79C3C34C52B45572883A05D425EB0F82
Guidelines for Institutional ReviewCommittees (IRCs) for Health Research inNepal (2016)
http://nhrc.gov.np/wp-content/uploads/2017/02/IRC-guidlines-Printed-version.pdf
http://leaux.net/URLS/ConvertAPI Text Files/B93BE81B54951936C92C5B8ECE09763F.en.txt
Examining the file media/Synopses/B93BE81B54951936C92C5B8ECE09763F.html:
This file was generated: 2020-12-01 07:36:26
| 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:
(return to top)
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.000020: procedures and the understanding of the aetiology and pathogenesis of disease.
p.000020:
p.000020: In current medical practice, most diagnostic, therapeutic or prophylactic procedures involve
p.000020: hazards. This applies especially to biomedical research. Medical progress is based on research, which
p.000020: ultimately must rest in part on experimentation involving human subjects.
p.000020:
p.000020: In the field of biomedical research a fundamental distinction must be recognized between medical research in which the
p.000020: aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of
p.000020: which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the
p.000020: research.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: Special caution must be exercised in the conduct of research which may affect the environment, and the welfare
p.000021: of animals used for research must be respected. Because it is essential that the results of laboratory experiments
p.000021: be applied to human beings to further scientific knowledge and to help suffering humanity, the World
p.000021: Medical Association has prepared the following recommendations as a guide to every physician in biomedical research
p.000021: involving human subjects. They should be kept under review in the future. It must be stressed that the standards as
p.000021: drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal,
p.000021: civil and ethical responsibilities under the laws of their own countries.
p.000021:
p.000021: I. Basic Principles
p.000021: 1. Biomedical research involving human subjects must conform to generally accepted scientific principles
p.000021: and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of
p.000021: the scientific literature.
p.000021: 2. The design and performance of each experimental procedure involving human subjects should be clearly
p.000021: formulated in an experimental protocol which should be transmitted for consideration, comment and
p.000021: guidance to a specially appointed committee independent of the investigator and the sponsor,
p.000021: provided that this independent committee is in conformity with the laws and regulations of the country in
p.000021: which the research experiment is performed.
p.000021: 3. Biomedical research involving human subjects should be conducted only by scientifically
p.000021: qualified persons and under the supervision of a clinically competent medical person. The
p.000021: responsibility for the human subject must always rest with a medically qualified person and never rest
p.000021: on the subject of the research, even though the subject has given his or her consent.
p.000021: 4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the
p.000021: objective is in proportion to the inherent risk to the subject.
p.000021: 5. Every biomedical research project involving human subjects should be preceded by careful assessment of
...
Political / nomad
Searching for indicator nomads:
(return to top)
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
p.000039:
p.000039:
p.000039:
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.000030: with limited literacy, the verbal communication of the consent document details should be provided along
p.000030: with proper documentation of consent, if it be given.
p.000030:
p.000030: Confidentiality
p.000030: Maintenance of the privacy of research participants including their personal identity and all personal
p.000030: information.
p.000030:
p.000030: Conflict of Interests
p.000030: A conflict of interest arises when a member (or members) of the IRC holds interests with respect to specific proposals
p.000030: for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the
p.000030: research focused on the protection of the research participant. Conflict of interests may arise when an IRC member(s)
p.000030: has financial, material, institutional, or social ties to the research.
p.000030:
p.000030: Contract
p.000030: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements
p.000030: regarding delegation and distribution of tasks and obligations and, if appropriate, financial matters. The
p.000030: protocol may serve as the basis of a contract.
p.000030:
p.000030: Decision
p.000030: The response given by the IRC to the research proposal following review, which may be either positive or
p.000030: negative.
p.000030:
p.000030: Direct Access
p.000030: Permission to examine, analyzes, verify, and reproduce any records and reports that are important to evaluation of a
p.000030: clinical trial. Any party (e.g. domestic and foreign regulatory authorities, sponsor's monitors or auditors) with
p.000030: direct access should take all reasonable precautions within the constraints of the applicable regulatory
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: requirement(s) to maintain the confidentiality of participants' identities and the sponsor's proprietary information.
p.000031:
p.000031: Documentation
p.000031: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical
p.000031: records, and scans, x-rays, and electrocardiograms) that describe or record the methods,
p.000031: conduct, and/or results of a trial/study, the factors affecting a study/trial, and the actions taken.
p.000031:
p.000031: Ethical Guidelines
p.000031: Guidance documents which assist with decisions relating to the responsibility to adhere to established and
p.000031: relevant standards of ethical principles and practice.
p.000031:
p.000031: Expedited Review
p.000031: Review of proposed research by the IRC Member Secretary or a designated voting member or group of voting
p.000031: members rather than by the entire IRC.
p.000031:
p.000031: Good Clinical Practice (GCP)
p.000031: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical
p.000031: trials/study that provides assurance that the data and reported results are credible and accurate, and that the
p.000031: rights, integrity, and confidentiality of trial/study participants are protected.
p.000031:
p.000031: ID
...
Searching for indicator political:
(return to top)
p.000002: 2. Objectives
p.000002: The overall objective of this guideline is to provide a framework for the formation of IRCs, to detail the functional
p.000002: procedures they should follow while reviewing and approving health-research proposals, and to ensure that the
p.000002: provisions of national guidelines published by NHRC are followed whenever a health-related research proposal is
p.000002: reviewed, approved and monitored.
p.000002:
p.000002: The specific objectives of this guideline are:
p.000002:
p.000002: • To ensure that all health care facilities, academic institutions and research institutions follow a similar
p.000002: process in the formation of institutional review committees
p.000002: • To ensure consistency of the ethical review procedures of all IRCs
p.000002: • To ensure consistency in the supervision and monitoring of health-related research
p.000002: • To protect the rights of humans and animals involved in research
p.000002:
p.000002: 3. Role of an IRC
p.000002: The role of an IRC is to safeguard the dignity, rights, safety and well-being of all actual or potential
p.000002: research participants and ensure that animals, if used for research, are treated humanely. The IRC should
p.000002: ensure the full review and evaluation of all ethical aspects of health-related research proposals it receives
p.000002: prior to any research being carried out in field and/or laboratory settings, according to national ethical
p.000002: guidelines prescribed by NHRC. The IRC should provide independent, competent, and timely review of
p.000002: research proposals. The tasks of the IRC should be executed free of bias and influence (political, institutional,
p.000002: professional, market etc).
p.000002:
p.000002: The IRC has the authority to ask for research protocol modifications, and to enforce and monitor the conduct of
p.000002: research projects. This includes issues of informed consent and right of all research participants
p.000002: (human or animal) and to suspend or stop any health-related research that violates any ethical
p.000002: issues. This type of supervision and monitoring is applicable to those research projects that are approved by the
p.000002: IRC.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 4. Establishing a System of Institutional Review Process
p.000003: Any health institution which undertakes at least 10 health-related researches in a year is eligible to
p.000003: establish an IRC. The following system should be followed by an IRC:
p.000003:
p.000003: • It should work within the framework of the highest possible ethical and scientific standards in biomedical
p.000003: research.
p.000003: • It is mandatory that the IRC must be independent, autonomous and multidisciplinary in nature.
p.000003: • A mechanism must be developed to ensure clear and efficient communication, harmonization of
p.000003: standards, networking, and cooperation between the IRC and ERB of NHRC. An IRC may implement its own
p.000003: procedure to interact with other IRCs regarding matters of common interest as necessary. Such interactions enable IRCs
p.000003: to learn about prior decisions by other IRCs or the ERB of NHRC that may be relevant to proposed research
p.000003: under review.
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000006: state provisions available for IRC members to receive introductory training in the work of the IRC as
p.000006: well as ongoing opportunities for enhancing their capacity for ethical review.
p.000006:
p.000006: 10. Review Process and Communicating a Decision
p.000006: The IRC should provide independent, competent and timely reviews of the ethical aspects of research proposals. The IRC
p.000006: may decide upon the reviewer(s) involved for each proposal. Depending on the nature of the research proposal, it may be
p.000006: reviewed by more than one reviewer. A scoring checklist or format needs to be developed and made available to
p.000006: reviewers in order to maintain consistency and objectivity of the review process.
p.000006:
p.000006: If only a few proposals (two to three) need to be reviewed at a time, it would be advisable for all IRC members
p.000006: to review the full set of including all associated documents. If a large number of proposals need to be
p.000006: reviewed at each meeting, one IRC member (principal reviewer) is to undertake an in-depth review
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: including all forms, questionnaires etc., and prepare a summary containing essential details for other members
p.000007: to review.
p.000007:
p.000007: The following ethical issues should be carefully evaluated during the review process:
p.000007:
p.000007: • Potential risk to participants should reasonably be less than anticipated benefits.
p.000007: • Selection of participants should be equitable. If the research involves vulnerable populations, additional
p.000007: safeguards should be included in the research protocol to protect the rights of these people.
p.000007: • Informed consent should be obtained in an appropriate language understandable by the participant. The
p.000007: informed consent should be signed by the participant or a witness. The participant should be allowed to
p.000007: withdraw from the research at any time without explanation.
p.000007: • There should be adequate provisions to protect the privacy of participants and maintain confidentiality of
p.000007: data.
p.000007: • The research plan should make adequate provisions for monitoring during data collection to ensure the safety
p.000007: of participants. The mechanism for compensation in case of injury should be well documented.
p.000007: • The expected duration of research should be specified prior to approval. In case of amendments, prior
p.000007: approval needs to be given befor implimentation of amended research activities.
p.000007: • The IRC should receive periodic and final reports from researchers, a copy of which need to be submitted to NHRC’s
p.000007: ERB.
p.000007:
p.000007: Expedited Review: Most projects will require formal review by the full IRC, but there may be some studies that
p.000007: do not pose any ethical problems (“ethically minor” investigations), where there is minimum risk of distress or
...
p.000017: given to the informed consent process, documentation, and the suitability and feasibility of the protocol. The IRC
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
p.000017: 2.2 The characteristics of the populations from which research participants will be drawn (including
p.000017: gender, age, and economic status). Be aware of any potential vulnerable populations in the study including women,
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
p.000018: 3.9 The provisions for compensation/treatment in the case of the injury/disability/death of a research
p.000018: participant attributable to participation in the research.
p.000018:
...
p.000037:
p.000037: Study Site
p.000037: The location(s) where study-related activities are conducted.
p.000037:
p.000037: Supervision and Monitoring
p.000037: An officially conducted procedure (i.e. review of the conduct of certain research), either by an independent IRC
p.000037: team or jointly with the national ERB (if necessary) at the site of investigation.
p.000037:
p.000037: Unexpected ADR
p.000037: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.
p.000037: investigator's brochure for an unapproved investigational product or package insert/summary of characteristics of an
p.000037: approved product)
p.000037:
p.000037: Verification (Validation) of Data
p.000037: The procedures carried out to ensure that the data contained in the final report match original observations. These
p.000037: procedures may apply to raw data or data in case-report forms (in hard copy or electronic form), computer
p.000037: printouts, statistical analyses and tables.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Voluntary
p.000038: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted, or suggested by another;
p.000038: (2) free of coercion, duress, or undue inducement. Used in the health and disability care and research contexts to
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
p.000039: Fax : +977 1 4262469
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000001: institutions that are involved in approving health research proposals.
p.000001:
p.000001: In this context, we would like to express our sincere thanks and gratitude to all the members of the
p.000001: Taskforce committee: Prof. Dr. Ramesh Kant Adhikari, Prof. Dr. Jeevan Bahadur Sherchand, Associate
p.000001: Prof. Dr. Aarati Shah, Prof. Dr. Rajendra Kumar BC, Mr. Mohan Krishna Shrestha, Mr. Purushottam
p.000001: Dhakal, Ms. Namita Ghimire, and Dr. Krishna Kumar Aryal.
p.000001:
p.000001: We are grateful to former Chairman Prof. Dharma Kant Bastola, and former Executive Chief Dr. Guna Raj Lohani for
p.000001: all the support and guidance they provided during the revision process.
p.000001:
p.000001: We extend our profound thanks to all the participants of the consultative meeting for their
p.000001: enthusiastic participation and thoughtful comments which have made this document more relevant and suited to the
p.000001: context of reality. Heartfelt thanks are offered for their hard work and valuable contributions.
p.000001:
p.000001: We also express our thanks to the Ethical Review, Monitoring & Evaluation (ER, M & E Section) and all staffs
p.000001: of NHRC, Mr. Nirbhay Kumar Sharma, Mr. Subodh Kumar Karna, Dr. Meghanath Dhimal, Mr. Bijay Kumar Jha, Ms. Sabina
p.000001: Bhandari and Mr. David Norrish who have contributed to the revision of this guideline.
p.000001:
p.000001: Dr. Khem Bahadur Karki
p.000001: Member - Secretary
p.000001: Dr. Krishna Prasad Adhikary
p.000001: Chairman
p.000001:
p.000001: III
p.000001:
p.000001: Abbreviations
p.000001:
p.000001: AE Adverse Event
p.000001: ADR Adverse Drug Reaction
p.000001: CIOMS Council for International Organizations of Medical Sciences
p.000001: ERB Ethical Review Board
p.000001: GCP Good Clinical Practice
p.000001: GLP Good Laboratory Practice
p.000001: GoN Government of Nepal
p.000001: NHRC Nepal Health Research Council PI Principal Investigator
p.000001: QA Quality Assurance
p.000001: QC Quality Control
p.000001: ICH International Conference on Harmonization IRC Institutional Review Committee
p.000001: SAE Serious Adverse Event
p.000001: SOP Standard Operating Procedure
p.000001: ER M & E Ethical Review Monitoring & Evaluation
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:
p.000001:
p.000001: Page No
p.000001: Preface I
p.000001: Acknowledgements III
p.000001: Abbreviations IV
p.000001: 1. Introduction 1
p.000001: 2. Objectives 3
p.000001: 3. Role of an Institutional Review Committee (IRC) 3
p.000001: 4. Establishing a System of Institutional Review Process 4
p.000001: 5. Formation of IRCs 4
p.000001: 6. IRC Office 6
...
p.000019: 5.2 The steps taken for consultation with concerned communities regarding the research procedure.
p.000019: 5.3 The influence of community on the consent of individuals.
p.000019: 5.4 The extent to which the research contributes to capacity building, such as the enhancement
p.000019: of local healthcare, research, and the ability to respond to public health needs.
p.000019:
p.000019: 6. Expedited Review
p.000019: 6.1 For expedited review, the IRC should establish
p.000019: 6.1.1 Procedures for the expedited review of research involving minimal risks to participants. These
p.000019: procedures should specify the following:
p.000019: 6.1.2 The nature of the applications, amendments and other considerations that will be eligible for
p.000019: expedited review.
p.000019: 6.1.3 The types of research to which an expedited review procedure is to apply.
p.000019: 6.1.4 The scope of the Member-Secretary's authority.
p.000019: 6.1.5 The delegation of tasks to sub-committees.
p.000019: 6.1.6 The quorum requirement for expedited review.
p.000019: 6.1.7 The status of decisions (e.g. subject to confirmation by the full IRC or not).
p.000019: 6.1.8 The method of reporting and ratifying decisions by the full Committee.
p.000019: 6.2 Research with potential for physical or psychological harm should generally not be considered for
p.000019: expedited review. This includes drug trials, research involving invasive physical procedures and
p.000019: research exploring sensitive personal or cultural issues.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Appendix – II
p.000020: Declaration of Helsinki** Recommendations Guiding Physicians in
p.000020: Biomedical Research Involving Human Subjects
p.000020:
p.000020: Introduction
p.000020: It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are
p.000020: dedicated to the fulfillment of this mission.
p.000020:
p.000020: The Declaration of Geneva of the World Medical Association binds the physician with the words "The health of my
p.000020: patient will be my first consideration" and the International Code of Medical Ethics declares "A physician shall
p.000020: act only in the patient's interest when providing medical care which might have the effect of weakening the physical
p.000020: and mental condition of the patient."
p.000020:
p.000020: The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic
p.000020: procedures and the understanding of the aetiology and pathogenesis of disease.
p.000020:
p.000020: In current medical practice, most diagnostic, therapeutic or prophylactic procedures involve
p.000020: hazards. This applies especially to biomedical research. Medical progress is based on research, which
p.000020: ultimately must rest in part on experimentation involving human subjects.
p.000020:
...
p.000025:
p.000025: National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure, Nepal Health Research
p.000025: Council, 2011.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: National Institute of Health, Guidelines for Writing Informed Consent Documents, Information Sheet no 6 (Revised),
p.000026: Bethesda, Maryland: June 1998
p.000026:
p.000026: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries, London, October, 1999
p.000026:
p.000026: Standards and Operational Guidance for Ethics Review of Health-related Research with Human
p.000026: Participants, WHO, 2011.
p.000026:
p.000026: TDRIWHO Guideline, 2000.
p.000026: The World Medical Association, Declaration of Helsinki, Republic of South Africa: 48th General Assembly,
p.000026: October, 1996.
p.000026:
p.000026: The World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000026: Human Subjects, Scotland: 52nd General Assembly, October 2000
p.000026:
p.000026: World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research,
p.000026: Geneva, 2000
p.000026:
p.000026: 19. Glossary
p.000026: Adverse Drug Reaction (ADR)
p.000026: In the pre-approval clinical experience with a new medicinal product or a product's new usages, particularly as the
p.000026: therapeutic dose(s) may not be established, all harmful and unintended responses to a medicinal product related to
p.000026: any dose should be considered adverse drug reactions.
p.000026:
p.000026: Adverse Event (AE)
p.000026: Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical
p.000026: product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any
p.000026: unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease
p.000026: temporally associated with the use of a medicinal (investigational) product, whether or not related to the
p.000026: medicinal (investigational) product.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: Approval
p.000027: The affirmative decision of the IRC that the study proposal has been reviewed and may be conducted at the
p.000027: institution site within the constraints set forth by the IRC, the institution, good clinical practice (GCP), good
p.000027: laboratory practice (GLP), and the applicable regulatory requirements.
p.000027:
p.000027: Benefit: A favorable consequence arising from a study, for example the demonstration that a drug/vaccine is
p.000027: effective in a randomized controlled trial.
p.000027:
p.000027: Blinding
p.000027: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000027: Single-blinding usually refers to the participant(s) being unaware, and double-blinding usually refers to the
p.000027: participant (s), investigator(s), monitor, and, in some cases, data analyst(s), being unaware of the treatment
p.000027: assignment(s).
p.000027:
p.000027: Clinical Investigation
p.000027: Any experiment in which a drug/vaccine is administered, dispensed or otherwise used, involving a required number of
p.000027: research participants. For the purposes of this document, an experiment is any use of a drug/vaccine
p.000027: except for the use of a marketed drug/vaccine in the course of medical practice.
p.000027:
p.000027: Clinical Trial
p.000027: A systematic study involvinga pharmaceutical product or biomedical devicewithresearch participants in order to
p.000027: discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to
p.000027: study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining
p.000027: their efficacy and safety. Clinical trials are generally classified into Phases I to IV. It is not possible to draw
p.000027: distinct lines between the phases, and diverging opinions about details and methodology do exist. A brief
p.000027: description of the individual phases, based on their purposes as related to the clinical development of a
p.000027: pharmaceutical product or device, is given below:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: Phase I: These are the first trials of a new active ingredient or new formulations or device in human beings, often
p.000028: carried out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000028: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000028: humans, or sensitivity or specificity of a device.
p.000028:
p.000028: Phase II: These trials are performed in a limited number of human participants and are often of a comparative
p.000028: (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and to assess
p.000028: short-term safety of the active ingredient or device in patients suffering from a disease or condition for which the
p.000028: active ingredient or device is intended. This phase also aims at the determination of appropriate dose ranges
p.000028: or regimens or exposure to a device and (if possible) clarification of dose-response or
p.000028: device-response relationships in order to provide an optimal background for the design of extensive therapeutic trials.
p.000028:
p.000028: Phase III: Trials in larger (and possibly varied) patient groups with th e purpose of determining the short and
p.000028: long-term safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall and
p.000028: relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated and special
p.000028: features of the product or device must be explored (e.g. clinically relevant drug interactions, factors leading to
p.000028: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000028: designs may be acceptable, e.g. long-term safety studies. Generally, the conditions under which these
p.000028: trials are carried out should be as close as possible to normal conditions of use.
p.000028:
p.000028: Phase IV: Studies performed after marketing of the pharmaceutical product or device. Trials in phase IV are
p.000028: carried out on the basis of the product or device characteristics on which the marketing authorization was granted
p.000028: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value
p.000028: or treatment strategies or sensitivity or specificity of a device. Although methods may differ, these
p.000028: studies should use the same scientific and ethical standards as applied in pre-marketing studies.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: After a product or device has been placed on the market, clinical trials designed to explore new indications, new
p.000029: methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical
p.000029: products or devices.
p.000029:
p.000029: Community
p.000029: A community is a group of people understood as having a certain identity due to the sharing of common
p.000029: interests or to a shared proximity. A community may be identified as a group of people living in the same village,
p.000029: town, or country and, thus, sharing geographically proximity. A community may be otherwise identified as a group of
...
