79C3C34C52B45572883A05D425EB0F82
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
https://www.leaux.net/URLS/General/Standards_and_Operational_Guidance_for_Ethics_Review_of_Health-Related_Research_with_Human_Participants.pdf
http://leaux.net/URLS/ConvertAPI Text Files/B729F006030D9140E3F81F67713E0C99.en.txt
Examining the file media/Synopses/B729F006030D9140E3F81F67713E0C99.html:
This file was generated: 2020-12-01 09:26:50
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 / nomad
Searching for indicator nomads:
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p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
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p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
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Political / vulnerable
Searching for indicator vulnerable:
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p.000009: should be taken.
p.000009: 5. Researchers have a means of discussing concerns with REC members, both on general matters and in response to REC
p.000009: decisions on particular research studies.
p.000009: 6. REC decisions, excluding confidential information, are made publicly available, through
p.000009: mechanisms such as clinical trial registries, web sites, newsletters, and bulletin boards.
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p.000010: Chapter III
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p.000010: Standards and guidance for members of the research ethics committees
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p.000010: CHAPTER III
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p.000010: The primary task of an REC is the ethical review of research protocols and their supporting documents. Approval or
p.000010: disapproval is based on the ethical acceptability of the research, including its social value and scientific
p.000010: validity, an acceptable ratio of potential benefits to risks of harm, the minimization of risks, adequate
p.000010: informed consent procedures (including cultural appropriateness and mechanisms to ensure
p.000010: voluntariness), measures to ensure protection of vulnerable populations, fair procedures for selection of participants,
p.000010: and attention to the impact of research on the communities from which participants will be drawn, both during the
p.000010: research and after it is complete. The review take into account any prior scientific reviews and applicable laws.
p.000010:
p.000010: Standard 7: Ethical basis for decision-making in research ethics committees
p.000010: The REC bases its decisions about research that it reviews on a coherent and consistent application of the
p.000010: ethical principles articulated in international guidance documents and human rights instruments, as well as any
p.000010: national laws or policies consistent with those principles. The REC makes clear the specific ethical guidelines on
p.000010: which it relies in making decisions and makes them readily available to researchers and the public. When an REC
p.000010: develops reliance agreements for review of research under its jurisdiction by another REC, it is the responsibility of
p.000010: the delegating REC to assure that the same ethical principles serve as the basis of the other REC’s decision-making.
p.000010: To aid in determining the ethical acceptability of research protocols, an REC may utilize a checklist to
p.000010: ensure that all relevant criteria are considered during review and that, as a general rule, similar protocols are
p.000010: treated similarly. When an REC determines that an approach it has taken on a particular ethical issue in the past is no
p.000010: longer appropriate, it provides an explicit rationale for its change in position. In communicating decisions about
p.000010: particular protocols to researchers, the REC explains its analysis of any significant ethical issues that arose in the
p.000010: review.
...
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p.000040: 40
p.000040:
p.000040: GLOSSARY
p.000040:
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p.000040: considerations. Some of these considerations may be provided in other documents referred to in the protocol.
p.000040: Revision: Requirement by the research ethics committee to alter the protocol in some way prior to approval or
p.000040: additional review by the committee.
p.000040: Risk: The probability that an event, favourable or adverse, will occur within a defined time interval. Although often
p.000040: contrasted to benefit (as in a “risk/ benefit ratio”), the term “potential harm” is better for that context, leaving
p.000040: “risk” in its formal epidemiological sense to express the probability of a (typically adverse) event or
p.000040: outcome.
p.000040: Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation,
p.000040: management, and/or financing of research.
p.000040: Voluntary: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted,
p.000040: or suggested by another; (2) free of coercion, duress, or undue inducement. Used in the health and disability
p.000040: care and research contexts to refer to a consumer’s or participant’s decision to receive health or disability care or
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
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...
Health / Drug Usage
Searching for indicator drug:
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p.000012: representation at the WHO informal consultation, and later, in the critical comments received from the chief of the
p.000012: bioethics section of UNESCO, Dafna Feinholz.
p.000012: The feedback provided to earlier drafts of this document by the participants of the 8th Global Summit of
p.000012: National Bioethics Advisory Bodies (Singapore, July 2010), the 10th World Congress of Bioethics (Singapore,
p.000012: July 2010), the Third National Bioethics Conference (India, November 2010), the 5th National Meeting of Bioethics
p.000012: Commissions of Mexico (November 2010), the medical ethics conference: Is medical Ethics Really in the Best Interest of
p.000012: the Patient? (Sweden, June 2010), and the 10th FERCAP International Conference on Networking and Alliance
p.000012: Building for Ethical Health Research (China, November 2010) shaped the final version of this document.
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p.000012: viii
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p.000012: ACKNOWLEDGEMENTS
p.000012:
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p.000012: WHO gratefully acknowledges the contributions of the following reviewers, who provided a review and
p.000012: critical comments on an earlier draft of this document:
p.000012: Dieudonné Adiogo, M. Chi Primus Che, Nchangwi Syntia Munung, Odile Ouwe-Missi-Oukem-Boyer, Ludovic Reveiz,
p.000012: Godfrey B. Tangwa, and M. Jerome Mbih Tosam (on behalf of Cameroon Bioethics Initiative [CAMBIN]), Julian Rodriguez
p.000012: Alvarez and Martha M. Fors López (Centro Nacional Coordinador de Ensayos Clínicos, Cuba), Leslie Ball,
p.000012: Joanne Less, Kevin Prohaska, and Joseph Salewski (Food and Drug Administration [FDA], USA), Nika Berlic
p.000012: (Ministry of Health, Slovenia), Anne Buvé, Raffaella Ravinetto, Jef Verellen, and Bjorn Van Den Sande (Institute of
p.000012: Tropical Medicine, Belgium), Alistair Campbell and Donald Chalmers (University of Tasmania, Australia), Barbara
p.000012: DeCausey (Centers for Disease Control and Prevention [CDC], USA), Hans van Delden, Sev Fluss, Gunilla Sjölin
p.000012: Forsberg, and Rieke van der Graaf (on behalf of CIOMS, Switzerland), Christiane Druml (Ethics- Committee of the
p.000012: Medical University of Vienna, Austria), Gillian Fletcher (La Trobe University, Australia), Dirce Guilhem (on
p.000012: behalf of Foro Latinoamericano y del Caribe de Comités de Ética en Investigación para la Salud [FLACEIS]), Me
p.000012: Marie Hirtle (Biotika, Canada), Nuria Homedes (University of Texas, USA on behalf of Salud y Farmacos and
p.000012: Latin American Network on Clinical Trials and Ethics [RELEM]), Tawfik A. M. Khoja (Health Ministers Council for
p.000012: Cooperation Council, Kingdom of Saudi Arabia), Robert J. Levine, (Yale University, USA), Michael Makanga (European and
p.000012: Developing Countries Clinical Trials Partnership Secretariat Cape Town, S. Africa), Roli Mathur (Indian Council
p.000012: of Medical Research [ICMR], India), Joseph Millum (on behalf of the Fogarty International Center, National
p.000012: Institutes of Health, [NIH], USA), Keymanthri Moodley (University of Stellenbosch, South Africa), Mikkel Møller
...
p.000023: October 2011)
p.000023: 2. ICH Good Clinical Practice Guidelines (1996) (Available at http://www.
p.000023: ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E6_R1/Step4/E6_R1 Guideline.pdf
p.000023: 3. ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials (2000)
p.000023: (Available at http://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_
p.000023: Guideline.pdf , accessed 05 October 2011)
p.000023:
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p.000026: 26
p.000026:
p.000026: ANNEX
p.000026:
p.000026:
p.000026: 4. Council of Europe. Convention on Human Rights and Biomedicine, 1997 (Available at
p.000026: http://conventions.coe.int/treaty/EN/Treaties/ Html/164.htm, accessed 05 October 2011)
p.000026: 5. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning
p.000026: Biomedical Research, 2005 (Available at http://conventions.coe.int/treaty/EN/Treaties/Html/195. htm , accessed
p.000026: on 05 October 2011))
p.000026: 6. Directive of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.000026: laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
p.000026: practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European
p.000026: Communities, 2001 : L121/34. (Available at http://www.eortc.be/Services/Doc/clinical-EU- directive-04-April-01.pdf ,
p.000026: accessed 05 October 2011)
p.000026: 7. The Common Rule (45 CFR Part 46) ( Available at http://www.hhs.gov/ ohrp/policy/ohrpregulations.pdf accessed 05
p.000026: October 2011)
p.000026: 8. United States Food and Drug Administration regulations for the protection of
p.000026: humansubjectsCFR—CodeofFederalRegulationsTitle21,Part50(Available at
p.000026: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=50, accessed 15 August 2011
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p.000027: 27
p.000027:
p.000027: ANNEX
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p.000027: Annex 2
p.000027: Guidance for developing terms of reference for the Secretariat of the research ethics committee
p.000027: Institutions hosting RECs provide the RECs with a Secretariat that is adequately staffed to support them in
p.000027: their review and record keeping duties. At a minimum, the functions of the Secretariat include:
p.000027: 1. Informing and advising the principal investigators, sponsors, and new REC members of applicable regulations,
p.000027: guidelines, processes and procedures. In some cases the Secretariat maintains a website ensuring public access to this
p.000027: information.
p.000027: 2. Managing the timely progress of protocol review through initial and continuing contacts with
p.000027: Principal Investigators. This includes identifying and requesting missing documentation in applications and
p.000027: preparing the completed file for committee review.
p.000027: 3. Preparing the meetings of the REC, including the distribution of relevant documentation to the members, scheduling
...
Searching for indicator influence:
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p.000006: As an integral part of a health research institution or health system, an REC receives:
p.000006: 1. support staff, adequate in number and training to enable the REC to carry out its technical and administrative
p.000006: responsibilities;
p.000006: 2. adequate resources for the staff to fulfil its assigned functions, including office space and equipment
p.000006: and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct
p.000006: administrative business, to store committee files, and to keep documents secure and confidential;
p.000006: 3. access to appropriate space for the committee to meet and adequate means for members to communicate as needed
p.000006: between meetings;
p.000006: 4. adequate financial resources to permit the committee to produce high-quality work;
p.000006: 5. if considered necessary by the entity establishing the REC, resources necessary to compensate REC members,
p.000006: unless they are already being compensated for their time and effort on the REC through other means.
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p.000007: 7
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p.000007: CHAPTER II
p.000007:
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p.000007: Standard 4: Independence of research ethics committees
p.000007: Policies governing the REC include mechanisms to ensure independence of the REC’s operations, in order to
p.000007: protect decision- making from influence by any individual or entity that sponsors, conducts, or hosts the
p.000007: research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove
p.000007: themselves from the review of any research in which they or close family members have a conflicting interest.
p.000007: To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws,
p.000007: policies and/or procedural rules of the REC provide that:
p.000007: 1. the REC’s membership includes at least one person with no connection to the organization that sponsors
p.000007: or conducts the research under review;
p.000007: 2. researchers, sponsors, and funders may attend an REC meeting to answer questions about their
p.000007: research protocols and associated documents, but they are not present when the REC reaches decisions about their
p.000007: proposed research;
p.000007: 3. senior decision-makers of the entity creating the REC, or of any organization that sponsors or conducts
p.000007: the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members
p.000007: of the REC or its Chair;
p.000007: 4. the entity that establishes the REC ensures that REC members are protected from retaliation based on positions
p.000007: taken with respect to REC-related matters or review of research projects.
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p.000008: 8
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p.000008: CHAPTER II
p.000008:
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p.000008: Standard 5: Training the research ethics committee
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000022: b. any changes occur in the context of the research study that alter the potential benefits or risks
p.000022: c. the research project is completed
p.000022: d. results of the research are available.
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p.000023: 23
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p.000023: Annex
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p.000023: Annex 1. 2. 3.
p.000023: and Glossary
p.000023:
p.000023: ANNEX
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p.000023: Annex 1
p.000023: Guidelines and codes of best practice
p.000023: 1. Nuremberg Code (Available at: http://ohsr.od.nih.gov/guidelines/ nuremberg.html, accessed 17 January
p.000023: 2009)
p.000023: 2. Declaration of Helsinki (Available at http://www.wma.net/
p.000023: en/30publications/10policies/b3/index.html, accessed 05 October 2011)
p.000023: 3. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
p.000023: (Available at http://www.cioms.ch/ publications/layout_guide2002.pdf, accessed 05 October 2011)
p.000023: 4. CIOMS: International Ethical Guidelines for Epidemiological Research Involving Human Subjects (2009) (For more
p.000023: information click http:// www.cioms.ch/frame_ethical_guidelines_2009.htm)
p.000023: 5. UNAIDS/WHO, Ethical Considerations in Biomedical HIV Prevention Trials (2007) (Available at
p.000023: http://data.unaids.org/pub/Report/2007/ JC1399_ethical_considerations_en.pdf , accessed 05 October 2011)
p.000023: 6. UNESCO Universal Declaration on Bioethics and Human Rights (2005) (Available at
p.000023: http://portal.unesco.org/en/ev.php-URL_ ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000023: 7. Nuffield Council on Bioethics: the Ethics of Research related to Healthcare in Developing
p.000023: Countries (2002) (Available at http:// www.nuffieldbioethics.org/sites/default/files/Ethics%20of%20
p.000023: research%20related%20to%20healthcare%20in%20developing%20 countries%20I.pdf)
p.000023:
p.000023:
p.000023: Statutes and regulations
p.000023: 1. The Universal Declaration of Human Rights Available at http://www. un.org/en/documents/udhr/ accessed on 05
p.000023: October 2011)
p.000023: 2. ICH Good Clinical Practice Guidelines (1996) (Available at http://www.
p.000023: ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E6_R1/Step4/E6_R1 Guideline.pdf
p.000023: 3. ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials (2000)
p.000023: (Available at http://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_
p.000023: Guideline.pdf , accessed 05 October 2011)
p.000023:
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p.000026: 26
p.000026:
p.000026: ANNEX
p.000026:
p.000026:
p.000026: 4. Council of Europe. Convention on Human Rights and Biomedicine, 1997 (Available at
p.000026: http://conventions.coe.int/treaty/EN/Treaties/ Html/164.htm, accessed 05 October 2011)
...
