
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: 13.Confidentiality and Disclosure
p.000016: The research activity is carried out in such a way that the identity and data related to human participants are
...
Social / Fathers
Searching for indicator fathers:
(return to top)
p.000001:
p.000001:
p.000001: Printed Copies:1000
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Print & Design in Nepal by S.S.Printing Press
p.000001: Phone No.:+977-1-4700864
p.000001:
p.000001: Acknowledgement
p.000001:
p.000001: National Ethical Guidelines for Health Research in Nepal plays an important role in maintaining the high ethical
p.000001: and scientific standards for conducting health research. Therefore, the National Ethical Guidelines for
p.000001: Health Research in Nepal and Standard Operating Procedures are important documents to fulfill the objectives of
p.000001: NHRC.
p.000001:
p.000001: I wish to express my sincere thanks and gratitude to the members of the Taskforce Committee: Coordinator
p.000001: Prof. Ramesh Kant Adhikari, Dr. Aarati Shah, Dr. Ramesh Prasad Aacharya, Dr. Arjun Karki, Mr. Harihar Dahal and Prof.
p.000001: Shiba Kumar Rai and Member-Secretary Dr. Shanker Pratap Singh for their impressive contributions and
p.000001: dedication to this most important task. I would also like to give special thanks to the former
p.000001: Member-Secretaries Dr. Sharad Raj Onta, Dr. Sarita Upadhyaya and Dr. Shri Krishna Giri who provided
p.000001: valuable contribution. I also sincerely thank Fr. Joseph L. Thaler,
p.000001: M.M. and Mr. Meghnath Dhimal, Chief Research Officer of Nepal Health Research Council for their
p.000001: contribution in editing the revised guidelines. I would like to acknowledge all others who made valuable
p.000001: contributions and who have partnered with NHRC to make the updating of the ethical guidelines possible.
p.000001:
p.000001: I would also like to express my heartfelt gratitude to Maryknoll Fathers and Brothers Project for the
p.000001: support. I am also most grateful to the NHRC staffs for their support especially to Ms. Shailee Singh Rathour and Mr.
p.000001: Gopal Krishna Prajapati for their multifaceted assistance in finalizing this document.
p.000001:
p.000001:
p.000001: Prof. (Dr.) Chop Lal Bhusal
p.000001: Executive Chairman
p.000001: Nepal Health Research Council
p.000001:
p.000001:
p.000001: i
p.000001:
p.000001: Preface
p.000001:
p.000001: Nepal Health Research Council (NHRC) has been entrusted with the responsibility of promoting quality
p.000001: heath research because of its mandate that situates it as the apical body for all health research in the country. As
p.000001: per Nepal Health Research Council (NHRC) Act 1991 and its by-laws, NHRC is permitted to publish and
p.000001: disseminate guidelines in order to make health research more scientific and ethically sound. NHRC has
p.000001: taken unique steps with the contributions and input from various experts as well as from different disciplines
p.000001: during several workshops and meetings in order to publish these ethical guidelines.
p.000001:
p.000001: To date NHRC has published a variety of Guidelines that include the following: National Ethical
p.000001: Guidelines for Health Research in Nepal, 2001, National Health Care Waste Management Guidelines, 2002,
p.000001: Ethical Guidelines for the Care and Use of Animals in Health Research in Nepal, 2005, National Guidelines on
p.000001: Clinical Trials with the Use of Pharmaceutical Products, 2005, and Guidelines for Institutional
p.000001: Review Committees for Health Research in Nepal, 2005.
p.000001:
...
Social / Fetus/Neonate
Searching for indicator fetuses:
(return to top)
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
p.000010: investigators according to a research proposal (protocol) that clearly identifies the purpose, questions,
...
Social / Incarcerated
Searching for indicator prison:
(return to top)
p.000026: 6.2.1.o Measures to ensure the confidentiality of the research participants
p.000026: 6.2.1.p Description about who has access to data and biological samples
p.000026: 6.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: 6.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event
p.000027: 6.2.1.s Description about the provision of availability of the research product for the participants
p.000027: after completion of the research project
p.000027:
p.000027: 6.2.2 Informed consent process
p.000027: 6.2.2.a A full description of the process for obtaining informed consent including the description
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
p.000027: In the following situations the ERB will allow the Member Secretary to expedite the review of the proposal.
p.000027: 6.3.1 If the research is non interventional, based on secondary data, leading to thesis or has
p.000027: received approval from the Institutional Review Committee
p.000027: 6.3.2 If t he r esearch i s carried out under t he circumstances of outbreak, disaster and
p.000027: other emergency conditions
p.000027:
p.000028: 28
p.000028:
p.000028: 6.3.3 If the proposal i s found technically and scientifically sound after reviewing by internal
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
p.000028: The ERB will consider the following while making decision about the research proposal
p.000028: 7.1 The ERB will make the decision only if the meeting has met required quorum as noted in 2.18-20
p.000028: 7.2 Normally the decision will be taken by consensus, (if consensus is not possible then a vote will be
p.000028: taken)
...
Social / Institutionalized
Searching for indicator institutionalized:
(return to top)
p.000009: 5.2.3 Risks should be reduced to those necessary to achieve the research objectives
p.000009: 5.2.4 When research involves significant risk, extra ordinary insistence on the justification of the risk is
p.000009: necessary
p.000009: 5.2.5 When vulnerable populations are involved in research, the necessity of involving them should be
p.000009: clearly demonstrated
p.000009: 5.2.6 Relevant risks and benefits should be clearly and thoroughly spelled out in the documents used in the
p.000009: informed consent process
p.000009:
p.000009: 5.3. Selection of the Research Participants
p.000009: 5.3.1. The system of justice requires that there be fair procedures and outcome in the selection of
p.000009: research participants. Individual justice in the selection of participants requires that researchers exhibit
p.000009: fairness. Thus they should not offer potentially beneficial research only to some who are in their favor or
p.000009: select only „undesirable‟ participants for risky research. Social justice requires that distinction be
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000005: consent of a properly authorized representative.
p.000005:
p.000005: The informed consent process can be analyzed as having the following components:
p.000005:
p.000005: 5.1.1 Information
p.000005: The research participants should be given sufficient Information of the proposed research including
p.000005: information on the research procedures, their purpose, risks and discomforts and anticipated
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: benefit, alternative procedures and a statement offering the participant the opportunity to ask questions and to
p.000006: withdraw any time from the research without any fear of negative consequences.
p.000006:
p.000006: A special problem of consent arises when informing participants of some pertinent aspect of research that is
p.000006: likely to impair the validity of the research. Such circumstances should be discussed with the ERB who will then
p.000006: decide on the matter.
p.000006:
p.000006: 5.1.2 Comprehension
p.000006: It is the investigator‟s responsibility to ascertain that the research participant is competent and has
p.000006: comprehended the information. If the research participant is not capable of comprehending the information or is
p.000006: incompetent, the proxy consent of a properly authorized representative is necessary.
p.000006:
p.000006: It is necessary to adapt the presentation of the information to the participants‟ capacities in a language
p.000006: the participant can understand. necessary attention and sensitivity should be given to cultural
p.000006: particularities.
p.000006:
p.000006: 5.1.3 Voluntariness
p.000006: Informed consent is valid only if it is given voluntarily. Therefore there should be no coercion in the
p.000006: form of any threat or undue influence in the form of excessive, unwarranted, inappropriate or improper
p.000006: award.
p.000006:
p.000006: When the research design involves no more than minimal risk, that is, risk that is no more likely and not
p.000006: greater that attached to routine medical or psychological examination, and it is not practical to obtain informed
p.000006: consent from each participant, the Ethical Review Board may waive some or all of the elements of informed
p.000006: consent.
p.000006:
p.000006: Even though the legal guardian of a child or a person with a mental disorder gives the actual consent for
p.000006: participation in research, whenever possible, the assent of the child or the person with a mental disorder, to the
p.000006: extent possible, has to be obtained.
p.000006:
p.000007: 7
p.000007:
p.000007: 5.1.4 Process and Information Contained in an Informed Consent Form
p.000007:
p.000007: 5.1.4 (a) Obtaining consent from the participants
p.000007: It is important to know who will explain the research questions, and who will receive the informed consent
p.000007: from the participant. Consider how much time is essential for this important matter.
p.000007:
p.000007: 5.1.4 (b) Is there any coercion or deception?
p.000007: The consent form must clearly indicate that the participants volunteer of their own free will for the research.
p.000007: There should be no coercion or deception during the process of obtaining consent.
p.000007:
p.000007: 5.1.4 (c) The consent form should be prepared in English as well as the relevant local language and should include
p.000007: the following information:
p.000007: 1. The nature of the study-whether investigational, in terms of the use of drugs or procedure, or whether
p.000007: information seeking, or if questionnaires or interviews are to be used
p.000007: 2. The number of participants
p.000007: 3. The purpose/objective of the study
p.000007: 4. The expected duration of the research study and he frequency of the participant‟s involvement
p.000007: 5. The participant‟s responsibility
p.000007: 6. A statement that the participation is voluntary
p.000007: 7. A statement that the participant can withdraw from the study at any time without giving any reason and
p.000007: without fear
p.000007: 8. A statement guaranteeing confidentiality
p.000007: 9. A statement of any re-imbursement/compensation for the research participant
p.000007: 10. A statement on exactly what is expected of the research participant
p.000007: 11. In the case of a clinical trial, the following information should be included
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: a. The Trial treatment and the probability for random assignment to different treatments
p.000008: b. A detailed explanation of the trial procedures including all invasive procedures
p.000008: c. The potential or direct benefits (if any) from participation
p.000008: d. The alternative procedure(s) or treatment(s) that may be available
p.000008: e. The risks,discomforts, and inconveniences associated with the study
p.000008: f. The provisions for management of adverse reaction
p.000008: g. The provision of insurance coverage for any permanent disability death caused directly by the
p.000008: investigational treatment or procedure
...
p.000022: 4. On-Going Education of the ERB Members
p.000022: 4.1 All new ERB members will be provided with orientation training.
p.000022: 4.2 ERB will conduct regular training programmes for ERB members and Institutional Review Committee
p.000022: members at least two times in a year. Such training programmes will provide opportunities for hands on
p.000022: experience of reviewing the research proposals as well as problems faced while reviewing, implementing or
p.000022: disseminating of research.
p.000022: 4.3 ERB will forward requests from ERB members for participation in national, regional or
p.000022: international training programmes‟ on ethics in health research. EB of NHRC will try to accommodate such requests as
p.000022: far as possible.
p.000022:
p.000022: 5. Submitting the Application
p.000022: Individuals or institutions desirous of conducting health research in Nepal are required to submit their health
p.000022: research proposal to ERB of NHRC.
p.000022:
p.000022: 5.1 Application Submission
p.000022: 5.1.1 The Principal Investigator (PI) and/or the one responsible for the health research will submit
p.000022: the health research proposal for review
p.000022:
p.000022: 5.2 Application Requirements Include
p.000022: 5.2.1 Application: Application should be addressing to the Member Secretary of ERB
p.000022: 5.2.2 Format for Application: Application should be submitted in the format provided by NHRC. The
p.000022: prescribed format can be accessed from the website (www.nhrc.org.np) of NHRC or a hard copy can be obtained from NHRC
p.000022: office
p.000022: 5.2.3 Language of Applications: All Applications should be submitted in English
p.000022:
p.000023: 23
p.000023:
p.000023: 5.2.4 Application should include one hard copy and an electronic copy of the proposal.
p.000023: 5.2.5 Only those applications fulfilling the requirements will be accepted for review. Deficits in
p.000023: the application shall be informed to the applicants within two weeks of submission. Incomplete applications
p.000023: will have to be resubmitted
p.000023: 5.2.6 A receipt of the accepted application will be provided to the researcher
p.000023: 5.2.7 Application Fee: Applications should be submitted along with processing fee as per NHRC rule/
p.000023: decision made by the Executive Board of NHRC
p.000023: 5.2.8 Additional documents or changes: ERB can request the applicant for supplementary documents/or changes
p.000023: to the proposal during the review which will be communicated to the applicant and the application will
p.000023: be considered in the subsequent meeting after those changes are made by the researcher.
p.000023: 5.2.9 Amendments: If any amendments are made in the proposal already submitted and approved, the
p.000023: researcher must submit in writing the changes made with reasoning. The proposal will be reviewed again in the
p.000023: ERB, taking the amendments into consideration during the re-approval process.
p.000023: 5.2.10 Informed consent: Application should include the Informed Consent Form as a separate copy which is to
p.000023: be used while undertaking the research. In addition, this can include a translation copy, in a local
p.000023: language if that is applicable.
p.000023:
p.000023: 5.3 Documentation Requirements for the Application All the documents that are required by the ERB for a
p.000023: process of review and approval should be submitted along with the application. If any additional documents
p.000023: are required during the review process, the researcher will be notified by ERB.
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 5.3.1 The application form should be submitted with the signature and date of submission using the NHRC format
p.000024: 5.3.2 Application must include the most current version of the curriculum vitae of the Principal
p.000024: Investigator and co-investigators with special mention of academic qualification and research experiences
p.000024: 5.3.3 Application must include the protocol of the proposed research project in the provided format
p.000024: together with the supporting documents. (A copy of research tools, questionnaires etc)
p.000024: 5.3.4 A copy of informed consent form should be included in the application. This should include a
p.000024: detail description of the process of giving the information to the research participant and its content,
p.000024: process of obtaining the consent, the person responsible for obtaining the informed consent and
p.000024: documentation of the signature of the researcher/research participant and /witness if applicable
p.000024: 5.3.5 Any compensation to be given to the research participant should be clearly mentioned. (E.g.
p.000024: any transportation costs, food, free health care or insurance coverage etc that is to be borne by the
...