Searching for indicator influence:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: 2. Objectives
p.000002: The overall objective of this guideline is to provide a framework for the formation of IRCs, to detail the functional
p.000002: procedures they should follow while reviewing and approving health-research proposals, and to ensure that the
p.000002: provisions of national guidelines published by NHRC are followed whenever a health-related research proposal is
p.000002: reviewed, approved and monitored.
p.000002:
p.000002: The specific objectives of this guideline are:
p.000002:
p.000002: • To ensure that all health care facilities, academic institutions and research institutions follow a similar
p.000002: process in the formation of institutional review committees
p.000002: • To ensure consistency of the ethical review procedures of all IRCs
p.000002: • To ensure consistency in the supervision and monitoring of health-related research
p.000002: • To protect the rights of humans and animals involved in research
p.000002:
p.000002: 3. Role of an IRC
p.000002: The role of an IRC is to safeguard the dignity, rights, safety and well-being of all actual or potential
p.000002: research participants and ensure that animals, if used for research, are treated humanely. The IRC should
p.000002: ensure the full review and evaluation of all ethical aspects of health-related research proposals it receives
p.000002: prior to any research being carried out in field and/or laboratory settings, according to national ethical
p.000002: guidelines prescribed by NHRC. The IRC should provide independent, competent, and timely review of
p.000002: research proposals. The tasks of the IRC should be executed free of bias and influence (political, institutional,
p.000002: professional, market etc).
p.000002:
p.000002: The IRC has the authority to ask for research protocol modifications, and to enforce and monitor the conduct of
p.000002: research projects. This includes issues of informed consent and right of all research participants
p.000002: (human or animal) and to suspend or stop any health-related research that violates any ethical
p.000002: issues. This type of supervision and monitoring is applicable to those research projects that are approved by the
p.000002: IRC.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 4. Establishing a System of Institutional Review Process
p.000003: Any health institution which undertakes at least 10 health-related researches in a year is eligible to
p.000003: establish an IRC. The following system should be followed by an IRC:
p.000003:
p.000003: • It should work within the framework of the highest possible ethical and scientific standards in biomedical
p.000003: research.
p.000003: • It is mandatory that the IRC must be independent, autonomous and multidisciplinary in nature.
p.000003: • A mechanism must be developed to ensure clear and efficient communication, harmonization of
p.000003: standards, networking, and cooperation between the IRC and ERB of NHRC. An IRC may implement its own
p.000003: procedure to interact with other IRCs regarding matters of common interest as necessary. Such interactions enable IRCs
p.000003: to learn about prior decisions by other IRCs or the ERB of NHRC that may be relevant to proposed research
p.000003: under review.
...
p.000018: participant attributable to participation in the research.
p.000018:
p.000018: 4. Informed Consent Process
p.000018: 4.1 A full description of the process for obtaining informed consent, and detailed identification of person(s)
p.000018: responsible for obtaining the informed consent.
p.000018: 4.2 Clear justification for the intention to include in the research participants who cannot provide
p.000018: consent, and a full account of the arrangements for obtaining consent or authorization for the participation of
p.000018: such individuals.
p.000018: 4.3 Assurances that research participants will receive information that becomes available during the course of the
p.000018: research relevant to their participation.
p.000018: 4.4 The provisions made for receiving and responding to queries and complaints from research participants or
p.000018: their representatives during the course of the research project.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: 5. Community Considerations
p.000019: 5.1 The impact and relevance of the research to the local community and concerned
p.000019: communities from which research participants are to be drawn.
p.000019: 5.2 The steps taken for consultation with concerned communities regarding the research procedure.
p.000019: 5.3 The influence of community on the consent of individuals.
p.000019: 5.4 The extent to which the research contributes to capacity building, such as the enhancement
p.000019: of local healthcare, research, and the ability to respond to public health needs.
p.000019:
p.000019: 6. Expedited Review
p.000019: 6.1 For expedited review, the IRC should establish
p.000019: 6.1.1 Procedures for the expedited review of research involving minimal risks to participants. These
p.000019: procedures should specify the following:
p.000019: 6.1.2 The nature of the applications, amendments and other considerations that will be eligible for
p.000019: expedited review.
p.000019: 6.1.3 The types of research to which an expedited review procedure is to apply.
p.000019: 6.1.4 The scope of the Member-Secretary's authority.
p.000019: 6.1.5 The delegation of tasks to sub-committees.
p.000019: 6.1.6 The quorum requirement for expedited review.
p.000019: 6.1.7 The status of decisions (e.g. subject to confirmation by the full IRC or not).
p.000019: 6.1.8 The method of reporting and ratifying decisions by the full Committee.
p.000019: 6.2 Research with potential for physical or psychological harm should generally not be considered for
p.000019: expedited review. This includes drug trials, research involving invasive physical procedures and
...
p.000032: 32
p.000032:
p.000032: after all appropriate information has been given about the research project, its objectives, potential
p.000032: benefits, risks and inconveniences, and of the subject's rights and responsibilities in accordance with the
p.000032: current revision of the Declaration of Helsinki (see Appendix 1).
p.000032:
p.000032: Inspection
p.000032: The act by a regulatory authority (/ies) of conducting an official review of documents, facilities, records, and
p.000032: any other resources that are deemed by the authority (/ies) to be related to the clinical trial/study and that may
p.000032: be located at the site of the trial/study, at the sponsor's and/or contract research organization's facilities, or
p.000032: at other establishments deemed appropriate by the regulatory authority (/ies).
p.000032:
p.000032: Institution
p.000032: Any public or private entity or agency or medical or health facility where study/clinical trials are conducted.
p.000032:
p.000032: Institutional Review Committee (IRC)
p.000032: An independent body comprised of medical, scientific and non-medical members, whose responsibility is to ensure the
p.000032: protection of the rights, safety, and well-being of human participants participating in a particular research project,
p.000032: and to consider general health research ethics, thereby providing public reassurance. It should be
p.000032: constituted and operated so that its tasks can be executed free from bias and from any influence of those who are
p.000032: conducting health research in the respective institution.
p.000032:
p.000032: Investigator
p.000032: A duly qualified member of the respective institution can function as an investigator. He or she should be
p.000032: responsible for the conduct of a research project and for the rights, health and welfare of the research
p.000032: participants. The investigator should have qualifications and competence in accordance with
p.000032: national laws and regulations as evidenced by up-to-date curriculum vitae and other credentials. A person
p.000032: who has
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: an academic degree in relevant biomedical or health-related subjects and other necessary professional credentials could
p.000033: be an investigator for a research project.
p.000033:
p.000033: IRC Approval
p.000033: A decision by the IRC that the proposal has been reviewed and may be conducted at an institution in accordance with the
p.000033: conditions set forth by the IRC.
p.000033:
p.000033: Minimum Risk
p.000033: When the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
p.000033: themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000033: psychological examinations or tests.
p.000033:
p.000033: Personal Data
p.000033: Data that relate to a living person and contain personally identifying information.
p.000033:
p.000033: Principal Investigator (PI)
p.000033: The main researcher responsible for the overall execution of a particular research project.
p.000033:
p.000033: Privacy
...
Searching for indicator substance:
(return to top)
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
...
Health / Healthy People
Searching for indicator healthy volunteers:
(return to top)
p.000027: participant (s), investigator(s), monitor, and, in some cases, data analyst(s), being unaware of the treatment
p.000027: assignment(s).
p.000027:
p.000027: Clinical Investigation
p.000027: Any experiment in which a drug/vaccine is administered, dispensed or otherwise used, involving a required number of
p.000027: research participants. For the purposes of this document, an experiment is any use of a drug/vaccine
p.000027: except for the use of a marketed drug/vaccine in the course of medical practice.
p.000027:
p.000027: Clinical Trial
p.000027: A systematic study involvinga pharmaceutical product or biomedical devicewithresearch participants in order to
p.000027: discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to
p.000027: study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining
p.000027: their efficacy and safety. Clinical trials are generally classified into Phases I to IV. It is not possible to draw
p.000027: distinct lines between the phases, and diverging opinions about details and methodology do exist. A brief
p.000027: description of the individual phases, based on their purposes as related to the clinical development of a
p.000027: pharmaceutical product or device, is given below:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: Phase I: These are the first trials of a new active ingredient or new formulations or device in human beings, often
p.000028: carried out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000028: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000028: humans, or sensitivity or specificity of a device.
p.000028:
p.000028: Phase II: These trials are performed in a limited number of human participants and are often of a comparative
p.000028: (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and to assess
p.000028: short-term safety of the active ingredient or device in patients suffering from a disease or condition for which the
p.000028: active ingredient or device is intended. This phase also aims at the determination of appropriate dose ranges
p.000028: or regimens or exposure to a device and (if possible) clarification of dose-response or
p.000028: device-response relationships in order to provide an optimal background for the design of extensive therapeutic trials.
p.000028:
p.000028: Phase III: Trials in larger (and possibly varied) patient groups with th e purpose of determining the short and
p.000028: long-term safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall and
p.000028: relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated and special
p.000028: features of the product or device must be explored (e.g. clinically relevant drug interactions, factors leading to
p.000028: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
...
Searching for indicator volunteers:
(return to top)
p.000023: measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
p.000023: 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best
p.000023: proven diagnostic and therapeutic method.
p.000023: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
p.000023: proposal should be stated in the experimental protocol for transmission to the independent committee (1,2).
p.000023: 6. The physician can combine medical research with professional care, the objective being the acquisition of
p.000023: new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic
p.000023: value for the patient.
p.000023:
p.000023: III. Non-therapeutic Biomedical Research involving Human Subjects (Non-clinical Biomedical Researc)
p.000023: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000023: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000023: out.
p.000023: 2. The subjects should be volunteers - either healthy persons or a patient for whom the experimental
p.000023: design is not related to the patient's illness.
p.000023: 3. The investigator or the investigating team should discontinue the research if in his/her or their
p.000023: judgment it may, if continued, be harmful to the individual.
p.000023: 4. In research on man, the interest of science and society should never take precedence over considerations related
p.000023: to the well-being of the subject.
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: **Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and amended by the 29th World
p.000024: Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983 and the
p.000024: 41st World Medical Assembly, Hong Kong, September 1989. World Medical Association, Handbook of
p.000024: declarations, Ferney- Voltaire 1992 (unpublished document; available on request from the World Medical Association, 28
p.000024: avenue des Alpes, 01210 Ferney- Voltaire, France). [Internet address:
p.000024: http://www.wma.net/]
p.000024:
p.000024: 18. Bibliography
p.000024: Belmont Report: Ethical Principles and guidelines for the Protection of Human Subjects of Research
p.000024:
p.000024: Council of International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO),
p.000024: International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993
p.000024:
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
p.000018: 3.9 The provisions for compensation/treatment in the case of the injury/disability/death of a research
p.000018: participant attributable to participation in the research.
p.000018:
p.000018: 4. Informed Consent Process
p.000018: 4.1 A full description of the process for obtaining informed consent, and detailed identification of person(s)
p.000018: responsible for obtaining the informed consent.
p.000018: 4.2 Clear justification for the intention to include in the research participants who cannot provide
p.000018: consent, and a full account of the arrangements for obtaining consent or authorization for the participation of
p.000018: such individuals.
p.000018: 4.3 Assurances that research participants will receive information that becomes available during the course of the
p.000018: research relevant to their participation.
p.000018: 4.4 The provisions made for receiving and responding to queries and complaints from research participants or
p.000018: their representatives during the course of the research project.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: 5. Community Considerations
p.000019: 5.1 The impact and relevance of the research to the local community and concerned
p.000019: communities from which research participants are to be drawn.
p.000019: 5.2 The steps taken for consultation with concerned communities regarding the research procedure.
p.000019: 5.3 The influence of community on the consent of individuals.
...
p.000035: A person who engages in the methodical and systematic investigation of any health study with the goal of contributing
p.000035: to new knowledge.
p.000035:
p.000035: Research Participant
p.000035: An individual who is or becomes a participant in research, either as a recipient of the test article [investigational
p.000035: product(s)] or as a control. A participant may be either a healthy individual or a patient.
p.000035:
p.000035: Revision
p.000035: Requirement by the IRC to alter the protocol in some way prior to approval or additional review by the
p.000035: committee.
p.000035:
p.000035: Risk
p.000035: Risks include physical risks (such as the possibility of having an allergic reaction), psychological risks (such as
p.000035: the possibility of emotional distress), social risks (such as the possibility of embarrassment or ridicule
p.000035: by peers), legal risks (such as the possibility of being sued because of information shared with the
p.000035: researcher), and economic risks (such as the possibility of being fired from one's job for sharing information with
p.000035: the researcher). Higher risk-levels are acceptable only when there are greater potential benefits (such as in cancer
p.000035: research).
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Serious Adverse Event (SAE)
p.000036: Any untoward medical occurrence that, at any dose:
p.000036: • results in death
p.000036: • is life-threatening
p.000036: • requires inpatient hospitalization or prolongation of existing hospitalization
p.000036: • results in persistent or significant disability/incapacity or
p.000036: • is a congenital anomaly/birth defect
p.000036: • results in important medical events that may not be immediately life-threatening or cause death or
p.000036: hospitalization, but may jeopardize the patient or may require intervention to prevent the afore mentioned outcomes
p.000036:
p.000036: Source Data
p.000036: All information in original records and certified copies of original records of clinical findings,
p.000036: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000036: Source data are contained in source documents (original records or certified copies)
p.000036:
p.000036: Source Documents
p.000036: Original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda,
p.000036: participant's diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated
p.000036: instruments, copies or transcriptions certified after verification as being accurate copies,
p.000036: microfiches, photographic negatives, microfilm, magnetic media, X-rays, participant files, and records kept
p.000036: at the study laboratories, pharmacies, and medico-technical departments involved in the study.
p.000036:
p.000036: Sponsor
p.000036: An individual, company, institution, or organization which takes responsibility for the initiation,
p.000036: management, and/or financing of a research study.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: Standard Operating Procedure (SOP)
p.000037: A detailed, written instruction to achieve uniformity of performance of a specific function.
p.000037:
p.000037: Study Report
p.000037: A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000037: participants, in which the clinical and statistical description, presentations, and analyses are fully
p.000037: integrated into a single report.
p.000037:
p.000037: Study Site
p.000037: The location(s) where study-related activities are conducted.
p.000037:
p.000037: Supervision and Monitoring
p.000037: An officially conducted procedure (i.e. review of the conduct of certain research), either by an independent IRC
p.000037: team or jointly with the national ERB (if necessary) at the site of investigation.
p.000037:
p.000037: Unexpected ADR
p.000037: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.
p.000037: investigator's brochure for an unapproved investigational product or package insert/summary of characteristics of an
p.000037: approved product)
p.000037:
p.000037: Verification (Validation) of Data
p.000037: The procedures carried out to ensure that the data contained in the final report match original observations. These
p.000037: procedures may apply to raw data or data in case-report forms (in hard copy or electronic form), computer
p.000037: printouts, statistical analyses and tables.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Voluntary
p.000038: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted, or suggested by another;
p.000038: (2) free of coercion, duress, or undue inducement. Used in the health and disability care and research contexts to
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000037: team or jointly with the national ERB (if necessary) at the site of investigation.
p.000037:
p.000037: Unexpected ADR
p.000037: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.
p.000037: investigator's brochure for an unapproved investigational product or package insert/summary of characteristics of an
p.000037: approved product)
p.000037:
p.000037: Verification (Validation) of Data
p.000037: The procedures carried out to ensure that the data contained in the final report match original observations. These
p.000037: procedures may apply to raw data or data in case-report forms (in hard copy or electronic form), computer
p.000037: printouts, statistical analyses and tables.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Voluntary
p.000038: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted, or suggested by another;
p.000038: (2) free of coercion, duress, or undue inducement. Used in the health and disability care and research contexts to
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
p.000039: Fax : +977 1 4262469
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
p.000023: 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best
p.000023: proven diagnostic and therapeutic method.
p.000023: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
p.000023: proposal should be stated in the experimental protocol for transmission to the independent committee (1,2).
p.000023: 6. The physician can combine medical research with professional care, the objective being the acquisition of
p.000023: new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic
p.000023: value for the patient.
p.000023:
p.000023: III. Non-therapeutic Biomedical Research involving Human Subjects (Non-clinical Biomedical Researc)
p.000023: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000023: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000023: out.
p.000023: 2. The subjects should be volunteers - either healthy persons or a patient for whom the experimental
p.000023: design is not related to the patient's illness.
p.000023: 3. The investigator or the investigating team should discontinue the research if in his/her or their
p.000023: judgment it may, if continued, be harmful to the individual.
p.000023: 4. In research on man, the interest of science and society should never take precedence over considerations related
p.000023: to the well-being of the subject.
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: **Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and amended by the 29th World
p.000024: Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983 and the
p.000024: 41st World Medical Assembly, Hong Kong, September 1989. World Medical Association, Handbook of
p.000024: declarations, Ferney- Voltaire 1992 (unpublished document; available on request from the World Medical Association, 28
p.000024: avenue des Alpes, 01210 Ferney- Voltaire, France). [Internet address:
p.000024: http://www.wma.net/]
p.000024:
p.000024: 18. Bibliography
p.000024: Belmont Report: Ethical Principles and guidelines for the Protection of Human Subjects of Research
p.000024:
p.000024: Council of International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO),
p.000024: International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993
p.000024:
p.000024: Declaration of Helsinki (Available at http://www.wma.net / en / 30 publications /10policies / b3 / index.html,
p.000024: accessed 05 October 2011)
p.000024:
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.000022: that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is
p.000022: completely independent of this official relationship.
p.000022: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000022: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
p.000022: in accordance with national legislation. Whenever the minor child is in fact able to give consent, the minor's consent
p.000022: must be obtained in addition to the consent of the minor's legal guardian.
p.000022: 12. The research protocol should always contain a statement of the ethical considerations involved and should
p.000022: indicate that the principles enunciated in the present Declaration are complied with.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: II. Medical Research Combined with Clinical Care (Clinical Research)
p.000023: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic
p.000023: measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
p.000023: 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best
p.000023: proven diagnostic and therapeutic method.
p.000023: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
p.000023: proposal should be stated in the experimental protocol for transmission to the independent committee (1,2).
p.000023: 6. The physician can combine medical research with professional care, the objective being the acquisition of
p.000023: new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic
p.000023: value for the patient.
p.000023:
p.000023: III. Non-therapeutic Biomedical Research involving Human Subjects (Non-clinical Biomedical Researc)
p.000023: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000023: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000023: out.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
p.000039: Fax : +977 1 4262469
...