Health / Healthy People
Searching for indicator volunteers:
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p.000012: Health Organization [ETH/WHO]), Carl Coleman (Seton Hall Law School, USA), Nancy Kass (Berman Institute of
p.000012: Bioethics, Bloomberg School of Public Health, USA), Juntra Laothavorn (Special Programme for Research and Training in
p.000012: Tropical Diseases [TDR]/WHO), Abha Saxena (ETH/WHO), and Sheryl Vanderpoel (Special Programme of Research,
p.000012: Development and Research Training in Human Reproduction [HRP]/WHO). In particular the conceptualization of the
p.000012: standards and the re-styling of the second edition was the outcome of discussions between Nancy Kass, Tikki Pang, and
p.000012: Abha Saxena. Comments on this document were also provided by members of the Technical Working Group on Ethics, members
p.000012: of the Research Ethics Review Committee, and focal points for WHO’s Strategy on Research for Health - Robert Terry
p.000012: - and the Global Strategy and Plan of Action on public health, innovation and intellectual property (GSPA -
p.000012: PHI ) – Precious Matsoso. This work was accomplished with the support of three WHO Directors, namely Rüdiger Krech
p.000012: (ETH/WHO), Tikki Pang (IER/ WHO), and Robert Ridley (TDR/WHO).
p.000012: The support provided by the Research Ethics Review Committee (WHO ERC), particularly the Chair of the Committee,
p.000012: Ronald Johnson, is gratefully acknowledged.
p.000012: The support provided by the regional offices of WHO in dissemination of the document for review purposes was invaluable
p.000012: and is gratefully acknowledged. We would also like to thank the various interns and volunteers at WHO, namely
p.000012: Lindsay Heck, Nola Tomaska, Ning Wong, and Yeyang Su, who over time have made important contributions to the project.
p.000012: Special thanks are due to the members of the WHO informal consultation noted below, who provided comments on the first
p.000012: draft of this document. Their detailed review and comments have shaped the development of the Standards:
p.000012:
p.000012: Clement Adebamowo (University of Ibadan, Nigeria), David Borasky (RTI International, USA), Ingrid Callies
p.000012: (Institut Pasteur, France), Alexander M. Capron (University of Southern California, USA), Julie
p.000012: Chaumont (Partnership for Appropriate Technology in Health,
p.000012:
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p.000012: vii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: France), Julius Ecuru (National Council for Science and Technology, Uganda), David G. Forster (Western
p.000012: Institutional Review Board, USA), Dirceu Greco, (Federal University of Minas Gerais, Brazil), Nouzha Guessous
p.000012: (Independent Researcher and Consultant, Morocco), Reva Gutnick (Independent Consultant), Samia Hurst (University
p.000012: of Geneva, Switzerland), Carel IJsselmuiden (Council on Health Research for Development [COHRED],
p.000012: Switzerland), Amar Jesani (Anusandhan Trust, India), Irakli Khodeli (United Nations Educational, Scientific
p.000012: and Cultural Organization [UNESCO], France), Otmar Kloiber (World Medical Association [WMA], France), Gottfried Kreutz
p.000012: (formerly of the Council for International Organizations of Medical Sciences [CIOMS], Switzerland) , Laurence Lwoff (on
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000039: Research protocol: A document that provides the background, rationale, and objective(s) of a biomedical
p.000039: research project and describes its design, methodology, and organization, including ethical and
p.000039: statistical
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: GLOSSARY
p.000040:
p.000040:
p.000040: considerations. Some of these considerations may be provided in other documents referred to in the protocol.
p.000040: Revision: Requirement by the research ethics committee to alter the protocol in some way prior to approval or
p.000040: additional review by the committee.
p.000040: Risk: The probability that an event, favourable or adverse, will occur within a defined time interval. Although often
p.000040: contrasted to benefit (as in a “risk/ benefit ratio”), the term “potential harm” is better for that context, leaving
p.000040: “risk” in its formal epidemiological sense to express the probability of a (typically adverse) event or
p.000040: outcome.
p.000040: Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation,
p.000040: management, and/or financing of research.
p.000040: Voluntary: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted,
p.000040: or suggested by another; (2) free of coercion, duress, or undue inducement. Used in the health and disability
p.000040: care and research contexts to refer to a consumer’s or participant’s decision to receive health or disability care or
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000040: Revision: Requirement by the research ethics committee to alter the protocol in some way prior to approval or
p.000040: additional review by the committee.
p.000040: Risk: The probability that an event, favourable or adverse, will occur within a defined time interval. Although often
p.000040: contrasted to benefit (as in a “risk/ benefit ratio”), the term “potential harm” is better for that context, leaving
p.000040: “risk” in its formal epidemiological sense to express the probability of a (typically adverse) event or
p.000040: outcome.
p.000040: Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation,
p.000040: management, and/or financing of research.
p.000040: Voluntary: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted,
p.000040: or suggested by another; (2) free of coercion, duress, or undue inducement. Used in the health and disability
p.000040: care and research contexts to refer to a consumer’s or participant’s decision to receive health or disability care or
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
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...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000006: and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct
p.000006: administrative business, to store committee files, and to keep documents secure and confidential;
p.000006: 3. access to appropriate space for the committee to meet and adequate means for members to communicate as needed
p.000006: between meetings;
p.000006: 4. adequate financial resources to permit the committee to produce high-quality work;
p.000006: 5. if considered necessary by the entity establishing the REC, resources necessary to compensate REC members,
p.000006: unless they are already being compensated for their time and effort on the REC through other means.
p.000006:
p.000006:
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p.000007: 7
p.000007:
p.000007: CHAPTER II
p.000007:
p.000007:
p.000007: Standard 4: Independence of research ethics committees
p.000007: Policies governing the REC include mechanisms to ensure independence of the REC’s operations, in order to
p.000007: protect decision- making from influence by any individual or entity that sponsors, conducts, or hosts the
p.000007: research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove
p.000007: themselves from the review of any research in which they or close family members have a conflicting interest.
p.000007: To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws,
p.000007: policies and/or procedural rules of the REC provide that:
p.000007: 1. the REC’s membership includes at least one person with no connection to the organization that sponsors
p.000007: or conducts the research under review;
p.000007: 2. researchers, sponsors, and funders may attend an REC meeting to answer questions about their
p.000007: research protocols and associated documents, but they are not present when the REC reaches decisions about their
p.000007: proposed research;
p.000007: 3. senior decision-makers of the entity creating the REC, or of any organization that sponsors or conducts
p.000007: the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members
p.000007: of the REC or its Chair;
p.000007: 4. the entity that establishes the REC ensures that REC members are protected from retaliation based on positions
p.000007: taken with respect to REC-related matters or review of research projects.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
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p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: CHAPTER II
p.000008:
p.000008:
p.000008: Standard 5: Training the research ethics committee
p.000008: Training on the ethical aspects of health-related research with human participants, how ethical
p.000008: considerations apply to different types of research, and how the REC conducts its review of research, is provided
p.000008: to REC members when they join the committee and periodically during their committee service.
...
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000012: 12
p.000012:
p.000012: CHAPTER III
p.000012:
p.000012:
p.000012: 1. Scientific design and conduct of the study
p.000012: Research is ethically acceptable only if it relies on valid scientific methods. Research that is not scientifically
p.000012: valid exposes research participants or their communities to risks of harm without any possibility of benefit.
p.000012: RECs should have documentation from a prior scientific review, or should themselves determine that the research methods
p.000012: are scientifically sound, and should examine the ethical implications of the chosen research design or strategy. Unless
p.000012: already determined by a prior scientific review, RECs should also assess how the study will be conducted, the
p.000012: qualifications of the researcher(s), the adequacy of provisions made for monitoring and auditing, as well as the
p.000012: adequacy of the study site (e.g. availability of qualified staff and appropriate infrastructures).
p.000012: 2. Risks and potential benefits
p.000012: In ethically acceptable research, risks have been minimized (both by preventing potential harms and minimizing
p.000012: their negative impacts should they occur) and are reasonable in relation to the potential benefits of the study. The
p.000012: nature of the risks may differ according to the type of research to be conducted. REC members should be aware that
p.000012: risks may occur in different dimensions (e.g. physical, social, financial, or psychological), all of which require
p.000012: serious consideration. Further, harm may occur either at an individual level or at the family or population level.
p.000012: 3. Selection of study population and recruitment of research participants
p.000012: Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens
p.000012: of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research;
p.000012: these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is
p.000012: designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear
p.000012: the risks of participating in the research is likely to benefit from the knowledge derived from the research. In
p.000012: addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the
p.000012: purpose of the research, the risks and potential benefits of participating in the research, and other
p.000012: relevant details.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: CHAPTER III
p.000013:
p.000013:
p.000013: 4. Inducements, financial benefits, and financial costs
p.000013: It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated
p.000013: with participation in research, including transportation, child care, or lost wages. Many RECs also believe
p.000013: that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or
p.000013: free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000003: appointed in sufficient numbers to ensure that they feel comfortable voicing their views.
p.000003: 3. In order to enhance independence, committee membership includes members who are not affiliated with organizations
p.000003: that sponsor, fund, or conduct research reviewed by the REC (see also Standard 4).
p.000003: 4. Committees are large enough to ensure that multiple perspectives are brought into the discussion. To this end,
p.000003: quorum requirements provide that at least five people, including at least one lay member and one non-affiliated member,
p.000003: are present to make decisions about the proposed research.
p.000003:
p.000003:
p.000003:
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p.000003:
p.000006: 6
p.000006:
p.000006: CHAPTER II
p.000006:
p.000006:
p.000006: Standard 3: Research ethics committee resources
p.000006: The entity establishing the REC supports it with adequate resources, including staffing, facilities, and financial
p.000006: resources to allow the REC to effectively carry out its responsibilities.
p.000006: As an integral part of a health research institution or health system, an REC receives:
p.000006: 1. support staff, adequate in number and training to enable the REC to carry out its technical and administrative
p.000006: responsibilities;
p.000006: 2. adequate resources for the staff to fulfil its assigned functions, including office space and equipment
p.000006: and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct
p.000006: administrative business, to store committee files, and to keep documents secure and confidential;
p.000006: 3. access to appropriate space for the committee to meet and adequate means for members to communicate as needed
p.000006: between meetings;
p.000006: 4. adequate financial resources to permit the committee to produce high-quality work;
p.000006: 5. if considered necessary by the entity establishing the REC, resources necessary to compensate REC members,
p.000006: unless they are already being compensated for their time and effort on the REC through other means.
p.000006:
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p.000006:
p.000007: 7
p.000007:
p.000007: CHAPTER II
p.000007:
p.000007:
p.000007: Standard 4: Independence of research ethics committees
p.000007: Policies governing the REC include mechanisms to ensure independence of the REC’s operations, in order to
p.000007: protect decision- making from influence by any individual or entity that sponsors, conducts, or hosts the
p.000007: research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove
p.000007: themselves from the review of any research in which they or close family members have a conflicting interest.
p.000007: To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws,
p.000007: policies and/or procedural rules of the REC provide that:
p.000007: 1. the REC’s membership includes at least one person with no connection to the organization that sponsors
...
p.000018: documentation for the meetings, inviting non-members of the REC, approving the meeting minutes, and any related process
p.000018: issues. Procedures for deliberation and decision-making are clearly established and described. Specific quorum
p.000018: requirements for reviewing and making decisions or taking actions are clearly established in the standard operating
p.000018: procedures.
p.000018: 5. Communicating a decision
p.000018: The REC’s policies and procedures describe procedures for communicating the decisions of the
p.000018: REC and specify the maximum amount of time between the decision about the application and when the applicant is
p.000018: informed.
p.000018: 6. Follow-up reviews and monitoring of proposed research
p.000018: Standard operating procedures describe the process by which RECs will follow up the progress of all approved
p.000018: studies—from the time that the approval decision is taken until the termination or completion of the
p.000018: research.
p.000018: 7. Documentation and archiving
p.000018: All of the REC’s documentation and communication is dated, filed, and archived according to the committee’s
p.000018: written procedures. Records may be kept either in hard copy or electronically. In either case, sufficient
p.000018: safeguards are established (e.g. locked cabinets for hard copy files, password protection and encryption
p.000018: for electronic files) to maintain confidentiality. Members of staff are sufficiently trained to understand
p.000018: their responsibilities related to record-keeping, retrieval, and confidentiality. Procedures outline who is authorized
p.000018: to access committee files and documents.
p.000018: Further guidance on REC written procedures is provided in Annex 3.