Searching for indicator linguistic:
(return to top)
p.000004: they are junior
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: or subordinate member of a hierarchical group. Accordingly, special provisions must be made for the protection
p.000005: of the rights and welfare of all the persons in vulnerable situation.
p.000005:
p.000005: 4.4. Principle IV: Respect for the Environment
p.000005: This principle requires that health research is undertaken within a context of respect for the social, cultural
p.000005: and natural heritage of a society. This fundamental ethical principle is re-enforced by WMA Declaration
p.000005: of Helsinki, which stresses the special precautions that must be exercised for the protection of the environment in
p.000005: the conduct of research. In view of the increasing world movement for the protection of the environment, every
p.000005: researcher is responsible for a moral engagement to protect the social, cultural and natural heritage of
p.000005: communities and societies. This responsibility includes commitment to the following:
p.000005: 4.4 (a) To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical and
p.000005: field research
p.000005: 4.4 (b) To safeguard the cultural, linguistic and religious heritage of communities and individuals
p.000005: 4.4 (c) To treat the biologic and genetic heritage of the people with respect and caution. This requires respecting
p.000005: the principles of informed consent and confidentiality of genetic data
p.000005:
p.000005: 5. Application of Ethical Principles in Health Research
p.000005: 5.1 Informed Consent
p.000005: For all health research involving human participants, the investigators must obtain the informed consent of the
p.000005: prospective participants or in the case of an individual who is not capable of giving informed consent, the proxy
p.000005: consent of a properly authorized representative.
p.000005:
p.000005: The informed consent process can be analyzed as having the following components:
p.000005:
p.000005: 5.1.1 Information
p.000005: The research participants should be given sufficient Information of the proposed research including
p.000005: information on the research procedures, their purpose, risks and discomforts and anticipated
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: benefit, alternative procedures and a statement offering the participant the opportunity to ask questions and to
p.000006: withdraw any time from the research without any fear of negative consequences.
p.000006:
...
p.000016: be
p.000016: considered as compelling legal reason.
p.000016:
p.000016: 14.Professional, Legal and Moral Responsibility
p.000016: Researchers and his/ her team, institution where the research is conducted, sponsors and agencies funding the research
p.000016: should take professional, legal and moral responsibility to abide by the principles, guidelines and
p.000016: directives of the Ethical Review Board or Institutional Review Committee.
p.000016:
p.000016: 15.Transparency and Conflict of Interest
p.000016: The researchers and their associates will conduct the research with fairness, honesty, impartiality and
p.000016: transparency. All involved in the research activity will fully disclose their interest in different
p.000016: aspects of study and their conflicts of interest, if any. Failure to disclose relevant information can
p.000016: lead to suspension of the approval of research activity or penalty determined by law. In case of suspension of
p.000016: the research, researcher should have ample occasion to lodge a complaint against such a decision to a body
p.000016: constituted by the Ethical Review Board of Nepal
p.000016: Health Research Council.
p.000016:
p.000016: 16.Research and the Environment
p.000016: Researchers will respect the environment while conducting any health research. Respect for the environment
p.000016: is demonstrated through research being undertaken within a context of social, cultural and natural heritage of a
p.000016: society. Health research proposals will have to ensure proper and safe disposal of all kinds of hazardous waste from a
p.000016: laboratory, clinical or field research and also safeguard the cultural, linguistic and religious heritage of
p.000016: individuals and communities.
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 17. International and/or Externally Sponsored Research
p.000017: Research conducted in collaboration with international or external sponsorship can be conducted only if it
p.000017: is of relevance to the Nepalese people and/ or which can‟t be conducted in the sponsoring country alone.
p.000017: Externally sponsored research should demonstrate provisions for capacity building and strengthening that field of
p.000017: research. It is mandatory that such research have one co-investigator from Nepal.
p.000017:
p.000017: 18.Transfer of Biological Samples Outside of Nepal
p.000017: If the health research involves the transfer of biological samples to other countries, the researcher(s) will provide
p.000017: convincing reasons for the same. Such transfers will be permitted only for the reasons originally stated in the
p.000017: research proposal. Such research must be sensitive to the need and existing culture and social norms of the
p.000017: communities where it will be carried out.
p.000017:
p.000017: 19.Approval Required for all Health Research in Nepal
p.000017: All health research conducted in Nepal will have to receive approval from Ethical Review Board of Nepal Health
p.000017: Research Council or of the Institutional Review Committees approved by NHRC. Researchers conducting health
p.000017: research without such approval are liable to penalty determined by law.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.000013: disease.
p.000013:
p.000013: 2. Voluntary Participation
p.000013: The human participation in research must have been ensured voluntarily. The voluntary participation should be
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 2011
p.000001:
p.000001:
p.000001: Publisher
p.000001: Nepal Health Research council (NHRC)
p.000001: Ramshah Path, Kathmandu,Nepal
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Nepal Health Research council
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Revised Edition: January,2011
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Printed Copies:1000
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Print & Design in Nepal by S.S.Printing Press
p.000001: Phone No.:+977-1-4700864
p.000001:
p.000001: Acknowledgement
p.000001:
p.000001: National Ethical Guidelines for Health Research in Nepal plays an important role in maintaining the high ethical
p.000001: and scientific standards for conducting health research. Therefore, the National Ethical Guidelines for
p.000001: Health Research in Nepal and Standard Operating Procedures are important documents to fulfill the objectives of
p.000001: NHRC.
p.000001:
p.000001: I wish to express my sincere thanks and gratitude to the members of the Taskforce Committee: Coordinator
p.000001: Prof. Ramesh Kant Adhikari, Dr. Aarati Shah, Dr. Ramesh Prasad Aacharya, Dr. Arjun Karki, Mr. Harihar Dahal and Prof.
p.000001: Shiba Kumar Rai and Member-Secretary Dr. Shanker Pratap Singh for their impressive contributions and
p.000001: dedication to this most important task. I would also like to give special thanks to the former
p.000001: Member-Secretaries Dr. Sharad Raj Onta, Dr. Sarita Upadhyaya and Dr. Shri Krishna Giri who provided
p.000001: valuable contribution. I also sincerely thank Fr. Joseph L. Thaler,
p.000001: M.M. and Mr. Meghnath Dhimal, Chief Research Officer of Nepal Health Research Council for their
p.000001: contribution in editing the revised guidelines. I would like to acknowledge all others who made valuable
p.000001: contributions and who have partnered with NHRC to make the updating of the ethical guidelines possible.
p.000001:
p.000001: I would also like to express my heartfelt gratitude to Maryknoll Fathers and Brothers Project for the
p.000001: support. I am also most grateful to the NHRC staffs for their support especially to Ms. Shailee Singh Rathour and Mr.
p.000001: Gopal Krishna Prajapati for their multifaceted assistance in finalizing this document.
p.000001:
p.000001:
p.000001: Prof. (Dr.) Chop Lal Bhusal
p.000001: Executive Chairman
p.000001: Nepal Health Research Council
p.000001:
p.000001:
p.000001: i
p.000001:
p.000001: Preface
p.000001:
p.000001: Nepal Health Research Council (NHRC) has been entrusted with the responsibility of promoting quality
p.000001: heath research because of its mandate that situates it as the apical body for all health research in the country. As
p.000001: per Nepal Health Research Council (NHRC) Act 1991 and its by-laws, NHRC is permitted to publish and
p.000001: disseminate guidelines in order to make health research more scientific and ethically sound. NHRC has
p.000001: taken unique steps with the contributions and input from various experts as well as from different disciplines
p.000001: during several workshops and meetings in order to publish these ethical guidelines.
p.000001:
p.000001: To date NHRC has published a variety of Guidelines that include the following: National Ethical
p.000001: Guidelines for Health Research in Nepal, 2001, National Health Care Waste Management Guidelines, 2002,
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000011: 5.4.2. Data should be handled, processed, and analyzed by competent and qualified persons led by
p.000011: qualified health professionals. Ethical responsibility of managers/handlers of data for safety,
p.000011: confidentiality, and prevention of misuse should be strictly upheld.
p.000011:
p.000011: 5.5. Externally Sponsored Research
p.000011: The following conditions must be considered before externally sponsored research can take place in Nepal:
p.000011: 5.5.1. The research is preferably responsive to the health needs and priorities of Nepal as well as being
p.000011: sensitive to the existing environmental factors including culture, religious and social values
p.000011: 5.5.2. The research cannot be carried out reasonably well in the sponsors‟ country
p.000011: 5.5.3. The research protocol has the approval of the Ethical Review Board/Institutional Review Board of the
p.000011: country of the sponsor
p.000011: 5.5.4. The sponsor should consider means in which the research capability of Nepal can be strengthened
p.000011: and other means of compensating the community
p.000011: 5.5.5. The research process should be transparent
p.000011: 5.5.6. External sponsors should apply insurance to research participants in health research that involves
p.000011: more than minimal risks
p.000011: 5.5.7. In case it is necessary to transfer biological samples abroad, a memorandum of understanding has to be
p.000011: signed by the sponsor and NHRC defining clearly the purpose for the transfer, the material that is being
p.000011: transferred, ownership of intellectual property rights, and provisions for privacy protection
p.000011: 5.5.8. The proposal has to be approved by NHRC
p.000011:
p.000012: 12
p.000012:
p.000012: 5.6. Scientific Merit of a Health Research Proposal
p.000012: A technical team will review the proposals before submitting it for ethical review. The scientific merit of a
p.000012: submitted research proposal will be evaluated on the following criteria:
p.000012: 5.6.1. Relevance of the study to the national health priorities
p.000012: 5.6.2. Clearly stated objectives, hypothesis and conceptual framework
p.000012: 5.6.3. Methodology suggested is valid for the objectives to be achieved
p.000012: 5.6.4. Sampling frame and size are adequate to reach the valid conclusion
p.000012: 5.6.5. Plans for data collection and analysis are adequate and appropriate
p.000012: 5.6.6. Researcher(s)/the research institution(s) have the capability of conducting the research. This includes
p.000012: submitting CVs of the researcher(s) as well as the necessary documentation from the institution(s)
p.000012: 5.6.7. Plans for supervising and monitoring the data collection and analysis are appropriate
p.000012: 5.6.8. Mechanism for the dissemination of the findings has been articulated
p.000012: 5.6.9. Mechanism for the utilization of the study findings by other researchers or by the health system has
p.000012: been specified
p.000012: 5.6.10. The scientific merit of the proposal could include provisions for research involving qualitative methodologies
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:
p.000012:
p.000013: 13
p.000013:
p.000013: Section B
p.000013: BASIC PRINCIPLES OF
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000004:
p.000005: 5
p.000005:
p.000005: or subordinate member of a hierarchical group. Accordingly, special provisions must be made for the protection
p.000005: of the rights and welfare of all the persons in vulnerable situation.
p.000005:
p.000005: 4.4. Principle IV: Respect for the Environment
p.000005: This principle requires that health research is undertaken within a context of respect for the social, cultural
p.000005: and natural heritage of a society. This fundamental ethical principle is re-enforced by WMA Declaration
p.000005: of Helsinki, which stresses the special precautions that must be exercised for the protection of the environment in
p.000005: the conduct of research. In view of the increasing world movement for the protection of the environment, every
p.000005: researcher is responsible for a moral engagement to protect the social, cultural and natural heritage of
p.000005: communities and societies. This responsibility includes commitment to the following:
p.000005: 4.4 (a) To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical and
p.000005: field research
p.000005: 4.4 (b) To safeguard the cultural, linguistic and religious heritage of communities and individuals
p.000005: 4.4 (c) To treat the biologic and genetic heritage of the people with respect and caution. This requires respecting
p.000005: the principles of informed consent and confidentiality of genetic data
p.000005:
p.000005: 5. Application of Ethical Principles in Health Research
p.000005: 5.1 Informed Consent
p.000005: For all health research involving human participants, the investigators must obtain the informed consent of the
p.000005: prospective participants or in the case of an individual who is not capable of giving informed consent, the proxy
p.000005: consent of a properly authorized representative.
p.000005:
p.000005: The informed consent process can be analyzed as having the following components:
p.000005:
p.000005: 5.1.1 Information
p.000005: The research participants should be given sufficient Information of the proposed research including
p.000005: information on the research procedures, their purpose, risks and discomforts and anticipated
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: benefit, alternative procedures and a statement offering the participant the opportunity to ask questions and to
p.000006: withdraw any time from the research without any fear of negative consequences.
p.000006:
p.000006: A special problem of consent arises when informing participants of some pertinent aspect of research that is
...