Health / ill
Searching for indicator ill:
(return to top)
p.000007: informed consent should be signed by the participant or a witness. The participant should be allowed to
p.000007: withdraw from the research at any time without explanation.
p.000007: • There should be adequate provisions to protect the privacy of participants and maintain confidentiality of
p.000007: data.
p.000007: • The research plan should make adequate provisions for monitoring during data collection to ensure the safety
p.000007: of participants. The mechanism for compensation in case of injury should be well documented.
p.000007: • The expected duration of research should be specified prior to approval. In case of amendments, prior
p.000007: approval needs to be given befor implimentation of amended research activities.
p.000007: • The IRC should receive periodic and final reports from researchers, a copy of which need to be submitted to NHRC’s
p.000007: ERB.
p.000007:
p.000007: Expedited Review: Most projects will require formal review by the full IRC, but there may be some studies that
p.000007: do not pose any ethical problems (“ethically minor” investigations), where there is minimum risk of distress or
p.000007: injury, be it physical or psychological, to the human participants. This includes outbreak studies,
p.000007: assessments of patient information and education. Such projects may not require review by the full committee.
p.000007: Similarly, under exceptional circumstances of urgency (e.g. a patient with some rare or ill understood condition,
p.000007: epidemics, etc.) the Member–Secretary, in consultation with other IRC members, may give expedited approval. However,
p.000007: the Member-Secretary has the duty to report these approvals to the Chairperson of the IRC at the next meeting of the
p.000007: committee. In the case of any confusion, an application should be reviewed by the full committee.
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: The IRC may also use the expedited review procedure to review minor changes in previously approved research during the
p.000008: period covered by the original approval. In such cases, the reviewer(s) may exercise all authority of the IRC except
p.000008: disapproval of the proposal. Research may only be disapproved following review by the full committee (Appendix I).
p.000008:
p.000008: Decisions should only be made by a meeting of the IRC that satisfies quorum requirement. All relevant documents
p.000008: must be considered before a decision is made.
p.000008:
p.000008: Conduct of Meetings: Meetings should be held on a regular basis at a convenient time and place. The frequency of
p.000008: meetings shall depend on the number of applications that need reviewing. The number of agenda items should be
p.000008: reasonable so that sufficient time can be given to each item for proper discussion. Members should have had sufficient
p.000008: time to peruse the applications prior to the meeting. The principal reviewers in particular should have had
p.000008: adequate time to review the applications assigned to them, and to consult with applicants if necessary.
p.000008:
p.000008: Depending upon the nature of the research proposal, the IRC can invite the applicant to present the proposal to the
...
Health / visual impairment
Searching for indicator blind:
(return to top)
p.000028: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000028: humans, or sensitivity or specificity of a device.
p.000028:
p.000028: Phase II: These trials are performed in a limited number of human participants and are often of a comparative
p.000028: (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and to assess
p.000028: short-term safety of the active ingredient or device in patients suffering from a disease or condition for which the
p.000028: active ingredient or device is intended. This phase also aims at the determination of appropriate dose ranges
p.000028: or regimens or exposure to a device and (if possible) clarification of dose-response or
p.000028: device-response relationships in order to provide an optimal background for the design of extensive therapeutic trials.
p.000028:
p.000028: Phase III: Trials in larger (and possibly varied) patient groups with th e purpose of determining the short and
p.000028: long-term safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall and
p.000028: relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated and special
p.000028: features of the product or device must be explored (e.g. clinically relevant drug interactions, factors leading to
p.000028: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000028: designs may be acceptable, e.g. long-term safety studies. Generally, the conditions under which these
p.000028: trials are carried out should be as close as possible to normal conditions of use.
p.000028:
p.000028: Phase IV: Studies performed after marketing of the pharmaceutical product or device. Trials in phase IV are
p.000028: carried out on the basis of the product or device characteristics on which the marketing authorization was granted
p.000028: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value
p.000028: or treatment strategies or sensitivity or specificity of a device. Although methods may differ, these
p.000028: studies should use the same scientific and ethical standards as applied in pre-marketing studies.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: After a product or device has been placed on the market, clinical trials designed to explore new indications, new
p.000029: methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical
p.000029: products or devices.
p.000029:
p.000029: Community
p.000029: A community is a group of people understood as having a certain identity due to the sharing of common
p.000029: interests or to a shared proximity. A community may be identified as a group of people living in the same village,
p.000029: town, or country and, thus, sharing geographically proximity. A community may be otherwise identified as a group of
p.000029: people sharing a common set of values, a common set of interests, or a common disease.
p.000029:
p.000029: Comparator Product
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000012:
p.000012: Any research participants involved in a research project have the right to raise complaints or concerns directly either
p.000012: to the chairperson of the IRC or head the institution. In case of an appeal to the IRC by a research
p.000012: participant, the IRC should determine the validity of the complaint and notify the principal investigator
p.000012: of its judgment in the matter. The latter will abide by the decision of the IRC.
p.000012:
p.000012: 13. Recording & Reporting / Documentation & Archiving
p.000012: The following should constitute the recording and reporting procedure:
p.000012: • Copies should be kept of all research proposals reviewed, scientific evaluations (if any) that accompany
p.000012: proposals, approved sample consent documents, progress reports and other related documents.
p.000012: • Minutes of meetings.
p.000012: • Records of continuing review activities.
p.000012: • Copies of all correspondence between the IRC and researchers
p.000012: • A list of all members, reviewers and experts, including their contact details.
p.000012: • Records should be kept for at least 5 years even after completion of the research study. The records shall be
p.000012: accessible for inspection and copying by authorized representatives of relevant institutions.
p.000012:
p.000012: The following will constitute the documentation and archiving procedure: All documentation and
p.000012: communication of the IRC should be dated, filed and archived according to written procedures. Proper storage
p.000012: space should be provided for this by the parent institution. A statement is required defining the access and
p.000012: retrieval procedure (including authorized persons) for the various documents and files kept in archive.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Documents that should be filed and archived include, but are not limited to:
p.000013: • The constitution, written SOP of the IRC, and regular (monthly/annual) reports
p.000013: • The CVs of all IRC members
p.000013: • A record of all expenses (including allowances and reimbursements) of the IRC
p.000013: • Agendas of IRC meetings
p.000013: • The minutes of IRC meetings
p.000013: • Copies of all research proposal documents
p.000013: • Copies of all correspondence of the IRC
p.000013: • A copy of all decisions and advice given by the IRC
p.000013: • Notification notices of the completion, premature suspension or termination of all research proposals
p.000013: commenced
p.000013: • The final summary or final report of all research studies approved by the IRC
p.000013:
p.000013: 14. IRC's Relationship with NHRC
p.000013: IRCs must receive approval from the ERB of NHRC to be established, by paying Rs. 5000 (five thousand only) as a
p.000013: one-time processing fee to the NHRC. The IRC approval should be renewd every three year from ERB of NHRC. At renewal
p.000013: time, the IRC must pay Rs. 1000 (one thousand only) as a renewal processing fee. The processing fee and renewal fee
p.000013: will not be refundable. If the renewal process is not commenced within 6 months of expiry date, the IRC will
p.000013: be notified for termination of approval. An IRC should inform the ERB of NHRC if there are any changes in its
p.000013: composition.
p.000013:
p.000013: All approved IRCs should display their approval status from the NHRC prominently in their letter pads. Their decisions
...
p.000029: products or devices.
p.000029:
p.000029: Community
p.000029: A community is a group of people understood as having a certain identity due to the sharing of common
p.000029: interests or to a shared proximity. A community may be identified as a group of people living in the same village,
p.000029: town, or country and, thus, sharing geographically proximity. A community may be otherwise identified as a group of
p.000029: people sharing a common set of values, a common set of interests, or a common disease.
p.000029:
p.000029: Comparator Product
p.000029: A pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trial.
p.000029:
p.000029: Compensation
p.000029: That which is given in recompense, as an equivalent rendered, or remuneration.
p.000029:
p.000029: Compliance
p.000029: Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.
p.000029:
p.000029: Consent Form
p.000029: An easily understandable written document that documents a potential participant’s consent to be involved in research
p.000029: and which describes the rights of an enrolled research participant. This form should communicate the following
p.000029: in a clear and respectful manner: research time-frame; title of research; researchers involved; purpose
p.000029: of research; description of research; potential harms and benefits; treatment alternatives; statement
p.000029: of confidentiality; information and data to be collected; how long the data will be kept, how it will be stored and
p.000029: who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000029: participation at
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: any point; and declarative statement of understanding that the potential participant agrees to and signs. The
p.000030: consent form should be in a language that the potential participant understands. For potential participants
p.000030: with limited literacy, the verbal communication of the consent document details should be provided along
p.000030: with proper documentation of consent, if it be given.
p.000030:
p.000030: Confidentiality
p.000030: Maintenance of the privacy of research participants including their personal identity and all personal
p.000030: information.
p.000030:
p.000030: Conflict of Interests
p.000030: A conflict of interest arises when a member (or members) of the IRC holds interests with respect to specific proposals
p.000030: for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the
p.000030: research focused on the protection of the research participant. Conflict of interests may arise when an IRC member(s)
p.000030: has financial, material, institutional, or social ties to the research.
p.000030:
p.000030: Contract
p.000030: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements
p.000030: regarding delegation and distribution of tasks and obligations and, if appropriate, financial matters. The
p.000030: protocol may serve as the basis of a contract.
p.000030:
p.000030: Decision
p.000030: The response given by the IRC to the research proposal following review, which may be either positive or
p.000030: negative.
p.000030:
p.000030: Direct Access
p.000030: Permission to examine, analyzes, verify, and reproduce any records and reports that are important to evaluation of a
p.000030: clinical trial. Any party (e.g. domestic and foreign regulatory authorities, sponsor's monitors or auditors) with
p.000030: direct access should take all reasonable precautions within the constraints of the applicable regulatory
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: requirement(s) to maintain the confidentiality of participants' identities and the sponsor's proprietary information.
p.000031:
p.000031: Documentation
p.000031: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical
p.000031: records, and scans, x-rays, and electrocardiograms) that describe or record the methods,
p.000031: conduct, and/or results of a trial/study, the factors affecting a study/trial, and the actions taken.
p.000031:
p.000031: Ethical Guidelines
p.000031: Guidance documents which assist with decisions relating to the responsibility to adhere to established and
p.000031: relevant standards of ethical principles and practice.
p.000031:
p.000031: Expedited Review
p.000031: Review of proposed research by the IRC Member Secretary or a designated voting member or group of voting
p.000031: members rather than by the entire IRC.
p.000031:
p.000031: Good Clinical Practice (GCP)
p.000031: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical
p.000031: trials/study that provides assurance that the data and reported results are credible and accurate, and that the
p.000031: rights, integrity, and confidentiality of trial/study participants are protected.
p.000031:
p.000031: ID
p.000031: A unique identifier assigned by the investigator to each study/trial participant to protect the participant's
p.000031: identify and used in lieu of the participant's name when the investigator reports adverse events and/or other
p.000031: study/trial-related data.
...
Social / Age
Searching for indicator age:
(return to top)
p.000003: under review.
p.000003: • As an IRC may review different types of health-related research, it should be familiar with the different
p.000003: methodologies and ethical considerations that apply to each type of proposed research. As such, a clear
p.000003: procedure needs to be established for the effective review of health-related research proposals.
p.000003: • The IRC should also develop and establish a mechanism to train its members in order to maintain a high ethical and
p.000003: scientific standard.
p.000003: • The IRC must be supplied with administrative and financial support from the institute.
p.000003: • The IRC should outline a clear registration process and fee for reviewing a research proposal.
p.000003:
p.000003: 5. Formation of IRC
p.000003: Composition of IRC
p.000003: Each health institution shall set up a mechanism for the establishment of an IRC and for the selection of members to
p.000003: the IRC. The IRC should be multidisciplinary and pluralistic. The chief executive officer or head of the institution
p.000003: should not be the member of any IRC. The IRC should have the freedom to work independently and decide on the merits of
p.000003: research-related proposals without interference from within the institutional framework.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: The number of members in the committee shall, in general, depend on the number of fields from which they will
p.000004: be drawn. However, a minimum of 7 to a maximum of 15 is suggested, with an attention to gender, age and discipline
p.000004: balance. The committee should include at least one member who is not affiliated with the institution. If any IRC
p.000004: includes a member from NHRC, the member from NHRC should not be a voting member of the IRC.
p.000004:
p.000004: Persons with expertise in the following disciplines will be eligible for IRC membership:
p.000004:
p.000004: • Public health/epidemiology/research methodology
p.000004: • Biomedical/laboratory science
p.000004: • Clinical science
p.000004: • Nursing
p.000004: • Behavioral and social sciences
p.000004: • Biostatistics
p.000004: • Pharmacy/Pharmacologist
p.000004: • Law/ Teaching/ Journalism/ Community Leadership
p.000004:
p.000004: Appointment of IRC Members
p.000004: A clear procedure for recruiting potential IRC members should be established. IRC members should be
p.000004: appointed by the institutional authority. The selection process should be transparent. There should not be any
p.000004: conflicts of interest while making appointments. Only the chairperson should be appointed by the head of the
p.000004: institution. Other members including member-secretary, will be appointed by the chairperson. Member
p.000004: composition should include a balance of gender. The initial orientation, training requirements and means of continuing
p.000004: education of IRC members should be specified. Provisions should be made to appoint an expert consultant on an ad-hoc
p.000004: basis to the IRC, but the consultant should not be considered as a voting member of the IRC.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
...
p.000017: 17. Appendixes Appendix – I
p.000017: Elements of Ethical Review by the IRC
p.000017: The primary task of the IRC is to review research proposals and their supporting documents, with special attention
p.000017: given to the informed consent process, documentation, and the suitability and feasibility of the protocol. The IRC
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
p.000017: 2.2 The characteristics of the populations from which research participants will be drawn (including
p.000017: gender, age, and economic status). Be aware of any potential vulnerable populations in the study including women,
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
p.000018: 3.9 The provisions for compensation/treatment in the case of the injury/disability/death of a research
...
p.000028: carried out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000028: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000028: humans, or sensitivity or specificity of a device.
p.000028:
p.000028: Phase II: These trials are performed in a limited number of human participants and are often of a comparative
p.000028: (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and to assess
p.000028: short-term safety of the active ingredient or device in patients suffering from a disease or condition for which the
p.000028: active ingredient or device is intended. This phase also aims at the determination of appropriate dose ranges
p.000028: or regimens or exposure to a device and (if possible) clarification of dose-response or
p.000028: device-response relationships in order to provide an optimal background for the design of extensive therapeutic trials.
p.000028:
p.000028: Phase III: Trials in larger (and possibly varied) patient groups with th e purpose of determining the short and
p.000028: long-term safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall and
p.000028: relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated and special
p.000028: features of the product or device must be explored (e.g. clinically relevant drug interactions, factors leading to
p.000028: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000028: designs may be acceptable, e.g. long-term safety studies. Generally, the conditions under which these
p.000028: trials are carried out should be as close as possible to normal conditions of use.
p.000028:
p.000028: Phase IV: Studies performed after marketing of the pharmaceutical product or device. Trials in phase IV are
p.000028: carried out on the basis of the product or device characteristics on which the marketing authorization was granted
p.000028: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value
p.000028: or treatment strategies or sensitivity or specificity of a device. Although methods may differ, these
p.000028: studies should use the same scientific and ethical standards as applied in pre-marketing studies.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: After a product or device has been placed on the market, clinical trials designed to explore new indications, new
p.000029: methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical
p.000029: products or devices.
p.000029:
p.000029: Community
p.000029: A community is a group of people understood as having a certain identity due to the sharing of common
p.000029: interests or to a shared proximity. A community may be identified as a group of people living in the same village,
p.000029: town, or country and, thus, sharing geographically proximity. A community may be otherwise identified as a group of
p.000029: people sharing a common set of values, a common set of interests, or a common disease.
p.000029:
p.000029: Comparator Product
...
Social / Child
Searching for indicator child:
(return to top)
p.000022: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000022: his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed
p.000022: consent, preferably in writing.
p.000022: 10 When obtaining informed consent for the research project the physician should be particularly
p.000022: cautious if the subject is in a dependent relationship to him or her or may consent under duress. In
p.000022: that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is
p.000022: completely independent of this official relationship.
p.000022: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000022: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
p.000022: in accordance with national legislation. Whenever the minor child is in fact able to give consent, the minor's consent
p.000022: must be obtained in addition to the consent of the minor's legal guardian.
p.000022: 12. The research protocol should always contain a statement of the ethical considerations involved and should
p.000022: indicate that the principles enunciated in the present Declaration are complied with.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: II. Medical Research Combined with Clinical Care (Clinical Research)
p.000023: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic
p.000023: measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
p.000023: 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best
p.000023: proven diagnostic and therapeutic method.
p.000023: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
...
Searching for indicator children:
(return to top)
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
p.000017: 2.2 The characteristics of the populations from which research participants will be drawn (including
p.000017: gender, age, and economic status). Be aware of any potential vulnerable populations in the study including women,
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
p.000018: 3.9 The provisions for compensation/treatment in the case of the injury/disability/death of a research
p.000018: participant attributable to participation in the research.
p.000018:
p.000018: 4. Informed Consent Process
...
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
p.000039: Fax : +977 1 4262469
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
p.000017: 2.2 The characteristics of the populations from which research participants will be drawn (including
p.000017: gender, age, and economic status). Be aware of any potential vulnerable populations in the study including women,
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
p.000018: 3.9 The provisions for compensation/treatment in the case of the injury/disability/death of a research
p.000018: participant attributable to participation in the research.
p.000018:
p.000018: 4. Informed Consent Process
p.000018: 4.1 A full description of the process for obtaining informed consent, and detailed identification of person(s)
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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 / Incarcerated
Searching for indicator liberty:
(return to top)
p.000021: objective is in proportion to the inherent risk to the subject.
p.000021: 5. Every biomedical research project involving human subjects should be preceded by careful assessment of
p.000021: predicable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of
p.000021: the subject must always prevail over the interests of science and society.
p.000021:
p.000021:
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: 6. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution
p.000022: should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical
p.000022: and mental integrity and on the personality of the subject.
p.000022: 7. Physicians should abstain from engaging in research projects involving human subjects unless they
p.000022: are satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000022: investigation if the hazards are found to outweigh the potential benefits.
p.000022: 8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy
p.000022: of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration
p.000022: should not be accepted for publication.
p.000022: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000022: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000022: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000022: his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed
p.000022: consent, preferably in writing.
p.000022: 10 When obtaining informed consent for the research project the physician should be particularly
p.000022: cautious if the subject is in a dependent relationship to him or her or may consent under duress. In
p.000022: that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is
p.000022: completely independent of this official relationship.
p.000022: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000022: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000006: The IRC should provide independent, competent and timely reviews of the ethical aspects of research proposals. The IRC
p.000006: may decide upon the reviewer(s) involved for each proposal. Depending on the nature of the research proposal, it may be
p.000006: reviewed by more than one reviewer. A scoring checklist or format needs to be developed and made available to
p.000006: reviewers in order to maintain consistency and objectivity of the review process.
p.000006:
p.000006: If only a few proposals (two to three) need to be reviewed at a time, it would be advisable for all IRC members
p.000006: to review the full set of including all associated documents. If a large number of proposals need to be
p.000006: reviewed at each meeting, one IRC member (principal reviewer) is to undertake an in-depth review
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: including all forms, questionnaires etc., and prepare a summary containing essential details for other members
p.000007: to review.
p.000007:
p.000007: The following ethical issues should be carefully evaluated during the review process:
p.000007:
p.000007: • Potential risk to participants should reasonably be less than anticipated benefits.
p.000007: • Selection of participants should be equitable. If the research involves vulnerable populations, additional
p.000007: safeguards should be included in the research protocol to protect the rights of these people.
p.000007: • Informed consent should be obtained in an appropriate language understandable by the participant. The
p.000007: informed consent should be signed by the participant or a witness. The participant should be allowed to
p.000007: withdraw from the research at any time without explanation.
p.000007: • There should be adequate provisions to protect the privacy of participants and maintain confidentiality of
p.000007: data.
p.000007: • The research plan should make adequate provisions for monitoring during data collection to ensure the safety
p.000007: of participants. The mechanism for compensation in case of injury should be well documented.
p.000007: • The expected duration of research should be specified prior to approval. In case of amendments, prior
p.000007: approval needs to be given befor implimentation of amended research activities.
p.000007: • The IRC should receive periodic and final reports from researchers, a copy of which need to be submitted to NHRC’s
p.000007: ERB.
p.000007:
p.000007: Expedited Review: Most projects will require formal review by the full IRC, but there may be some studies that
p.000007: do not pose any ethical problems (“ethically minor” investigations), where there is minimum risk of distress or
p.000007: injury, be it physical or psychological, to the human participants. This includes outbreak studies,
p.000007: assessments of patient information and education. Such projects may not require review by the full committee.