p.000018:
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p.000018:
p.000019: 19
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p.000019:
p.000019:
p.000019: Chapter V
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Standards and guidance
p.000019: for researchers
p.000019:
p.000019: ANNEX
p.000019:
p.000019:
p.000019: Standard 10: Researchers’ responsibilities
p.000019: Research is performed only by persons with scientific, clinical, or other relevant qualifications
p.000019: appropriate to the project, who are familiar with the ethical standards applicable to their research, who submit
p.000019: the necessary information to the REC for review (including both the research protocol and disclosures of
p.000019: any conflicting interests), and who carry out the research in compliance with the requirements established by the
p.000019: REC.
p.000019: The person conducting research fulfils the following criteria in the conduct of ethical research.
p.000019: 1. Submitting an application for review
p.000019: a. An application or review of the ethics of proposed health-related research is submitted by a
p.000019: researcher qualified to undertake the particular study, who is directly responsible for the ethical and
p.000019: scientific conduct of the research. In certain jurisdictions, the sponsor of a study is responsible for submitting the
p.000019: research protocol to the REC.
p.000019: b. Student applications are submitted under the responsibility of a qualified advisor / faculty member
p.000019: involved in the oversight of the student’s work or in the student’s name, co-signed by the qualified faculty
p.000019: supervisor.
p.000019: c. All information required for a thorough and complete review of the ethics of proposed research is submitted,
p.000019: including disclosures about researchers’ conflicting interests, if any.
p.000019: 2. Conduct of research
p.000019: a. The research is conducted in compliance with the protocol approved
p.000019: by the REC.
p.000019: b. No deviation or changes are made to the approved protocol or in following it, without prior
p.000019: approval of the REC, except where immediate action is necessary to avoid harm to research participants. In such a
p.000019: case, the REC is informed promptly of the changes/deviations made, and the justification for doing so.
p.000019: c. The REC is informed of any changes at the research site that significantly affect the conduct of
p.000019: the trial, and/or reduce the protections or decrease the benefits provided or increase the risk to
p.000019: participants (e.g. closing down of a health facility at the
p.000019:
p.000019:
p.000019:
p.000022: 22
p.000022:
p.000022: ANNEX
p.000022:
p.000022:
p.000022: research site or other impediments to obtaining access to health care that was originally available).
p.000022: 3. Safety reporting
p.000022: a. All serious, unexpected adverse events related to the conduct of the study/study product or unanticipated
p.000022: problems involving risks of harm to the participants or others are promptly reported to the REC and/or other relevant
p.000022: authorities, as required by REC policies and applicable laws.
p.000022: b. Any recommendations provided by the REC in response to such reporting are immediately implemented.
p.000022: 4. Ongoing reporting and follow-up
p.000022: a. The researcher submits written summaries of the research status to
p.000022: the REC annually, or more frequently, if requested by the REC.
p.000022: b. Researchers inform the REC when a study is completed or prematurely suspended/terminated.
p.000022: c. In the case of the early suspension/termination by the researcher or sponsor, the researcher notifies the
p.000022: REC of the reasons for suspension/termination; provides a summary of results obtained prior to prematurely
p.000022: suspending or terminating the study; and describes the manner by which enrolled participants will be
p.000022: notified of the suspension or termination and the plans for care and follow-up for the participants.
p.000022: d. If the REC terminates or suspends its approval of a study, the researcher informs the institution under whose
p.000022: authority the research is being conducted, the sponsor of the research, and any other applicable organizations.
p.000022: 5. Information to research participants
p.000022: Researchers have a responsibility to keep the research participants and their communities informed of the progress of
...
p.000026: Communities, 2001 : L121/34. (Available at http://www.eortc.be/Services/Doc/clinical-EU- directive-04-April-01.pdf ,
p.000026: accessed 05 October 2011)
p.000026: 7. The Common Rule (45 CFR Part 46) ( Available at http://www.hhs.gov/ ohrp/policy/ohrpregulations.pdf accessed 05
p.000026: October 2011)
p.000026: 8. United States Food and Drug Administration regulations for the protection of
p.000026: humansubjectsCFR—CodeofFederalRegulationsTitle21,Part50(Available at
p.000026: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=50, accessed 15 August 2011
p.000026:
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p.000027: 27
p.000027:
p.000027: ANNEX
p.000027:
p.000027:
p.000027: Annex 2
p.000027: Guidance for developing terms of reference for the Secretariat of the research ethics committee
p.000027: Institutions hosting RECs provide the RECs with a Secretariat that is adequately staffed to support them in
p.000027: their review and record keeping duties. At a minimum, the functions of the Secretariat include:
p.000027: 1. Informing and advising the principal investigators, sponsors, and new REC members of applicable regulations,
p.000027: guidelines, processes and procedures. In some cases the Secretariat maintains a website ensuring public access to this
p.000027: information.
p.000027: 2. Managing the timely progress of protocol review through initial and continuing contacts with
p.000027: Principal Investigators. This includes identifying and requesting missing documentation in applications and
p.000027: preparing the completed file for committee review.
p.000027: 3. Preparing the meetings of the REC, including the distribution of relevant documentation to the members, scheduling
p.000027: the meetings, and ensuring the quorum.
p.000027: 4. In close collaboration with the chair of the REC, preparing applications that will be evaluated through expedited
p.000027: review.
p.000027: 5. Following-up with tasks that the REC requests the principal investigators to perform such as progress
p.000027: reports, final reports, corrective actions, amendment of the approved protocol or consent documents etc.
p.000027: 6. In close collaboration with the Chair of the REC, preparing reports of REC meetings and annual reports of REC
p.000027: activities. The annual report includes information about sources of funding and expenses of the REC.
p.000027: 7. Record keeping, including maintaining research protocols and all correspondence in relation to their
p.000027: review, as well as records of any continuing oversight that may be required after approval. The Secretariat
p.000027: ensures that the confidentiality of REC records is maintained.
p.000027: 8. Facilitating access to literature and educational programmes useful to the members of REC.
p.000027:
p.000027: 9. Up dating information about REC membership, including declarations of potential conflicts of interests.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: ANNEX
p.000028:
p.000028:
p.000028: Additional responsibilities may be delegated to the Secretariat staff by the entity creating the REC and/or
p.000028: the REC Chair, as appropriate in light of the Secretariat’s training, expertise, capacity, and resources;
p.000028: such responsibilities may include keeping abreast of developments in research ethics and regulation,
p.000028: engaging in community outreach and education, serving as a liaison between the REC and the research community,
p.000028: facilitating implementation of quality improvement and quality assurance programs etc.
p.000028:
p.000028:
p.000028:
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p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: ANNEX
p.000029:
p.000029:
p.000029: Annex 3
p.000029: Guidance for developing written procedures for the research ethics committee
...
p.000031: under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and
p.000031: toxicological data available on the study product, together with a summary of clinical experience with the study
p.000031: product to date (e.g. recent investigator’s brochure, published data, a summary of the product’s characteristics)
p.000031: 7. current curricula vitae of the principle investigators
p.000031: 8. all data collection forms to be used in the research project, including but not limited to case report
p.000031: forms, diary cards, questionnaires, interview schedules, etc., clearly identified and dated
p.000031: 9. all forms, documents, advertisements to be used in recruitment of potential participants
p.000031: 10. a detailed description of the recruitment process and strategies
p.000031: 11. informed consent form(s) (with date and version number) in languages understood and at a reading
p.000031: level appropriate for the potential research participants and when required, in other languages
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: ANNEX
p.000032:
p.000032:
p.000032: 12. a description of the process that will be used to obtain and document informed consent
p.000032: 13. a description of measures that will be taken to ensure the protection of participants’ privacy and the
p.000032: confidentiality of data
p.000032: 14. a statement describing any remuneration or other goods or services to be provided to study
p.000032: participants, including reimbursement of expenses and access to medical care
p.000032: 15. a description of arrangements for insurance coverage for research participants, if applicable
p.000032: 16. disclosure of all previous decisions (including those leading to a negative decision or modified
p.000032: proposal) by other RECs or regulatory authorities for the proposed study, whether in the same location or
p.000032: elsewhere, and indication of the reasons for previous negative decisions and modification(s) to the proposal
p.000032: made on that account
p.000032: 17. a statement that the researcher(s) agree to comply with ethical principles set out in relevant guidelines.
p.000032: c) Review procedures
p.000032: The REC’s written procedures specify the process by which the REC will decide which projects should be reviewed by the
p.000032: full convened committee and which projects may be reviewed through an expedited procedure. The written procedures
p.000032: address who will have the responsibility of making this determination, as well as the number of reviewers required for
p.000032: expedited review and how those reviewers will be selected. The Chair regularly notifies the REC members of expedited
p.000032: reviews that have been conducted between convened REC meetings. The REC’s written procedures state the procedures for
p.000032: coordinating with and/or relying on the reviews and decisions of other domestic RECs or RECs in other countries.
p.000032: d) REC meetings
p.000032: RECs should meet regularly as a committee on dates that are announced in advance. The written procedures should
p.000032: describe the process for setting up meetings, circulating documentation for the meetings, inviting non-members of the
p.000032: REC, approving the meeting minutes, and any related process issues. The following issues are outlined in the written
p.000032: procedures:
...
p.000036: 1. any protocol amendment likely to affect the rights, safety, and/or well-being of the research participants or
p.000036: the conduct of the study
p.000036: 2. serious unexpected adverse events related to the conduct of the study or study product
p.000036: 3. any event or new information that might affect the potential benefits or risks of harm involved in the
p.000036: study
p.000036: 4. decisions made by a data safety monitoring board (DSMB) or other monitoring or regulatory authorities to suspend
p.000036: a study in whole or in part
p.000036: e) a decision resulting from a follow up review should be issued and communicated to the applicant,
p.000036: indicating either that the original decision is still valid or that there has been a modification, suspension, or
p.000036: withdrawal of the REC’s original decision.
p.000036:
p.000036: VII. Documentation and archiving
p.000036: All of the REC’s documentation and communication is dated, filed, and archived according to the committee’s
p.000036: policies and written procedures. Such policies should be consistent with any relevant local laws or institutional
p.000036: policies. REC records may be kept in hard copy, electronically, or both. In either case, sufficient safeguards are
p.000036: established (e.g. locked cabinets for hard copy files, password
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: ANNEX
p.000037:
p.000037:
p.000037: protection and encryption for electronic files) to maintain confidentiality. Members of staff are
p.000037: sufficiently trained to understand their responsibilities related to record keeping, retrieval, and
p.000037: confidentiality. Procedures outline who is authorized to access committee files and documents.
p.000037: a) Committee-related documents
p.000037: Committee-related documents that should be filed and archived include, but are not limited to:
p.000037: 1. any documents formally establishing the REC
p.000037: 2. the REC’s standard operating procedures
p.000037: 3. the published guidelines for submission of documents to the REC
p.000037: 4. annual reports summarizing REC activities; such reports will promote transparency and will help raise
p.000037: awareness of the REC within its institution or jurisdiction, as well as serving as an ongoing reminder of the
p.000037: resources necessary to run the committee
p.000037: 5. curricula vitae of all REC members
p.000037: 6. record of all income and expenses of the REC, including allowances and reimbursements made to the
p.000037: secretariat and REC members and for what purposes
p.000037: 7. agendas of the REC meetings
p.000037: 8. minutes of the REC meetings
p.000037: 9. regulatory texts used by the REC
p.000037: b) Project-related documents
p.000037: All documents and materials related to the review of specific projects should be filed. Committee procedures should
p.000037: specify length of time documents must be archived—for example, with studies under ICH GCP, the documents are archived
p.000037: for a minimum period of 3 years following completion of the study. These include, but are not limited to:
p.000037: 1. one copy of all materials submitted by an applicant
p.000037: 2. any correspondence by the REC with applicants or concerned parties regarding applications, decisions, and
p.000037: follow-up
p.000037: 3. a copy of initial and follow up decisions and any advice or requirements sent to an applicant
p.000037: 4. all written documentation received during the follow-up, including any advice or requirements sent
...
p.000038: Bioethics: A field of ethical enquiry that examines ethical issues and dilemmas arising from health, health
p.000038: care, and research involving humans.
p.000038: Compensation: That which is given in recompense, as an equivalent rendered, or remuneration.
p.000038: Confidentiality: The obligation to keep information secret unless its disclosure has been appropriately
p.000038: authorized by the person concerned or, in extraordinary circumstances, by the appropriate authorities.
p.000038: Conflict of interest: In the research context, scientists have a conflict of interest if they stand to achieve
p.000038: personal gain (money or the equivalent) by failing to discharge professional obligations, either to protect the welfare
p.000038: of participants or to uphold the integrity of the scientific process.
p.000038: Consent form: An easily understandable written document that documents a potential participant’s consent to be involved
p.000038: in research which describes the rights of an enrolled research participant. This form should communicate the following
p.000038: in a clear and respectful manner: research time-frame; title of research; researchers involved;
p.000038: purpose of research; description of research; potential harms and benefits; treatment alternatives;
p.000038: statement of confidentiality; information and data to be collected; how long the data will be kept, how it will be
p.000038: stored and who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000038: participation at any point; and declarative statement of understanding that the potential participant agrees to and
p.000038: signs. The consent form should be in a language that the potential participant understands. For potential participants
p.000038: with limited literacy, the verbal communication of the consent document details should be provided along with proper
p.000038: documentation of consent, if it be given.
p.000038: Ethical guidelines: Guidance documents which assist with decisions relating to the responsibility to adhere to
p.000038: established and relevant standards of ethical principles and practice.
p.000038: Expedited review: Review of proposed research by the REC chair or a designated voting member or group of
p.000038: voting members rather than by the entire REC.
p.000038: Informed consent: Is a decision to participate in research, taken by a competent individual who has
p.000038: received the necessary information; who
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: GLOSSARY
p.000039:
p.000039:
p.000039: has adequately understood the information; and who, after considering the information, has arrived at a decision
p.000039: without having been subjected to coercion, undue influence or inducement, or intimidation.