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
p.000010: investigators according to a research proposal (protocol) that clearly identifies the purpose, questions,
p.000010: and methodology of the study. The proposal should be scientifically and ethically appraised by one or
p.000010: more suitably and legally constituted review body, independent of the investigators. The
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: implementation of the research should follow best research practices including internationally accepted Good
p.000011: Clinical Practice Guidelines, Good Laboratory Practice Guidelines, and Good Manufacturing Practice Guidelines.
p.000011: 5.4.2. Data should be handled, processed, and analyzed by competent and qualified persons led by
p.000011: qualified health professionals. Ethical responsibility of managers/handlers of data for safety,
p.000011: confidentiality, and prevention of misuse should be strictly upheld.
p.000011:
p.000011: 5.5. Externally Sponsored Research
p.000011: The following conditions must be considered before externally sponsored research can take place in Nepal:
p.000011: 5.5.1. The research is preferably responsive to the health needs and priorities of Nepal as well as being
p.000011: sensitive to the existing environmental factors including culture, religious and social values
p.000011: 5.5.2. The research cannot be carried out reasonably well in the sponsors‟ country
p.000011: 5.5.3. The research protocol has the approval of the Ethical Review Board/Institutional Review Board of the
p.000011: country of the sponsor
p.000011: 5.5.4. The sponsor should consider means in which the research capability of Nepal can be strengthened
p.000011: and other means of compensating the community
p.000011: 5.5.5. The research process should be transparent
p.000011: 5.5.6. External sponsors should apply insurance to research participants in health research that involves
p.000011: more than minimal risks
p.000011: 5.5.7. In case it is necessary to transfer biological samples abroad, a memorandum of understanding has to be
p.000011: signed by the sponsor and NHRC defining clearly the purpose for the transfer, the material that is being
p.000011: transferred, ownership of intellectual property rights, and provisions for privacy protection
p.000011: 5.5.8. The proposal has to be approved by NHRC
p.000011:
p.000012: 12
p.000012:
p.000012: 5.6. Scientific Merit of a Health Research Proposal
p.000012: A technical team will review the proposals before submitting it for ethical review. The scientific merit of a
p.000012: submitted research proposal will be evaluated on the following criteria:
p.000012: 5.6.1. Relevance of the study to the national health priorities
p.000012: 5.6.2. Clearly stated objectives, hypothesis and conceptual framework
p.000012: 5.6.3. Methodology suggested is valid for the objectives to be achieved
p.000012: 5.6.4. Sampling frame and size are adequate to reach the valid conclusion
...
p.000016: 14.Professional, Legal and Moral Responsibility
p.000016: Researchers and his/ her team, institution where the research is conducted, sponsors and agencies funding the research
p.000016: should take professional, legal and moral responsibility to abide by the principles, guidelines and
p.000016: directives of the Ethical Review Board or Institutional Review Committee.
p.000016:
p.000016: 15.Transparency and Conflict of Interest
p.000016: The researchers and their associates will conduct the research with fairness, honesty, impartiality and
p.000016: transparency. All involved in the research activity will fully disclose their interest in different
p.000016: aspects of study and their conflicts of interest, if any. Failure to disclose relevant information can
p.000016: lead to suspension of the approval of research activity or penalty determined by law. In case of suspension of
p.000016: the research, researcher should have ample occasion to lodge a complaint against such a decision to a body
p.000016: constituted by the Ethical Review Board of Nepal
p.000016: Health Research Council.
p.000016:
p.000016: 16.Research and the Environment
p.000016: Researchers will respect the environment while conducting any health research. Respect for the environment
p.000016: is demonstrated through research being undertaken within a context of social, cultural and natural heritage of a
p.000016: society. Health research proposals will have to ensure proper and safe disposal of all kinds of hazardous waste from a
p.000016: laboratory, clinical or field research and also safeguard the cultural, linguistic and religious heritage of
p.000016: individuals and communities.
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 17. International and/or Externally Sponsored Research
p.000017: Research conducted in collaboration with international or external sponsorship can be conducted only if it
p.000017: is of relevance to the Nepalese people and/ or which can‟t be conducted in the sponsoring country alone.
p.000017: Externally sponsored research should demonstrate provisions for capacity building and strengthening that field of
p.000017: research. It is mandatory that such research have one co-investigator from Nepal.
p.000017:
p.000017: 18.Transfer of Biological Samples Outside of Nepal
p.000017: If the health research involves the transfer of biological samples to other countries, the researcher(s) will provide
p.000017: convincing reasons for the same. Such transfers will be permitted only for the reasons originally stated in the
p.000017: research proposal. Such research must be sensitive to the need and existing culture and social norms of the
p.000017: communities where it will be carried out.
p.000017:
p.000017: 19.Approval Required for all Health Research in Nepal
p.000017: All health research conducted in Nepal will have to receive approval from Ethical Review Board of Nepal Health
p.000017: Research Council or of the Institutional Review Committees approved by NHRC. Researchers conducting health
p.000017: research without such approval are liable to penalty determined by law.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Section C
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
p.000014: should have made provisions to compensate the efforts and time of the participants for the purpose of research.
p.000014: The information related to the provision for compensation should have been communicated to the research
p.000014: participant.
p.000014:
p.000015: 15
p.000015:
p.000015: 9. Qualifications and Competence for the Research
p.000015: Principal investigator of any research must have relevant qualifications and competence to conduct research.
p.000015:
p.000015: 10.Equal Distribution
p.000015: The selection of research participants should be such that there is equal distribution of the burden and
...
p.000038: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries-, London, October,
p.000038: 1999.
p.000038:
p.000038: Operational Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing, The ENGAGE
p.000038: Guidelines, Supplement to the EFGCP News, September 1998.
p.000038:
p.000038: P.P. De Deyn, Ethical and Scientific Challenges of Placebo Control Arms in Clinical Trials, International Journal of
p.000038: Pharmaceutical Medicine, 14, 149-157, 2000.
p.000038:
p.000038: Patricia Marshall, Cultural Absolutism vs. Cultural Relativism, Paper presented during the workshop on
p.000038: Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June 13,2000.
p.000038:
p.000038: Ruth Fischbach, Discussion of NIH Guidelines/Office for Human Research Protection, Paper presented during
p.000038: the workshop on Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June
p.000038: 15, 2000.
p.000038:
p.000038: The National Institutes of Health, Assurance of Compliance with DHHS Regulations for the Protection of Human
p.000038: Subjects (45 CFR 46), Bethesda, Maryland, May I, 1998.
p.000038:
p.000038: The Nuremberg Code. Trial of War Criminals before the Nuremberg Military Tribunals under Control Council Law
p.000038: No. 10, Washington DC: US Government Printing Office, 1949; No.2 pp, 181-182.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000038: Human Subjects, Scotland: 52nd General Assembly, October, 2000.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Republic of South Africa: 48th General Assembly,
p.000038: October, 1996.
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: The World Medical Association, Declaration of Lisbon, The Right of the Patient, France; September 1995.
p.000039:
p.000039: World Health Organization, Draft Report of 25th Session of WHO South- East Asia Advisory Committee on Health Research,
p.000039: Bali, Indonesia, April 17-20, 2000, SEA/ACHR/Draft Report, Release date: 20 April, 2000.
p.000039:
p.000039: World Health Organization, Health Ethics In South East Asia, Volume 2, SEAlHSD/226, New Delhi, June, 1999.
p.000039:
p.000039: World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva,
p.000039: 2000.
p.000039:
p.000039: World Health Organization, The Appraisal of Health Systems Research,
p.000039: Technical Publication, SEARO, No. 12: New Delhi, 1993.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000005: information on the research procedures, their purpose, risks and discomforts and anticipated
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: benefit, alternative procedures and a statement offering the participant the opportunity to ask questions and to
p.000006: withdraw any time from the research without any fear of negative consequences.
p.000006:
p.000006: A special problem of consent arises when informing participants of some pertinent aspect of research that is
p.000006: likely to impair the validity of the research. Such circumstances should be discussed with the ERB who will then
p.000006: decide on the matter.
p.000006:
p.000006: 5.1.2 Comprehension
p.000006: It is the investigator‟s responsibility to ascertain that the research participant is competent and has
p.000006: comprehended the information. If the research participant is not capable of comprehending the information or is
p.000006: incompetent, the proxy consent of a properly authorized representative is necessary.
p.000006:
p.000006: It is necessary to adapt the presentation of the information to the participants‟ capacities in a language
p.000006: the participant can understand. necessary attention and sensitivity should be given to cultural
p.000006: particularities.
p.000006:
p.000006: 5.1.3 Voluntariness
p.000006: Informed consent is valid only if it is given voluntarily. Therefore there should be no coercion in the
p.000006: form of any threat or undue influence in the form of excessive, unwarranted, inappropriate or improper
p.000006: award.
p.000006:
p.000006: When the research design involves no more than minimal risk, that is, risk that is no more likely and not
p.000006: greater that attached to routine medical or psychological examination, and it is not practical to obtain informed
p.000006: consent from each participant, the Ethical Review Board may waive some or all of the elements of informed
p.000006: consent.
p.000006:
p.000006: Even though the legal guardian of a child or a person with a mental disorder gives the actual consent for
p.000006: participation in research, whenever possible, the assent of the child or the person with a mental disorder, to the
p.000006: extent possible, has to be obtained.
p.000006:
p.000007: 7
p.000007:
p.000007: 5.1.4 Process and Information Contained in an Informed Consent Form
p.000007:
p.000007: 5.1.4 (a) Obtaining consent from the participants
p.000007: It is important to know who will explain the research questions, and who will receive the informed consent
p.000007: from the participant. Consider how much time is essential for this important matter.
p.000007:
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000003: at a community level involving humans in groups, all these principles are considered in a composite way.
p.000003: The principle of respect for the environment proposes to ensure respect for the culture of communities,
p.000003: their environment, benefit to the members of the community and not harming them ensuring that the justice is
p.000003: done to them.
p.000003:
p.000003: 4.1. Principle I: Respect for the Autonomy of the Participant The obligation to respect the dignity of
p.000003: participating individuals in all activities of health and biomedical research is the cornerstone of research ethics.
p.000003: This principle is based on the premise that an individual when informed of all aspects of an activity can
p.000003: decide for her/himself a correct course of action. This requires specific attention to the following:
p.000003: 4.1 (a) An individual‟s right to decide what is best for her/him can not be overruled by any consideration
p.000003: of person
p.000003: 4.1 (b) Researchers must actively safeguard the interests of the persons with impaired or diminished
p.000003: autonomy and ensure that the vulnerable people are afforded security against harm, abuse or exploitation
p.000003: 4.1 (c) No researches should take precedence over respect for human rights, fundamental freedom and human dignity,
p.000003: and practices contrary to human dignity should be prohibited.
p.000003:
p.000003: The provisions of respect for autonomy of the human \participants in health research are implemented
p.000003: primarily through the instrument of “informed consent”
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 4.2. Principle II: Beneficence and Non-Malfeasance
p.000004: The principle of beneficence requires that the research activity should benefit the participants directly or
p.000004: indirectly, in the present or in future, individually or through collective benefits. If none of these
p.000004: benefits are obvious, the researcher should ensure that the participation in research does not lead to any
p.000004: harm. All attempts to maximize the benefits and minimize the risks should have been taken by the researcher.
p.000004:
p.000004: This requires that all health and biomedical research activities be preceded by a careful assessment of the potential
p.000004: risks and burdens in comparison to the potential benefits to the prospective research participant and their
p.000004: communities. This does not preclude the participation of healthy volunteers in research. However, in all cases
p.000004: the research should promote the health of the population represented.
p.000004:
p.000004: Beneficence and non malfeasance also requires that the researchers are qualified to carry out proposed
...
Social / Women
Searching for indicator women:
(return to top)
p.000001: 4.4 Principle IV: Respect for the Environment 6
p.000001: 5. Application of Ethical Principles in Health Research 6
p.000001: 5.1 Informed Consent 6
p.000001: 5.1.1 Information 6
p.000001: 5.1.2 Comprehension 7
p.000001: 5.1.3 Voluntariness 7
p.000001: 5.1.4 Process and Information Contained in an
p.000001: Informed Consent Form 8
p.000001: 5.2 Assessment of Risks and Benefits 9
p.000001: 5.3 Selection of the Research Participants 10
p.000001: 5.4 Best Research Practices 11
p.000001: 5.5 Externally Sponsored Research 12
p.000001: 5.6 Scientific Merit of a Health Research Proposal 13
p.000001: v
p.000001:
p.000001: Section B
p.000001: Basic Principles of Health Research Involving Human Participants
p.000001: 14-18
p.000001: 1. Essential Research 14
p.000001: 2. Voluntary Participation 14
p.000001: 3. Children in Health Research 15
p.000001: 4. Pregnant Women in Health Research 15
p.000001: 5. Other Vulnerable People in Health Research 15
p.000001: 6. Potential Benefit 15
p.000001: 7. Harm and Risks 15
p.000001: 8. Compensation 15
p.000001: 9. Qualifications and Competence for the Research 16
p.000001: 10. Equal Distribution 16
p.000001: 11. Dissemination of Research Findings 16
p.000001: 12. Institutional Research Arrangements 16
p.000001: 13. Confidentiality and Disclosure 17
p.000001: 14. Professional, Legal and Moral Responsibility 17
p.000001: 15. Transparency and Conflict of Interest 17
p.000001: 16. Research and the Environment 17
p.000001: 17. International and/or Externally Sponsored Research 18
p.000001: 18. Transfer of Biological Samples Outside of Nepal 18
p.000001: 19. Approval Required for all Health Research in Nepal 18
p.000001: vi
p.000001:
p.000001: Section C
p.000001: Standard Operating Procedures for the Ethical Review Board of Nepal Health Research Council
p.000001: 19– 32
p.000001: Introduction 19
p.000001: 1. Function and Duties of ERB 19
...
p.000009: drawn between classes of participants that ought and ought not to participate in any particular kind of
p.000009: research. Thus, it is a matter of social justice that there is an order of preference in the selection of
p.000009: classes of participants (e.g. institutionalized, mentally infirmed or prisoners may be involved as research
p.000009: participants, if at all, only on certain conditions). Special attention should be taken in research
p.000009: involving medical students and soldiers because of their potentially vulnerable situation.
p.000009:
p.000010: 10
p.000010:
p.000010: 5.3.2. In accordance with this principle, a new drug or appliance developed elsewhere can only be
p.000010: tested in the Nepal after a Phase 1 trial has been conducted elsewhere.