...
p.000029:
p.000029: Comparator Product
p.000029: A pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trial.
p.000029:
p.000029: Compensation
p.000029: That which is given in recompense, as an equivalent rendered, or remuneration.
p.000029:
p.000029: Compliance
p.000029: Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.
p.000029:
p.000029: Consent Form
p.000029: An easily understandable written document that documents a potential participant’s consent to be involved in research
p.000029: and which describes the rights of an enrolled research participant. This form should communicate the following
p.000029: in a clear and respectful manner: research time-frame; title of research; researchers involved; purpose
p.000029: of research; description of research; potential harms and benefits; treatment alternatives; statement
p.000029: of confidentiality; information and data to be collected; how long the data will be kept, how it will be stored and
p.000029: who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000029: participation at
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: any point; and declarative statement of understanding that the potential participant agrees to and signs. The
p.000030: consent form should be in a language that the potential participant understands. For potential participants
p.000030: with limited literacy, the verbal communication of the consent document details should be provided along
p.000030: with proper documentation of consent, if it be given.
p.000030:
p.000030: Confidentiality
p.000030: Maintenance of the privacy of research participants including their personal identity and all personal
p.000030: information.
p.000030:
p.000030: Conflict of Interests
p.000030: A conflict of interest arises when a member (or members) of the IRC holds interests with respect to specific proposals
p.000030: for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the
p.000030: research focused on the protection of the research participant. Conflict of interests may arise when an IRC member(s)
p.000030: has financial, material, institutional, or social ties to the research.
p.000030:
p.000030: Contract
p.000030: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements
p.000030: regarding delegation and distribution of tasks and obligations and, if appropriate, financial matters. The
p.000030: protocol may serve as the basis of a contract.
p.000030:
p.000030: Decision
p.000030: The response given by the IRC to the research proposal following review, which may be either positive or
p.000030: negative.
p.000030:
p.000030: Direct Access
p.000030: Permission to examine, analyzes, verify, and reproduce any records and reports that are important to evaluation of a
...
Social / Literacy
Searching for indicator literacy:
(return to top)
p.000029:
p.000029: Compensation
p.000029: That which is given in recompense, as an equivalent rendered, or remuneration.
p.000029:
p.000029: Compliance
p.000029: Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.
p.000029:
p.000029: Consent Form
p.000029: An easily understandable written document that documents a potential participant’s consent to be involved in research
p.000029: and which describes the rights of an enrolled research participant. This form should communicate the following
p.000029: in a clear and respectful manner: research time-frame; title of research; researchers involved; purpose
p.000029: of research; description of research; potential harms and benefits; treatment alternatives; statement
p.000029: of confidentiality; information and data to be collected; how long the data will be kept, how it will be stored and
p.000029: who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000029: participation at
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: any point; and declarative statement of understanding that the potential participant agrees to and signs. The
p.000030: consent form should be in a language that the potential participant understands. For potential participants
p.000030: with limited literacy, the verbal communication of the consent document details should be provided along
p.000030: with proper documentation of consent, if it be given.
p.000030:
p.000030: Confidentiality
p.000030: Maintenance of the privacy of research participants including their personal identity and all personal
p.000030: information.
p.000030:
p.000030: Conflict of Interests
p.000030: A conflict of interest arises when a member (or members) of the IRC holds interests with respect to specific proposals
p.000030: for review that may jeopardize his/her (their) ability to provide a free and independent evaluation of the
p.000030: research focused on the protection of the research participant. Conflict of interests may arise when an IRC member(s)
p.000030: has financial, material, institutional, or social ties to the research.
p.000030:
p.000030: Contract
p.000030: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements
p.000030: regarding delegation and distribution of tasks and obligations and, if appropriate, financial matters. The
p.000030: protocol may serve as the basis of a contract.
p.000030:
p.000030: Decision
p.000030: The response given by the IRC to the research proposal following review, which may be either positive or
p.000030: negative.
p.000030:
p.000030: Direct Access
p.000030: Permission to examine, analyzes, verify, and reproduce any records and reports that are important to evaluation of a
p.000030: clinical trial. Any party (e.g. domestic and foreign regulatory authorities, sponsor's monitors or auditors) with
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000026: In the pre-approval clinical experience with a new medicinal product or a product's new usages, particularly as the
p.000026: therapeutic dose(s) may not be established, all harmful and unintended responses to a medicinal product related to
p.000026: any dose should be considered adverse drug reactions.
p.000026:
p.000026: Adverse Event (AE)
p.000026: Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical
p.000026: product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any
p.000026: unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease
p.000026: temporally associated with the use of a medicinal (investigational) product, whether or not related to the
p.000026: medicinal (investigational) product.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: Approval
p.000027: The affirmative decision of the IRC that the study proposal has been reviewed and may be conducted at the
p.000027: institution site within the constraints set forth by the IRC, the institution, good clinical practice (GCP), good
p.000027: laboratory practice (GLP), and the applicable regulatory requirements.
p.000027:
p.000027: Benefit: A favorable consequence arising from a study, for example the demonstration that a drug/vaccine is
p.000027: effective in a randomized controlled trial.
p.000027:
p.000027: Blinding
p.000027: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000027: Single-blinding usually refers to the participant(s) being unaware, and double-blinding usually refers to the
p.000027: participant (s), investigator(s), monitor, and, in some cases, data analyst(s), being unaware of the treatment
p.000027: assignment(s).
p.000027:
p.000027: Clinical Investigation
p.000027: Any experiment in which a drug/vaccine is administered, dispensed or otherwise used, involving a required number of
p.000027: research participants. For the purposes of this document, an experiment is any use of a drug/vaccine
p.000027: except for the use of a marketed drug/vaccine in the course of medical practice.
p.000027:
p.000027: Clinical Trial
p.000027: A systematic study involvinga pharmaceutical product or biomedical devicewithresearch participants in order to
p.000027: discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to
p.000027: study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining
p.000027: their efficacy and safety. Clinical trials are generally classified into Phases I to IV. It is not possible to draw
p.000027: distinct lines between the phases, and diverging opinions about details and methodology do exist. A brief
p.000027: description of the individual phases, based on their purposes as related to the clinical development of a
p.000027: pharmaceutical product or device, is given below:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: Phase I: These are the first trials of a new active ingredient or new formulations or device in human beings, often
...
p.000036:
p.000036: Source Data
p.000036: All information in original records and certified copies of original records of clinical findings,
p.000036: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000036: Source data are contained in source documents (original records or certified copies)
p.000036:
p.000036: Source Documents
p.000036: Original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda,
p.000036: participant's diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated
p.000036: instruments, copies or transcriptions certified after verification as being accurate copies,
p.000036: microfiches, photographic negatives, microfilm, magnetic media, X-rays, participant files, and records kept
p.000036: at the study laboratories, pharmacies, and medico-technical departments involved in the study.
p.000036:
p.000036: Sponsor
p.000036: An individual, company, institution, or organization which takes responsibility for the initiation,
p.000036: management, and/or financing of a research study.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: Standard Operating Procedure (SOP)
p.000037: A detailed, written instruction to achieve uniformity of performance of a specific function.
p.000037:
p.000037: Study Report
p.000037: A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000037: participants, in which the clinical and statistical description, presentations, and analyses are fully
p.000037: integrated into a single report.
p.000037:
p.000037: Study Site
p.000037: The location(s) where study-related activities are conducted.
p.000037:
p.000037: Supervision and Monitoring
p.000037: An officially conducted procedure (i.e. review of the conduct of certain research), either by an independent IRC
p.000037: team or jointly with the national ERB (if necessary) at the site of investigation.
p.000037:
p.000037: Unexpected ADR
p.000037: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.
p.000037: investigator's brochure for an unapproved investigational product or package insert/summary of characteristics of an
p.000037: approved product)
p.000037:
p.000037: Verification (Validation) of Data
p.000037: The procedures carried out to ensure that the data contained in the final report match original observations. These
p.000037: procedures may apply to raw data or data in case-report forms (in hard copy or electronic form), computer
p.000037: printouts, statistical analyses and tables.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Voluntary
p.000038: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted, or suggested by another;
p.000038: (2) free of coercion, duress, or undue inducement. Used in the health and disability care and research contexts to
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000034: include photographic negatives, microfilm or digital media (e.g. computer CD).
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: Reimburse
p.000035: To repay (a sum of money which has been spent or lost).
p.000035:
p.000035: Regulatory Authorities
p.000035: Bodies having the power to regulate. This includes the authorities that review submitted study data and those that
p.000035: conduct inspections.
p.000035:
p.000035: Research
p.000035: A systematic investigation including research development, testing and evaluation, designed to develop or
p.000035: contribute to generalizable knowledge.
p.000035:
p.000035: Researcher
p.000035: A person who engages in the methodical and systematic investigation of any health study with the goal of contributing
p.000035: to new knowledge.
p.000035:
p.000035: Research Participant
p.000035: An individual who is or becomes a participant in research, either as a recipient of the test article [investigational
p.000035: product(s)] or as a control. A participant may be either a healthy individual or a patient.
p.000035:
p.000035: Revision
p.000035: Requirement by the IRC to alter the protocol in some way prior to approval or additional review by the
p.000035: committee.
p.000035:
p.000035: Risk
p.000035: Risks include physical risks (such as the possibility of having an allergic reaction), psychological risks (such as
p.000035: the possibility of emotional distress), social risks (such as the possibility of embarrassment or ridicule
p.000035: by peers), legal risks (such as the possibility of being sued because of information shared with the
p.000035: researcher), and economic risks (such as the possibility of being fired from one's job for sharing information with
p.000035: the researcher). Higher risk-levels are acceptable only when there are greater potential benefits (such as in cancer
p.000035: research).
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Serious Adverse Event (SAE)
p.000036: Any untoward medical occurrence that, at any dose:
p.000036: • results in death
p.000036: • is life-threatening
p.000036: • requires inpatient hospitalization or prolongation of existing hospitalization
p.000036: • results in persistent or significant disability/incapacity or
p.000036: • is a congenital anomaly/birth defect
p.000036: • results in important medical events that may not be immediately life-threatening or cause death or
p.000036: hospitalization, but may jeopardize the patient or may require intervention to prevent the afore mentioned outcomes
p.000036:
p.000036: Source Data
p.000036: All information in original records and certified copies of original records of clinical findings,
p.000036: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000036: Source data are contained in source documents (original records or certified copies)
p.000036:
p.000036: Source Documents
p.000036: Original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda,
p.000036: participant's diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated
p.000036: instruments, copies or transcriptions certified after verification as being accurate copies,
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000003:
p.000003: • It should work within the framework of the highest possible ethical and scientific standards in biomedical
p.000003: research.
p.000003: • It is mandatory that the IRC must be independent, autonomous and multidisciplinary in nature.
p.000003: • A mechanism must be developed to ensure clear and efficient communication, harmonization of
p.000003: standards, networking, and cooperation between the IRC and ERB of NHRC. An IRC may implement its own
p.000003: procedure to interact with other IRCs regarding matters of common interest as necessary. Such interactions enable IRCs
p.000003: to learn about prior decisions by other IRCs or the ERB of NHRC that may be relevant to proposed research
p.000003: under review.
p.000003: • As an IRC may review different types of health-related research, it should be familiar with the different
p.000003: methodologies and ethical considerations that apply to each type of proposed research. As such, a clear
p.000003: procedure needs to be established for the effective review of health-related research proposals.
p.000003: • The IRC should also develop and establish a mechanism to train its members in order to maintain a high ethical and
p.000003: scientific standard.
p.000003: • The IRC must be supplied with administrative and financial support from the institute.
p.000003: • The IRC should outline a clear registration process and fee for reviewing a research proposal.
p.000003:
p.000003: 5. Formation of IRC
p.000003: Composition of IRC
p.000003: Each health institution shall set up a mechanism for the establishment of an IRC and for the selection of members to
p.000003: the IRC. The IRC should be multidisciplinary and pluralistic. The chief executive officer or head of the institution
p.000003: should not be the member of any IRC. The IRC should have the freedom to work independently and decide on the merits of
p.000003: research-related proposals without interference from within the institutional framework.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: The number of members in the committee shall, in general, depend on the number of fields from which they will
p.000004: be drawn. However, a minimum of 7 to a maximum of 15 is suggested, with an attention to gender, age and discipline
p.000004: balance. The committee should include at least one member who is not affiliated with the institution. If any IRC
p.000004: includes a member from NHRC, the member from NHRC should not be a voting member of the IRC.
p.000004:
p.000004: Persons with expertise in the following disciplines will be eligible for IRC membership:
p.000004:
p.000004: • Public health/epidemiology/research methodology
p.000004: • Biomedical/laboratory science
p.000004: • Clinical science
p.000004: • Nursing
p.000004: • Behavioral and social sciences
p.000004: • Biostatistics
p.000004: • Pharmacy/Pharmacologist
p.000004: • Law/ Teaching/ Journalism/ Community Leadership
p.000004:
p.000004: Appointment of IRC Members
p.000004: A clear procedure for recruiting potential IRC members should be established. IRC members should be
p.000004: appointed by the institutional authority. The selection process should be transparent. There should not be any
p.000004: conflicts of interest while making appointments. Only the chairperson should be appointed by the head of the
...
p.000015: violated or cannot be protected as a result of such circumstances, the IRC may be required to take the
p.000015: following steps:
p.000015:
p.000015: • Withdraw approval
p.000015: • Inform the principal investigator of such withdrawal
p.000015: • Recommend the suspension or discontinuation of the research project or, any necessary steps to be undertaken
p.000015: • Make sure that research activities are suspended, stopped or discontinued via the process of withdrawal of
p.000015: ethical approval
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016:
p.000016: 16. Annexes Annex – I
p.000016: Task Force Committee
p.000016: 1. Prof. Dr. Ramesh Kant Adhikari
p.000016: Former Co-odinator, Ethical Review Board, NHRC Ramshah Path, Kathmandu
p.000016: 2. Dr. Khem Bahadur Karki
p.000016: Member-Secretary, Executive Chief, NHRC Ramshah Path, Kathmandu
p.000016: 3. Prof. Dr. Jeevan Bahadur Sherchand
p.000016: Co-odinator, Ethical Review Board, NHRC Ramshah Path, Kathmandu
p.000016: 4. Associate Prof. Dr. Aarati Shah Member
p.000016: Ethical Review Board, NHRC Ramshah Path, Kathmandu
p.000016: 5. Prof. Dr. Rajendra Kumar BC
p.000016: Pokhara University Research Center (PURC) Pokhara University, Kaski
p.000016: 6. Mr. Mohan Krishna Shrestha Tilganga Institute of Ophthalmology, Gaushala, Kathmandu
p.000016: 7. Mr. Purushottam Dhakal
p.000016: Chief, Ethical Review M & E Section, NHRC Ramshah Path, Kathmandu
p.000016: 8. Ms. Namita Ghimire
p.000016: Research Officer, Ethical Review M & E Section, NHRC Ramshah Path, Kathmandu
p.000016: 9. Dr. Krishna Kumar Aryal
p.000016: Research Officer, Research Section, NHRC Ramshah Path, Kathmandu
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 17. Appendixes Appendix – I
p.000017: Elements of Ethical Review by the IRC
p.000017: The primary task of the IRC is to review research proposals and their supporting documents, with special attention
p.000017: given to the informed consent process, documentation, and the suitability and feasibility of the protocol. The IRC
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000005: their current curriculum vitae, and sign for acceptance of the appointment.
p.000005:
p.000005: 6. IRC Office
p.000005: The institution can setup an IRC Office with necessary administrative support. It should clearly designate the
p.000005: Chairperson, Member-Secretary and Members. The list of the name of IRC members should be displayed in front of the IRC
p.000005: office. There should be at least one administrative or clerical support staff provided by the institution for
p.000005: the IRC office otherwise such tasks should be delegated to one of the officers of the institution. Duties &
p.000005: responsibilities of each IRC member should be clearly stated. All working procedures must be in writing; for
p.000005: example, agenda, minutes, notification of decisions, monitoring and supervision etc.
p.000005:
p.000005: 7. Quorum Requirements
p.000005: The presence of at least 51% members of the total number of IRC members shall be deemed to constitute
p.000005: quorum or the meeting of IRC. At least one female member and one legal or non-affiliated member must be
p.000005: present to make decisions about any proposed research. Invited experts/consultants should not be counted in
p.000005: meeting quorum requirement.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: 8. Panel of Experts/Consultants
p.000006: The IRC can prepare a list of potential experts who are capable and interested in reviewing research proposals. These
p.000006: experts/consultants can be specialists in specific diseases, particular health
p.000006: problems/conditions, health systems, health research methodologies, legal or ethical aspects, or members of special
p.000006: interest/minority groups who can provide special expertise to the IRC on proposed research protocols. It is strongly
p.000006: recommended that the IRC should develop terms of reference for all independent consultants.
p.000006:
p.000006: 9. Qualification of IRC Members
p.000006: All IRC members should hold an appropriate educational degree, trainings and research experience in
p.000006: health-related research processes. These members should be given an initial orientation on basic principles of
p.000006: research ethics and the proposal approval process adopted by the IRC. The conditions of appointment to the IRC should
p.000006: state provisions available for IRC members to receive introductory training in the work of the IRC as
p.000006: well as ongoing opportunities for enhancing their capacity for ethical review.
p.000006:
p.000006: 10. Review Process and Communicating a Decision
p.000006: The IRC should provide independent, competent and timely reviews of the ethical aspects of research proposals. The IRC
p.000006: may decide upon the reviewer(s) involved for each proposal. Depending on the nature of the research proposal, it may be
p.000006: reviewed by more than one reviewer. A scoring checklist or format needs to be developed and made available to
p.000006: reviewers in order to maintain consistency and objectivity of the review process.
p.000006:
p.000006: If only a few proposals (two to three) need to be reviewed at a time, it would be advisable for all IRC members
p.000006: to review the full set of including all associated documents. If a large number of proposals need to be
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
p.000039: Fax : +977 1 4262469
...
Social / Women
Searching for indicator women:
(return to top)
p.000017: given to the informed consent process, documentation, and the suitability and feasibility of the protocol. The IRC
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
p.000017: 2.2 The characteristics of the populations from which research participants will be drawn (including
p.000017: gender, age, and economic status). Be aware of any potential vulnerable populations in the study including women,
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
p.000018: 3.9 The provisions for compensation/treatment in the case of the injury/disability/death of a research
p.000018: participant attributable to participation in the research.
p.000018:
p.000018: 4. Informed Consent Process
...
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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:
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: Nepal Health Research Council (NHRC)
p.000039: Ramshah Path, Kathmandu, Nepal Tel : +977 1 4254220
p.000039: Fax : +977 1 4262469
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000007: • Selection of participants should be equitable. If the research involves vulnerable populations, additional
p.000007: safeguards should be included in the research protocol to protect the rights of these people.
p.000007: • Informed consent should be obtained in an appropriate language understandable by the participant. The
p.000007: informed consent should be signed by the participant or a witness. The participant should be allowed to
p.000007: withdraw from the research at any time without explanation.
p.000007: • There should be adequate provisions to protect the privacy of participants and maintain confidentiality of
p.000007: data.
p.000007: • The research plan should make adequate provisions for monitoring during data collection to ensure the safety
p.000007: of participants. The mechanism for compensation in case of injury should be well documented.
p.000007: • The expected duration of research should be specified prior to approval. In case of amendments, prior
p.000007: approval needs to be given befor implimentation of amended research activities.
p.000007: • The IRC should receive periodic and final reports from researchers, a copy of which need to be submitted to NHRC’s
p.000007: ERB.
p.000007:
p.000007: Expedited Review: Most projects will require formal review by the full IRC, but there may be some studies that
p.000007: do not pose any ethical problems (“ethically minor” investigations), where there is minimum risk of distress or
p.000007: injury, be it physical or psychological, to the human participants. This includes outbreak studies,
p.000007: assessments of patient information and education. Such projects may not require review by the full committee.
p.000007: Similarly, under exceptional circumstances of urgency (e.g. a patient with some rare or ill understood condition,
p.000007: epidemics, etc.) the Member–Secretary, in consultation with other IRC members, may give expedited approval. However,
p.000007: the Member-Secretary has the duty to report these approvals to the Chairperson of the IRC at the next meeting of the
p.000007: committee. In the case of any confusion, an application should be reviewed by the full committee.