...
Social / Child
Searching for indicator child:
(return to top)
p.000012: risks may occur in different dimensions (e.g. physical, social, financial, or psychological), all of which require
p.000012: serious consideration. Further, harm may occur either at an individual level or at the family or population level.
p.000012: 3. Selection of study population and recruitment of research participants
p.000012: Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens
p.000012: of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research;
p.000012: these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is
p.000012: designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear
p.000012: the risks of participating in the research is likely to benefit from the knowledge derived from the research. In
p.000012: addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the
p.000012: purpose of the research, the risks and potential benefits of participating in the research, and other
p.000012: relevant details.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: CHAPTER III
p.000013:
p.000013:
p.000013: 4. Inducements, financial benefits, and financial costs
p.000013: It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated
p.000013: with participation in research, including transportation, child care, or lost wages. Many RECs also believe
p.000013: that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or
p.000013: free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to
p.000013: participate in the research against their better judgement or to compromise their understanding of the research.
p.000013: 5. Protection of research participants’ privacy and confidentiality
p.000013: Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss
p.000013: of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or
p.000013: lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard
p.000013: participants’ privacy and confidentiality.
p.000013: 6. Informed consent process
p.000013: The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled
p.000013: to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what
p.000013: the research entails. Decisions for children or adults who lack the mental capacity to provide informed
p.000013: consent should be made by an authorized surrogate decision-maker.
...
Searching for indicator children:
(return to top)
p.000013: It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated
p.000013: with participation in research, including transportation, child care, or lost wages. Many RECs also believe
p.000013: that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or
p.000013: free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to
p.000013: participate in the research against their better judgement or to compromise their understanding of the research.
p.000013: 5. Protection of research participants’ privacy and confidentiality
p.000013: Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss
p.000013: of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or
p.000013: lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard
p.000013: participants’ privacy and confidentiality.
p.000013: 6. Informed consent process
p.000013: The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled
p.000013: to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what
p.000013: the research entails. Decisions for children or adults who lack the mental capacity to provide informed
p.000013: consent should be made by an authorized surrogate decision-maker.
p.000013: RECs should examine the process through which informed consent will occur, as well as the information that will be
p.000013: provided. RECs may waive the requirement of informed consent only when doing so is consistent with international
p.000013: guidelines and national standards.
p.000013: While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to
p.000013: research does not, in itself, mean that the research is ethically acceptable.
p.000013: 7. Community considerations
p.000013: Research has impacts not only on the individuals who participate, but also on the communities where the research occurs
p.000013: and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as
p.000013: far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local
p.000013: capacity, and
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: CHAPTER III
p.000014:
p.000014:
p.000014: promoting, as relevant, positive effects on communities, including those related to health effects or capacity
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
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p.000041:
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p.000041:
p.000041:
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p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
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p.000041:
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p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
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p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000012: that Member States may find it useful to have a set of global standards for high quality decision-making against which
p.000012: RECs might measure their own performance. The meeting participants recommended that WHO coordinate efforts to
p.000012: draft standards for RECs and to revise the 2000 Operational guidelines to describe specific procedures to
p.000012: meet the standards. WHO also consulted widely during the course of revising these guidelines through open
p.000012: consultation at a number of international conferences, through list-serves, and with other agencies as listed in the
p.000012: Acknowledgements.
p.000012: This second edition of the 2000 Operational guidelines was developed as a result of these global developments.
p.000012: It consists of a compilation of 10 standards that are applicable to the ethics review of health- related
p.000012: research with human participants. The term “standards” is
p.000012:
p.000012:
p.000012: 1 http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf accessed on 21.06.2011
p.000012: 2 http://apps.who.int/gb/ebwha/pdf_files/WHA61-REC1/A61_Rec1-part2-en.pdf and http://apps.
p.000012: who.int/gb/ebwha/pdf_files/WHA63-REC1/WHA63_REC1-P2-en.pdf accessed on 21.06.2011
p.000012:
p.000012:
p.000012:
p.000012: xii
p.000012:
p.000012: PREFACE
p.000012:
p.000012:
p.000012: used to delineate general principles and norms that all research ethics systems are expected to follow. Standards (set
p.000012: forth in bold type) in this document are intended to help RECs achieve high quality performance and to provide a common
p.000012: language that establishes specific outcomes or characteristics against which achievements can be benchmarked.
p.000012: The standards put forward in this document do not represent new ideas for REC functioning. Rather, they are based on
p.000012: requirements for RECs delineated in existing international guidance documents. Their purpose is to underscore essential
p.000012: considerations relevant to the ethical review of research, not to take a substantive position on how specific ethical
p.000012: dilemmas should be resolved. Accompanying the standards are a series of “operational guidance” points (set forth in
p.000012: regular type), which reflect commonly used strategies for implementing and fulfilling each of the standards.
p.000012: In addition to delineating standards for the research ethics system, three other changes have been made in this
p.000012: edition. First, the title has been changed to reflect the purpose of the document. Second, the importance of a systems
p.000012: approach to research ethics—alluded to in the first edition of the book—has been further elaborated, and
p.000012: expanded to include and delineate the role of national governments and relevant legal and regulatory
p.000012: authorities. Third, the scope of the document has been enlarged to include all health-related research ethics
p.000012: committees, whether they review biomedical, social science, epidemiological, operational, or health systems research.
p.000012: This document is intended provide guidance on the research ethics review process, not to take a substantive
...
p.000022: a. All serious, unexpected adverse events related to the conduct of the study/study product or unanticipated
p.000022: problems involving risks of harm to the participants or others are promptly reported to the REC and/or other relevant
p.000022: authorities, as required by REC policies and applicable laws.
p.000022: b. Any recommendations provided by the REC in response to such reporting are immediately implemented.
p.000022: 4. Ongoing reporting and follow-up
p.000022: a. The researcher submits written summaries of the research status to
p.000022: the REC annually, or more frequently, if requested by the REC.
p.000022: b. Researchers inform the REC when a study is completed or prematurely suspended/terminated.
p.000022: c. In the case of the early suspension/termination by the researcher or sponsor, the researcher notifies the
p.000022: REC of the reasons for suspension/termination; provides a summary of results obtained prior to prematurely
p.000022: suspending or terminating the study; and describes the manner by which enrolled participants will be
p.000022: notified of the suspension or termination and the plans for care and follow-up for the participants.
p.000022: d. If the REC terminates or suspends its approval of a study, the researcher informs the institution under whose
p.000022: authority the research is being conducted, the sponsor of the research, and any other applicable organizations.
p.000022: 5. Information to research participants
p.000022: Researchers have a responsibility to keep the research participants and their communities informed of the progress of
p.000022: research by appropriate means, at suitable time-frames in simple and non-technical language, for example, when:
p.000022: a. the research study is terminated or cancelled
p.000022: b. any changes occur in the context of the research study that alter the potential benefits or risks
p.000022: c. the research project is completed
p.000022: d. results of the research are available.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex 1. 2. 3.
p.000023: and Glossary
p.000023:
p.000023: ANNEX
p.000023:
p.000023:
p.000023: Annex 1
p.000023: Guidelines and codes of best practice
p.000023: 1. Nuremberg Code (Available at: http://ohsr.od.nih.gov/guidelines/ nuremberg.html, accessed 17 January
p.000023: 2009)
p.000023: 2. Declaration of Helsinki (Available at http://www.wma.net/
p.000023: en/30publications/10policies/b3/index.html, accessed 05 October 2011)
p.000023: 3. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
p.000023: (Available at http://www.cioms.ch/ publications/layout_guide2002.pdf, accessed 05 October 2011)
p.000023: 4. CIOMS: International Ethical Guidelines for Epidemiological Research Involving Human Subjects (2009) (For more
p.000023: information click http:// www.cioms.ch/frame_ethical_guidelines_2009.htm)
...
p.000030: notifying decisions to applicants).
p.000030:
p.000030: III. Independent consultants
p.000030: Written procedures define the circumstances under which an REC may call upon independent consultants to provide special
p.000030: expertise to the REC on specific research projects, populations, or topics. Such consultants could include
p.000030: experts in ethics, law, or specific medical specialties or procedures, or they might be representatives of communities,
p.000030: patients, or other groups relevant to the deliberations required. Written procedures require terms of reference for
p.000030: independent consultants and confidentiality agreement, and clarify that—because consultants are not members of the
p.000030: REC—they do not have any voting or decision-making authority.
p.000030:
p.000030: IV. Submissions, documents required for review, review pro- cedures, and decision-making
p.000030: a) Submission procedures
p.000030: The written procedures describe the requirements for submitting a research project for review. Submission
p.000030: requirements and required forms should be readily available to prospective applicants. Application
p.000030: instructions generally include at least the following:
p.000030: 1. the name(s) and address(es) of the REC secretariat, officers, or member(s) to whom the application material
p.000030: should be submitted
p.000030: 2. all written documentation to be submitted as part of the application
p.000030: 3. the format for submission
p.000030: 4. the language(s) in which (core) documents are to be submitted
p.000030: 5. the number of copies to be submitted
p.000030: 6. the deadlines for submission of the application in relation to review dates
p.000030: 7. the means by which applications will be acknowledged and by which notices about the incompleteness
p.000030: of an application package will be communicated
p.000030: 8. the expected time for notification of the decision following review
p.000030: 9. the time-frame to be followed in cases where the REC requests supplementary information or changes to documents
p.000030: from the applicant
p.000030: 10. a fair and transparent fee structure, if any, for reviewing a research project
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: ANNEX
p.000031:
p.000031:
p.000031: 11. the procedure for seeking amendments to the protocol, or its related documents
p.000031: 12. the required format for recruitment material, information to be given to prospective research participants,
p.000031: and the informed consent form
p.000031: 13. if appropriate and necessary, a check list for the above procedures.
p.000031: b) Documents required for review
p.000031: All documents required for a thorough and complete review of the proposed research project should be submitted by the
p.000031: applicant, in the REC’s working language. As applicable, this may include, but is not limited to:
p.000031: 1. signed and dated application form, including signatures of listed co-applicants and institutional
p.000031: officials (e.g. heads of departments) where relevant
p.000031: 2. the protocol for the proposed research project, clearly identified and dated, together with supporting documents
p.000031: and annexes
p.000031: 3. a project summary or synopsis in non-technical language
p.000031: 4. a description (which may be included in the protocol) of the ethical considerations involved in the
p.000031: proposed research
p.000031: 5. background information on previous research in the same area of work that justifies and/or supports the proposal
p.000031: 6. when the research involves an experimental product (such as a pharmaceutical or medical device
p.000031: under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and
p.000031: toxicological data available on the study product, together with a summary of clinical experience with the study
p.000031: product to date (e.g. recent investigator’s brochure, published data, a summary of the product’s characteristics)
p.000031: 7. current curricula vitae of the principle investigators
p.000031: 8. all data collection forms to be used in the research project, including but not limited to case report
p.000031: forms, diary cards, questionnaires, interview schedules, etc., clearly identified and dated
p.000031: 9. all forms, documents, advertisements to be used in recruitment of potential participants
p.000031: 10. a detailed description of the recruitment process and strategies
p.000031: 11. informed consent form(s) (with date and version number) in languages understood and at a reading
p.000031: level appropriate for the potential research participants and when required, in other languages
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: ANNEX
p.000032:
p.000032:
p.000032: 12. a description of the process that will be used to obtain and document informed consent
...
p.000038: Confidentiality: The obligation to keep information secret unless its disclosure has been appropriately
p.000038: authorized by the person concerned or, in extraordinary circumstances, by the appropriate authorities.
p.000038: Conflict of interest: In the research context, scientists have a conflict of interest if they stand to achieve
p.000038: personal gain (money or the equivalent) by failing to discharge professional obligations, either to protect the welfare
p.000038: of participants or to uphold the integrity of the scientific process.
p.000038: Consent form: An easily understandable written document that documents a potential participant’s consent to be involved
p.000038: in research which describes the rights of an enrolled research participant. This form should communicate the following
p.000038: in a clear and respectful manner: research time-frame; title of research; researchers involved;
p.000038: purpose of research; description of research; potential harms and benefits; treatment alternatives;
p.000038: statement of confidentiality; information and data to be collected; how long the data will be kept, how it will be
p.000038: stored and who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000038: participation at any point; and declarative statement of understanding that the potential participant agrees to and
p.000038: signs. The consent form should be in a language that the potential participant understands. For potential participants
p.000038: with limited literacy, the verbal communication of the consent document details should be provided along with proper
p.000038: documentation of consent, if it be given.
p.000038: Ethical guidelines: Guidance documents which assist with decisions relating to the responsibility to adhere to
p.000038: established and relevant standards of ethical principles and practice.
p.000038: Expedited review: Review of proposed research by the REC chair or a designated voting member or group of
p.000038: voting members rather than by the entire REC.
p.000038: Informed consent: Is a decision to participate in research, taken by a competent individual who has
p.000038: received the necessary information; who
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: GLOSSARY
p.000039:
p.000039:
p.000039: has adequately understood the information; and who, after considering the information, has arrived at a decision
p.000039: without having been subjected to coercion, undue influence or inducement, or intimidation.
p.000039: Multi-site research: A clinical trial conducted according to a single protocol but at more than one site, and,
p.000039: therefore, carried out by more than one investigator.
p.000039: Personal data: Data that relate to a living person and contain personally identifying information.