p.000010: 5.3.3. Prisoners must not be made subjects of intervention research that involves more than minimal risk, as the
p.000010: consent given by them may not be given voluntarily or may have been unduly influenced by expectations of reward. Other
p.000010: types of research involving prisoners will be reviewed fully by the ERB.
p.000010: 5.3.4. Pregnant and nursing women should not be participants in a clinical trial except those that are
p.000010: designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants and for
p.000010: which they are the only suitable participants.
p.000010: 5.3.5 Children cannot be considered „mini adults‟, and therefore any new drug intended for use in children
p.000010: has to be studied in children for its rational and scientific use. However, before undertaking research in
p.000010: children, it has to be ensured that:
p.000010: 5.3.5 (a) Children will not be involved in research that might be carried out equally well in adults
p.000010: 5.3.5(b) The purpose of the research is to obtain knowledge relevant to the health needs of the children
p.000010: 5.3.6. Before undertaking research in mentally disadvantaged persons the following has to be ensured:
p.000010: 5.3.6 (a) Such research cannot be carried out satisfactorily in person in full possession of their mental
p.000010: faculties (i.e. persons capable of consent)
p.000010: 5.3.6 (b) The purpose of the research is to obtain knowledge relevant to the health needs of persons with mental
p.000010: disorders
p.000010:
p.000010: 5.4. Best Research Practices
p.000010: 5.4.1. Research involving human participants should be carried out by qualified, competent, and responsible
...
p.000013: Research involving human participants should have been considered essential for the understanding of a
p.000013: problem or disease process, or to identify a better diagnostic, therapeutic or preventive approach to a
p.000013: disease.
p.000013:
p.000013: 2. Voluntary Participation
p.000013: The human participation in research must have been ensured voluntarily. The voluntary participation should be
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
p.000014: be in favor of benefits and the researcher must demonstrate that all efforts have been made to minimize the risks and
p.000014: maximize the benefits.
p.000014:
p.000014: 8. Compensation
p.000014: The researcher should have made provisions for compensating the research participants or if
p.000014: relevant to the community for the harms incurred in the research process. In addition, the researcher
...
Social / education
Searching for indicator education:
(return to top)
p.000001: 7. Harm and Risks 15
p.000001: 8. Compensation 15
p.000001: 9. Qualifications and Competence for the Research 16
p.000001: 10. Equal Distribution 16
p.000001: 11. Dissemination of Research Findings 16
p.000001: 12. Institutional Research Arrangements 16
p.000001: 13. Confidentiality and Disclosure 17
p.000001: 14. Professional, Legal and Moral Responsibility 17
p.000001: 15. Transparency and Conflict of Interest 17
p.000001: 16. Research and the Environment 17
p.000001: 17. International and/or Externally Sponsored Research 18
p.000001: 18. Transfer of Biological Samples Outside of Nepal 18
p.000001: 19. Approval Required for all Health Research in Nepal 18
p.000001: vi
p.000001:
p.000001: Section C
p.000001: Standard Operating Procedures for the Ethical Review Board of Nepal Health Research Council
p.000001: 19– 32
p.000001: Introduction 19
p.000001: 1. Function and Duties of ERB 19
p.000001: 2. Membership of ERB 20
p.000001: 3. Independent Consultant(s) to the ERB 22
p.000001: 4. On-Going Education of the ERB Members 23
p.000001: 5. Submitting the Application 23
p.000001: 5.1 Application Submission 23
p.000001: 5.2 Application Requirements 23
p.000001: 5.3 Documentation Requirements for the Application 24
p.000001: 6. Ethical Review Process 26
p.000001: 6.1 Meeting of the ERB 26
p.000001: 6.2 Elements of the Review Process 26
p.000001: 6.3 Expedited Review 28
p.000001: 7. Decision Making 29
p.000001: 8. Communicating a Decision 29
p.000001: 9. Follow up of the ERB 30
p.000001: 10. Documentation and Archiving 31
p.000001: APPENDICES
p.000001: Appendix I:Checklist for the Ethical Review of a Proposal 33
p.000001: Appendix II: Ethical Questions 35
p.000001: Bibliography 37-40
p.000001: vii
p.000001:
p.000001:
p.000001:
p.000001: Section A
p.000001: GUIDING PRINCIPLES FOR
p.000001: HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS
p.000001: 1. Introduction
p.000001: The word ethics is derived from the Greek word „ethos‟, which means
p.000001: „character‟, „disposition‟ or „a fundamental outlook influencing behaviour related to customs and moral values of
...
p.000021: Secretary will be assisted in his or her tasks by an administrative secretary.
p.000021: 2.17 ERB will prepare a regular annual report which will be published after its approval by EB of NHRC.
p.000021:
p.000021: Quorum requirements for ERB
p.000021: 2.18 ERB will have 11 members.
p.000021: 2.19 At least 6 members must be present to compose a quorum. Presence of members of only one gender will
p.000021: not constitute a quorum.
p.000021: 2.20 At least one member present should have expertise in areas other than the subject under discussion.
p.000021: Preferably a member from outside of the health science background must be present.
p.000021:
p.000021: 3. Independent Consultant(s) to the ERB
p.000021: 3.1 ERB will prepare a list of independent consultants who can be called upon by ERB to provide expert
p.000021: opinion on proposed research proposals. These consultants will be subject specialists, methodologists,
p.000021: Environmentalists, legal specialists, ethicists, sociologists, psychologists, anthropologists or representative
p.000021: of specific communities, patient groups and special interest groups.
p.000021: 3.2 Independent consultants who agree to help the ERB will have to sign a confidentiality agreement regarding
p.000021: their assignment, meeting deliberations, applications, information on research participants and related matters.
p.000021:
p.000022: 22
p.000022:
p.000022: 3.3 Independent consultants will be paid remuneration as per NHRC regulations.
p.000022:
p.000022: 4. On-Going Education of the ERB Members
p.000022: 4.1 All new ERB members will be provided with orientation training.
p.000022: 4.2 ERB will conduct regular training programmes for ERB members and Institutional Review Committee
p.000022: members at least two times in a year. Such training programmes will provide opportunities for hands on
p.000022: experience of reviewing the research proposals as well as problems faced while reviewing, implementing or
p.000022: disseminating of research.
p.000022: 4.3 ERB will forward requests from ERB members for participation in national, regional or
p.000022: international training programmes‟ on ethics in health research. EB of NHRC will try to accommodate such requests as
p.000022: far as possible.
p.000022:
p.000022: 5. Submitting the Application
p.000022: Individuals or institutions desirous of conducting health research in Nepal are required to submit their health
p.000022: research proposal to ERB of NHRC.
p.000022:
p.000022: 5.1 Application Submission
p.000022: 5.1.1 The Principal Investigator (PI) and/or the one responsible for the health research will submit
p.000022: the health research proposal for review
p.000022:
p.000022: 5.2 Application Requirements Include
p.000022: 5.2.1 Application: Application should be addressing to the Member Secretary of ERB
p.000022: 5.2.2 Format for Application: Application should be submitted in the format provided by NHRC. The
p.000022: prescribed format can be accessed from the website (www.nhrc.org.np) of NHRC or a hard copy can be obtained from NHRC
p.000022: office
p.000022: 5.2.3 Language of Applications: All Applications should be submitted in English
p.000022:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000020: experience and affiliations would be publicized through the reports of NHRC, ERB.
p.000020: 2.11 Member accepting to serve in the ERB should agree that the remunerations paid to him or her in course of ERB
p.000020: work will be recorded and will be made available to the public on request.
p.000020: 2.12 Member accepting to serve in the ERB will have to sign a confidentiality agreement regarding
p.000020: meeting deliberations, applications, information on research participants and related matters.
p.000020: 2.13 All administrative staff working for ERB will also have to sign a confidentiality agreement
p.000020: regarding meeting deliberations, applications information on research participants and related matters.
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Office of the ERB
p.000021: 2.14 NHRC will assign space within the premises of NHRC for the exclusive use by Chairman or coordinator
p.000021: of the ERB and administrative staff.
p.000021: 2.15 ERB of NHRC will have its own phone, fax, photocopy cupboard and administrative staff.
p.000021:
p.000021: Meetings
p.000021: 2.16 Member Secretary of the ERB will prepare the agenda for the meeting in consultation with the Chairman of the
p.000021: ERB. The Member Secretary will also keep minutes of the meeting and notify decisions to the researcher. The Member
p.000021: Secretary will be assisted in his or her tasks by an administrative secretary.
p.000021: 2.17 ERB will prepare a regular annual report which will be published after its approval by EB of NHRC.
p.000021:
p.000021: Quorum requirements for ERB
p.000021: 2.18 ERB will have 11 members.
p.000021: 2.19 At least 6 members must be present to compose a quorum. Presence of members of only one gender will
p.000021: not constitute a quorum.
p.000021: 2.20 At least one member present should have expertise in areas other than the subject under discussion.
p.000021: Preferably a member from outside of the health science background must be present.
p.000021:
p.000021: 3. Independent Consultant(s) to the ERB
p.000021: 3.1 ERB will prepare a list of independent consultants who can be called upon by ERB to provide expert
p.000021: opinion on proposed research proposals. These consultants will be subject specialists, methodologists,
p.000021: Environmentalists, legal specialists, ethicists, sociologists, psychologists, anthropologists or representative
p.000021: of specific communities, patient groups and special interest groups.
p.000021: 3.2 Independent consultants who agree to help the ERB will have to sign a confidentiality agreement regarding
p.000021: their assignment, meeting deliberations, applications, information on research participants and related matters.
p.000021:
p.000022: 22
p.000022:
p.000022: 3.3 Independent consultants will be paid remuneration as per NHRC regulations.
p.000022:
p.000022: 4. On-Going Education of the ERB Members
p.000022: 4.1 All new ERB members will be provided with orientation training.
p.000022: 4.2 ERB will conduct regular training programmes for ERB members and Institutional Review Committee
p.000022: members at least two times in a year. Such training programmes will provide opportunities for hands on
p.000022: experience of reviewing the research proposals as well as problems faced while reviewing, implementing or
p.000022: disseminating of research.
...
Social / genetic heritage
Searching for indicator genetic heritage:
(return to top)
p.000005: of the rights and welfare of all the persons in vulnerable situation.
p.000005:
p.000005: 4.4. Principle IV: Respect for the Environment
p.000005: This principle requires that health research is undertaken within a context of respect for the social, cultural
p.000005: and natural heritage of a society. This fundamental ethical principle is re-enforced by WMA Declaration
p.000005: of Helsinki, which stresses the special precautions that must be exercised for the protection of the environment in
p.000005: the conduct of research. In view of the increasing world movement for the protection of the environment, every
p.000005: researcher is responsible for a moral engagement to protect the social, cultural and natural heritage of
p.000005: communities and societies. This responsibility includes commitment to the following:
p.000005: 4.4 (a) To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical and
p.000005: field research
p.000005: 4.4 (b) To safeguard the cultural, linguistic and religious heritage of communities and individuals
p.000005: 4.4 (c) To treat the biologic and genetic heritage of the people with respect and caution. This requires respecting
p.000005: the principles of informed consent and confidentiality of genetic data
p.000005:
p.000005: 5. Application of Ethical Principles in Health Research
p.000005: 5.1 Informed Consent
p.000005: For all health research involving human participants, the investigators must obtain the informed consent of the
p.000005: prospective participants or in the case of an individual who is not capable of giving informed consent, the proxy
p.000005: consent of a properly authorized representative.
p.000005:
p.000005: The informed consent process can be analyzed as having the following components:
p.000005:
p.000005: 5.1.1 Information
p.000005: The research participants should be given sufficient Information of the proposed research including
p.000005: information on the research procedures, their purpose, risks and discomforts and anticipated
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: benefit, alternative procedures and a statement offering the participant the opportunity to ask questions and to
p.000006: withdraw any time from the research without any fear of negative consequences.
p.000006:
p.000006: A special problem of consent arises when informing participants of some pertinent aspect of research that is
p.000006: likely to impair the validity of the research. Such circumstances should be discussed with the ERB who will then
p.000006: decide on the matter.
p.000006:
p.000006: 5.1.2 Comprehension
...
Social / parents
Searching for indicator parents:
(return to top)
p.000013: knowledge
p.000013: and equitable utilization of such knowledge.
p.000013:
p.000013: In order to achieve these aims the following ethical guiding principles are to be followed:
p.000013:
p.000013: 1. Essential Research
p.000013: Research involving human participants should have been considered essential for the understanding of a
p.000013: problem or disease process, or to identify a better diagnostic, therapeutic or preventive approach to a
p.000013: disease.
p.000013:
p.000013: 2. Voluntary Participation
p.000013: The human participation in research must have been ensured voluntarily. The voluntary participation should be
p.000013: secured through a process of providing information to the participants, comprehension by participants of the
p.000013: aims, objectives of research; risks and benefits involved and an understanding that the participation is
p.000013: with their consent, voluntary and with a provision that the participant can withdraw any time without any negative
p.000013: consequences.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: 3. Children in Health Research
p.000014: No research which could be done in adults should be carried out in children. Only those researches which
p.000014: are of relevance to children should be carried out on children. Research involving children should be carried out only
p.000014: after taking informed consent from the parents or legal guardian of the child.
p.000014:
p.000014: 4. Pregnant Women in Health Research
p.000014: Research involving pregnant women and lactating mothers should not be carried out unless the study is related to
p.000014: pregnancy and lactation.
p.000014:
p.000014: 5. Other Vulnerable People in Health Research
p.000014: Special attention should be given while recruiting participants from vulnerable groups of people such as
p.000014: prisoners, students or military personnel or adults who are mentally challenged or in an unconscious
p.000014: state.
p.000014:
p.000014: 6. Potential Benefit
p.000014: The participation in a research activity should be of potential benefit to the participant or to his or her community
p.000014: or the population in general.
p.000014:
p.000014: 7. Harm and Risks
p.000014: The participation in a research activity should not in any way harm the research participant. If there
p.000014: are risks involved in participating in the research, it should be of minimal nature. The risks/benefit ratio must
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000020: 2.13 All administrative staff working for ERB will also have to sign a confidentiality agreement
p.000020: regarding meeting deliberations, applications information on research participants and related matters.