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: The IRC may also use the expedited review procedure to review minor changes in previously approved research during the
p.000008: period covered by the original approval. In such cases, the reviewer(s) may exercise all authority of the IRC except
p.000008: disapproval of the proposal. Research may only be disapproved following review by the full committee (Appendix I).
p.000008:
p.000008: Decisions should only be made by a meeting of the IRC that satisfies quorum requirement. All relevant documents
p.000008: must be considered before a decision is made.
p.000008:
p.000008: Conduct of Meetings: Meetings should be held on a regular basis at a convenient time and place. The frequency of
p.000008: meetings shall depend on the number of applications that need reviewing. The number of agenda items should be
p.000008: reasonable so that sufficient time can be given to each item for proper discussion. Members should have had sufficient
p.000008: time to peruse the applications prior to the meeting. The principal reviewers in particular should have had
p.000008: adequate time to review the applications assigned to them, and to consult with applicants if necessary.
p.000008:
p.000008: Depending upon the nature of the research proposal, the IRC can invite the applicant to present the proposal to the
p.000008: panel of experts and IRC members. This will help the IRC to understand the proposal better and guide the researcher
p.000008: appropriately. This procedure should be followed if an independent (expert) reviewer is invited to advise on any
p.000008: particular topic. Minutes of IRC meetings should be maintained in a confidential manner in a standard format.
p.000008:
p.000008: Conflict of Interest: A conflict of interest is present and interferes with the ability to make an objective
...
p.000022: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000022: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000022: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000022: his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed
p.000022: consent, preferably in writing.
p.000022: 10 When obtaining informed consent for the research project the physician should be particularly
p.000022: cautious if the subject is in a dependent relationship to him or her or may consent under duress. In
p.000022: that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is
p.000022: completely independent of this official relationship.
p.000022: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000022: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
p.000022: in accordance with national legislation. Whenever the minor child is in fact able to give consent, the minor's consent
p.000022: must be obtained in addition to the consent of the minor's legal guardian.
p.000022: 12. The research protocol should always contain a statement of the ethical considerations involved and should
p.000022: indicate that the principles enunciated in the present Declaration are complied with.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: II. Medical Research Combined with Clinical Care (Clinical Research)
p.000023: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic
p.000023: measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
p.000023: 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best
p.000023: proven diagnostic and therapeutic method.
p.000023: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
p.000023: proposal should be stated in the experimental protocol for transmission to the independent committee (1,2).
p.000023: 6. The physician can combine medical research with professional care, the objective being the acquisition of
p.000023: new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic
p.000023: value for the patient.
p.000023:
...
Social / education
Searching for indicator education:
(return to top)
p.000004:
p.000004: The number of members in the committee shall, in general, depend on the number of fields from which they will
p.000004: be drawn. However, a minimum of 7 to a maximum of 15 is suggested, with an attention to gender, age and discipline
p.000004: balance. The committee should include at least one member who is not affiliated with the institution. If any IRC
p.000004: includes a member from NHRC, the member from NHRC should not be a voting member of the IRC.
p.000004:
p.000004: Persons with expertise in the following disciplines will be eligible for IRC membership:
p.000004:
p.000004: • Public health/epidemiology/research methodology
p.000004: • Biomedical/laboratory science
p.000004: • Clinical science
p.000004: • Nursing
p.000004: • Behavioral and social sciences
p.000004: • Biostatistics
p.000004: • Pharmacy/Pharmacologist
p.000004: • Law/ Teaching/ Journalism/ Community Leadership
p.000004:
p.000004: Appointment of IRC Members
p.000004: A clear procedure for recruiting potential IRC members should be established. IRC members should be
p.000004: appointed by the institutional authority. The selection process should be transparent. There should not be any
p.000004: conflicts of interest while making appointments. Only the chairperson should be appointed by the head of the
p.000004: institution. Other members including member-secretary, will be appointed by the chairperson. Member
p.000004: composition should include a balance of gender. The initial orientation, training requirements and means of continuing
p.000004: education of IRC members should be specified. Provisions should be made to appoint an expert consultant on an ad-hoc
p.000004: basis to the IRC, but the consultant should not be considered as a voting member of the IRC.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: Terms and Conditions of Appointment
p.000005: Appointments should be made for tenure of three years, with a provision for re-appointment. A rotational system
p.000005: for membership should be considered that allows for continuity, the development and maintenance of expertise
p.000005: within the IRC, and the regular input of fresh ideas and approaches. Institutions should plan in such away
p.000005: that not more than 50% of the members retire at once, in order to facilite or ensure continuity of the IRC.
p.000005: Procedures for reappointment, resignation, and discontinuation of appointment (such as for non-attendance) should be
p.000005: specified in the respective SOP. Moreover, the duties and responsibilities of the IRC
p.000005: chairperson, member - secretary and members should clearly be stated in the SOP. The IRC members should provide
p.000005: their current curriculum vitae, and sign for acceptance of the appointment.
p.000005:
p.000005: 6. IRC Office
p.000005: The institution can setup an IRC Office with necessary administrative support. It should clearly designate the
p.000005: Chairperson, Member-Secretary and Members. The list of the name of IRC members should be displayed in front of the IRC
p.000005: office. There should be at least one administrative or clerical support staff provided by the institution for
p.000005: the IRC office otherwise such tasks should be delegated to one of the officers of the institution. Duties &
...
p.000007: • Informed consent should be obtained in an appropriate language understandable by the participant. The
p.000007: informed consent should be signed by the participant or a witness. The participant should be allowed to
p.000007: withdraw from the research at any time without explanation.
p.000007: • There should be adequate provisions to protect the privacy of participants and maintain confidentiality of
p.000007: data.
p.000007: • The research plan should make adequate provisions for monitoring during data collection to ensure the safety
p.000007: of participants. The mechanism for compensation in case of injury should be well documented.
p.000007: • The expected duration of research should be specified prior to approval. In case of amendments, prior
p.000007: approval needs to be given befor implimentation of amended research activities.
p.000007: • The IRC should receive periodic and final reports from researchers, a copy of which need to be submitted to NHRC’s
p.000007: ERB.
p.000007:
p.000007: Expedited Review: Most projects will require formal review by the full IRC, but there may be some studies that
p.000007: do not pose any ethical problems (“ethically minor” investigations), where there is minimum risk of distress or
p.000007: injury, be it physical or psychological, to the human participants. This includes outbreak studies,
p.000007: assessments of patient information and education. Such projects may not require review by the full committee.
p.000007: Similarly, under exceptional circumstances of urgency (e.g. a patient with some rare or ill understood condition,
p.000007: epidemics, etc.) the Member–Secretary, in consultation with other IRC members, may give expedited approval. However,
p.000007: the Member-Secretary has the duty to report these approvals to the Chairperson of the IRC at the next meeting of the
p.000007: committee. In the case of any confusion, an application should be reviewed by the full committee.
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: The IRC may also use the expedited review procedure to review minor changes in previously approved research during the
p.000008: period covered by the original approval. In such cases, the reviewer(s) may exercise all authority of the IRC except
p.000008: disapproval of the proposal. Research may only be disapproved following review by the full committee (Appendix I).
p.000008:
p.000008: Decisions should only be made by a meeting of the IRC that satisfies quorum requirement. All relevant documents
p.000008: must be considered before a decision is made.
p.000008:
p.000008: Conduct of Meetings: Meetings should be held on a regular basis at a convenient time and place. The frequency of
p.000008: meetings shall depend on the number of applications that need reviewing. The number of agenda items should be
p.000008: reasonable so that sufficient time can be given to each item for proper discussion. Members should have had sufficient
p.000008: time to peruse the applications prior to the meeting. The principal reviewers in particular should have had
...
p.000037: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.
p.000037: investigator's brochure for an unapproved investigational product or package insert/summary of characteristics of an
p.000037: approved product)
p.000037:
p.000037: Verification (Validation) of Data
p.000037: The procedures carried out to ensure that the data contained in the final report match original observations. These
p.000037: procedures may apply to raw data or data in case-report forms (in hard copy or electronic form), computer
p.000037: printouts, statistical analyses and tables.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Voluntary
p.000038: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted, or suggested by another;
p.000038: (2) free of coercion, duress, or undue inducement. Used in the health and disability care and research contexts to
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
...
Searching for indicator educational:
(return to top)
p.000005: office. There should be at least one administrative or clerical support staff provided by the institution for
p.000005: the IRC office otherwise such tasks should be delegated to one of the officers of the institution. Duties &
p.000005: responsibilities of each IRC member should be clearly stated. All working procedures must be in writing; for
p.000005: example, agenda, minutes, notification of decisions, monitoring and supervision etc.
p.000005:
p.000005: 7. Quorum Requirements
p.000005: The presence of at least 51% members of the total number of IRC members shall be deemed to constitute
p.000005: quorum or the meeting of IRC. At least one female member and one legal or non-affiliated member must be
p.000005: present to make decisions about any proposed research. Invited experts/consultants should not be counted in
p.000005: meeting quorum requirement.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: 8. Panel of Experts/Consultants
p.000006: The IRC can prepare a list of potential experts who are capable and interested in reviewing research proposals. These
p.000006: experts/consultants can be specialists in specific diseases, particular health
p.000006: problems/conditions, health systems, health research methodologies, legal or ethical aspects, or members of special
p.000006: interest/minority groups who can provide special expertise to the IRC on proposed research protocols. It is strongly
p.000006: recommended that the IRC should develop terms of reference for all independent consultants.
p.000006:
p.000006: 9. Qualification of IRC Members
p.000006: All IRC members should hold an appropriate educational degree, trainings and research experience in
p.000006: health-related research processes. These members should be given an initial orientation on basic principles of
p.000006: research ethics and the proposal approval process adopted by the IRC. The conditions of appointment to the IRC should
p.000006: state provisions available for IRC members to receive introductory training in the work of the IRC as
p.000006: well as ongoing opportunities for enhancing their capacity for ethical review.
p.000006:
p.000006: 10. Review Process and Communicating a Decision
p.000006: The IRC should provide independent, competent and timely reviews of the ethical aspects of research proposals. The IRC
p.000006: may decide upon the reviewer(s) involved for each proposal. Depending on the nature of the research proposal, it may be
p.000006: reviewed by more than one reviewer. A scoring checklist or format needs to be developed and made available to
p.000006: reviewers in order to maintain consistency and objectivity of the review process.
p.000006:
p.000006: If only a few proposals (two to three) need to be reviewed at a time, it would be advisable for all IRC members
p.000006: to review the full set of including all associated documents. If a large number of proposals need to be
p.000006: reviewed at each meeting, one IRC member (principal reviewer) is to undertake an in-depth review
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: including all forms, questionnaires etc., and prepare a summary containing essential details for other members
p.000007: to review.
p.000007:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000038: (2) free of coercion, duress, or undue inducement. Used in the health and disability care and research contexts to
p.000038: refer to a consumer’s or participant’s decision to receive health or disability care or to participate (or
p.000038: continue to participate) in a research activity.
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
...
Social / ethnic minority
Searching for indicator ethnic minority:
(return to top)
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
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 / gender
Searching for indicator gender:
(return to top)
p.000003: to learn about prior decisions by other IRCs or the ERB of NHRC that may be relevant to proposed research
p.000003: under review.
p.000003: • As an IRC may review different types of health-related research, it should be familiar with the different
p.000003: methodologies and ethical considerations that apply to each type of proposed research. As such, a clear
p.000003: procedure needs to be established for the effective review of health-related research proposals.
p.000003: • The IRC should also develop and establish a mechanism to train its members in order to maintain a high ethical and
p.000003: scientific standard.
p.000003: • The IRC must be supplied with administrative and financial support from the institute.
p.000003: • The IRC should outline a clear registration process and fee for reviewing a research proposal.
p.000003:
p.000003: 5. Formation of IRC
p.000003: Composition of IRC
p.000003: Each health institution shall set up a mechanism for the establishment of an IRC and for the selection of members to
p.000003: the IRC. The IRC should be multidisciplinary and pluralistic. The chief executive officer or head of the institution
p.000003: should not be the member of any IRC. The IRC should have the freedom to work independently and decide on the merits of
p.000003: research-related proposals without interference from within the institutional framework.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: The number of members in the committee shall, in general, depend on the number of fields from which they will
p.000004: be drawn. However, a minimum of 7 to a maximum of 15 is suggested, with an attention to gender, age and discipline
p.000004: balance. The committee should include at least one member who is not affiliated with the institution. If any IRC
p.000004: includes a member from NHRC, the member from NHRC should not be a voting member of the IRC.
p.000004:
p.000004: Persons with expertise in the following disciplines will be eligible for IRC membership:
p.000004:
p.000004: • Public health/epidemiology/research methodology
p.000004: • Biomedical/laboratory science
p.000004: • Clinical science
p.000004: • Nursing
p.000004: • Behavioral and social sciences
p.000004: • Biostatistics
p.000004: • Pharmacy/Pharmacologist
p.000004: • Law/ Teaching/ Journalism/ Community Leadership
p.000004:
p.000004: Appointment of IRC Members
p.000004: A clear procedure for recruiting potential IRC members should be established. IRC members should be
p.000004: appointed by the institutional authority. The selection process should be transparent. There should not be any
p.000004: conflicts of interest while making appointments. Only the chairperson should be appointed by the head of the
p.000004: institution. Other members including member-secretary, will be appointed by the chairperson. Member
p.000004: composition should include a balance of gender. The initial orientation, training requirements and means of continuing
p.000004: education of IRC members should be specified. Provisions should be made to appoint an expert consultant on an ad-hoc
p.000004: basis to the IRC, but the consultant should not be considered as a voting member of the IRC.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: Terms and Conditions of Appointment
p.000005: Appointments should be made for tenure of three years, with a provision for re-appointment. A rotational system
p.000005: for membership should be considered that allows for continuity, the development and maintenance of expertise
p.000005: within the IRC, and the regular input of fresh ideas and approaches. Institutions should plan in such away
p.000005: that not more than 50% of the members retire at once, in order to facilite or ensure continuity of the IRC.
p.000005: Procedures for reappointment, resignation, and discontinuation of appointment (such as for non-attendance) should be
p.000005: specified in the respective SOP. Moreover, the duties and responsibilities of the IRC
p.000005: chairperson, member - secretary and members should clearly be stated in the SOP. The IRC members should provide
p.000005: their current curriculum vitae, and sign for acceptance of the appointment.
p.000005:
p.000005: 6. IRC Office
p.000005: The institution can setup an IRC Office with necessary administrative support. It should clearly designate the
p.000005: Chairperson, Member-Secretary and Members. The list of the name of IRC members should be displayed in front of the IRC
p.000005: office. There should be at least one administrative or clerical support staff provided by the institution for
...
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 17. Appendixes Appendix – I
p.000017: Elements of Ethical Review by the IRC
p.000017: The primary task of the IRC is to review research proposals and their supporting documents, with special attention
p.000017: given to the informed consent process, documentation, and the suitability and feasibility of the protocol. The IRC
p.000017: also needs to take into account prior scientific reviews, if any, and the requirements of applicable
p.000017: laws and regulations. The following are possible issues to be considered during the ethical review process by the
p.000017: IRC:
p.000017:
p.000017: 1. Scientific design and responsible conduct of the study
p.000017: 1.1 The appropriateness of the study design in relation to the
p.000017: objectives of the study, the statistical methodology including sample size, and the potential for sound
p.000017: conclusions.
p.000017: 1.2 The justification of predictable risks and inconveniences as well as the anticipated benefits for the research
p.000017: participants and the concerned communities.
p.000017: 1.3 Criteria for withdrawal at any time by research participants.
p.000017: 1.4 Criteria for suspending or terminating the research as a whole.
p.000017: 1.5 Provisions for monitoring and supervision of the research.
p.000017: 1.6 Provisions for dissemination of the research results through publication and other media.
p.000017:
p.000017: 2. Recruitment of Research Participants
p.000017:
p.000017: 2.1 Content of the informed consent form.
p.000017: 2.2 The characteristics of the populations from which research participants will be drawn (including
p.000017: gender, age, and economic status). Be aware of any potential vulnerable populations in the study including women,
p.000017: children, the elderly etc.
p.000017: 2.3 The process by which initial contact and recruitment is to be conducted.
p.000017: 2.4 The way by which full information is to be conveyed to the potential research participants or their
p.000017: representatives.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: 3. Care and Protection of Research Participants
p.000018: 3.1 The suitability of the investigator(s)’ qualifications and experience for the proposed study.
p.000018: 3.2 Any plans to withdraw or withhold information or standard therapies for the purpose of the
p.000018: research, and justification for such action.
p.000018: 3.3 Any medical care to be provided to research participants during and after the course of the research.
p.000018: 3.4 The adequacy of medical supervision and psychosocial support for research participants.
p.000018: 3.5 Steps to be taken if research participants voluntarily withdraw from the research.
p.000018: 3.6 Outline of any plans to make the study product available to the research participants following completion of
p.000018: research.
p.000018: 3.7 A description of any financial costs to research participants.
p.000018: 3.8 The compensation/reward for research participants (including money, services and/or gifts).
...
Social / parents
Searching for indicator parent:
(return to top)
p.000011: • Proposed changes in the protocol
p.000011: • Unforeseen events that might affect the continual ethical acceptability of the project
p.000011:
p.000011: During the supervision and monitoring process, the IRC should review the problems (if any) in the implementation of the
p.000011: research proposal and guide the study team to solve them. It is also recommended that the IRC may provide feedback
p.000011: to the study team in the research process, particularly on problems of identification, methodology, data analysis
p.000011: and lacunae identified in the ethical and scientific aspects of the research (if any), and advise on corrective steps
p.000011: to be taken. The IRC may offer advice regarding the soundness of the conclusions reached on the basis of
p.000011: results of the study, and their relevance to the scientific body of knowledge as well as to health services. It may
p.000011: also advise on the dissemination process, application of research findings into practice and their use in further
p.000011: research.
p.000011:
p.000011: 12. Right of Appeal and Complaints
p.000011: There should be a clear understanding of who bears ultimate responsibility in the event of complaints
p.000011: and/or litigation by dissatisfied clients of the IRC or research participants. Any institution with an IRC shall
p.000011: establish a mechanism for receiving and promptly handling appeals/complaints or concerns of this nature.
p.000011:
p.000011: The IRC should have the freedom to work independently and be responsible for their decisions. Such
p.000011: decisions should be based on diligent examination of the proposals and the application of approved methodology.
p.000011: Provided there have been no shortcomings in the review process, it would be the parent institution or
p.000011: organizations responsibility to bear the ultimate responsibility in cases of litigation. Suitable indemnity should be
p.000011: provided for IRC members.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: A researcher who receives an unfavorable decision by the IRC has the right of appeal. This appeal is initiated by
p.000012: filing a notice of appeal in writing to the head of the institution within thirty (30) days of the date that he/she
p.000012: received notice of the IRC’s decision. In such circumstances, the head of the institution may
p.000012: request the IRC to re-review the proposal. The IRC shall notify the researcher of the rehearing, and the
p.000012: researcher shall have the right to appear at the rehearing to defend the research proposal.
p.000012:
p.000012: Any research participants involved in a research project have the right to raise complaints or concerns directly either
p.000012: to the chairperson of the IRC or head the institution. In case of an appeal to the IRC by a research
p.000012: participant, the IRC should determine the validity of the complaint and notify the principal investigator
p.000012: of its judgment in the matter. The latter will abide by the decision of the IRC.
p.000012:
p.000012: 13. Recording & Reporting / Documentation & Archiving
p.000012: The following should constitute the recording and reporting procedure:
p.000012: • Copies should be kept of all research proposals reviewed, scientific evaluations (if any) that accompany
p.000012: proposals, approved sample consent documents, progress reports and other related documents.
p.000012: • Minutes of meetings.
p.000012: • Records of continuing review activities.
p.000012: • Copies of all correspondence between the IRC and researchers
p.000012: • A list of all members, reviewers and experts, including their contact details.
p.000012: • Records should be kept for at least 5 years even after completion of the research study. The records shall be
p.000012: accessible for inspection and copying by authorized representatives of relevant institutions.