...
Social / Literacy
Searching for indicator literacy:
(return to top)
p.000038: authorized by the person concerned or, in extraordinary circumstances, by the appropriate authorities.
p.000038: Conflict of interest: In the research context, scientists have a conflict of interest if they stand to achieve
p.000038: personal gain (money or the equivalent) by failing to discharge professional obligations, either to protect the welfare
p.000038: of participants or to uphold the integrity of the scientific process.
p.000038: Consent form: An easily understandable written document that documents a potential participant’s consent to be involved
p.000038: in research which describes the rights of an enrolled research participant. This form should communicate the following
p.000038: in a clear and respectful manner: research time-frame; title of research; researchers involved;
p.000038: purpose of research; description of research; potential harms and benefits; treatment alternatives;
p.000038: statement of confidentiality; information and data to be collected; how long the data will be kept, how it will be
p.000038: stored and who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000038: participation at any point; and declarative statement of understanding that the potential participant agrees to and
p.000038: signs. The consent form should be in a language that the potential participant understands. For potential participants
p.000038: with limited literacy, the verbal communication of the consent document details should be provided along with proper
p.000038: documentation of consent, if it be given.
p.000038: Ethical guidelines: Guidance documents which assist with decisions relating to the responsibility to adhere to
p.000038: established and relevant standards of ethical principles and practice.
p.000038: Expedited review: Review of proposed research by the REC chair or a designated voting member or group of
p.000038: voting members rather than by the entire REC.
p.000038: Informed consent: Is a decision to participate in research, taken by a competent individual who has
p.000038: received the necessary information; who
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: GLOSSARY
p.000039:
p.000039:
p.000039: has adequately understood the information; and who, after considering the information, has arrived at a decision
p.000039: without having been subjected to coercion, undue influence or inducement, or intimidation.
p.000039: Multi-site research: A clinical trial conducted according to a single protocol but at more than one site, and,
p.000039: therefore, carried out by more than one investigator.
p.000039: Personal data: Data that relate to a living person and contain personally identifying information.
p.000039: Principal investigator (PI): The main researcher overseeing or conducting the research process.
p.000039: Privacy: The state or condition of being alone, undisturbed, or free from public attention, as a matter of choice
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000038: participation at any point; and declarative statement of understanding that the potential participant agrees to and
p.000038: signs. The consent form should be in a language that the potential participant understands. For potential participants
p.000038: with limited literacy, the verbal communication of the consent document details should be provided along with proper
p.000038: documentation of consent, if it be given.
p.000038: Ethical guidelines: Guidance documents which assist with decisions relating to the responsibility to adhere to
p.000038: established and relevant standards of ethical principles and practice.
p.000038: Expedited review: Review of proposed research by the REC chair or a designated voting member or group of
p.000038: voting members rather than by the entire REC.
p.000038: Informed consent: Is a decision to participate in research, taken by a competent individual who has
p.000038: received the necessary information; who
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: GLOSSARY
p.000039:
p.000039:
p.000039: has adequately understood the information; and who, after considering the information, has arrived at a decision
p.000039: without having been subjected to coercion, undue influence or inducement, or intimidation.
p.000039: Multi-site research: A clinical trial conducted according to a single protocol but at more than one site, and,
p.000039: therefore, carried out by more than one investigator.
p.000039: Personal data: Data that relate to a living person and contain personally identifying information.
p.000039: Principal investigator (PI): The main researcher overseeing or conducting the research process.
p.000039: Privacy: The state or condition of being alone, undisturbed, or free from public attention, as a matter of choice
p.000039: or right; seclusion; freedom from interference or intrusion; absence or avoidance of publicity or
p.000039: display; secrecy, concealment, discretion; protection from public knowledge or availability.
p.000039: Quorum: A quorum is the minimum number of members that must be present to constitute a valid meeting where
p.000039: decisions can be taken concerning submissions put forward for ethical review. A meeting is quorate when a quorum is
p.000039: present.
p.000039: Reimburse: To repay (a sum of money which has been spent or lost).
p.000039: Researcher: A person who engages in the methodical and systematic investigation of hypotheses with the goal of
p.000039: contributing to new knowledge.
p.000039: Research ethics committee (REC) (also known as ethical review board [ERB], ethical review committee [ERC],
p.000039: human research ethics committee [HREC], institutional review board [IRB]: Group of individuals who undertake
p.000039: the ethical review of research protocols involving humans, applying agreed ethical principles.
p.000039: Research involving human participants: Any social science, biomedical, behavioural, or epidemiological activity that
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000029: 2. managing conflicts of interest in making appointments (see Standard 4).
p.000029: b) Terms of appointment, including:
p.000029: 1. the duration of an appointment
p.000029: 2. the policy for the renewal of an appointment
p.000029: 3. the disqualification procedure
p.000029: 4. the resignation procedure
p.000029: 5. the replacement procedure.
p.000029: c) Conditions of appointment, including:
p.000029: 1. that an REC member shall agree to publicize his/her full name, profession and affiliations
p.000029: 2. whether a member receives any reimbursement for travel expenses and/or lost wages and that such
p.000029: reimbursements, if any, shall be recorded and information about such reimbursements made available to the public
p.000029: 3. that REC members and staff shall sign confidentiality agreements regarding sensitive aspects of protocols,
p.000029: meeting deliberations and related matters (e.g. information about trade secrets or personal information about
p.000029: research participants).
p.000029:
p.000029: II. Committee governance
p.000029: The REC establishes clearly defined offices for the good functioning of ethical review. The REC’s policies and
p.000029: procedures define how the REC will establish its officers (e.g. Chair, Vice-Chairs, etc.). Terms of reference are
p.000029: established for officers that outline:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: ANNEX
p.000030:
p.000030:
p.000030: 1. procedures for selecting and appointing officers
p.000030: 2. the requirements for holding the office
p.000030: 3. the terms and conditions of each office
p.000030: 4. the duties, responsibilities, and authority of each officer (e.g. running a meeting, setting the agenda,
p.000030: notifying decisions to applicants).
p.000030:
p.000030: III. Independent consultants
p.000030: Written procedures define the circumstances under which an REC may call upon independent consultants to provide special
p.000030: expertise to the REC on specific research projects, populations, or topics. Such consultants could include
p.000030: experts in ethics, law, or specific medical specialties or procedures, or they might be representatives of communities,
p.000030: patients, or other groups relevant to the deliberations required. Written procedures require terms of reference for
p.000030: independent consultants and confidentiality agreement, and clarify that—because consultants are not members of the
p.000030: REC—they do not have any voting or decision-making authority.
p.000030:
p.000030: IV. Submissions, documents required for review, review pro- cedures, and decision-making
p.000030: a) Submission procedures
p.000030: The written procedures describe the requirements for submitting a research project for review. Submission
p.000030: requirements and required forms should be readily available to prospective applicants. Application
p.000030: instructions generally include at least the following:
p.000030: 1. the name(s) and address(es) of the REC secretariat, officers, or member(s) to whom the application material
p.000030: should be submitted
p.000030: 2. all written documentation to be submitted as part of the application
p.000030: 3. the format for submission
p.000030: 4. the language(s) in which (core) documents are to be submitted
p.000030: 5. the number of copies to be submitted
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000012: V. Communicating a decision 35
p.000012: VI. Follow-up reviews and monitoring of proposed research 36
p.000012: VII. Documentation and archiving 37
p.000012: GLOSSARY 39
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: vi
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: Acknowledgements
p.000012: This document was prepared by Marie-Charlotte Bouesseau (Department of Ethics, Equity, Trade and Human Rights, World
p.000012: Health Organization [ETH/WHO]), Carl Coleman (Seton Hall Law School, USA), Nancy Kass (Berman Institute of
p.000012: Bioethics, Bloomberg School of Public Health, USA), Juntra Laothavorn (Special Programme for Research and Training in
p.000012: Tropical Diseases [TDR]/WHO), Abha Saxena (ETH/WHO), and Sheryl Vanderpoel (Special Programme of Research,
p.000012: Development and Research Training in Human Reproduction [HRP]/WHO). In particular the conceptualization of the
p.000012: standards and the re-styling of the second edition was the outcome of discussions between Nancy Kass, Tikki Pang, and
p.000012: Abha Saxena. Comments on this document were also provided by members of the Technical Working Group on Ethics, members
p.000012: of the Research Ethics Review Committee, and focal points for WHO’s Strategy on Research for Health - Robert Terry
p.000012: - and the Global Strategy and Plan of Action on public health, innovation and intellectual property (GSPA -
p.000012: PHI ) – Precious Matsoso. This work was accomplished with the support of three WHO Directors, namely Rüdiger Krech
p.000012: (ETH/WHO), Tikki Pang (IER/ WHO), and Robert Ridley (TDR/WHO).
p.000012: The support provided by the Research Ethics Review Committee (WHO ERC), particularly the Chair of the Committee,
p.000012: Ronald Johnson, is gratefully acknowledged.
p.000012: The support provided by the regional offices of WHO in dissemination of the document for review purposes was invaluable
p.000012: and is gratefully acknowledged. We would also like to thank the various interns and volunteers at WHO, namely
p.000012: Lindsay Heck, Nola Tomaska, Ning Wong, and Yeyang Su, who over time have made important contributions to the project.
p.000012: Special thanks are due to the members of the WHO informal consultation noted below, who provided comments on the first
p.000012: draft of this document. Their detailed review and comments have shaped the development of the Standards:
p.000012:
p.000012: Clement Adebamowo (University of Ibadan, Nigeria), David Borasky (RTI International, USA), Ingrid Callies
p.000012: (Institut Pasteur, France), Alexander M. Capron (University of Southern California, USA), Julie
p.000012: Chaumont (Partnership for Appropriate Technology in Health,
p.000012:
p.000012:
p.000012:
p.000012: vii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: France), Julius Ecuru (National Council for Science and Technology, Uganda), David G. Forster (Western
p.000012: Institutional Review Board, USA), Dirceu Greco, (Federal University of Minas Gerais, Brazil), Nouzha Guessous
...
p.000012: organizations and agencies at international (see Annex 1), regional, and national levels over the past 50 years.
p.000012: Adherence to these guidelines helps to promote the ethical conduct of research and enhances and protects
p.000012: the rights and well- being of research participants and communities. A core component of all contemporary research
p.000012: ethics guidelines is that research should be subject to prior ethical review by a competent REC. Such
p.000012: review is intended to ensure that the ethical principles and practices put forward in the guidelines will be followed
p.000012: in the proposed research.
p.000012: In 2000, the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
p.000012: published Operational guidelines for ethics committees that review biomedical research, in response to
p.000012: requests from collaborating researchers throughout the world. These Guidelines were reviewed by multiple experts,
p.000012: stakeholders, researchers, and organizations, including officials of the African Malaria Vaccine Testing Network, the
p.000012: Council of Europe, the National Institutes of Health (USA), the International Conference on Harmonization
p.000012: (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the World Medical
p.000012: Association. Since 2000, the Guidelines have been translated into more than 25 languages, widely
p.000012: disseminated, and used by RECs in more than 100 countries.
p.000012: In 2006, the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)
p.000012: recognized the need for raising the capacity for ethical review of research, noting that “Further efforts should be
p.000012: made to strengthen the clinical trials and regulatory infrastructure in developing countries, in particular in
p.000012: sub-Saharan Africa, including the
p.000012:
p.000012:
p.000012:
p.000012: xi
p.000012:
p.000012: PREFACE
p.000012:
p.000012:
p.000012: improvement of ethical review standards.”1 The Commission further noted that the World Health Organization (WHO)
p.000012: has an important role to play in the improvement of ethical review standards. Under Resolution
p.000012: 61.21 in 2008, and 63.21 in 2010, while endorsing the Research Strategy for Health, the World Health Assembly
p.000012: further urged Member States to “establish governance mechanisms for research for health, to ensure rigorous
p.000012: application of good research norms and standards, including protection for human subjects involved in research”,
p.000012: and requested the Director-General to support Member States in strengthening mechanisms for ethical review of research,
p.000012: especially in developing countries.2
p.000012: In November 2009, WHO organized a consultation in Geneva of key international experts, including
p.000012: researchers, ethicists, members and chairs of ethics committees, and representatives of international
p.000012: organizations, to discuss what additional guidance, if any, was needed by RECs globally—given the observation of the
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000013: guidelines and national standards.
p.000013: While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to
p.000013: research does not, in itself, mean that the research is ethically acceptable.
p.000013: 7. Community considerations
p.000013: Research has impacts not only on the individuals who participate, but also on the communities where the research occurs
p.000013: and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as
p.000013: far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local
p.000013: capacity, and
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: CHAPTER III
p.000014:
p.000014:
p.000014: promoting, as relevant, positive effects on communities, including those related to health effects or capacity
p.000014: development. Researchers should actively engage with communities in decision-making about the design and conduct of
p.000014: research (including the informed consent process), while being sensitive to and respecting the communities’ cultural,
p.000014: traditional and religious practices.
p.000014:
p.000014: Standard 8: Decision-making procedures for research ethics committees
p.000014: Decisions on research protocols designated for review by the convened REC are based on a thorough and inclusive process
p.000014: of discussion and deliberation. Protocols involving no more than minimal risk and burden to research
p.000014: participants may be reviewed on an expedited basis by one or more members (rather than the full committee), if
p.000014: the REC has established written procedures permitting such a procedure.
p.000014: 1. During meetings of the REC, members engage in discussions to elicit all concerns and opinions
p.000014: related to the protocols and the associated documents under consideration. The REC’s rules ensure that the
p.000014: discussions are respectful of all opinions and allow for varied beliefs to be aired. The Chair fosters a respectful and
p.000014: inclusive tone and allows adequate time for deliberation, during which only REC members participate and decisions are
p.000014: made only by those who were present during the entire discussion. The Chair is responsible for the
p.000014: decision-making process, in particular for determining when consensus is needed to achieve the decision.
p.000014: Researchers, funders, or others directly associated with the protocol in question are not present during committee
p.000014: deliberations.
p.000014: 2. REC members recognize the limitations of their knowledge and seek external input when necessary, particularly in
p.000014: relation to research that involves people whose life experiences may differ significantly from those of the committee
p.000014: members.