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Office of the ERB
p.000021: 2.14 NHRC will assign space within the premises of NHRC for the exclusive use by Chairman or coordinator
p.000021: of the ERB and administrative staff.
p.000021: 2.15 ERB of NHRC will have its own phone, fax, photocopy cupboard and administrative staff.
p.000021:
p.000021: Meetings
p.000021: 2.16 Member Secretary of the ERB will prepare the agenda for the meeting in consultation with the Chairman of the
p.000021: ERB. The Member Secretary will also keep minutes of the meeting and notify decisions to the researcher. The Member
p.000021: Secretary will be assisted in his or her tasks by an administrative secretary.
p.000021: 2.17 ERB will prepare a regular annual report which will be published after its approval by EB of NHRC.
p.000021:
p.000021: Quorum requirements for ERB
p.000021: 2.18 ERB will have 11 members.
p.000021: 2.19 At least 6 members must be present to compose a quorum. Presence of members of only one gender will
p.000021: not constitute a quorum.
p.000021: 2.20 At least one member present should have expertise in areas other than the subject under discussion.
p.000021: Preferably a member from outside of the health science background must be present.
p.000021:
p.000021: 3. Independent Consultant(s) to the ERB
p.000021: 3.1 ERB will prepare a list of independent consultants who can be called upon by ERB to provide expert
p.000021: opinion on proposed research proposals. These consultants will be subject specialists, methodologists,
p.000021: Environmentalists, legal specialists, ethicists, sociologists, psychologists, anthropologists or representative
p.000021: of specific communities, patient groups and special interest groups.
p.000021: 3.2 Independent consultants who agree to help the ERB will have to sign a confidentiality agreement regarding
p.000021: their assignment, meeting deliberations, applications, information on research participants and related matters.
p.000021:
p.000022: 22
p.000022:
p.000022: 3.3 Independent consultants will be paid remuneration as per NHRC regulations.
p.000022:
p.000022: 4. On-Going Education of the ERB Members
p.000022: 4.1 All new ERB members will be provided with orientation training.
p.000022: 4.2 ERB will conduct regular training programmes for ERB members and Institutional Review Committee
p.000022: members at least two times in a year. Such training programmes will provide opportunities for hands on
p.000022: experience of reviewing the research proposals as well as problems faced while reviewing, implementing or
p.000022: disseminating of research.
p.000022: 4.3 ERB will forward requests from ERB members for participation in national, regional or
p.000022: international training programmes‟ on ethics in health research. EB of NHRC will try to accommodate such requests as
p.000022: far as possible.
p.000022:
p.000022: 5. Submitting the Application
p.000022: Individuals or institutions desirous of conducting health research in Nepal are required to submit their health
p.000022: research proposal to ERB of NHRC.
p.000022:
...
p.000024: 5.3.7 A signed statement by the researcher stating that he or she will abide by the ethical principles
p.000024: of research
p.000024: 5.3.8 Information about any previous submission of this
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: application to ERB or any other Institutional Review Committee and the result of such submission in the
p.000025: past will have to be provided along with the application
p.000025: 5.3.9 A declaration of the conflict of interest, if applicable, should be mentioned in the
p.000025: application
p.000025:
p.000025: 6. Ethical Review Process
p.000025: The ERB will review all the submitted health research proposals in a timely manner and in accordance with
p.000025: the set review process.
p.000025:
p.000025: 6.1 Meeting of the ERB
p.000025: The meetings of the ERB will be held on a regularly scheduled dates that will be announced in advance. The
p.000025: Member Secretary of ERB with the permission of the Chairman of the ERB will call the meeting. The followings are
p.000025: considered as applicable for an ERB meeting:
p.000025: 6.1.1 The meeting of ERB will be planned in accordance with the workloads and
p.000025: number of proposals received for review. Normally, ERB will meet once a month
p.000025: 6.1.2 ERB members will be informed about the meeting at least 72 hours prior to the scheduled date
p.000025: 6.1.3 If felt necessary by the ERB, the applicant researcher or sponsor of the research can be invited to
p.000025: present the proposal or elaborate on specific issues of the proposal. Similarly, if necessary, experts can
p.000025: also be invited to the meeting for expert opinion about the research
p.000025: 6.1.4 Minutes will be kept of all decisions and procedures of the meeting
p.000025: 6.1.5 All the members and invitees present in the meeting should sign the minutes to indicate their presence
p.000025:
p.000025: 6.2 Elements of the Review Process
p.000025: Technical Review by the Reviewers: Once the application is submitted and screened for completeness of
p.000025: documents, technical review of the proposal is done by the internal reviewers for the
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: scientific and technical contents. The application received after internal review is then subjected for review
p.000026: by the external reviewers.
p.000026:
p.000026: Ethical Review: Those applications which qualify are then submitted to the Member-Secretary of the Ethical Review
p.000026: Board and then discussed in full board ERB meeting for ethical review.
p.000026: 6.2.1 Scientific Design of Research Proposal and Conduct of Research
p.000026: 6.2.1.a The appropriateness of the study design in relation to the objectives of the study
p.000026: 6.2.1.b Statistical methods: sampling method, sample size and analysis of data
p.000026: 6.2.1.c Justification of predictable risks and inconveniences against the anticipated benefits for the
p.000026: research participants and community by the proposed study
p.000026: 6.2.1.d Justification of the use of control arm (if relevant for the study)
p.000026: 6.2.1.e Criteria for prematurely withdrawing research participants
p.000026: 6.2.1.f Criteria for suspending or terminating the research
p.000026: 6.2.1.g Provisions for data safety monitoring board(DSMB)
p.000026: 6.2.1.h Plan for dissemination or publication of research results
...
Searching for indicator philosophy:
(return to top)
p.000001: 6. Ethical Review Process 26
p.000001: 6.1 Meeting of the ERB 26
p.000001: 6.2 Elements of the Review Process 26
p.000001: 6.3 Expedited Review 28
p.000001: 7. Decision Making 29
p.000001: 8. Communicating a Decision 29
p.000001: 9. Follow up of the ERB 30
p.000001: 10. Documentation and Archiving 31
p.000001: APPENDICES
p.000001: Appendix I:Checklist for the Ethical Review of a Proposal 33
p.000001: Appendix II: Ethical Questions 35
p.000001: Bibliography 37-40
p.000001: vii
p.000001:
p.000001:
p.000001:
p.000001: Section A
p.000001: GUIDING PRINCIPLES FOR
p.000001: HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS
p.000001: 1. Introduction
p.000001: The word ethics is derived from the Greek word „ethos‟, which means
p.000001: „character‟, „disposition‟ or „a fundamental outlook influencing behaviour related to customs and moral values of
p.000001: the people‟. Aristotle described ethics as moderation in the choice between extremes or as the decision of a
p.000001: prudent person.
p.000001:
p.000001: Ethics is the branch of philosophy which deals with the process of determining correctness of an activity.
p.000001: It draws guidance from the moral principles prevalent in the society. Ethics is guided by the concept of
p.000001: human rights, social and professional responsibility.
p.000001:
p.000001: In health research, ethics is concerned with the process of determining whether an activity proposed under
p.000001: research is ethical or not. It concerns primarily with safeguarding the interests of research participants and aims to
p.000001: promote their dignity and rights.
p.000001:
p.000001: 2. Historical Background
p.000001: Codes of medical ethics are to be found as far back as Babylon with Hammurabi‟s “Code of Law” (Babylon
p.000001: 1790 BC), Agnivesa‟s “Charaka Samhita” (Indian subcontinent 800 BC to 400 AD) and the Hippocratic Oath
p.000001: (Greece 600 BC). Recorded writings on medical ethics are to be found even earlier in the ancient writings of
p.000001: Egyptian, Arabic and Greek scientists and philosophers. More recently, in the west the concept of just moral propriety
p.000001: in medicine was propounded by Thomas Hobbes in 1651 and that of medical humanism by John Gregory in the 18th
p.000001: century. Thomas Percival came up with the concept of bio-ethics and legislative aspects of ethics related
p.000001: behavior.
p.000001:
p.000001: 1
p.000001:
p.000001:
p.000001: In 1946 the International Health Conference meeting in New York adopted the constitutional structure of
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000003:
p.000003: 4. Ethical Principles
p.000003: The ethical principles which guide the health research and care are the principles of respect for
p.000003: autonomy of an individual, beneficence, non malfeasance and the principle of justice. While conducting research
p.000003: at a community level involving humans in groups, all these principles are considered in a composite way.
p.000003: The principle of respect for the environment proposes to ensure respect for the culture of communities,
p.000003: their environment, benefit to the members of the community and not harming them ensuring that the justice is
p.000003: done to them.
p.000003:
p.000003: 4.1. Principle I: Respect for the Autonomy of the Participant The obligation to respect the dignity of
p.000003: participating individuals in all activities of health and biomedical research is the cornerstone of research ethics.
p.000003: This principle is based on the premise that an individual when informed of all aspects of an activity can
p.000003: decide for her/himself a correct course of action. This requires specific attention to the following:
p.000003: 4.1 (a) An individual‟s right to decide what is best for her/him can not be overruled by any consideration
p.000003: of person
p.000003: 4.1 (b) Researchers must actively safeguard the interests of the persons with impaired or diminished
p.000003: autonomy and ensure that the vulnerable people are afforded security against harm, abuse or exploitation
p.000003: 4.1 (c) No researches should take precedence over respect for human rights, fundamental freedom and human dignity,
p.000003: and practices contrary to human dignity should be prohibited.
p.000003:
p.000003: The provisions of respect for autonomy of the human \participants in health research are implemented
p.000003: primarily through the instrument of “informed consent”
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 4.2. Principle II: Beneficence and Non-Malfeasance
p.000004: The principle of beneficence requires that the research activity should benefit the participants directly or
p.000004: indirectly, in the present or in future, individually or through collective benefits. If none of these
p.000004: benefits are obvious, the researcher should ensure that the participation in research does not lead to any
p.000004: harm. All attempts to maximize the benefits and minimize the risks should have been taken by the researcher.
p.000004:
p.000004: This requires that all health and biomedical research activities be preceded by a careful assessment of the potential
p.000004: risks and burdens in comparison to the potential benefits to the prospective research participant and their
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: iii
p.000001:
p.000001: Acronyms
p.000001: CIOMS: Council of International Organization of Medical Sciences EB: Executive Board
p.000001: ERB: Ethical Review Board
p.000001:
p.000001:
p.000001: NHRC: Nepal Health Research Council IRC: Institutional Review Committee
p.000001: SOP: Standard Operating Procedure
p.000001:
p.000001:
p.000001: WHO: World Health Organization
p.000001:
p.000001:
p.000001: WMA: World Medical Association
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: iv
p.000001:
p.000001: Table of Contents
p.000001: Acknowledgement i
p.000001: Preface ii
p.000001: Acronym iv
p.000001: Section A
p.000001: Guiding Principles for Health Research Involving Human Participants
p.000001: 1 -13
p.000001: 1. Introduction 1
p.000001: 2. Historical Background 1
p.000001: 3. Definitions 2
p.000001: 4. Ethical Principles 4
p.000001: 4.1 Principle I: Respect for the Autonomy of the Participant 4
p.000001: 4.2 Principle II: Beneficence and Non-Malfeasance 5
p.000001: 4.3 Principle III: Justice 5
p.000001: 4.4 Principle IV: Respect for the Environment 6
p.000001: 5. Application of Ethical Principles in Health Research 6
p.000001: 5.1 Informed Consent 6
p.000001: 5.1.1 Information 6
p.000001: 5.1.2 Comprehension 7
p.000001: 5.1.3 Voluntariness 7
p.000001: 5.1.4 Process and Information Contained in an
p.000001: Informed Consent Form 8
p.000001: 5.2 Assessment of Risks and Benefits 9
p.000001: 5.3 Selection of the Research Participants 10
p.000001: 5.4 Best Research Practices 11
p.000001: 5.5 Externally Sponsored Research 12
p.000001: 5.6 Scientific Merit of a Health Research Proposal 13
p.000001: v
p.000001:
p.000001: Section B
p.000001: Basic Principles of Health Research Involving Human Participants
p.000001: 14-18
p.000001: 1. Essential Research 14
p.000001: 2. Voluntary Participation 14
...
p.000002: 3.3. Controlled trials of diagnostic, preventive or therapeutic methods or measures in persons
p.000002: designed to demonstrate a specific generalized response to these measures against a background of individual
p.000002: biological variation.
p.000002: 3.4. Studies designed to determine the consequences for Individuals and communities of specific
p.000002: preventive or therapeutic measures.
p.000002: 3.5. Studies concerning human health related behaviour in a variety of circumstances and environments.