p.000012:
p.000012: The following will constitute the documentation and archiving procedure: All documentation and
p.000012: communication of the IRC should be dated, filed and archived according to written procedures. Proper storage
p.000012: space should be provided for this by the parent institution. A statement is required defining the access and
p.000012: retrieval procedure (including authorized persons) for the various documents and files kept in archive.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Documents that should be filed and archived include, but are not limited to:
p.000013: • The constitution, written SOP of the IRC, and regular (monthly/annual) reports
p.000013: • The CVs of all IRC members
p.000013: • A record of all expenses (including allowances and reimbursements) of the IRC
p.000013: • Agendas of IRC meetings
p.000013: • The minutes of IRC meetings
p.000013: • Copies of all research proposal documents
p.000013: • Copies of all correspondence of the IRC
p.000013: • A copy of all decisions and advice given by the IRC
p.000013: • Notification notices of the completion, premature suspension or termination of all research proposals
p.000013: commenced
p.000013: • The final summary or final report of all research studies approved by the IRC
p.000013:
p.000013: 14. IRC's Relationship with NHRC
p.000013: IRCs must receive approval from the ERB of NHRC to be established, by paying Rs. 5000 (five thousand only) as a
p.000013: one-time processing fee to the NHRC. The IRC approval should be renewd every three year from ERB of NHRC. At renewal
p.000013: time, the IRC must pay Rs. 1000 (one thousand only) as a renewal processing fee. The processing fee and renewal fee
p.000013: will not be refundable. If the renewal process is not commenced within 6 months of expiry date, the IRC will
p.000013: be notified for termination of approval. An IRC should inform the ERB of NHRC if there are any changes in its
p.000013: composition.
p.000013:
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000022: should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical
p.000022: and mental integrity and on the personality of the subject.
p.000022: 7. Physicians should abstain from engaging in research projects involving human subjects unless they
p.000022: are satisfied that the hazards involved are believed to be predictable. Physicians should cease any
p.000022: investigation if the hazards are found to outweigh the potential benefits.
p.000022: 8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy
p.000022: of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration
p.000022: should not be accepted for publication.
p.000022: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000022: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000022: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000022: his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed
p.000022: consent, preferably in writing.
p.000022: 10 When obtaining informed consent for the research project the physician should be particularly
p.000022: cautious if the subject is in a dependent relationship to him or her or may consent under duress. In
p.000022: that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is
p.000022: completely independent of this official relationship.
p.000022: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000022: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
p.000022: in accordance with national legislation. Whenever the minor child is in fact able to give consent, the minor's consent
p.000022: must be obtained in addition to the consent of the minor's legal guardian.
p.000022: 12. The research protocol should always contain a statement of the ethical considerations involved and should
p.000022: indicate that the principles enunciated in the present Declaration are complied with.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: II. Medical Research Combined with Clinical Care (Clinical Research)
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000022: of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration
p.000022: should not be accepted for publication.
p.000022: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000022: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000022: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000022: his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed
p.000022: consent, preferably in writing.
p.000022: 10 When obtaining informed consent for the research project the physician should be particularly
p.000022: cautious if the subject is in a dependent relationship to him or her or may consent under duress. In
p.000022: that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is
p.000022: completely independent of this official relationship.
p.000022: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in
p.000022: accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
p.000022: in accordance with national legislation. Whenever the minor child is in fact able to give consent, the minor's consent
p.000022: must be obtained in addition to the consent of the minor's legal guardian.
p.000022: 12. The research protocol should always contain a statement of the ethical considerations involved and should
p.000022: indicate that the principles enunciated in the present Declaration are complied with.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: II. Medical Research Combined with Clinical Care (Clinical Research)
p.000023: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic
p.000023: measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
...
p.000035: to new knowledge.
p.000035:
p.000035: Research Participant
p.000035: An individual who is or becomes a participant in research, either as a recipient of the test article [investigational
p.000035: product(s)] or as a control. A participant may be either a healthy individual or a patient.
p.000035:
p.000035: Revision
p.000035: Requirement by the IRC to alter the protocol in some way prior to approval or additional review by the
p.000035: committee.
p.000035:
p.000035: Risk
p.000035: Risks include physical risks (such as the possibility of having an allergic reaction), psychological risks (such as
p.000035: the possibility of emotional distress), social risks (such as the possibility of embarrassment or ridicule
p.000035: by peers), legal risks (such as the possibility of being sued because of information shared with the
p.000035: researcher), and economic risks (such as the possibility of being fired from one's job for sharing information with
p.000035: the researcher). Higher risk-levels are acceptable only when there are greater potential benefits (such as in cancer
p.000035: research).
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Serious Adverse Event (SAE)
p.000036: Any untoward medical occurrence that, at any dose:
p.000036: • results in death
p.000036: • is life-threatening
p.000036: • requires inpatient hospitalization or prolongation of existing hospitalization
p.000036: • results in persistent or significant disability/incapacity or
p.000036: • is a congenital anomaly/birth defect
p.000036: • results in important medical events that may not be immediately life-threatening or cause death or
p.000036: hospitalization, but may jeopardize the patient or may require intervention to prevent the afore mentioned outcomes
p.000036:
p.000036: Source Data
p.000036: All information in original records and certified copies of original records of clinical findings,
p.000036: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000036: Source data are contained in source documents (original records or certified copies)
p.000036:
p.000036: Source Documents
p.000036: Original documents, data, and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda,
p.000036: participant's diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated
p.000036: instruments, copies or transcriptions certified after verification as being accurate copies,
p.000036: microfiches, photographic negatives, microfilm, magnetic media, X-rays, participant files, and records kept
p.000036: at the study laboratories, pharmacies, and medico-technical departments involved in the study.
p.000036:
p.000036: Sponsor
p.000036: An individual, company, institution, or organization which takes responsibility for the initiation,
p.000036: management, and/or financing of a research study.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: Standard Operating Procedure (SOP)
p.000037: A detailed, written instruction to achieve uniformity of performance of a specific function.
p.000037:
p.000037: Study Report
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000038:
p.000038: Vulnerable (Research) Participants
p.000038: Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
p.000038: interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other
p.000038: needed attributes to protect their own interests. Individuals whose willingness to volunteer in a research
p.000038: study may be unduly influenced by the expectation, whether justified or not, of benefits associated with
p.000038: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate may
p.000038: also be considered vulnerable. Examples include members of a group with a hierarchical structure, such as medical,
p.000038: pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical
p.000038: industry, members of the armed forces, and persons kept in detention (e.g. prisoners). Other vulnerable persons
p.000038: include patients with incurable diseases, people in nursing homes, unemployed or impoverished people, patients
p.000038: in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors, people with physical
p.000038: frailty, mental disability or substance abuse-related disorders, and those incapable of giving consent.
p.000038: This list may not be exhaustive as there may be circumstances in which other groups are considered vulnerable:
p.000038: for example women in an orthodox patriarchal society, pregnant women and children.
p.000038:
p.000038: Witness
p.000038: A person who will not be influenced in any way by those who are involved in the research project, who
p.000038: is present and may provide assistance if required when the subject's informed consent is being obtained,
p.000038: and documents that this consent is given freely by signing and dating the informed consent form.
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: procedures they should follow while reviewing and approving health-research proposals, and to ensure that the
p.000002: provisions of national guidelines published by NHRC are followed whenever a health-related research proposal is
p.000002: reviewed, approved and monitored.
p.000002:
p.000002: The specific objectives of this guideline are:
p.000002:
p.000002: • To ensure that all health care facilities, academic institutions and research institutions follow a similar
p.000002: process in the formation of institutional review committees
p.000002: • To ensure consistency of the ethical review procedures of all IRCs
p.000002: • To ensure consistency in the supervision and monitoring of health-related research
p.000002: • To protect the rights of humans and animals involved in research
p.000002:
p.000002: 3. Role of an IRC
p.000002: The role of an IRC is to safeguard the dignity, rights, safety and well-being of all actual or potential
p.000002: research participants and ensure that animals, if used for research, are treated humanely. The IRC should
p.000002: ensure the full review and evaluation of all ethical aspects of health-related research proposals it receives
p.000002: prior to any research being carried out in field and/or laboratory settings, according to national ethical
p.000002: guidelines prescribed by NHRC. The IRC should provide independent, competent, and timely review of
p.000002: research proposals. The tasks of the IRC should be executed free of bias and influence (political, institutional,
p.000002: professional, market etc).
p.000002:
p.000002: The IRC has the authority to ask for research protocol modifications, and to enforce and monitor the conduct of
p.000002: research projects. This includes issues of informed consent and right of all research participants
p.000002: (human or animal) and to suspend or stop any health-related research that violates any ethical
p.000002: issues. This type of supervision and monitoring is applicable to those research projects that are approved by the
p.000002: IRC.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: 4. Establishing a System of Institutional Review Process
p.000003: Any health institution which undertakes at least 10 health-related researches in a year is eligible to
p.000003: establish an IRC. The following system should be followed by an IRC:
p.000003:
p.000003: • It should work within the framework of the highest possible ethical and scientific standards in biomedical
p.000003: research.
p.000003: • It is mandatory that the IRC must be independent, autonomous and multidisciplinary in nature.
p.000003: • A mechanism must be developed to ensure clear and efficient communication, harmonization of
p.000003: standards, networking, and cooperation between the IRC and ERB of NHRC. An IRC may implement its own
p.000003: procedure to interact with other IRCs regarding matters of common interest as necessary. Such interactions enable IRCs
p.000003: to learn about prior decisions by other IRCs or the ERB of NHRC that may be relevant to proposed research
p.000003: under review.
p.000003: • As an IRC may review different types of health-related research, it should be familiar with the different
p.000003: methodologies and ethical considerations that apply to each type of proposed research. As such, a clear
...
p.000003: the IRC. The IRC should be multidisciplinary and pluralistic. The chief executive officer or head of the institution
p.000003: should not be the member of any IRC. The IRC should have the freedom to work independently and decide on the merits of
p.000003: research-related proposals without interference from within the institutional framework.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: The number of members in the committee shall, in general, depend on the number of fields from which they will
p.000004: be drawn. However, a minimum of 7 to a maximum of 15 is suggested, with an attention to gender, age and discipline
p.000004: balance. The committee should include at least one member who is not affiliated with the institution. If any IRC
p.000004: includes a member from NHRC, the member from NHRC should not be a voting member of the IRC.
p.000004:
p.000004: Persons with expertise in the following disciplines will be eligible for IRC membership:
p.000004:
p.000004: • Public health/epidemiology/research methodology
p.000004: • Biomedical/laboratory science
p.000004: • Clinical science
p.000004: • Nursing
p.000004: • Behavioral and social sciences
p.000004: • Biostatistics
p.000004: • Pharmacy/Pharmacologist
p.000004: • Law/ Teaching/ Journalism/ Community Leadership
p.000004:
p.000004: Appointment of IRC Members
p.000004: A clear procedure for recruiting potential IRC members should be established. IRC members should be
p.000004: appointed by the institutional authority. The selection process should be transparent. There should not be any
p.000004: conflicts of interest while making appointments. Only the chairperson should be appointed by the head of the
p.000004: institution. Other members including member-secretary, will be appointed by the chairperson. Member
p.000004: composition should include a balance of gender. The initial orientation, training requirements and means of continuing
p.000004: education of IRC members should be specified. Provisions should be made to appoint an expert consultant on an ad-hoc
p.000004: basis to the IRC, but the consultant should not be considered as a voting member of the IRC.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: Terms and Conditions of Appointment
p.000005: Appointments should be made for tenure of three years, with a provision for re-appointment. A rotational system
p.000005: for membership should be considered that allows for continuity, the development and maintenance of expertise
p.000005: within the IRC, and the regular input of fresh ideas and approaches. Institutions should plan in such away
p.000005: that not more than 50% of the members retire at once, in order to facilite or ensure continuity of the IRC.
p.000005: Procedures for reappointment, resignation, and discontinuation of appointment (such as for non-attendance) should be
p.000005: specified in the respective SOP. Moreover, the duties and responsibilities of the IRC
p.000005: chairperson, member - secretary and members should clearly be stated in the SOP. The IRC members should provide
p.000005: their current curriculum vitae, and sign for acceptance of the appointment.
...
p.000007: approval needs to be given befor implimentation of amended research activities.
p.000007: • The IRC should receive periodic and final reports from researchers, a copy of which need to be submitted to NHRC’s
p.000007: ERB.
p.000007:
p.000007: Expedited Review: Most projects will require formal review by the full IRC, but there may be some studies that
p.000007: do not pose any ethical problems (“ethically minor” investigations), where there is minimum risk of distress or
p.000007: injury, be it physical or psychological, to the human participants. This includes outbreak studies,
p.000007: assessments of patient information and education. Such projects may not require review by the full committee.
p.000007: Similarly, under exceptional circumstances of urgency (e.g. a patient with some rare or ill understood condition,
p.000007: epidemics, etc.) the Member–Secretary, in consultation with other IRC members, may give expedited approval. However,
p.000007: the Member-Secretary has the duty to report these approvals to the Chairperson of the IRC at the next meeting of the
p.000007: committee. In the case of any confusion, an application should be reviewed by the full committee.
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: The IRC may also use the expedited review procedure to review minor changes in previously approved research during the
p.000008: period covered by the original approval. In such cases, the reviewer(s) may exercise all authority of the IRC except
p.000008: disapproval of the proposal. Research may only be disapproved following review by the full committee (Appendix I).
p.000008:
p.000008: Decisions should only be made by a meeting of the IRC that satisfies quorum requirement. All relevant documents
p.000008: must be considered before a decision is made.
p.000008:
p.000008: Conduct of Meetings: Meetings should be held on a regular basis at a convenient time and place. The frequency of
p.000008: meetings shall depend on the number of applications that need reviewing. The number of agenda items should be
p.000008: reasonable so that sufficient time can be given to each item for proper discussion. Members should have had sufficient
p.000008: time to peruse the applications prior to the meeting. The principal reviewers in particular should have had
p.000008: adequate time to review the applications assigned to them, and to consult with applicants if necessary.
p.000008:
p.000008: Depending upon the nature of the research proposal, the IRC can invite the applicant to present the proposal to the
p.000008: panel of experts and IRC members. This will help the IRC to understand the proposal better and guide the researcher
p.000008: appropriately. This procedure should be followed if an independent (expert) reviewer is invited to advise on any
p.000008: particular topic. Minutes of IRC meetings should be maintained in a confidential manner in a standard format.
p.000008:
p.000008: Conflict of Interest: A conflict of interest is present and interferes with the ability to make an objective
p.000008: evaluation when any of the IRC members are investigators/advisors in a research study being
p.000008: reviewed. In such a situation, the member(s) should disclose the conflict of interest and refrain from
p.000008: participating in the review process by leaving the meeting room.
...
p.000018: 4.3 Assurances that research participants will receive information that becomes available during the course of the
p.000018: research relevant to their participation.
p.000018: 4.4 The provisions made for receiving and responding to queries and complaints from research participants or
p.000018: their representatives during the course of the research project.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: 5. Community Considerations
p.000019: 5.1 The impact and relevance of the research to the local community and concerned
p.000019: communities from which research participants are to be drawn.
p.000019: 5.2 The steps taken for consultation with concerned communities regarding the research procedure.
p.000019: 5.3 The influence of community on the consent of individuals.
p.000019: 5.4 The extent to which the research contributes to capacity building, such as the enhancement
p.000019: of local healthcare, research, and the ability to respond to public health needs.
p.000019:
p.000019: 6. Expedited Review
p.000019: 6.1 For expedited review, the IRC should establish
p.000019: 6.1.1 Procedures for the expedited review of research involving minimal risks to participants. These
p.000019: procedures should specify the following:
p.000019: 6.1.2 The nature of the applications, amendments and other considerations that will be eligible for
p.000019: expedited review.
p.000019: 6.1.3 The types of research to which an expedited review procedure is to apply.
p.000019: 6.1.4 The scope of the Member-Secretary's authority.
p.000019: 6.1.5 The delegation of tasks to sub-committees.
p.000019: 6.1.6 The quorum requirement for expedited review.
p.000019: 6.1.7 The status of decisions (e.g. subject to confirmation by the full IRC or not).
p.000019: 6.1.8 The method of reporting and ratifying decisions by the full Committee.
p.000019: 6.2 Research with potential for physical or psychological harm should generally not be considered for
p.000019: expedited review. This includes drug trials, research involving invasive physical procedures and
p.000019: research exploring sensitive personal or cultural issues.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Appendix – II
p.000020: Declaration of Helsinki** Recommendations Guiding Physicians in
p.000020: Biomedical Research Involving Human Subjects
p.000020:
p.000020: Introduction
p.000020: It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are
p.000020: dedicated to the fulfillment of this mission.
p.000020:
p.000020: The Declaration of Geneva of the World Medical Association binds the physician with the words "The health of my
p.000020: patient will be my first consideration" and the International Code of Medical Ethics declares "A physician shall
p.000020: act only in the patient's interest when providing medical care which might have the effect of weakening the physical
p.000020: and mental condition of the patient."
...
p.000031:
p.000031: Expedited Review
p.000031: Review of proposed research by the IRC Member Secretary or a designated voting member or group of voting
p.000031: members rather than by the entire IRC.
p.000031:
p.000031: Good Clinical Practice (GCP)
p.000031: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical
p.000031: trials/study that provides assurance that the data and reported results are credible and accurate, and that the
p.000031: rights, integrity, and confidentiality of trial/study participants are protected.
p.000031:
p.000031: ID
p.000031: A unique identifier assigned by the investigator to each study/trial participant to protect the participant's
p.000031: identify and used in lieu of the participant's name when the investigator reports adverse events and/or other
p.000031: study/trial-related data.
p.000031:
p.000031: Informed Consent
p.000031: A process by which a research participant voluntarily confirms his or her willingness to participate in a
p.000031: particular research project. This consent should only be sought
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: after all appropriate information has been given about the research project, its objectives, potential
p.000032: benefits, risks and inconveniences, and of the subject's rights and responsibilities in accordance with the
p.000032: current revision of the Declaration of Helsinki (see Appendix 1).
p.000032:
p.000032: Inspection
p.000032: The act by a regulatory authority (/ies) of conducting an official review of documents, facilities, records, and
p.000032: any other resources that are deemed by the authority (/ies) to be related to the clinical trial/study and that may
p.000032: be located at the site of the trial/study, at the sponsor's and/or contract research organization's facilities, or
p.000032: at other establishments deemed appropriate by the regulatory authority (/ies).
p.000032:
p.000032: Institution
p.000032: Any public or private entity or agency or medical or health facility where study/clinical trials are conducted.
p.000032:
p.000032: Institutional Review Committee (IRC)
p.000032: An independent body comprised of medical, scientific and non-medical members, whose responsibility is to ensure the
p.000032: protection of the rights, safety, and well-being of human participants participating in a particular research project,
p.000032: and to consider general health research ethics, thereby providing public reassurance. It should be
p.000032: constituted and operated so that its tasks can be executed free from bias and from any influence of those who are
p.000032: conducting health research in the respective institution.
p.000032:
p.000032: Investigator
p.000032: A duly qualified member of the respective institution can function as an investigator. He or she should be
p.000032: responsible for the conduct of a research project and for the rights, health and welfare of the research
p.000032: participants. The investigator should have qualifications and competence in accordance with
p.000032: national laws and regulations as evidenced by up-to-date curriculum vitae and other credentials. A person
p.000032: who has
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: an academic degree in relevant biomedical or health-related subjects and other necessary professional credentials could
p.000033: be an investigator for a research project.
p.000033:
p.000033: IRC Approval
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000001: institutions that are involved in approving health research proposals.
p.000001:
p.000001: In this context, we would like to express our sincere thanks and gratitude to all the members of the
p.000001: Taskforce committee: Prof. Dr. Ramesh Kant Adhikari, Prof. Dr. Jeevan Bahadur Sherchand, Associate
p.000001: Prof. Dr. Aarati Shah, Prof. Dr. Rajendra Kumar BC, Mr. Mohan Krishna Shrestha, Mr. Purushottam
p.000001: Dhakal, Ms. Namita Ghimire, and Dr. Krishna Kumar Aryal.
p.000001:
p.000001: We are grateful to former Chairman Prof. Dharma Kant Bastola, and former Executive Chief Dr. Guna Raj Lohani for
p.000001: all the support and guidance they provided during the revision process.
p.000001:
p.000001: We extend our profound thanks to all the participants of the consultative meeting for their
p.000001: enthusiastic participation and thoughtful comments which have made this document more relevant and suited to the
p.000001: context of reality. Heartfelt thanks are offered for their hard work and valuable contributions.
p.000001:
p.000001: We also express our thanks to the Ethical Review, Monitoring & Evaluation (ER, M & E Section) and all staffs
p.000001: of NHRC, Mr. Nirbhay Kumar Sharma, Mr. Subodh Kumar Karna, Dr. Meghanath Dhimal, Mr. Bijay Kumar Jha, Ms. Sabina
p.000001: Bhandari and Mr. David Norrish who have contributed to the revision of this guideline.
p.000001:
p.000001: Dr. Khem Bahadur Karki
p.000001: Member - Secretary
p.000001: Dr. Krishna Prasad Adhikary
p.000001: Chairman
p.000001:
p.000001: III
p.000001:
p.000001: Abbreviations
p.000001:
p.000001: AE Adverse Event
p.000001: ADR Adverse Drug Reaction
p.000001: CIOMS Council for International Organizations of Medical Sciences
p.000001: ERB Ethical Review Board
p.000001: GCP Good Clinical Practice
p.000001: GLP Good Laboratory Practice
p.000001: GoN Government of Nepal
p.000001: NHRC Nepal Health Research Council PI Principal Investigator
p.000001: QA Quality Assurance
p.000001: QC Quality Control
p.000001: ICH International Conference on Harmonization IRC Institutional Review Committee
p.000001: SAE Serious Adverse Event
p.000001: SOP Standard Operating Procedure
p.000001: ER M & E Ethical Review Monitoring & Evaluation
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:
p.000001:
p.000001: Page No
p.000001: Preface I
p.000001: Acknowledgements III
p.000001: Abbreviations IV
p.000001: 1. Introduction 1
p.000001: 2. Objectives 3
p.000001: 3. Role of an Institutional Review Committee (IRC) 3
p.000001: 4. Establishing a System of Institutional Review Process 4
p.000001: 5. Formation of IRCs 4
p.000001: 6. IRC Office 6
p.000001: 7. Quorum Requirements 6
...
p.000023: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000023: out.
p.000023: 2. The subjects should be volunteers - either healthy persons or a patient for whom the experimental
p.000023: design is not related to the patient's illness.
p.000023: 3. The investigator or the investigating team should discontinue the research if in his/her or their
p.000023: judgment it may, if continued, be harmful to the individual.
p.000023: 4. In research on man, the interest of science and society should never take precedence over considerations related
p.000023: to the well-being of the subject.