...
Social / Student
Searching for indicator student:
(return to top)
p.000018: Further guidance on REC written procedures is provided in Annex 3.
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Chapter V
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Standards and guidance
p.000019: for researchers
p.000019:
p.000019: ANNEX
p.000019:
p.000019:
p.000019: Standard 10: Researchers’ responsibilities
p.000019: Research is performed only by persons with scientific, clinical, or other relevant qualifications
p.000019: appropriate to the project, who are familiar with the ethical standards applicable to their research, who submit
p.000019: the necessary information to the REC for review (including both the research protocol and disclosures of
p.000019: any conflicting interests), and who carry out the research in compliance with the requirements established by the
p.000019: REC.
p.000019: The person conducting research fulfils the following criteria in the conduct of ethical research.
p.000019: 1. Submitting an application for review
p.000019: a. An application or review of the ethics of proposed health-related research is submitted by a
p.000019: researcher qualified to undertake the particular study, who is directly responsible for the ethical and
p.000019: scientific conduct of the research. In certain jurisdictions, the sponsor of a study is responsible for submitting the
p.000019: research protocol to the REC.
p.000019: b. Student applications are submitted under the responsibility of a qualified advisor / faculty member
p.000019: involved in the oversight of the student’s work or in the student’s name, co-signed by the qualified faculty
p.000019: supervisor.
p.000019: c. All information required for a thorough and complete review of the ethics of proposed research is submitted,
p.000019: including disclosures about researchers’ conflicting interests, if any.
p.000019: 2. Conduct of research
p.000019: a. The research is conducted in compliance with the protocol approved
p.000019: by the REC.
p.000019: b. No deviation or changes are made to the approved protocol or in following it, without prior
p.000019: approval of the REC, except where immediate action is necessary to avoid harm to research participants. In such a
p.000019: case, the REC is informed promptly of the changes/deviations made, and the justification for doing so.
p.000019: c. The REC is informed of any changes at the research site that significantly affect the conduct of
p.000019: the trial, and/or reduce the protections or decrease the benefits provided or increase the risk to
p.000019: participants (e.g. closing down of a health facility at the
p.000019:
p.000019:
p.000019:
p.000022: 22
p.000022:
p.000022: ANNEX
p.000022:
p.000022:
p.000022: research site or other impediments to obtaining access to health care that was originally available).
p.000022: 3. Safety reporting
p.000022: a. All serious, unexpected adverse events related to the conduct of the study/study product or unanticipated
p.000022: problems involving risks of harm to the participants or others are promptly reported to the REC and/or other relevant
p.000022: authorities, as required by REC policies and applicable laws.
...
Social / Threat of Stigma
Searching for indicator stigma:
(return to top)
p.000012: designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear
p.000012: the risks of participating in the research is likely to benefit from the knowledge derived from the research. In
p.000012: addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the
p.000012: purpose of the research, the risks and potential benefits of participating in the research, and other
p.000012: relevant details.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: CHAPTER III
p.000013:
p.000013:
p.000013: 4. Inducements, financial benefits, and financial costs
p.000013: It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated
p.000013: with participation in research, including transportation, child care, or lost wages. Many RECs also believe
p.000013: that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or
p.000013: free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to
p.000013: participate in the research against their better judgement or to compromise their understanding of the research.
p.000013: 5. Protection of research participants’ privacy and confidentiality
p.000013: Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss
p.000013: of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or
p.000013: lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard
p.000013: participants’ privacy and confidentiality.
p.000013: 6. Informed consent process
p.000013: The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled
p.000013: to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what
p.000013: the research entails. Decisions for children or adults who lack the mental capacity to provide informed
p.000013: consent should be made by an authorized surrogate decision-maker.
p.000013: RECs should examine the process through which informed consent will occur, as well as the information that will be
p.000013: provided. RECs may waive the requirement of informed consent only when doing so is consistent with international
p.000013: guidelines and national standards.
p.000013: While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to
p.000013: research does not, in itself, mean that the research is ethically acceptable.
p.000013: 7. Community considerations
p.000013: Research has impacts not only on the individuals who participate, but also on the communities where the research occurs
p.000013: and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as
p.000013: far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local
p.000013: capacity, and
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: CHAPTER III
p.000014:
p.000014:
p.000014: promoting, as relevant, positive effects on communities, including those related to health effects or capacity
p.000014: development. Researchers should actively engage with communities in decision-making about the design and conduct of
p.000014: research (including the informed consent process), while being sensitive to and respecting the communities’ cultural,
p.000014: traditional and religious practices.
p.000014:
p.000014: Standard 8: Decision-making procedures for research ethics committees
p.000014: Decisions on research protocols designated for review by the convened REC are based on a thorough and inclusive process
p.000014: of discussion and deliberation. Protocols involving no more than minimal risk and burden to research
p.000014: participants may be reviewed on an expedited basis by one or more members (rather than the full committee), if
p.000014: the REC has established written procedures permitting such a procedure.
p.000014: 1. During meetings of the REC, members engage in discussions to elicit all concerns and opinions
p.000014: related to the protocols and the associated documents under consideration. The REC’s rules ensure that the
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000012: (Independent Researcher and Consultant, Morocco), Reva Gutnick (Independent Consultant), Samia Hurst (University
p.000012: of Geneva, Switzerland), Carel IJsselmuiden (Council on Health Research for Development [COHRED],
p.000012: Switzerland), Amar Jesani (Anusandhan Trust, India), Irakli Khodeli (United Nations Educational, Scientific
p.000012: and Cultural Organization [UNESCO], France), Otmar Kloiber (World Medical Association [WMA], France), Gottfried Kreutz
p.000012: (formerly of the Council for International Organizations of Medical Sciences [CIOMS], Switzerland) , Laurence Lwoff (on
p.000012: behalf of Council of Europe, France), James Lavery (University of Toronto, Canada), Jacob Leveridge
p.000012: (Wellcome Trust, UK), Florencia Luna (National Scientific and Technical Research Council [CONICET], Argentina), Paul
p.000012: Ndebele (University of Botswana, Botswana), Aceme Nyika (African Malaria Network Trust [AMANET]), Muriel Socquet
p.000012: (Partnership for Appropriate Technology in Health, [PATH], France), Marjorie Speers (Association for the
p.000012: Accreditation of Human Research Protection Programs, Inc. [AAHR], USA), Christina Torres (Forum for Ethical Review
p.000012: Committees in the Asian and Western Pacific Region [FERCAP], Thailand), Douglas Wassenaar (University
p.000012: KwaZulu-Natal, South Africa), Hugh Whittall (Nuffield Council on Bioethics, UK), John Williams (formerly of
p.000012: the World Medical Association [WMA], France), Xiaomei Zhai (Peking Union Medical College, China).
p.000012: Collaboration with UNESCO in the development of these standards has been especially valuable, both in its
p.000012: representation at the WHO informal consultation, and later, in the critical comments received from the chief of the
p.000012: bioethics section of UNESCO, Dafna Feinholz.
p.000012: The feedback provided to earlier drafts of this document by the participants of the 8th Global Summit of
p.000012: National Bioethics Advisory Bodies (Singapore, July 2010), the 10th World Congress of Bioethics (Singapore,
p.000012: July 2010), the Third National Bioethics Conference (India, November 2010), the 5th National Meeting of Bioethics
p.000012: Commissions of Mexico (November 2010), the medical ethics conference: Is medical Ethics Really in the Best Interest of
p.000012: the Patient? (Sweden, June 2010), and the 10th FERCAP International Conference on Networking and Alliance
p.000012: Building for Ethical Health Research (China, November 2010) shaped the final version of this document.
p.000012:
p.000012:
p.000012: viii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: WHO gratefully acknowledges the contributions of the following reviewers, who provided a review and
p.000012: critical comments on an earlier draft of this document:
p.000012: Dieudonné Adiogo, M. Chi Primus Che, Nchangwi Syntia Munung, Odile Ouwe-Missi-Oukem-Boyer, Ludovic Reveiz,
p.000012: Godfrey B. Tangwa, and M. Jerome Mbih Tosam (on behalf of Cameroon Bioethics Initiative [CAMBIN]), Julian Rodriguez
p.000012: Alvarez and Martha M. Fors López (Centro Nacional Coordinador de Ensayos Clínicos, Cuba), Leslie Ball,
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.000040: care and research contexts to refer to a consumer’s or participant’s decision to receive health or disability care or
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
Social / Women
Searching for indicator women:
(return to top)
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
Social / education
Searching for indicator education:
(return to top)
p.000007: or conducts the research under review;
p.000007: 2. researchers, sponsors, and funders may attend an REC meeting to answer questions about their
p.000007: research protocols and associated documents, but they are not present when the REC reaches decisions about their
p.000007: proposed research;
p.000007: 3. senior decision-makers of the entity creating the REC, or of any organization that sponsors or conducts
p.000007: the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members
p.000007: of the REC or its Chair;
p.000007: 4. the entity that establishes the REC ensures that REC members are protected from retaliation based on positions
p.000007: taken with respect to REC-related matters or review of research projects.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: CHAPTER II
p.000008:
p.000008:
p.000008: Standard 5: Training the research ethics committee
p.000008: Training on the ethical aspects of health-related research with human participants, how ethical
p.000008: considerations apply to different types of research, and how the REC conducts its review of research, is provided
p.000008: to REC members when they join the committee and periodically during their committee service.
p.000008: The training provided to REC members, either directly by the appointing entity or through cooperative arrangements
p.000008: with other RECs and/or organizations that provide education on research ethics, focuses on:
p.000008: 1. the role and responsibilities of the REC, and its role vis-à-vis other relevant entities, according to relevant
p.000008: international guidelines (e.g. the Council for International Organizations of Medical Societies [CIOMS]
p.000008: International Ethical Guidelines for Biomedical Research, CIOMS International Ethical Guidelines for
p.000008: Epidemiological Research, International Council on Harmonization [ICH] Good Clinical Practice [GCP] guidelines
p.000008: in the case of clinical trials), national laws, and institutional policies;
p.000008: 2. the full range of ethical considerations relevant to research with human participants;
p.000008: 3. the application of such ethical considerations to different types of research;
p.000008: 4. basic aspects of research methodology and design (for members who lack such background);
p.000008: 5. the impact of different scientific designs and objectives on the ethics of a research study;
p.000008: 6. the various approaches for recognizing and resolving the tensions that can arise among different ethical
p.000008: considerations and modes of ethical reasoning.
p.000008:
p.000008: When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no
p.000008: control, direct or indirect, over the content of the training.
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: CHAPTER II
p.000009:
p.000009:
...
p.000027: reports, final reports, corrective actions, amendment of the approved protocol or consent documents etc.
p.000027: 6. In close collaboration with the Chair of the REC, preparing reports of REC meetings and annual reports of REC
p.000027: activities. The annual report includes information about sources of funding and expenses of the REC.
p.000027: 7. Record keeping, including maintaining research protocols and all correspondence in relation to their
p.000027: review, as well as records of any continuing oversight that may be required after approval. The Secretariat
p.000027: ensures that the confidentiality of REC records is maintained.
p.000027: 8. Facilitating access to literature and educational programmes useful to the members of REC.
p.000027:
p.000027: 9. Up dating information about REC membership, including declarations of potential conflicts of interests.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: ANNEX
p.000028:
p.000028:
p.000028: Additional responsibilities may be delegated to the Secretariat staff by the entity creating the REC and/or
p.000028: the REC Chair, as appropriate in light of the Secretariat’s training, expertise, capacity, and resources;
p.000028: such responsibilities may include keeping abreast of developments in research ethics and regulation,
p.000028: engaging in community outreach and education, serving as a liaison between the REC and the research community,
p.000028: facilitating implementation of quality improvement and quality assurance programs etc.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: ANNEX
p.000029:
p.000029:
p.000029: Annex 3
p.000029: Guidance for developing written procedures for the research ethics committee
p.000029: REC written procedures address the following issues:
p.000029: I. Membership of the Committee
p.000029: a) Authority for appointment of committee members specifying the name or description of the entity responsible
p.000029: for making appointments and the procedures for:
p.000029: 1. selecting and appointing the REC Chair and members, including the method by which new members and the Chair are
p.000029: selected (e.g. by consensus or majority vote of existing members, by direct appointment of the Chair or other
p.000029: official)
p.000029: 2. managing conflicts of interest in making appointments (see Standard 4).
p.000029: b) Terms of appointment, including:
p.000029: 1. the duration of an appointment
p.000029: 2. the policy for the renewal of an appointment
p.000029: 3. the disqualification procedure
p.000029: 4. the resignation procedure
p.000029: 5. the replacement procedure.