p.000002: 3.6. Studies in which environmental factors are manipulated in a way that could affect incidentally
p.000002: exposed individuals; for example, exposure to toxic chemicals, radiation, or pathogenic organisms or agents (or
p.000002: the absence of these); also psychosocial challenges or deprivations, and the implementation of health
p.000002: policy or management options influencing environment of the participants should be considered as research
p.000002: involving human participants.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 3.7. Epidemiological or observational studies aimed at exploring the distribution and determinants or
p.000003: risk factors or health related events or problems in a specified population and geographic area in order
p.000003: to prevent, control, and or manage health problems and or promote healthy or environment friendly behavior.
p.000003:
p.000003: 4. Ethical Principles
p.000003: The ethical principles which guide the health research and care are the principles of respect for
p.000003: autonomy of an individual, beneficence, non malfeasance and the principle of justice. While conducting research
p.000003: at a community level involving humans in groups, all these principles are considered in a composite way.
p.000003: The principle of respect for the environment proposes to ensure respect for the culture of communities,
p.000003: their environment, benefit to the members of the community and not harming them ensuring that the justice is
p.000003: done to them.
p.000003:
p.000003: 4.1. Principle I: Respect for the Autonomy of the Participant The obligation to respect the dignity of
p.000003: participating individuals in all activities of health and biomedical research is the cornerstone of research ethics.
p.000003: This principle is based on the premise that an individual when informed of all aspects of an activity can
p.000003: decide for her/himself a correct course of action. This requires specific attention to the following:
p.000003: 4.1 (a) An individual‟s right to decide what is best for her/him can not be overruled by any consideration
p.000003: of person
p.000003: 4.1 (b) Researchers must actively safeguard the interests of the persons with impaired or diminished
p.000003: autonomy and ensure that the vulnerable people are afforded security against harm, abuse or exploitation
p.000003: 4.1 (c) No researches should take precedence over respect for human rights, fundamental freedom and human dignity,
p.000003: and practices contrary to human dignity should be prohibited.
p.000003:
p.000003: The provisions of respect for autonomy of the human \participants in health research are implemented
p.000003: primarily through the instrument of “informed consent”
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 4.2. Principle II: Beneficence and Non-Malfeasance
p.000004: The principle of beneficence requires that the research activity should benefit the participants directly or
p.000004: indirectly, in the present or in future, individually or through collective benefits. If none of these
p.000004: benefits are obvious, the researcher should ensure that the participation in research does not lead to any
p.000004: harm. All attempts to maximize the benefits and minimize the risks should have been taken by the researcher.
p.000004:
p.000004: This requires that all health and biomedical research activities be preceded by a careful assessment of the potential
p.000004: risks and burdens in comparison to the potential benefits to the prospective research participant and their
p.000004: communities. This does not preclude the participation of healthy volunteers in research. However, in all cases
p.000004: the research should promote the health of the population represented.
p.000004:
p.000004: Beneficence and non malfeasance also requires that the researchers are qualified to carry out proposed
p.000004: research that they are committed to promoting, protecting the health of the participants and their communities.
p.000004: The principle of non malfeasance proscribes those researches which are likely to cause deliberate harm to the
p.000004: participants.
p.000004:
...
General/Other / Manipulable
Searching for indicator manipulated:
(return to top)
p.000002: health. “Biomedical” research refers to research related, directly or indirectly, to the advancement of
p.000002: medicine. “Clinical” research refers to any study of which one or more components is diagnostic, prophylactic or
p.000002: therapeutic in nature and is
p.000002: applied to human participants.
p.000002:
p.000002: Research involving human participants may involve physical, chemical, psychological or social interventions, or
p.000002: it may be strictly observational or historical in its methodology. The study of existing records or generated records
p.000002: containing biomedical or other information, or of tissue samples or biological material, about individual that
p.000002: may or may not be identifiable, is also to be understood as research involving human participants.
p.000002:
p.000002: Research involving human participants includes the following:
p.000002: 3.1. Studies of physiological, biochemical or pathological processes.
p.000002: 3.2. Studies of responses to physical, chemical, genetic, psychological or social interventions.
p.000002: 3.3. Controlled trials of diagnostic, preventive or therapeutic methods or measures in persons
p.000002: designed to demonstrate a specific generalized response to these measures against a background of individual
p.000002: biological variation.
p.000002: 3.4. Studies designed to determine the consequences for Individuals and communities of specific
p.000002: preventive or therapeutic measures.
p.000002: 3.5. Studies concerning human health related behaviour in a variety of circumstances and environments.
p.000002: 3.6. Studies in which environmental factors are manipulated in a way that could affect incidentally
p.000002: exposed individuals; for example, exposure to toxic chemicals, radiation, or pathogenic organisms or agents (or
p.000002: the absence of these); also psychosocial challenges or deprivations, and the implementation of health
p.000002: policy or management options influencing environment of the participants should be considered as research
p.000002: involving human participants.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 3.7. Epidemiological or observational studies aimed at exploring the distribution and determinants or
p.000003: risk factors or health related events or problems in a specified population and geographic area in order
p.000003: to prevent, control, and or manage health problems and or promote healthy or environment friendly behavior.
p.000003:
p.000003: 4. Ethical Principles
p.000003: The ethical principles which guide the health research and care are the principles of respect for
p.000003: autonomy of an individual, beneficence, non malfeasance and the principle of justice. While conducting research
p.000003: at a community level involving humans in groups, all these principles are considered in a composite way.
p.000003: The principle of respect for the environment proposes to ensure respect for the culture of communities,
p.000003: their environment, benefit to the members of the community and not harming them ensuring that the justice is
p.000003: done to them.
p.000003:
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000027: about who is responsible for obtaining the informed consent
p.000027: 6.2.2.b Process of communication with the research Participants about the objectives, methods, risks and
p.000027: benefit of the research
p.000027: 6.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,
p.000027: elderly, disabled, prison population, people in uniform services, etc.)
p.000027: 6.2.2.d Description about the provision for the participants to queries and complaints during the course of
p.000027: research
p.000027: Community considerations
p.000027: 6.2.2.e The relevance of the research for the community from where research participants are drawn
p.000027: 6.2.2.f The process taken for the consultation and communication with the community
p.000027: 6.2.2.g Description about how the research results will be Available for the community
p.000027:
p.000027: 6.3 Expedited Review
p.000027: In the following situations the ERB will allow the Member Secretary to expedite the review of the proposal.
p.000027: 6.3.1 If the research is non interventional, based on secondary data, leading to thesis or has
p.000027: received approval from the Institutional Review Committee
p.000027: 6.3.2 If t he r esearch i s carried out under t he circumstances of outbreak, disaster and
p.000027: other emergency conditions
p.000027:
p.000028: 28
p.000028:
p.000028: 6.3.3 If the proposal i s found technically and scientifically sound after reviewing by internal
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
p.000028: The ERB will consider the following while making decision about the research proposal
p.000028: 7.1 The ERB will make the decision only if the meeting has met required quorum as noted in 2.18-20
p.000028: 7.2 Normally the decision will be taken by consensus, (if consensus is not possible then a vote will be
p.000028: taken)
p.000028: 7.3 The ERB member should withdraw from the decision process when conflict of interests arises; the member
p.000028: should declare the conflict of interest
p.000028: 7.4 The ERB may approve the proposal conditionally with specific suggestions to the researcher
p.000028: 7.5 The negative decision on a proposal should be supported by clearly stated reasons
p.000028:
p.000028: 8. Communicating a Decision
p.000028: On behalf of the Ethical Review Board, the Member Secretary will communicate its decision to the
p.000028: applicant in writing within two weeks after the meeting. The communication of the decision will include, but is
p.000028: not limited to the following information:
p.000028: 8.1 The exact title of the research proposal reviewed
p.000028: 8.2 The clear identification of the protocol of the proposed Research or amendment, date and
p.000028: version number (if applicable) on which the decision is based;
p.000028: 8.3 The names and (where possible) specific identification numbers (version numbers/dates) of the
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: benefit, alternative procedures and a statement offering the participant the opportunity to ask questions and to
p.000006: withdraw any time from the research without any fear of negative consequences.
p.000006:
p.000006: A special problem of consent arises when informing participants of some pertinent aspect of research that is
p.000006: likely to impair the validity of the research. Such circumstances should be discussed with the ERB who will then
p.000006: decide on the matter.
p.000006:
p.000006: 5.1.2 Comprehension
p.000006: It is the investigator‟s responsibility to ascertain that the research participant is competent and has
p.000006: comprehended the information. If the research participant is not capable of comprehending the information or is
p.000006: incompetent, the proxy consent of a properly authorized representative is necessary.
p.000006:
p.000006: It is necessary to adapt the presentation of the information to the participants‟ capacities in a language
p.000006: the participant can understand. necessary attention and sensitivity should be given to cultural
p.000006: particularities.
p.000006:
p.000006: 5.1.3 Voluntariness
p.000006: Informed consent is valid only if it is given voluntarily. Therefore there should be no coercion in the
p.000006: form of any threat or undue influence in the form of excessive, unwarranted, inappropriate or improper
p.000006: award.
p.000006:
p.000006: When the research design involves no more than minimal risk, that is, risk that is no more likely and not
p.000006: greater that attached to routine medical or psychological examination, and it is not practical to obtain informed
p.000006: consent from each participant, the Ethical Review Board may waive some or all of the elements of informed
p.000006: consent.
p.000006:
p.000006: Even though the legal guardian of a child or a person with a mental disorder gives the actual consent for
p.000006: participation in research, whenever possible, the assent of the child or the person with a mental disorder, to the
p.000006: extent possible, has to be obtained.
p.000006:
p.000007: 7
p.000007:
p.000007: 5.1.4 Process and Information Contained in an Informed Consent Form
p.000007:
p.000007: 5.1.4 (a) Obtaining consent from the participants
p.000007: It is important to know who will explain the research questions, and who will receive the informed consent
p.000007: from the participant. Consider how much time is essential for this important matter.
p.000007:
p.000007: 5.1.4 (b) Is there any coercion or deception?
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000001: was disseminated in the Workshop on the Finalization of the Revised National Ethical Guidelines for Health
p.000001: Research in Nepal on April 26, 2010. With the accumulated valuable suggestions from this workshop definitive
p.000001: steps were taken to finalize the ethical guidelines. The document is divided into three sections. Section
p.000001: A: Guiding Principles for Health Research Involving Human Participants. Section B: Basic Principles of
p.000001: Health Research
p.000001: ii
p.000001:
p.000001: Involving Human Participants and Section C: Standard Operating Procedure For The Ethical Review
p.000001: Board of Nepal Health Research Council. In the revised Guidelines the section on the Standard Operating
p.000001: Procedure (SOP) has been added and is being implemented by the Ethical Review Board of NHRC.
p.000001:
p.000001: This document is an updated edition of National Ethical Guidelines for Health Research in Nepal and Standard
p.000001: Operating Procedure which will assist the Ethical Review Board of NHRC in the achievement of its
p.000001: commitment to promote, protect the dignity, rights, safety and well being of all in health research involving the
p.000001: culture and environment of Nepal.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: iii
p.000001:
p.000001: Acronyms
p.000001: CIOMS: Council of International Organization of Medical Sciences EB: Executive Board
p.000001: ERB: Ethical Review Board
p.000001:
p.000001:
p.000001: NHRC: Nepal Health Research Council IRC: Institutional Review Committee
p.000001: SOP: Standard Operating Procedure
p.000001:
p.000001:
p.000001: WHO: World Health Organization
p.000001:
p.000001:
p.000001: WMA: World Medical Association
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: iv
p.000001:
p.000001: Table of Contents
p.000001: Acknowledgement i
p.000001: Preface ii
p.000001: Acronym iv
p.000001: Section A
p.000001: Guiding Principles for Health Research Involving Human Participants
p.000001: 1 -13
p.000001: 1. Introduction 1
p.000001: 2. Historical Background 1
p.000001: 3. Definitions 2
p.000001: 4. Ethical Principles 4
p.000001: 4.1 Principle I: Respect for the Autonomy of the Participant 4
p.000001: 4.2 Principle II: Beneficence and Non-Malfeasance 5
...
p.000001: reiterated the responsibilities of government and health professionals for promoting and protecting the health of
p.000001: individuals and populations.
p.000001:
p.000001: As the key organization responsible for health within the structure of United Nations, the WHO promotes the
p.000001: Universal Bill of Human Rights which includes Universal Declaration of Human Rights composed in 1948, the
p.000001: International Covenant of Economic, Social and Cultural Rights (1966, ratified in 1976) and the International
p.000001: Covenant of Civil and Political Rights (1966). These three instruments define and describe basic human rights and
p.000001: fundamental freedoms. They form the nucleus of an interlocking set of international conventions, resolutions and
p.000001: declarations intent on promoting the rights and freedoms of persons through law. The Universal Declaration on Human
p.000001: Rights is supported and promoted by Nepal Health Research Council in all its activities.
p.000001:
p.000001: Ethics related to health and biomedical research is a more recent phenomenon. The first international
p.000001: document on this subject is the Nuremberg Code in 1947. This was followed by a series of international
p.000001: declarations, conventions and covenants related to ethics in health, health care and research. The most prominent of
p.000001: these documents are the World Medical Association (WMA) Declaration of Helsinki, the Council of International
p.000001: Organization of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving
p.000001: Human Subjects and the WHO and ICH Guidelines for Good Clinical Practice.
p.000001:
p.000001: The Nepalese national ethical guidelines for health research is cognizant of these declarations, code and
p.000001: guidelines and has followed the spirit in which they are written.
p.000001:
p.000001: 3. Definitions
p.000001: Research: The term research refers to a set of activities designed to develop or to contribute to
p.000001: generalizable knowledge consisting of theories, principles, relationships or the accumulation of information which they
p.000001: are based, that can be corroborated by accepted scientific methods of
p.000001:
p.000002: 2
p.000002:
p.000002: observation and inference. Health research includes medical and behavioural studies related to human
p.000002: health. “Biomedical” research refers to research related, directly or indirectly, to the advancement of
p.000002: medicine. “Clinical” research refers to any study of which one or more components is diagnostic, prophylactic or
p.000002: therapeutic in nature and is
p.000002: applied to human participants.
p.000002:
p.000002: Research involving human participants may involve physical, chemical, psychological or social interventions, or
p.000002: it may be strictly observational or historical in its methodology. The study of existing records or generated records
p.000002: containing biomedical or other information, or of tissue samples or biological material, about individual that
p.000002: may or may not be identifiable, is also to be understood as research involving human participants.
p.000002:
p.000002: Research involving human participants includes the following:
p.000002: 3.1. Studies of physiological, biochemical or pathological processes.