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: **Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and amended by the 29th World
p.000024: Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983 and the
p.000024: 41st World Medical Assembly, Hong Kong, September 1989. World Medical Association, Handbook of
p.000024: declarations, Ferney- Voltaire 1992 (unpublished document; available on request from the World Medical Association, 28
p.000024: avenue des Alpes, 01210 Ferney- Voltaire, France). [Internet address:
p.000024: http://www.wma.net/]
p.000024:
p.000024: 18. Bibliography
p.000024: Belmont Report: Ethical Principles and guidelines for the Protection of Human Subjects of Research
p.000024:
p.000024: Council of International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO),
p.000024: International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993
p.000024:
p.000024: Declaration of Helsinki (Available at http://www.wma.net / en / 30 publications /10policies / b3 / index.html,
p.000024: accessed 05 October 2011)
p.000024:
p.000024: Ethical Guidelines for the Care and Use of Animals in Health Research in Nepal, Nepal Health Research Council, 2005
p.000024:
p.000024: Ethics Review Committee Guidelines: A Guide for Developing Standard Operating Procedures for
p.000024: Committees that Review Biomedical Research proposal, Forum of Ethics Review Committees, Sri Lanka, 2007
p.000024:
p.000024: Francis P. Clawley, Ethical Review Committees: Local, Institutional and International Experiences, Bio-ethics:
p.000024: the Judiciary and Ethics Committees, International Journal of Bio-ethics, VollO, No.4, pp, 25-33, 1999
p.000024:
p.000024: Guidance for Institutional Review Boards and Clinical Investigators, 21 CFR Part 56 - Institutional Review Boards, 1998
p.000024: Update.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Guidelines for Institutional Review Committees for Health Research in Nepal, Nepal Health Research Council, 2005.
p.000025:
p.000025: Holly Gieszl, Elements of Informed Consent, Paper presented during the workshop on Ethical Issues in International
p.000025: Health Research held in Harvard School of Public Health, 13 June 2000
p.000025:
p.000025: ICH Good Clinical Practice Guidelines (1996) (Available at http://www.ich.org/fileadmin/
p.000025: Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6
p.000025: _R1 Guideline.pdf
p.000025:
p.000025: IRB Investigators' Handbook, the University of Texas Health Science Center at San Antonio (UTHSCSA) Institutional
p.000025: Review Boards (lRB), June 2005.
p.000025:
p.000025: John Bryant, Ethical Guidelines for Research Involving Human Subjects: Helsinki and CIOMS-Origins
p.000025: Patterns of Change, Paper presented during the Workshop on Ethical Issues in International Health Research
p.000025: held in Harvard School of Public Health, 12 June 2000
p.000025:
p.000025: Nepal Health Research Council Act, 1991.
p.000025:
p.000025: National Bio-ethics Advisory Commission (NBAC) Facts, Ethical and Policy Issues in International Research, April 2000.
p.000025:
p.000025: National Guidelines on Clinical Trials with the Use of Pharmaceutical Products, Nepal Health Research Council, 2005.
p.000025:
p.000025: National Ethical Guidelines for Health Research in Nepal, Nepal Health Research Council, 2001.
p.000025:
p.000025: National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure, Nepal Health Research
p.000025: Council, 2011.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: National Institute of Health, Guidelines for Writing Informed Consent Documents, Information Sheet no 6 (Revised),
p.000026: Bethesda, Maryland: June 1998
p.000026:
p.000026: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries, London, October, 1999
p.000026:
p.000026: Standards and Operational Guidance for Ethics Review of Health-related Research with Human
p.000026: Participants, WHO, 2011.
p.000026:
p.000026: TDRIWHO Guideline, 2000.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000019: of local healthcare, research, and the ability to respond to public health needs.
p.000019:
p.000019: 6. Expedited Review
p.000019: 6.1 For expedited review, the IRC should establish
p.000019: 6.1.1 Procedures for the expedited review of research involving minimal risks to participants. These
p.000019: procedures should specify the following:
p.000019: 6.1.2 The nature of the applications, amendments and other considerations that will be eligible for
p.000019: expedited review.
p.000019: 6.1.3 The types of research to which an expedited review procedure is to apply.
p.000019: 6.1.4 The scope of the Member-Secretary's authority.
p.000019: 6.1.5 The delegation of tasks to sub-committees.
p.000019: 6.1.6 The quorum requirement for expedited review.
p.000019: 6.1.7 The status of decisions (e.g. subject to confirmation by the full IRC or not).
p.000019: 6.1.8 The method of reporting and ratifying decisions by the full Committee.
p.000019: 6.2 Research with potential for physical or psychological harm should generally not be considered for
p.000019: expedited review. This includes drug trials, research involving invasive physical procedures and
p.000019: research exploring sensitive personal or cultural issues.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Appendix – II
p.000020: Declaration of Helsinki** Recommendations Guiding Physicians in
p.000020: Biomedical Research Involving Human Subjects
p.000020:
p.000020: Introduction
p.000020: It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are
p.000020: dedicated to the fulfillment of this mission.
p.000020:
p.000020: The Declaration of Geneva of the World Medical Association binds the physician with the words "The health of my
p.000020: patient will be my first consideration" and the International Code of Medical Ethics declares "A physician shall
p.000020: act only in the patient's interest when providing medical care which might have the effect of weakening the physical
p.000020: and mental condition of the patient."
p.000020:
p.000020: The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic
p.000020: procedures and the understanding of the aetiology and pathogenesis of disease.
p.000020:
p.000020: In current medical practice, most diagnostic, therapeutic or prophylactic procedures involve
p.000020: hazards. This applies especially to biomedical research. Medical progress is based on research, which
p.000020: ultimately must rest in part on experimentation involving human subjects.
p.000020:
p.000020: In the field of biomedical research a fundamental distinction must be recognized between medical research in which the
p.000020: aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of
p.000020: which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the
p.000020: research.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
...
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
p.000023: proposal should be stated in the experimental protocol for transmission to the independent committee (1,2).
p.000023: 6. The physician can combine medical research with professional care, the objective being the acquisition of
p.000023: new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic
p.000023: value for the patient.
p.000023:
p.000023: III. Non-therapeutic Biomedical Research involving Human Subjects (Non-clinical Biomedical Researc)
p.000023: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000023: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000023: out.
p.000023: 2. The subjects should be volunteers - either healthy persons or a patient for whom the experimental
p.000023: design is not related to the patient's illness.
p.000023: 3. The investigator or the investigating team should discontinue the research if in his/her or their
p.000023: judgment it may, if continued, be harmful to the individual.
p.000023: 4. In research on man, the interest of science and society should never take precedence over considerations related
p.000023: to the well-being of the subject.
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: **Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and amended by the 29th World
p.000024: Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983 and the
p.000024: 41st World Medical Assembly, Hong Kong, September 1989. World Medical Association, Handbook of
p.000024: declarations, Ferney- Voltaire 1992 (unpublished document; available on request from the World Medical Association, 28
p.000024: avenue des Alpes, 01210 Ferney- Voltaire, France). [Internet address:
p.000024: http://www.wma.net/]
p.000024:
p.000024: 18. Bibliography
p.000024: Belmont Report: Ethical Principles and guidelines for the Protection of Human Subjects of Research
p.000024:
p.000024: Council of International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO),
p.000024: International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993
p.000024:
p.000024: Declaration of Helsinki (Available at http://www.wma.net / en / 30 publications /10policies / b3 / index.html,
p.000024: accessed 05 October 2011)
p.000024:
p.000024: Ethical Guidelines for the Care and Use of Animals in Health Research in Nepal, Nepal Health Research Council, 2005
p.000024:
p.000024: Ethics Review Committee Guidelines: A Guide for Developing Standard Operating Procedures for
p.000024: Committees that Review Biomedical Research proposal, Forum of Ethics Review Committees, Sri Lanka, 2007
p.000024:
p.000024: Francis P. Clawley, Ethical Review Committees: Local, Institutional and International Experiences, Bio-ethics:
p.000024: the Judiciary and Ethics Committees, International Journal of Bio-ethics, VollO, No.4, pp, 25-33, 1999
p.000024:
p.000024: Guidance for Institutional Review Boards and Clinical Investigators, 21 CFR Part 56 - Institutional Review Boards, 1998
p.000024: Update.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Guidelines for Institutional Review Committees for Health Research in Nepal, Nepal Health Research Council, 2005.
p.000025:
p.000025: Holly Gieszl, Elements of Informed Consent, Paper presented during the workshop on Ethical Issues in International
p.000025: Health Research held in Harvard School of Public Health, 13 June 2000
p.000025:
p.000025: ICH Good Clinical Practice Guidelines (1996) (Available at http://www.ich.org/fileadmin/
p.000025: Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6
p.000025: _R1 Guideline.pdf
p.000025:
p.000025: IRB Investigators' Handbook, the University of Texas Health Science Center at San Antonio (UTHSCSA) Institutional
p.000025: Review Boards (lRB), June 2005.
p.000025:
p.000025: John Bryant, Ethical Guidelines for Research Involving Human Subjects: Helsinki and CIOMS-Origins
p.000025: Patterns of Change, Paper presented during the Workshop on Ethical Issues in International Health Research
p.000025: held in Harvard School of Public Health, 12 June 2000
p.000025:
p.000025: Nepal Health Research Council Act, 1991.
p.000025:
p.000025: National Bio-ethics Advisory Commission (NBAC) Facts, Ethical and Policy Issues in International Research, April 2000.
p.000025:
p.000025: National Guidelines on Clinical Trials with the Use of Pharmaceutical Products, Nepal Health Research Council, 2005.
p.000025:
p.000025: National Ethical Guidelines for Health Research in Nepal, Nepal Health Research Council, 2001.
p.000025:
p.000025: National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure, Nepal Health Research
p.000025: Council, 2011.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: National Institute of Health, Guidelines for Writing Informed Consent Documents, Information Sheet no 6 (Revised),
p.000026: Bethesda, Maryland: June 1998
p.000026:
p.000026: Nuffield Council on Bio-ethics, The Ethics of Clinical Research in Developing Countries, London, October, 1999
p.000026:
p.000026: Standards and Operational Guidance for Ethics Review of Health-related Research with Human
p.000026: Participants, WHO, 2011.
p.000026:
p.000026: TDRIWHO Guideline, 2000.
p.000026: The World Medical Association, Declaration of Helsinki, Republic of South Africa: 48th General Assembly,
p.000026: October, 1996.
p.000026:
p.000026: The World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000026: Human Subjects, Scotland: 52nd General Assembly, October 2000
p.000026:
p.000026: World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research,
p.000026: Geneva, 2000
p.000026:
p.000026: 19. Glossary
p.000026: Adverse Drug Reaction (ADR)
p.000026: In the pre-approval clinical experience with a new medicinal product or a product's new usages, particularly as the
p.000026: therapeutic dose(s) may not be established, all harmful and unintended responses to a medicinal product related to
p.000026: any dose should be considered adverse drug reactions.
p.000026:
p.000026: Adverse Event (AE)
p.000026: Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical
p.000026: product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any
p.000026: unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease
p.000026: temporally associated with the use of a medicinal (investigational) product, whether or not related to the
p.000026: medicinal (investigational) product.
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: Approval
p.000027: The affirmative decision of the IRC that the study proposal has been reviewed and may be conducted at the
p.000027: institution site within the constraints set forth by the IRC, the institution, good clinical practice (GCP), good
p.000027: laboratory practice (GLP), and the applicable regulatory requirements.
p.000027:
...
p.000031: Guidance documents which assist with decisions relating to the responsibility to adhere to established and
p.000031: relevant standards of ethical principles and practice.
p.000031:
p.000031: Expedited Review
p.000031: Review of proposed research by the IRC Member Secretary or a designated voting member or group of voting
p.000031: members rather than by the entire IRC.
p.000031:
p.000031: Good Clinical Practice (GCP)
p.000031: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical
p.000031: trials/study that provides assurance that the data and reported results are credible and accurate, and that the
p.000031: rights, integrity, and confidentiality of trial/study participants are protected.
p.000031:
p.000031: ID
p.000031: A unique identifier assigned by the investigator to each study/trial participant to protect the participant's
p.000031: identify and used in lieu of the participant's name when the investigator reports adverse events and/or other
p.000031: study/trial-related data.
p.000031:
p.000031: Informed Consent
p.000031: A process by which a research participant voluntarily confirms his or her willingness to participate in a
p.000031: particular research project. This consent should only be sought
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: after all appropriate information has been given about the research project, its objectives, potential
p.000032: benefits, risks and inconveniences, and of the subject's rights and responsibilities in accordance with the
p.000032: current revision of the Declaration of Helsinki (see Appendix 1).
p.000032:
p.000032: Inspection
p.000032: The act by a regulatory authority (/ies) of conducting an official review of documents, facilities, records, and
p.000032: any other resources that are deemed by the authority (/ies) to be related to the clinical trial/study and that may
p.000032: be located at the site of the trial/study, at the sponsor's and/or contract research organization's facilities, or
p.000032: at other establishments deemed appropriate by the regulatory authority (/ies).
p.000032:
p.000032: Institution
p.000032: Any public or private entity or agency or medical or health facility where study/clinical trials are conducted.
p.000032:
p.000032: Institutional Review Committee (IRC)
p.000032: An independent body comprised of medical, scientific and non-medical members, whose responsibility is to ensure the
p.000032: protection of the rights, safety, and well-being of human participants participating in a particular research project,
p.000032: and to consider general health research ethics, thereby providing public reassurance. It should be
p.000032: constituted and operated so that its tasks can be executed free from bias and from any influence of those who are
p.000032: conducting health research in the respective institution.
p.000032:
p.000032: Investigator
p.000032: A duly qualified member of the respective institution can function as an investigator. He or she should be
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.000022: informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject
p.000022: in accordance with national legislation. Whenever the minor child is in fact able to give consent, the minor's consent
p.000022: must be obtained in addition to the consent of the minor's legal guardian.
p.000022: 12. The research protocol should always contain a statement of the ethical considerations involved and should
p.000022: indicate that the principles enunciated in the present Declaration are complied with.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: II. Medical Research Combined with Clinical Care (Clinical Research)
p.000023: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic
p.000023: measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating
p.000023: suffering.
p.000023: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the
p.000023: advantage of the best current diagnostic and therapeutic methods.
p.000023: 3. In any medical study, every patient - including those of a control group, if any - should be assured of the best
p.000023: proven diagnostic and therapeutic method.
p.000023: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000023: relationship.
p.000023: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this
p.000023: proposal should be stated in the experimental protocol for transmission to the independent committee (1,2).
p.000023: 6. The physician can combine medical research with professional care, the objective being the acquisition of
p.000023: new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic
p.000023: value for the patient.
p.000023:
p.000023: III. Non-therapeutic Biomedical Research involving Human Subjects (Non-clinical Biomedical Researc)
p.000023: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000023: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000023: out.
p.000023: 2. The subjects should be volunteers - either healthy persons or a patient for whom the experimental
p.000023: design is not related to the patient's illness.
p.000023: 3. The investigator or the investigating team should discontinue the research if in his/her or their
p.000023: judgment it may, if continued, be harmful to the individual.
p.000023: 4. In research on man, the interest of science and society should never take precedence over considerations related
p.000023: to the well-being of the subject.
p.000023:
p.000023:
p.000023:
...
Searching for indicator placebo:
(return to top)
p.000027: except for the use of a marketed drug/vaccine in the course of medical practice.
p.000027:
p.000027: Clinical Trial
p.000027: A systematic study involvinga pharmaceutical product or biomedical devicewithresearch participants in order to
p.000027: discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to
p.000027: study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining
p.000027: their efficacy and safety. Clinical trials are generally classified into Phases I to IV. It is not possible to draw
p.000027: distinct lines between the phases, and diverging opinions about details and methodology do exist. A brief
p.000027: description of the individual phases, based on their purposes as related to the clinical development of a
p.000027: pharmaceutical product or device, is given below:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: Phase I: These are the first trials of a new active ingredient or new formulations or device in human beings, often
p.000028: carried out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000028: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000028: humans, or sensitivity or specificity of a device.
p.000028:
p.000028: Phase II: These trials are performed in a limited number of human participants and are often of a comparative
p.000028: (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and to assess
p.000028: short-term safety of the active ingredient or device in patients suffering from a disease or condition for which the
p.000028: active ingredient or device is intended. This phase also aims at the determination of appropriate dose ranges
p.000028: or regimens or exposure to a device and (if possible) clarification of dose-response or
p.000028: device-response relationships in order to provide an optimal background for the design of extensive therapeutic trials.
p.000028:
p.000028: Phase III: Trials in larger (and possibly varied) patient groups with th e purpose of determining the short and
p.000028: long-term safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall and
p.000028: relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated and special
p.000028: features of the product or device must be explored (e.g. clinically relevant drug interactions, factors leading to
p.000028: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000028: designs may be acceptable, e.g. long-term safety studies. Generally, the conditions under which these
p.000028: trials are carried out should be as close as possible to normal conditions of use.
p.000028:
p.000028: Phase IV: Studies performed after marketing of the pharmaceutical product or device. Trials in phase IV are
p.000028: carried out on the basis of the product or device characteristics on which the marketing authorization was granted
p.000028: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value
p.000028: or treatment strategies or sensitivity or specificity of a device. Although methods may differ, these
p.000028: studies should use the same scientific and ethical standards as applied in pre-marketing studies.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: After a product or device has been placed on the market, clinical trials designed to explore new indications, new
p.000029: methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical
p.000029: products or devices.
p.000029:
p.000029: Community
p.000029: A community is a group of people understood as having a certain identity due to the sharing of common
p.000029: interests or to a shared proximity. A community may be identified as a group of people living in the same village,
p.000029: town, or country and, thus, sharing geographically proximity. A community may be otherwise identified as a group of
p.000029: people sharing a common set of values, a common set of interests, or a common disease.
p.000029:
p.000029: Comparator Product
p.000029: A pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trial.
p.000029:
p.000029: Compensation
p.000029: That which is given in recompense, as an equivalent rendered, or remuneration.
p.000029:
p.000029: Compliance
p.000029: Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.
p.000029:
p.000029: Consent Form
p.000029: An easily understandable written document that documents a potential participant’s consent to be involved in research
p.000029: and which describes the rights of an enrolled research participant. This form should communicate the following
p.000029: in a clear and respectful manner: research time-frame; title of research; researchers involved; purpose
p.000029: of research; description of research; potential harms and benefits; treatment alternatives; statement
p.000029: of confidentiality; information and data to be collected; how long the data will be kept, how it will be stored and
p.000029: who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000029: participation at
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: any point; and declarative statement of understanding that the potential participant agrees to and signs. The
p.000030: consent form should be in a language that the potential participant understands. For potential participants
...