...
p.000040: Risk: The probability that an event, favourable or adverse, will occur within a defined time interval. Although often
p.000040: contrasted to benefit (as in a “risk/ benefit ratio”), the term “potential harm” is better for that context, leaving
p.000040: “risk” in its formal epidemiological sense to express the probability of a (typically adverse) event or
p.000040: outcome.
p.000040: Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation,
p.000040: management, and/or financing of research.
p.000040: Voluntary: (1) Performed or done of one’s own free will, impulse, or choice; not constrained, prompted,
p.000040: or suggested by another; (2) free of coercion, duress, or undue inducement. Used in the health and disability
p.000040: care and research contexts to refer to a consumer’s or participant’s decision to receive health or disability care or
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
...
Searching for indicator educational:
(return to top)
p.000012: Ronald Johnson, is gratefully acknowledged.
p.000012: The support provided by the regional offices of WHO in dissemination of the document for review purposes was invaluable
p.000012: and is gratefully acknowledged. We would also like to thank the various interns and volunteers at WHO, namely
p.000012: Lindsay Heck, Nola Tomaska, Ning Wong, and Yeyang Su, who over time have made important contributions to the project.
p.000012: Special thanks are due to the members of the WHO informal consultation noted below, who provided comments on the first
p.000012: draft of this document. Their detailed review and comments have shaped the development of the Standards:
p.000012:
p.000012: Clement Adebamowo (University of Ibadan, Nigeria), David Borasky (RTI International, USA), Ingrid Callies
p.000012: (Institut Pasteur, France), Alexander M. Capron (University of Southern California, USA), Julie
p.000012: Chaumont (Partnership for Appropriate Technology in Health,
p.000012:
p.000012:
p.000012:
p.000012: vii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: France), Julius Ecuru (National Council for Science and Technology, Uganda), David G. Forster (Western
p.000012: Institutional Review Board, USA), Dirceu Greco, (Federal University of Minas Gerais, Brazil), Nouzha Guessous
p.000012: (Independent Researcher and Consultant, Morocco), Reva Gutnick (Independent Consultant), Samia Hurst (University
p.000012: of Geneva, Switzerland), Carel IJsselmuiden (Council on Health Research for Development [COHRED],
p.000012: Switzerland), Amar Jesani (Anusandhan Trust, India), Irakli Khodeli (United Nations Educational, Scientific
p.000012: and Cultural Organization [UNESCO], France), Otmar Kloiber (World Medical Association [WMA], France), Gottfried Kreutz
p.000012: (formerly of the Council for International Organizations of Medical Sciences [CIOMS], Switzerland) , Laurence Lwoff (on
p.000012: behalf of Council of Europe, France), James Lavery (University of Toronto, Canada), Jacob Leveridge
p.000012: (Wellcome Trust, UK), Florencia Luna (National Scientific and Technical Research Council [CONICET], Argentina), Paul
p.000012: Ndebele (University of Botswana, Botswana), Aceme Nyika (African Malaria Network Trust [AMANET]), Muriel Socquet
p.000012: (Partnership for Appropriate Technology in Health, [PATH], France), Marjorie Speers (Association for the
p.000012: Accreditation of Human Research Protection Programs, Inc. [AAHR], USA), Christina Torres (Forum for Ethical Review
p.000012: Committees in the Asian and Western Pacific Region [FERCAP], Thailand), Douglas Wassenaar (University
p.000012: KwaZulu-Natal, South Africa), Hugh Whittall (Nuffield Council on Bioethics, UK), John Williams (formerly of
p.000012: the World Medical Association [WMA], France), Xiaomei Zhai (Peking Union Medical College, China).
p.000012: Collaboration with UNESCO in the development of these standards has been especially valuable, both in its
p.000012: representation at the WHO informal consultation, and later, in the critical comments received from the chief of the
p.000012: bioethics section of UNESCO, Dafna Feinholz.
p.000012: The feedback provided to earlier drafts of this document by the participants of the 8th Global Summit of
...
p.000027: guidelines, processes and procedures. In some cases the Secretariat maintains a website ensuring public access to this
p.000027: information.
p.000027: 2. Managing the timely progress of protocol review through initial and continuing contacts with
p.000027: Principal Investigators. This includes identifying and requesting missing documentation in applications and
p.000027: preparing the completed file for committee review.
p.000027: 3. Preparing the meetings of the REC, including the distribution of relevant documentation to the members, scheduling
p.000027: the meetings, and ensuring the quorum.
p.000027: 4. In close collaboration with the chair of the REC, preparing applications that will be evaluated through expedited
p.000027: review.
p.000027: 5. Following-up with tasks that the REC requests the principal investigators to perform such as progress
p.000027: reports, final reports, corrective actions, amendment of the approved protocol or consent documents etc.
p.000027: 6. In close collaboration with the Chair of the REC, preparing reports of REC meetings and annual reports of REC
p.000027: activities. The annual report includes information about sources of funding and expenses of the REC.
p.000027: 7. Record keeping, including maintaining research protocols and all correspondence in relation to their
p.000027: review, as well as records of any continuing oversight that may be required after approval. The Secretariat
p.000027: ensures that the confidentiality of REC records is maintained.
p.000027: 8. Facilitating access to literature and educational programmes useful to the members of REC.
p.000027:
p.000027: 9. Up dating information about REC membership, including declarations of potential conflicts of interests.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: ANNEX
p.000028:
p.000028:
p.000028: Additional responsibilities may be delegated to the Secretariat staff by the entity creating the REC and/or
p.000028: the REC Chair, as appropriate in light of the Secretariat’s training, expertise, capacity, and resources;
p.000028: such responsibilities may include keeping abreast of developments in research ethics and regulation,
p.000028: engaging in community outreach and education, serving as a liaison between the REC and the research community,
p.000028: facilitating implementation of quality improvement and quality assurance programs etc.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: ANNEX
p.000029:
p.000029:
p.000029: Annex 3
p.000029: Guidance for developing written procedures for the research ethics committee
p.000029: REC written procedures address the following issues:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000040: or suggested by another; (2) free of coercion, duress, or undue inducement. Used in the health and disability
p.000040: care and research contexts to refer to a consumer’s or participant’s decision to receive health or disability care or
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000002:
p.000002:
p.000002: Types of research studies
p.000002: RECs may review different types of research studies, including, but not limited to, the following:
p.000002: • clinical trials
p.000002: • epidemiological research
p.000002: • social science research
p.000002: • research on medical records or other personal information
p.000002: • research on stored samples
p.000002: • health systems research
p.000002: • implementation research
p.000002: RECs should be familiar with the different methodologies and ethical considerations that apply to each type of proposed
p.000002: research they review.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Chapter II
p.000003:
p.000003:
p.000003:
p.000003: Standards and guidance for entities that establish research ethics committees
p.000003:
p.000003: CHAPTER II
p.000003:
p.000003:
p.000003: Standard 2: Composition of research ethics committees
p.000003: The research ethics committee (REC) is constituted according to a charter or other document that establishes
p.000003: the manner in which members and the Chair will be appointed. The appointing entity ensures that the REC
p.000003: has a multidisciplinary and multisectoral membership, that its composition is gender balanced, that it reflects the
p.000003: social and cultural diversity of the communities from which research participants are most likely to be drawn,
p.000003: and that it includes individuals with backgrounds relevant to the areas of research the committee is most likely to
p.000003: review.
p.000003: The entity establishing the REC takes the following factors into consideration when appointing
p.000003: members.
p.000003: 1. Members include individuals with scientific expertise, including expertise in behavioural or social
p.000003: sciences; health care providers; members who have expertise in legal matters and/or ethics; and lay people
p.000003: whose primary role is to share their insights about the communities from which participants are likely to be drawn.
p.000003: 2. Lay people and other members, whose primary background is not in health research with human participants, are
p.000003: appointed in sufficient numbers to ensure that they feel comfortable voicing their views.
p.000003: 3. In order to enhance independence, committee membership includes members who are not affiliated with organizations
p.000003: that sponsor, fund, or conduct research reviewed by the REC (see also Standard 4).
p.000003: 4. Committees are large enough to ensure that multiple perspectives are brought into the discussion. To this end,
p.000003: quorum requirements provide that at least five people, including at least one lay member and one non-affiliated member,
p.000003: are present to make decisions about the proposed research.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000006: 6
p.000006:
p.000006: CHAPTER II
p.000006:
p.000006:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
p.000011:
p.000011:
p.000011:
p.000011: WHO Library Cataloguing-in-Publication Data
p.000011:
p.000011: Standards and operational guidance for ethics review of health-related research with human participants.
p.000011:
p.000011: 1.Research - standards. 2.Ethics, Medical. 3.Ethical review - standards. 4.Ethics committees. 5.Patient selection.
p.000011: 6.Guidelines. I.World Health Organization.
p.000011:
p.000011: ISBN 978 92 4 150294 8 (print) (NLM classification: W 50)
p.000011: ISBN 978 92 4 150295 5 (CD-ROM)
p.000011:
p.000011:
p.000011: © World Health Organization 2011
p.000011:
p.000011: All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or
p.000011: can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.:
p.000011: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int).
p.000011:
p.000011: Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution
p.000011: – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_
p.000011: form/en/index.html).
p.000011:
p.000011: The designations employed and the presentation of the material in this publication do not imply the
p.000011: expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any
p.000011: country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
p.000011: Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
p.000011:
p.000011: The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or
p.000011: recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors
p.000011: and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
p.000011:
p.000011: All reasonable precautions have been taken by the World Health Organization to verify the information contained in this
p.000011: publication. However, the published material is being distributed without warranty of any kind, either expressed or
p.000011: implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall
p.000011: the World Health Organization be liable for damages arising from its use.
p.000011:
p.000011: Printed by the WHO Document Production Services, Geneva, Switzerland.
p.000011:
p.000011: CONTENTS
p.000011:
p.000011:
p.000011: CONTENTS
p.000011: ACKNOWLEDGEMENTS vii
p.000011: PREFACE xi
p.000011: I. STANDARDS FOR THE RESEARCH ETHICS
p.000011: REVIEW SYSTEM 1
p.000011: Standard 1: Responsibility for establishing the research ethics
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000037: resources necessary to run the committee
p.000037: 5. curricula vitae of all REC members
p.000037: 6. record of all income and expenses of the REC, including allowances and reimbursements made to the
p.000037: secretariat and REC members and for what purposes
p.000037: 7. agendas of the REC meetings
p.000037: 8. minutes of the REC meetings
p.000037: 9. regulatory texts used by the REC
p.000037: b) Project-related documents
p.000037: All documents and materials related to the review of specific projects should be filed. Committee procedures should
p.000037: specify length of time documents must be archived—for example, with studies under ICH GCP, the documents are archived
p.000037: for a minimum period of 3 years following completion of the study. These include, but are not limited to:
p.000037: 1. one copy of all materials submitted by an applicant
p.000037: 2. any correspondence by the REC with applicants or concerned parties regarding applications, decisions, and
p.000037: follow-up
p.000037: 3. a copy of initial and follow up decisions and any advice or requirements sent to an applicant
p.000037: 4. all written documentation received during the follow-up, including any advice or requirements sent
p.000037: to the applicant
p.000037: 5. the notification of the completion, premature suspension, or premature termination of a study
p.000037: 6. the final summary or final report of the study
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: GLOSSARY
p.000038:
p.000038:
p.000038: Glossary
p.000038:
p.000038: Benefit: A favourable consequence arising from a study, for example the demonstration that a vaccine is effective in a
p.000038: randomized controlled trial or the identification of a workplace hazard in an observational study.
p.000038: Bioethics: A field of ethical enquiry that examines ethical issues and dilemmas arising from health, health
p.000038: care, and research involving humans.
p.000038: Compensation: That which is given in recompense, as an equivalent rendered, or remuneration.
p.000038: Confidentiality: The obligation to keep information secret unless its disclosure has been appropriately
p.000038: authorized by the person concerned or, in extraordinary circumstances, by the appropriate authorities.
p.000038: Conflict of interest: In the research context, scientists have a conflict of interest if they stand to achieve
p.000038: personal gain (money or the equivalent) by failing to discharge professional obligations, either to protect the welfare
p.000038: of participants or to uphold the integrity of the scientific process.
p.000038: Consent form: An easily understandable written document that documents a potential participant’s consent to be involved
p.000038: in research which describes the rights of an enrolled research participant. This form should communicate the following
p.000038: in a clear and respectful manner: research time-frame; title of research; researchers involved;
p.000038: purpose of research; description of research; potential harms and benefits; treatment alternatives;
p.000038: statement of confidentiality; information and data to be collected; how long the data will be kept, how it will be
p.000038: stored and who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000040: to participate (or continue to participate) in a research activity.
p.000040: Vulnerable (research) participants: Vulnerable persons are those who are relatively (or absolutely)
p.000040: incapable of protecting their own interests. More formally, they may have insufficient power, intelligence,
p.000040: education, resources, strength, or other needed attributes to protect their own interests. Individuals whose
p.000040: willingness to volunteer in a research study may be unduly influenced by the expectation, whether justified or not, of
p.000040: benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of
p.000040: refusal to participate may also be considered vulnerable. Examples are members of a group with a hierarchical
p.000040: structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel,
p.000040: employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other
p.000040: vulnerable persons include patients with incurable diseases, people in nursing homes, unemployed or impoverished
p.000040: people, patients in emergency situations, ethnic minority groups, homeless people, nomads, refugees, minors,
p.000040: and those incapable of giving consent.3 This list may not be exhaustive as there may be circumstances in which
p.000040: other groups are considered vulnerable, women for example, in an orthodox patriarchical society.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 3 International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). Geneva, ICH,
p.000040: 1996.