...
p.000036: Exp Clin Med, VoI.22, No.6, pp, 259-265, 1997.
p.000036:
p.000036: Guidelines for the Conduct of Research in the Intramural Research Programs at NIH, Website:
p.000036: http://www.nih.gov/campus/ irnews
p.000036: / guidelines.htm
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: Guidelines for the conduct of Research Involving Human Subjects at the National Institutes of Health, 3rd printing,
p.000037: February, 2000.
p.000037:
p.000037: Holly Gieszl, Elements of Informed Consent, Paper presented during the workshop on Ethical Issues in
p.000037: International Health Research held in Harvard School of Public Health, USA on June 13, 2000.
p.000037:
p.000037: ICH Harmonized Tripartite Guidelines, Guideline For Good Clinical Practice, International Conference on
p.000037: Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, May I, 1996.
p.000037:
p.000037: Indian council of Medical Research (ICMR), Ethical Guidelines for Biomedical Research on Human Subjects, New
p.000037: Delhi, 2000.
p.000037:
p.000037: Informal Listing of Selected International Codes, Declarations, Guidelines, etc. on Medical
p.000037: Ethics/Bioethics/Health Care Ethics/Human Rights Aspects of Health, International Guidelines on Bio-ethics, Revised
p.000037: Edition, Supplement to the EFGCP News, December,1999.
p.000037:
p.000037: International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), International
p.000037: Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993.
p.000037:
p.000037: Jeremy Sugarman, Anna C. Mastroianni, and Jaffrey P. Kahn (Editors), Ethics of Research with Human Subjects
p.000037: Selected Policies and Resources, May, 1998.
p.000037:
p.000037: John Bryant, Ethical Guidelines for Research Involving Human Subjects: Helsinki and ClaMS-Origins Patterns of Change,
p.000037: Paper presented during the Workshop on Ethical Issues in International Health Research held in Harvard School of Public
p.000037: Health, USA on June 12,2000.
p.000037:
p.000037: National Bio-ethics Advisory Commission (NBAC) Facts, Ethical and Policy Issues in International Research,
p.000037: April, 2000.
p.000037:
p.000037: National Institutes of Health (NIH), Guidelines for Writing Research Protocols, Information Sheet No.5
p.000037: (Revised), . Bethesda, Maryland, May 5, 1997.
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: National Institutes of Health, Guidelines for Writing Informed Consent Documents, Information Sheep No.6
p.000038: (Revised), Bethesda, Maryland: June, 1998.
p.000038:
p.000038: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries-, London, October,
p.000038: 1999.
p.000038:
p.000038: Operational Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing, The ENGAGE
...
General/Other / common rule
Searching for indicator 45XcfrX46:
(return to top)
p.000038: (Revised), Bethesda, Maryland: June, 1998.
p.000038:
p.000038: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries-, London, October,
p.000038: 1999.
p.000038:
p.000038: Operational Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing, The ENGAGE
p.000038: Guidelines, Supplement to the EFGCP News, September 1998.
p.000038:
p.000038: P.P. De Deyn, Ethical and Scientific Challenges of Placebo Control Arms in Clinical Trials, International Journal of
p.000038: Pharmaceutical Medicine, 14, 149-157, 2000.
p.000038:
p.000038: Patricia Marshall, Cultural Absolutism vs. Cultural Relativism, Paper presented during the workshop on
p.000038: Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June 13,2000.
p.000038:
p.000038: Ruth Fischbach, Discussion of NIH Guidelines/Office for Human Research Protection, Paper presented during
p.000038: the workshop on Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June
p.000038: 15, 2000.
p.000038:
p.000038: The National Institutes of Health, Assurance of Compliance with DHHS Regulations for the Protection of Human
p.000038: Subjects (45 CFR 46), Bethesda, Maryland, May I, 1998.
p.000038:
p.000038: The Nuremberg Code. Trial of War Criminals before the Nuremberg Military Tribunals under Control Council Law
p.000038: No. 10, Washington DC: US Government Printing Office, 1949; No.2 pp, 181-182.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000038: Human Subjects, Scotland: 52nd General Assembly, October, 2000.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Republic of South Africa: 48th General Assembly,
p.000038: October, 1996.
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: The World Medical Association, Declaration of Lisbon, The Right of the Patient, France; September 1995.
p.000039:
p.000039: World Health Organization, Draft Report of 25th Session of WHO South- East Asia Advisory Committee on Health Research,
p.000039: Bali, Indonesia, April 17-20, 2000, SEA/ACHR/Draft Report, Release date: 20 April, 2000.
p.000039:
p.000039: World Health Organization, Health Ethics In South East Asia, Volume 2, SEAlHSD/226, New Delhi, June, 1999.
p.000039:
p.000039: World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva,
p.000039: 2000.
p.000039:
p.000039: World Health Organization, The Appraisal of Health Systems Research,
p.000039: Technical Publication, SEARO, No. 12: New Delhi, 1993.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000001: the World Health Organization (WHO), which formally came into existence in 1948. This constitution
p.000001: reiterated the responsibilities of government and health professionals for promoting and protecting the health of
p.000001: individuals and populations.
p.000001:
p.000001: As the key organization responsible for health within the structure of United Nations, the WHO promotes the
p.000001: Universal Bill of Human Rights which includes Universal Declaration of Human Rights composed in 1948, the
p.000001: International Covenant of Economic, Social and Cultural Rights (1966, ratified in 1976) and the International
p.000001: Covenant of Civil and Political Rights (1966). These three instruments define and describe basic human rights and
p.000001: fundamental freedoms. They form the nucleus of an interlocking set of international conventions, resolutions and
p.000001: declarations intent on promoting the rights and freedoms of persons through law. The Universal Declaration on Human
p.000001: Rights is supported and promoted by Nepal Health Research Council in all its activities.
p.000001:
p.000001: Ethics related to health and biomedical research is a more recent phenomenon. The first international
p.000001: document on this subject is the Nuremberg Code in 1947. This was followed by a series of international
p.000001: declarations, conventions and covenants related to ethics in health, health care and research. The most prominent of
p.000001: these documents are the World Medical Association (WMA) Declaration of Helsinki, the Council of International
p.000001: Organization of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving
p.000001: Human Subjects and the WHO and ICH Guidelines for Good Clinical Practice.
p.000001:
p.000001: The Nepalese national ethical guidelines for health research is cognizant of these declarations, code and
p.000001: guidelines and has followed the spirit in which they are written.
p.000001:
p.000001: 3. Definitions
p.000001: Research: The term research refers to a set of activities designed to develop or to contribute to
p.000001: generalizable knowledge consisting of theories, principles, relationships or the accumulation of information which they
p.000001: are based, that can be corroborated by accepted scientific methods of
p.000001:
p.000002: 2
p.000002:
p.000002: observation and inference. Health research includes medical and behavioural studies related to human
p.000002: health. “Biomedical” research refers to research related, directly or indirectly, to the advancement of
p.000002: medicine. “Clinical” research refers to any study of which one or more components is diagnostic, prophylactic or
p.000002: therapeutic in nature and is
p.000002: applied to human participants.
p.000002:
p.000002: Research involving human participants may involve physical, chemical, psychological or social interventions, or
p.000002: it may be strictly observational or historical in its methodology. The study of existing records or generated records
p.000002: containing biomedical or other information, or of tissue samples or biological material, about individual that
p.000002: may or may not be identifiable, is also to be understood as research involving human participants.
p.000002:
...
p.000004: persons.
p.000004:
p.000004: The protection of persons in vulnerable situations is of special importance. Persons in vulnerable situations
p.000004: are those who are unable to express or protect fully their own interests owing to such impediments as lack of capacity
p.000004: to consent fully, an inability to obtain alternative means of medical care and or other health necessities, or because
p.000004: they are junior
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: or subordinate member of a hierarchical group. Accordingly, special provisions must be made for the protection
p.000005: of the rights and welfare of all the persons in vulnerable situation.
p.000005:
p.000005: 4.4. Principle IV: Respect for the Environment
p.000005: This principle requires that health research is undertaken within a context of respect for the social, cultural
p.000005: and natural heritage of a society. This fundamental ethical principle is re-enforced by WMA Declaration
p.000005: of Helsinki, which stresses the special precautions that must be exercised for the protection of the environment in
p.000005: the conduct of research. In view of the increasing world movement for the protection of the environment, every
p.000005: researcher is responsible for a moral engagement to protect the social, cultural and natural heritage of
p.000005: communities and societies. This responsibility includes commitment to the following:
p.000005: 4.4 (a) To ensure the proper and safe disposal of biologically hazardous waste from laboratory, clinical and
p.000005: field research
p.000005: 4.4 (b) To safeguard the cultural, linguistic and religious heritage of communities and individuals
p.000005: 4.4 (c) To treat the biologic and genetic heritage of the people with respect and caution. This requires respecting
p.000005: the principles of informed consent and confidentiality of genetic data
p.000005:
p.000005: 5. Application of Ethical Principles in Health Research
p.000005: 5.1 Informed Consent
p.000005: For all health research involving human participants, the investigators must obtain the informed consent of the
...
p.000037: February, 2000.
p.000037:
p.000037: Holly Gieszl, Elements of Informed Consent, Paper presented during the workshop on Ethical Issues in
p.000037: International Health Research held in Harvard School of Public Health, USA on June 13, 2000.
p.000037:
p.000037: ICH Harmonized Tripartite Guidelines, Guideline For Good Clinical Practice, International Conference on
p.000037: Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, May I, 1996.
p.000037:
p.000037: Indian council of Medical Research (ICMR), Ethical Guidelines for Biomedical Research on Human Subjects, New
p.000037: Delhi, 2000.
p.000037:
p.000037: Informal Listing of Selected International Codes, Declarations, Guidelines, etc. on Medical
p.000037: Ethics/Bioethics/Health Care Ethics/Human Rights Aspects of Health, International Guidelines on Bio-ethics, Revised
p.000037: Edition, Supplement to the EFGCP News, December,1999.
p.000037:
p.000037: International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), International
p.000037: Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993.
p.000037:
p.000037: Jeremy Sugarman, Anna C. Mastroianni, and Jaffrey P. Kahn (Editors), Ethics of Research with Human Subjects
p.000037: Selected Policies and Resources, May, 1998.
p.000037:
p.000037: John Bryant, Ethical Guidelines for Research Involving Human Subjects: Helsinki and ClaMS-Origins Patterns of Change,
p.000037: Paper presented during the Workshop on Ethical Issues in International Health Research held in Harvard School of Public
p.000037: Health, USA on June 12,2000.
p.000037:
p.000037: National Bio-ethics Advisory Commission (NBAC) Facts, Ethical and Policy Issues in International Research,
p.000037: April, 2000.
p.000037:
p.000037: National Institutes of Health (NIH), Guidelines for Writing Research Protocols, Information Sheet No.5
p.000037: (Revised), . Bethesda, Maryland, May 5, 1997.
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: National Institutes of Health, Guidelines for Writing Informed Consent Documents, Information Sheep No.6
p.000038: (Revised), Bethesda, Maryland: June, 1998.
p.000038:
p.000038: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries-, London, October,
p.000038: 1999.
p.000038:
p.000038: Operational Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing, The ENGAGE
p.000038: Guidelines, Supplement to the EFGCP News, September 1998.
p.000038:
p.000038: P.P. De Deyn, Ethical and Scientific Challenges of Placebo Control Arms in Clinical Trials, International Journal of
p.000038: Pharmaceutical Medicine, 14, 149-157, 2000.
p.000038:
p.000038: Patricia Marshall, Cultural Absolutism vs. Cultural Relativism, Paper presented during the workshop on
p.000038: Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June 13,2000.
p.000038:
p.000038: Ruth Fischbach, Discussion of NIH Guidelines/Office for Human Research Protection, Paper presented during
p.000038: the workshop on Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June
p.000038: 15, 2000.
p.000038:
p.000038: The National Institutes of Health, Assurance of Compliance with DHHS Regulations for the Protection of Human
p.000038: Subjects (45 CFR 46), Bethesda, Maryland, May I, 1998.
p.000038:
p.000038: The Nuremberg Code. Trial of War Criminals before the Nuremberg Military Tribunals under Control Council Law
p.000038: No. 10, Washington DC: US Government Printing Office, 1949; No.2 pp, 181-182.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000038: Human Subjects, Scotland: 52nd General Assembly, October, 2000.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Republic of South Africa: 48th General Assembly,
p.000038: October, 1996.