Orphaned Trigger Words
p.000001: Institutional Review Committees (IRCs) for
p.000001: Health Research in 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: NEPAL HEALTH RESEARCH COUNCIL (NHRC)
p.000001:
p.000001:
p.000001: Guidelines for Institutional Review Committees (IRCs) for
p.000001: Health Research in 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: Published By
p.000001: Nepal Health Research Council (NHRC) 2016
p.000001:
p.000001: Edition:
p.000001: First 2005
p.000001: Second 2016
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:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Published by:
p.000001: Nepal Health Research Council (NHRC)
p.000001: P.O. Box : 7626, Ramshah Path, Kathmandu, Nepal Phone : +977-1-4254220
p.000001: Fax : +977-1-4262469
p.000001: E-mail : nhrc@nhrc.org.np / approval@nhrc.org.np Web-site : http://www.nhrc.org.np
p.000001:
p.000001: Preface
p.000001: The Nepal Health Research Council (NHRC) would like to work in close collaboration with all agencies (health care
p.000001: facilities, academic and research institutions) involved in health research for the purpose of establishing
p.000001: a common system of institutional review process. Research on human beings has been conducted since the
p.000001: time of the ancient Greeks. However, ethics related to health and biomedical research is a more recent
p.000001: development. In 1995, NHRC published its first document on research ethics, "NHRC's Ethical Guidelines", which was
p.000001: primarily for research proposal reviewers, ethical committee members, health and medical researchers, health
p.000001: professionals and students of health and medical sciences. Since then NHRC has started to deliver one hour lectures
p.000001: on research ethics in most of the research-related training workshops it has conducted.
p.000001:
p.000001: In 2001, NHRC published the National Ethical Guidelines for Health Research in Nepal. Since then it has organized a
p.000001: series of workshops and consultative meetings on research ethics in Nepal. Similarly, in 2005, there were
p.000001: three publications: Ethical Guidelines for the Care and Use of Animals in Health Research in Nepal, National
p.000001: Guidelines on Clinical Trials with the Use of Pharmaceutical Products, and Guidelines for Institutional
p.000001: Review Committees (IRCs) for Health Research in Nepal. A workshop on ethics in health research, organized by NHRC
p.000001: on March 13-14, 2008, recommended that it had become time to revise the national ethical guidelines published in the
p.000001: year 2001. Consequently, seven members were delegated as a taskforce committee to accomplish this task,
p.000001: and over the period of revision, a series of workshops was held to garner further suggestions for revisions.
p.000001: The revised guideline was disseminated in a workshop on April 26, 2010. By incorporating the valuable
p.000001: suggestions from this workshop, definitive steps were taken to finalize the ethical guidelines, and a section on the
p.000001: Standard Operating Procedure (SOP) was added. The new national ethical document has been named "National Ethical
p.000001: Guidelines for Health Research in Nepal and SOP", and it was published in January 2011. It assists the
p.000001: Ethical Review Board (ERB) of NHRC in achieving its commitment to promote and protect the dignity, rights,
p.000001: safety and wellbeing of all involved in health research in the culture and environment of Nepal.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: I
p.000001:
p.000001: As NHRC has already revised its national ethical guidelines for health research in Nepal, it is high time to revise the
p.000001: Guidelines for IRCs for Health Research in Nepal. Therefore, nine members (Annex – I) were delegated as a taskforce
p.000001: committee to accomplish this work, and over the period of revision, a series of meetings have been conducted. The
p.000001: revised Guideline for IRCs for Health Research in Nepal was prepared on July 2014. It is the result of several
p.000001: modifications, and incorporates many valuable suggestions provided by the consultative meeting participants
p.000001: (Annex – II). The draft guideline was presented and widely discussed during a two-day consultative meeting held in
p.000001: Kathmandu on 13 and 14 July 2014.
p.000001:
p.000001: This document is an updated edition of the Guidelines for IRCs for Health Research in Nepal, which will
p.000001: assist the ERB of NHRC by creating new IRCs at health care facilities, academic and research
p.000001: institutions, and will also provide a basic framework for the development of quality and consistency
p.000001: in the ethical review process. The Guidelines for IRC are intended to facilitate and support ethical review in any
p.000001: institution approving and undertaking the health research process in Nepal. Ethical review should always take into
p.000001: consideration the basic principles of ethics, such as dignity/respect of the person, the values of beneficence,
p.000001: justice, etc., without compromising the scientific merit and quality of the health research.
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: II
p.000001:
p.000001: Acknowledgements
p.000001: The suggestions from the workshops on Networking of National Health Research Institutes and Strengthening the Linkage
p.000001: of Research and Policy Making on 21-23 June 2013 and Strengthening of ERB & IRC Systems and Practices on 25-26 February
p.000001: 2014 identified that it had become time to revise the Guidelines for lRCs for Health Research in Nepal. In particular,
p.000001: some portions of the previous guideline needed amendments to bring it into alignment with the latest National Ethical
p.000001: Guidelines for Health Research in Nepal and SOP. Therefore, the Guidelines for lRCs for Health Research in
p.000001: Nepal has been published, and is intended to contribute to the development of quality and consistency in
p.000001: the ethical review processes within the health care facilities, academic institutions and research
p.000001: institutions that are involved in approving health research proposals.
p.000001:
p.000001: In this context, we would like to express our sincere thanks and gratitude to all the members of the
p.000001: Taskforce committee: Prof. Dr. Ramesh Kant Adhikari, Prof. Dr. Jeevan Bahadur Sherchand, Associate
p.000001: Prof. Dr. Aarati Shah, Prof. Dr. Rajendra Kumar BC, Mr. Mohan Krishna Shrestha, Mr. Purushottam
p.000001: Dhakal, Ms. Namita Ghimire, and Dr. Krishna Kumar Aryal.
p.000001:
...
p.000001: Health-related Research 11
p.000001: 12. Right of Appeal and Complains 12
p.000001: 13. Recording and Reporting/Documentationand Archiving 13
p.000001: 14. IRC's relationship with NHRC 14
p.000001: 15. Suspension or Discontinuation of Research 16
p.000001: 16. Annexes 17
p.000001: Annex – I 17
p.000001: 17. Appendixes 18
p.000001: Appendix – I 18
p.000001: Appendix – II 21
p.000001: 18. Bibliography 25
p.000001: 19. Glossary 27
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: V
p.000001:
p.000001: 1. Introduction
p.000001: The Nepal Health Research Council (NHRC) was established as a result of a commitment by the Government of
p.000001: Nepal (GoN) to promote scientific and ethically sound health-related research in Nepal.
p.000001:
p.000001: As mandated by the Act establishing the council, NHRC has been initiating and supporting all
p.000001: activities which enhance research capability and culture in the country. One of the main responsibilities of NHRC
p.000001: is to review and approve health-related research proposals. While reviewing these proposals, NHRC has
p.000001: always prioritized the protection of the rights of humans as well as animals involved in research, while
p.000001: promoting scientifically valid research. The Ethical Review Board (ERB) of NHRC cannot possibly review and monitor
p.000001: all research being conducted in the country. Therefore, NHRC has been supporting the establishment of
p.000001: Institutional Review Committees (IRCs) at health care facilities, academic institutions and research
p.000001: institutions. For the proper functioning of such IRCs, in 2005 NHRC developed IRC guidelines through a
p.000001: consultative process. In the course of time, new theories, principles, and postulates have emerged that limit the
p.000001: proper functioning of IRCs. Thus, to address these issues in the previous guidelines, this document has been
p.000001: developed. The development of guidelines for IRCs is a logical approach to promote and strengthen the capacity for
p.000001: review of health-related research.
p.000001:
p.000001: The Guidelines for lRCs for Health Research in Nepal (2005) provides a basic framework for quality and
p.000001: consistency in the ethical review process to be undertaken by health care facilities, academic institutions and
p.000001: research institutions in Nepal. However, a series of national workshops, particularly Networking of
p.000001: National Health Research Institutes and Strengthening the Linkage of Research and Policy Making, held on
p.000001: 21-23 June 2013, and Strengthening of ERB & IRC Systems and Practices, held on 25-26 February 2014, have highlighted
p.000001: the need to revise the existing Guidelines for lRCs for Health Research in Nepal. Specifically, some sections of
p.000001: the original guideline need amendments to bring them into alignment with the latest National Ethical
p.000001: Guidelines for Health Research in Nepal and Standard Operating Procedure (SOP) (2011).
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001:
p.000001: All health-related research, including surveys and interventional studies, must be reviewed and
p.000001: approved by an IRC prior to commencement.
p.000001:
p.000001: This guideline is designed to enable IRCs throughout Nepal to develop their own SOPs to suit the administrative
p.000001: structure of their institute. The revised guideline for IRCs for health-related research in Nepal intends to
p.000001: contribute to the development of quality and consistency in the ethical review processes within
p.000001: institutions that are involved in approving health-related research proposals. The anticipated result
...
p.000008: evaluation when any of the IRC members are investigators/advisors in a research study being
p.000008: reviewed. In such a situation, the member(s) should disclose the conflict of interest and refrain from
p.000008: participating in the review process by leaving the meeting room.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Communicating a Decision: A decision should be communicated in writing to the applicant according to the
p.000009: IRC procedures. The communication of the decision should include, but not be limited to, the following:
p.000009:
p.000009: • The exact title of the research proposal reviewed
p.000009: • The name and title of the research applicant
p.000009: • The name of the site(s) for the research
p.000009: • The date and place of the decision
p.000009: • A clear statement of the decision reached
p.000009: • Any suggestions by the IRC concerning the research
p.000009:
p.000009: The name and title of the authorized representative of the IRC or the institution involved should include their
p.000009: signature in the letterhead of the correspondence. The date should be mentioned after the signature.
p.000009:
p.000009: In the case of a conditional decision, any requirements by the IRC, including suggestions for revision,
p.000009: and details of the procedure for having the application re-reviewed should be clearly stated.
p.000009:
p.000009: In the case of approval of the study, the communication should include:
p.000009: (a) the need to notify the IRC in case of protocol amendments, (b) the need to notify the IRC in the case of amendments
p.000009: to the recruitment of research participants or the informed consent form, (c) the need to report serious and
p.000009: unexpected adverse events related to the conduct of the study, (d) the need to report unforeseen circumstances,
p.000009: the termination of the study and any information the IRC expects to receive in order to perform ongoing monitoring and
p.000009: supervision of the research study, and (e) the final report and any research articles published in scientific journals.
p.000009:
p.000009: If the proposal is either rejected or recommended for amendment, clearly stated reason(s) should be provided.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: All IRCs shall maintain a record of all research protocols received and reviewed including the following:
p.000010: • Name and responsible institution or organization or group or individual
p.000010: • Project identification number(s)
p.000010: • Principal investigator/co-investigator(s)
p.000010: • Title of the research proposal
p.000010: • Ethical approval or non-approval or pending or in process, with date
p.000010: • Approval or non-approval of any changes to the protocol
p.000010: • The terms and conditions, if any, of approval of any protocol
p.000010: • Whether approval is by expedited review
p.000010: • Action to be taken by the IRC to monitor/supervise the research
p.000010:
p.000010: Exemption from Review: Ethical review may not be required for studies such as quality control, method
p.000010: validation, or medical audit on condition that the results are not made available in a form that identifies the
p.000010: participants. Use of personal medical records without approaching or involving the patients concerned is, in principle,
p.000010: ethically acceptable provided confidentiality and anonymity are preserved. Such studies are entitled for waiver of the
p.000010: requirement for obtaining informed consent.
p.000010:
p.000010: 11. IRC's Role in Supervision and Monitoring of Health-related Research
p.000010: The IRC and the institution have the responsibility to ensure that the conduct of all health-related research
p.000010: approved by the IRC be monitored and supervised by procedures and/or by using existing appropriate
p.000010: mechanisms within the institution.
p.000010:
p.000010: The IRC should establish a follow-up procedure for tracking the progress of all research studies for which a
p.000010: positive decision has been made, from the time of the decision until the termination of the research. The
p.000010: communication between the IRC and the researcher should be clearly documented. The frequency and type of
p.000010: monitoring and supervision needs to be determined by the IRC. The IRC needs to monitor the progress of the research to
p.000010: observe whether it has followed the specific approved research proposal.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: Review any proposed revision(s) in the original research proposal (if necessary) and approve or disapprove it/them. The
p.000011: IRC shall require that the principal investigator immediately reports anything which might warrant additional ethical
p.000011: approval of the protocol, including:
p.000011:
p.000011: • Serious or unexpected adverse effects on research participants or communities
p.000011: • Proposed changes in the protocol
p.000011: • Unforeseen events that might affect the continual ethical acceptability of the project
p.000011:
p.000011: During the supervision and monitoring process, the IRC should review the problems (if any) in the implementation of the
p.000011: research proposal and guide the study team to solve them. It is also recommended that the IRC may provide feedback
...
p.000014:
p.000014: All IRCs should forward the following research proposals to NHRC for approval:
p.000014: • Research proposed at the national or international level
p.000014: • Externally sponsored/funded research (the term “externally” indicates not only outside of the
p.000014: country but also outside of the particular health care facility or institution)
p.000014: • Clinical trials involving human and/or animal participants
p.000014:
p.000014: Note: the above-mentioned proposals are not to be approved by IRCs other than the national ERB of NHRC. The IRC is also
p.000014: not authorised to provide ethical clearance to any research proposals from researchers outside the instition.
p.000014:
p.000014: Special instructions to IRCs:
p.000014: • All research proposals approved by the ERB of NHRC do not need further approval or processing fees from any IRC in
p.000014: the country.
p.000014: • All IRCs may charge certain fees (for the purpose of research promotion or institutional support) for the
p.000014: approval of proposals, but such fees should not exceed the NHRC proposal reviewing fee structure.
p.000014: • If a researcher desires to transfer biological samples abroad after a project has been approved without provision
p.000014: for sample transfer, the researcher should resubmit an amended research proposal to the ERB of NHRC for approval.
p.000014: This process will only be valid for postgraduate students, not for externally funded research work.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: 15. Suspension or Discontinuation of Research
p.000015: When the IRC is confident that circumstances have arisen in which a research project is not being or cannot be
p.000015: conducted in accordance with the approved protocol, and the welfare and rights of research participants are
p.000015: violated or cannot be protected as a result of such circumstances, the IRC may be required to take the
p.000015: following steps:
p.000015:
p.000015: • Withdraw approval
p.000015: • Inform the principal investigator of such withdrawal
p.000015: • Recommend the suspension or discontinuation of the research project or, any necessary steps to be undertaken
p.000015: • Make sure that research activities are suspended, stopped or discontinued via the process of withdrawal of
p.000015: ethical approval
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016:
p.000016: 16. Annexes Annex – I
p.000016: Task Force Committee
p.000016: 1. Prof. Dr. Ramesh Kant Adhikari
p.000016: Former Co-odinator, Ethical Review Board, NHRC Ramshah Path, Kathmandu
p.000016: 2. Dr. Khem Bahadur Karki
p.000016: Member-Secretary, Executive Chief, NHRC Ramshah Path, Kathmandu
p.000016: 3. Prof. Dr. Jeevan Bahadur Sherchand
p.000016: Co-odinator, Ethical Review Board, NHRC Ramshah Path, Kathmandu
p.000016: 4. Associate Prof. Dr. Aarati Shah Member
p.000016: Ethical Review Board, NHRC Ramshah Path, Kathmandu
p.000016: 5. Prof. Dr. Rajendra Kumar BC
p.000016: Pokhara University Research Center (PURC) Pokhara University, Kaski
p.000016: 6. Mr. Mohan Krishna Shrestha Tilganga Institute of Ophthalmology, Gaushala, Kathmandu
p.000016: 7. Mr. Purushottam Dhakal
p.000016: Chief, Ethical Review M & E Section, NHRC Ramshah Path, Kathmandu
p.000016: 8. Ms. Namita Ghimire
...
p.000032: participants. The investigator should have qualifications and competence in accordance with
p.000032: national laws and regulations as evidenced by up-to-date curriculum vitae and other credentials. A person
p.000032: who has
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: an academic degree in relevant biomedical or health-related subjects and other necessary professional credentials could
p.000033: be an investigator for a research project.
p.000033:
p.000033: IRC Approval
p.000033: A decision by the IRC that the proposal has been reviewed and may be conducted at an institution in accordance with the
p.000033: conditions set forth by the IRC.
p.000033:
p.000033: Minimum Risk
p.000033: When the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
p.000033: themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000033: psychological examinations or tests.
p.000033:
p.000033: Personal Data
p.000033: Data that relate to a living person and contain personally identifying information.
p.000033:
p.000033: Principal Investigator (PI)
p.000033: The main researcher responsible for the overall execution of a particular research project.
p.000033:
p.000033: Privacy
p.000033: The state or condition of being alone, undisturbed, or free from public attention, as a matter of choice or
p.000033: right; seclusion; freedom from interference or intrusion; absence or avoidance of publicity or display; secrecy,
p.000033: concealment, discretion; protection from public knowledge or availability.
p.000033:
p.000033: Private Information
p.000033: Information about behavior that occurs in a context when an individual can reasonably expect that no observation or
p.000033: recording is taking place, and information which has been provided for a specific purpose by an individual and which
p.000033: the individual can reasonably expect will not be individually identifiable (i.e., a medical record, questionnaire,
p.000033: etc.).
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Protocol
p.000034: A document which states the background, rationale and objectives of a research project and describes its design,
p.000034: methodology including statistical considerations, and the conditions under which it is to be performed and
p.000034: managed. The protocol should be dated and signed by the investigator. The protocol also refers to protocol amendments.
p.000034:
p.000034: Protocol Amendments
p.000034: A written description of change(s) to, or formal clarification of, a protocol.
p.000034:
p.000034: Quality Assurance (QA)
p.000034: All those planned and systematic actions that are established to ensure that a study/trial is performed and data
p.000034: generated, documented (recorded), and reported in compliance with GCP and applicable regulatory
p.000034: requirement(s).
p.000034:
p.000034: Quality Control (QC)
p.000034: The operational techniques and activities undertaken within the quality assurance system to verify that the
p.000034: requirements for quality of the study/trial-related activities have been fulfilled.
p.000034:
p.000034: Quorum
p.000034: A quorum is the minimum number of members that must be present to constitute a valid meeting where decisions can be
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| blind | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| criminal | criminal |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| emergency | Public Emergency |
| employees | employees |
| ethnic minority | ethnic minority |
| gender | gender |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| homeless | Homeless Persons |
| ill | ill |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| influence | Drug Usage |
| job | Occupation |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| literacy | Literacy |
| minor | Youth/Minors |
| minority | Racial Minority |
| nomads | nomad |
| officer | Police Officer |
| parent | parents |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| sick | Physically Ill |
| single | Marital Status |
| substance | Drug Usage |
| unemployed | Unemployment |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| healthy volunteers | ['volunteers'] |
| influence | ['drug', 'substance'] |
| party | ['political'] |
| placebo | ['controlXgroup'] |
| political | ['party'] |
| substance | ['drug', 'influence'] |
| volunteers | ['healthyXvolunteers'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input