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: The World Medical Association, Declaration of Lisbon, The Right of the Patient, France; September 1995.
p.000039:
p.000039: World Health Organization, Draft Report of 25th Session of WHO South- East Asia Advisory Committee on Health Research,
p.000039: Bali, Indonesia, April 17-20, 2000, SEA/ACHR/Draft Report, Release date: 20 April, 2000.
p.000039:
p.000039: World Health Organization, Health Ethics In South East Asia, Volume 2, SEAlHSD/226, New Delhi, June, 1999.
p.000039:
p.000039: World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva,
p.000039: 2000.
p.000039:
p.000039: World Health Organization, The Appraisal of Health Systems Research,
p.000039: Technical Publication, SEARO, No. 12: New Delhi, 1993.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000037: Jeremy Sugarman, Anna C. Mastroianni, and Jaffrey P. Kahn (Editors), Ethics of Research with Human Subjects
p.000037: Selected Policies and Resources, May, 1998.
p.000037:
p.000037: John Bryant, Ethical Guidelines for Research Involving Human Subjects: Helsinki and ClaMS-Origins Patterns of Change,
p.000037: Paper presented during the Workshop on Ethical Issues in International Health Research held in Harvard School of Public
p.000037: Health, USA on June 12,2000.
p.000037:
p.000037: National Bio-ethics Advisory Commission (NBAC) Facts, Ethical and Policy Issues in International Research,
p.000037: April, 2000.
p.000037:
p.000037: National Institutes of Health (NIH), Guidelines for Writing Research Protocols, Information Sheet No.5
p.000037: (Revised), . Bethesda, Maryland, May 5, 1997.
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: National Institutes of Health, Guidelines for Writing Informed Consent Documents, Information Sheep No.6
p.000038: (Revised), Bethesda, Maryland: June, 1998.
p.000038:
p.000038: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries-, London, October,
p.000038: 1999.
p.000038:
p.000038: Operational Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing, The ENGAGE
p.000038: Guidelines, Supplement to the EFGCP News, September 1998.
p.000038:
p.000038: P.P. De Deyn, Ethical and Scientific Challenges of Placebo Control Arms in Clinical Trials, International Journal of
p.000038: Pharmaceutical Medicine, 14, 149-157, 2000.
p.000038:
p.000038: Patricia Marshall, Cultural Absolutism vs. Cultural Relativism, Paper presented during the workshop on
p.000038: Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June 13,2000.
p.000038:
p.000038: Ruth Fischbach, Discussion of NIH Guidelines/Office for Human Research Protection, Paper presented during
p.000038: the workshop on Ethical Issues in International Health Research held in Harvard School of Public Health, USA on June
p.000038: 15, 2000.
p.000038:
p.000038: The National Institutes of Health, Assurance of Compliance with DHHS Regulations for the Protection of Human
p.000038: Subjects (45 CFR 46), Bethesda, Maryland, May I, 1998.
p.000038:
p.000038: The Nuremberg Code. Trial of War Criminals before the Nuremberg Military Tribunals under Control Council Law
p.000038: No. 10, Washington DC: US Government Printing Office, 1949; No.2 pp, 181-182.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000038: Human Subjects, Scotland: 52nd General Assembly, October, 2000.
p.000038:
p.000038: The World Medical Association, Declaration of Helsinki, Republic of South Africa: 48th General Assembly,
p.000038: October, 1996.
p.000038:
p.000038:
...
Orphaned Trigger Words
p.000015: brought into the public domain through scientific and other publications. The research findings should be shared with
p.000015: the local stakeholders preferably through publication in local scientific journals. In case the researcher plans
p.000015: to publish the scientific paper in an internationally acclaimed indexed journal, a summary from such a
p.000015: publication must be published in the local scientific publication. Publications resulting from the research
p.000015: should be subject to such rights as are available to the researcher and her/his associates as determined by the
p.000015: law(s) in force at that time.
p.000015:
p.000015: 12.Institutional Research Arrangements
p.000015: The research activity should be carried out only after making necessary institutional arrangements required
p.000015: to conduct the research. Such institutional arrangements should include involvement of competent researchers
p.000015: and support staff, organizational set up conducive to research, ensuring safety and confidentiality of data and
p.000015: disseminating the research findings. Institutional arrangements for preservation and archiving of research
p.000015: materials, data and reports also must be in place. The research conducted in any institution should have
p.000015: received approval from the institutional chief and other related authorities.
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: 13.Confidentiality and Disclosure
p.000016: The research activity is carried out in such a way that the identity and data related to human participants are
p.000016: kept confidential as far as possible. However, under compelling scientific and legal situations, such
p.000016: disclosures could be made without informed consent of the participant. Recommendations of Data Safety
p.000016: Monitoring Board or a similar body will constitute the scientific reason and order from a court of law will
p.000016: be
p.000016: considered as compelling legal reason.
p.000016:
p.000016: 14.Professional, Legal and Moral Responsibility
p.000016: Researchers and his/ her team, institution where the research is conducted, sponsors and agencies funding the research
p.000016: should take professional, legal and moral responsibility to abide by the principles, guidelines and
p.000016: directives of the Ethical Review Board or Institutional Review Committee.
p.000016:
p.000016: 15.Transparency and Conflict of Interest
p.000016: The researchers and their associates will conduct the research with fairness, honesty, impartiality and
p.000016: transparency. All involved in the research activity will fully disclose their interest in different
p.000016: aspects of study and their conflicts of interest, if any. Failure to disclose relevant information can
p.000016: lead to suspension of the approval of research activity or penalty determined by law. In case of suspension of
p.000016: the research, researcher should have ample occasion to lodge a complaint against such a decision to a body
p.000016: constituted by the Ethical Review Board of Nepal
p.000016: Health Research Council.
p.000016:
p.000016: 16.Research and the Environment
p.000016: Researchers will respect the environment while conducting any health research. Respect for the environment
p.000016: is demonstrated through research being undertaken within a context of social, cultural and natural heritage of a
p.000016: society. Health research proposals will have to ensure proper and safe disposal of all kinds of hazardous waste from a
...
p.000018: promote scientific and ethical health research in Nepal.
p.000018:
p.000018: 1. Functions and Duties of the ERB
p.000018: 1.1. To review research proposals according to the National Ethical Guidelines for Health Research in
p.000018: Nepal with a view to approve, amend or reject the proposal
p.000018: 1.2 To supervise or monitor the implementation of health research projects approved by ERB
p.000018:
p.000019: 19
p.000019:
p.000019: 1.3. To conduct training programmes for members and reviewers of ERB and Institutional Review Committees
p.000019: (IRCs) on the ethical review process
p.000019: 1.4. To resolve ethical issues arising out of reviewing, approving , supervising and disseminating the research
p.000019: findings
p.000019: 1.5. To promote research in the process of review, implementation
p.000019: , supervision of research and dissemination of research findings
p.000019: 1.6. To accredit IRC‟s and oversee their functions and guide them periodically
p.000019:
p.000019: 2. Membership of ERB
p.000019: 2.1 Executive Board of NHRC will appoint the members and chairman of the ERB and the member secretary of
p.000019: NHRC will act as the secretary of the ERB.
p.000019: 2.2. Member Secretary of NHRC will prepare a list of potential candidates for the ERB membership and
p.000019: submit these names to the Chairman of NHRC who in consultation with EB of NHRC will make the appointments.
p.000019: Members will be drawn from multiple disciplines and members unaffiliated with NHRC will be included in the
p.000019: ERB. Potential candidates should be drawn from among the senior health professional possessing at least
p.000019: postgraduate qualification in a related scientific discipline, having received training in ethics and the ethical
p.000019: review process and served in an IRC or ERB as a member for at least a term of three years.
p.000019: 2.3. Member Secretary of NHRC, while preparing the list of potential candidate will give due
p.000019: consideration to the possible conflicts of interest of the different candidates. Each potential candidate will be
p.000019: asked to indicate possible conflicts of interests that might arise in the course of their ERB work. The
p.000019: Member Secretary records this data and informs the Chairman.
p.000019: 2.4. While making the appointment, at least 33% to 50% of the members of the existing ERB will be
p.000019: retained in order to ensure continuity of experience.
p.000019:
p.000020: 20
p.000020:
p.000020: Term of appointment to the ERB
p.000020: 2.5. The ERB member will be appointed for the duration of a three year term.
p.000020: 2.6. Policy for renewal: in order to maintain continuity of experience at least 33 to 50% of the
p.000020: members will be retained in a new ERB.
p.000020: 2.7 Disqualification procedure: A member who was found upon an investigation conducted by ERB acting
p.000020: contrary to the interests of NHRC, breaching the conditions of appointment will be disqualified from
p.000020: continuing in the ERB. This qualification would be made by the EB of NHRC. Legal prosecution will also lead to
p.000020: disqualification.
p.000020: 2.8 Resignation: a member who does not want to continue in on the ERB can submit his or her resignation to ERB
p.000020: of NHRC. On acceptance of the resignation by the ERB membership on the ERB will cease.
p.000020: 2.9 Replacement procedure: the process followed for appointment of members will be followed to replace the
p.000020: ERB members.
p.000020:
...
p.000028: reviewer of NHRC
p.000028: 6.3.4 The Member Secretary should inform to NHRC Chairman and in the ERB meeting about the
p.000028: proposals expedited.
p.000028:
p.000028: 7. Decision Making
p.000028: The ERB will consider the following while making decision about the research proposal
p.000028: 7.1 The ERB will make the decision only if the meeting has met required quorum as noted in 2.18-20
p.000028: 7.2 Normally the decision will be taken by consensus, (if consensus is not possible then a vote will be
p.000028: taken)
p.000028: 7.3 The ERB member should withdraw from the decision process when conflict of interests arises; the member
p.000028: should declare the conflict of interest
p.000028: 7.4 The ERB may approve the proposal conditionally with specific suggestions to the researcher
p.000028: 7.5 The negative decision on a proposal should be supported by clearly stated reasons
p.000028:
p.000028: 8. Communicating a Decision
p.000028: On behalf of the Ethical Review Board, the Member Secretary will communicate its decision to the
p.000028: applicant in writing within two weeks after the meeting. The communication of the decision will include, but is
p.000028: not limited to the following information:
p.000028: 8.1 The exact title of the research proposal reviewed
p.000028: 8.2 The clear identification of the protocol of the proposed Research or amendment, date and
p.000028: version number (if applicable) on which the decision is based;
p.000028: 8.3 The names and (where possible) specific identification numbers (version numbers/dates) of the
p.000028: documents reviewed, including the potential research participant information sheet/material and informed
p.000028: consent form;
p.000028: 8.4 The name and title of the applicant
p.000028: 8.5 The name of the research site(s)
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: 8.6 The date and place of the decision
p.000029: 8.7 A clear statement of the decision reached
p.000029: 8.8 Any advice by the ERB
p.000029: 8.9 In the case of a conditional decision, any requirements by the ERB, including suggestions for revision and
p.000029: the procedure for having the application re-reviewed
p.000029: 8.10 In the case of a positive decision the following is required:
p.000029: 8.10.1 A statement of the responsibilities of the applicant
p.000029: 8.10.2 Confirmation of the acceptance of any requirements imposed by the ERB
p.000029: 8.10.3 Deadlines for the submission of progress report(s)
p.000029: 8.10.4 The need to notify the ERB in cases of protocol amendments (other than amendments involving
p.000029: only logistical or administrative aspects of the study)
p.000029: 8.10.5 The need to notify the ERB in the case of amendments to the recruitment material, the
p.000029: potential research participant information, or the informed consent form
p.000029: 8.10.6 The need to report serious and unexpected adverse events related to the conduct of the study
p.000029: 8.10.7 The need to report unforeseen circumstances, the termination of the study, or significant
p.000029: decisions by other Ethical Committees
p.000029: 8.10.8 The information the ERB expects to receive in order to perform ongoing review and deadlines for the
p.000029: submission of final report
p.000029: 8.11 The schedule/plan of ongoing monitoring by the ERB
p.000029: 8.12 In the case of a negative decision, clearly stated reason(s) for the negative decision
p.000029: 8.13 Signature (dated) of the Member Secretary (or other Authorized person) of the ERB
p.000029:
p.000029: 9. Follow up of the ERB
p.000029: ERB will establish a follow-up procedure for following the progress of all studies for which a positive decision has
p.000029: been reached, from the time the decision was taken until the termination of the research.
p.000029:
p.000030: 30
p.000030:
p.000030: 9.1 The follow-up review intervals will be determined by the nature and the events of research
p.000030: projects, though each protocol should undergo a follow-up review at least once a year
p.000030: 9.2 The following instances or events require the follow-up review of a study
p.000030: 9.2.1 Any protocol amendment
p.000030: 9.2.2 Serious and unexpected adverse events related to the conduct of the study or study product, and
p.000030: the response taken by investigators, sponsors, and regulatory agencies
p.000030: 9.2.3 Any event or new information that may affect the benefit/ risk ratio of the study
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 45XcfrX46 | common rule |
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| elderly | Elderly |
| emergency | Public Emergency |
| ethnicity | Ethnicity |
| fathers | Fathers |
| fetuses | Fetus/Neonate |
| gender | gender |
| genetic heritage | genetic heritage |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| impaired | Cognitive Impairment |
| institutionalized | Institutionalized |
| language | Linguistic Proficiency |
| linguistic | Linguistic Proficiency |
| manipulated | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| mothers | Mothers |
| necessities | Access to Social Goods |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| philosophy | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| political | political affiliation |
| pregnant | Pregnant |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| religious | Religion |
| threat | Threat of Stigma |
| unconscious | Unconscious People |
| undue influence | Undue Influence |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access | ['necessities'] |
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| language | ['linguistic'] |
| linguistic | ['language'] |
| mentally | ['disabled', 'disability'] |
| necessities | ['access'] |
| opinion | ['philosophy'] |
| philosophy | ['opinion'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input