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Chapter IV
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Standards and guidance for the secretariat, staff, and administration of
p.000015: the research ethics committees
p.000015:
p.000015: CHAPTER IV
p.000015:
p.000015:
p.000015: Standard 9: Written policies and procedures
p.000015: Written policies and procedures specify the REC’s membership, committee governance, review procedures,
p.000015: decision-making, communications, follow-up, monitoring, documentation and archiving, training,
p.000015: quality assurance, and procedures for coordination with other RECs.
p.000015: The entity that creates the REC has a responsibility to establish the necessary policies to govern the REC. The REC
p.000015: adopts its rules of procedure and— with the secretariat/staff—promulgates comprehensive, written procedures, which are
p.000015: distributed to all committee members and made publicly available. To the fullest extent possible, the hosting
p.000015: institution provides RECs with a Secretariat whose staff have the necessary knowledge, expertise and
p.000015: training to support the REC in performing its review and record keeping function (for further guidance on the
p.000015: Secretariat function, see Annex 2) . To ensure efficient operation, the policies, rules, and written procedures are
p.000015: reviewed periodically in the light of ongoing assessment of performance and outcomes to determine whether any revisions
p.000015: are needed. REC policies and rules typically address the following topics.
p.000015: 1. Membership of the committee
p.000015: The REC’s policies and procedures delineate the authority, the terms, and the conditions of appointment. Staggered,
p.000015: finite terms of appointment should be considered, allowing continuity of some members when other members are newly
p.000015: appointed. Having limited terms also promotes the development of research ethics expertise and greater knowledge
p.000015: of REC procedures among the larger community of individuals who may rotate through committee service, and allows for
p.000015: input of fresh ideas and approaches to committee deliberations.
p.000015: 2. Committee governance
p.000015: The REC’s policies and procedures define how the REC will establish its offices (e.g. Chair, Vice-Chairs).
p.000015: The Chair is someone respectful of divergent views, able to encourage and help achieve consensus, and with the time to
p.000015: prepare adequately for meetings. The Chair is not a person who has a supervisory relationship toward other members of
p.000015: the committee.
p.000015: 3. Independent consultants
p.000015: The REC’s policies and procedures define the circumstances under which an REC may call upon independent
p.000015: consultants to provide special
p.000015:
p.000015:
p.000015:
p.000018: 18
p.000018:
p.000018: CHAPTER IV
p.000018:
p.000018:
p.000018: expertise to the REC on specific research protocols, populations, or topics.
p.000018: 4. Submissions, documents required for review, review procedures, and decision-making
p.000018: The REC’s policies and procedures describe the requirements for submitting an application for review, including
p.000018: the forms to be completed and the documents to be submitted. They also specify the process and procedure
p.000018: for review, process for coordinating review with other committees, process for setting up meetings, circulating
...
p.000019: participants (e.g. closing down of a health facility at the
p.000019:
p.000019:
p.000019:
p.000022: 22
p.000022:
p.000022: ANNEX
p.000022:
p.000022:
p.000022: research site or other impediments to obtaining access to health care that was originally available).
p.000022: 3. Safety reporting
p.000022: a. All serious, unexpected adverse events related to the conduct of the study/study product or unanticipated
p.000022: problems involving risks of harm to the participants or others are promptly reported to the REC and/or other relevant
p.000022: authorities, as required by REC policies and applicable laws.
p.000022: b. Any recommendations provided by the REC in response to such reporting are immediately implemented.
p.000022: 4. Ongoing reporting and follow-up
p.000022: a. The researcher submits written summaries of the research status to
p.000022: the REC annually, or more frequently, if requested by the REC.
p.000022: b. Researchers inform the REC when a study is completed or prematurely suspended/terminated.
p.000022: c. In the case of the early suspension/termination by the researcher or sponsor, the researcher notifies the
p.000022: REC of the reasons for suspension/termination; provides a summary of results obtained prior to prematurely
p.000022: suspending or terminating the study; and describes the manner by which enrolled participants will be
p.000022: notified of the suspension or termination and the plans for care and follow-up for the participants.
p.000022: d. If the REC terminates or suspends its approval of a study, the researcher informs the institution under whose
p.000022: authority the research is being conducted, the sponsor of the research, and any other applicable organizations.
p.000022: 5. Information to research participants
p.000022: Researchers have a responsibility to keep the research participants and their communities informed of the progress of
p.000022: research by appropriate means, at suitable time-frames in simple and non-technical language, for example, when:
p.000022: a. the research study is terminated or cancelled
p.000022: b. any changes occur in the context of the research study that alter the potential benefits or risks
p.000022: c. the research project is completed
p.000022: d. results of the research are available.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex 1. 2. 3.
p.000023: and Glossary
p.000023:
p.000023: ANNEX
p.000023:
p.000023:
p.000023: Annex 1
p.000023: Guidelines and codes of best practice
p.000023: 1. Nuremberg Code (Available at: http://ohsr.od.nih.gov/guidelines/ nuremberg.html, accessed 17 January
p.000023: 2009)
p.000023: 2. Declaration of Helsinki (Available at http://www.wma.net/
p.000023: en/30publications/10policies/b3/index.html, accessed 05 October 2011)
p.000023: 3. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
...
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: ANNEX
p.000028:
p.000028:
p.000028: Additional responsibilities may be delegated to the Secretariat staff by the entity creating the REC and/or
p.000028: the REC Chair, as appropriate in light of the Secretariat’s training, expertise, capacity, and resources;
p.000028: such responsibilities may include keeping abreast of developments in research ethics and regulation,
p.000028: engaging in community outreach and education, serving as a liaison between the REC and the research community,
p.000028: facilitating implementation of quality improvement and quality assurance programs etc.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: ANNEX
p.000029:
p.000029:
p.000029: Annex 3
p.000029: Guidance for developing written procedures for the research ethics committee
p.000029: REC written procedures address the following issues:
p.000029: I. Membership of the Committee
p.000029: a) Authority for appointment of committee members specifying the name or description of the entity responsible
p.000029: for making appointments and the procedures for:
p.000029: 1. selecting and appointing the REC Chair and members, including the method by which new members and the Chair are
p.000029: selected (e.g. by consensus or majority vote of existing members, by direct appointment of the Chair or other
p.000029: official)
p.000029: 2. managing conflicts of interest in making appointments (see Standard 4).
p.000029: b) Terms of appointment, including:
p.000029: 1. the duration of an appointment
p.000029: 2. the policy for the renewal of an appointment
p.000029: 3. the disqualification procedure
p.000029: 4. the resignation procedure
p.000029: 5. the replacement procedure.
p.000029: c) Conditions of appointment, including:
p.000029: 1. that an REC member shall agree to publicize his/her full name, profession and affiliations
p.000029: 2. whether a member receives any reimbursement for travel expenses and/or lost wages and that such
p.000029: reimbursements, if any, shall be recorded and information about such reimbursements made available to the public
p.000029: 3. that REC members and staff shall sign confidentiality agreements regarding sensitive aspects of protocols,
p.000029: meeting deliberations and related matters (e.g. information about trade secrets or personal information about
p.000029: research participants).
p.000029:
p.000029: II. Committee governance
p.000029: The REC establishes clearly defined offices for the good functioning of ethical review. The REC’s policies and
p.000029: procedures define how the REC will establish its officers (e.g. Chair, Vice-Chairs, etc.). Terms of reference are
p.000029: established for officers that outline:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: ANNEX
p.000030:
p.000030:
p.000030: 1. procedures for selecting and appointing officers
p.000030: 2. the requirements for holding the office
p.000030: 3. the terms and conditions of each office
p.000030: 4. the duties, responsibilities, and authority of each officer (e.g. running a meeting, setting the agenda,
p.000030: notifying decisions to applicants).
p.000030:
p.000030: III. Independent consultants
p.000030: Written procedures define the circumstances under which an REC may call upon independent consultants to provide special
p.000030: expertise to the REC on specific research projects, populations, or topics. Such consultants could include
p.000030: experts in ethics, law, or specific medical specialties or procedures, or they might be representatives of communities,
p.000030: patients, or other groups relevant to the deliberations required. Written procedures require terms of reference for
p.000030: independent consultants and confidentiality agreement, and clarify that—because consultants are not members of the
p.000030: REC—they do not have any voting or decision-making authority.
p.000030:
p.000030: IV. Submissions, documents required for review, review pro- cedures, and decision-making
p.000030: a) Submission procedures
p.000030: The written procedures describe the requirements for submitting a research project for review. Submission
p.000030: requirements and required forms should be readily available to prospective applicants. Application
p.000030: instructions generally include at least the following:
p.000030: 1. the name(s) and address(es) of the REC secretariat, officers, or member(s) to whom the application material
p.000030: should be submitted
p.000030: 2. all written documentation to be submitted as part of the application
p.000030: 3. the format for submission
p.000030: 4. the language(s) in which (core) documents are to be submitted
p.000030: 5. the number of copies to be submitted
p.000030: 6. the deadlines for submission of the application in relation to review dates
p.000030: 7. the means by which applications will be acknowledged and by which notices about the incompleteness
p.000030: of an application package will be communicated
p.000030: 8. the expected time for notification of the decision following review
p.000030: 9. the time-frame to be followed in cases where the REC requests supplementary information or changes to documents
p.000030: from the applicant
p.000030: 10. a fair and transparent fee structure, if any, for reviewing a research project
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: ANNEX
p.000031:
p.000031:
p.000031: 11. the procedure for seeking amendments to the protocol, or its related documents
p.000031: 12. the required format for recruitment material, information to be given to prospective research participants,
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000038: stored and who can access it; any conflicts of interest; a statement of the participant’s right to withdraw from
p.000038: participation at any point; and declarative statement of understanding that the potential participant agrees to and
p.000038: signs. The consent form should be in a language that the potential participant understands. For potential participants
p.000038: with limited literacy, the verbal communication of the consent document details should be provided along with proper
p.000038: documentation of consent, if it be given.
p.000038: Ethical guidelines: Guidance documents which assist with decisions relating to the responsibility to adhere to
p.000038: established and relevant standards of ethical principles and practice.
p.000038: Expedited review: Review of proposed research by the REC chair or a designated voting member or group of
p.000038: voting members rather than by the entire REC.
p.000038: Informed consent: Is a decision to participate in research, taken by a competent individual who has
p.000038: received the necessary information; who
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: GLOSSARY
p.000039:
p.000039:
p.000039: has adequately understood the information; and who, after considering the information, has arrived at a decision
p.000039: without having been subjected to coercion, undue influence or inducement, or intimidation.
p.000039: Multi-site research: A clinical trial conducted according to a single protocol but at more than one site, and,
p.000039: therefore, carried out by more than one investigator.
p.000039: Personal data: Data that relate to a living person and contain personally identifying information.
p.000039: Principal investigator (PI): The main researcher overseeing or conducting the research process.
p.000039: Privacy: The state or condition of being alone, undisturbed, or free from public attention, as a matter of choice
p.000039: or right; seclusion; freedom from interference or intrusion; absence or avoidance of publicity or
p.000039: display; secrecy, concealment, discretion; protection from public knowledge or availability.
p.000039: Quorum: A quorum is the minimum number of members that must be present to constitute a valid meeting where
p.000039: decisions can be taken concerning submissions put forward for ethical review. A meeting is quorate when a quorum is
p.000039: present.
p.000039: Reimburse: To repay (a sum of money which has been spent or lost).
p.000039: Researcher: A person who engages in the methodical and systematic investigation of hypotheses with the goal of
p.000039: contributing to new knowledge.
p.000039: Research ethics committee (REC) (also known as ethical review board [ERB], ethical review committee [ERC],
p.000039: human research ethics committee [HREC], institutional review board [IRB]: Group of individuals who undertake
p.000039: the ethical review of research protocols involving humans, applying agreed ethical principles.
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000012: Lindsay Heck, Nola Tomaska, Ning Wong, and Yeyang Su, who over time have made important contributions to the project.
p.000012: Special thanks are due to the members of the WHO informal consultation noted below, who provided comments on the first
p.000012: draft of this document. Their detailed review and comments have shaped the development of the Standards:
p.000012:
p.000012: Clement Adebamowo (University of Ibadan, Nigeria), David Borasky (RTI International, USA), Ingrid Callies
p.000012: (Institut Pasteur, France), Alexander M. Capron (University of Southern California, USA), Julie
p.000012: Chaumont (Partnership for Appropriate Technology in Health,
p.000012:
p.000012:
p.000012:
p.000012: vii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: France), Julius Ecuru (National Council for Science and Technology, Uganda), David G. Forster (Western
p.000012: Institutional Review Board, USA), Dirceu Greco, (Federal University of Minas Gerais, Brazil), Nouzha Guessous
p.000012: (Independent Researcher and Consultant, Morocco), Reva Gutnick (Independent Consultant), Samia Hurst (University
p.000012: of Geneva, Switzerland), Carel IJsselmuiden (Council on Health Research for Development [COHRED],
p.000012: Switzerland), Amar Jesani (Anusandhan Trust, India), Irakli Khodeli (United Nations Educational, Scientific
p.000012: and Cultural Organization [UNESCO], France), Otmar Kloiber (World Medical Association [WMA], France), Gottfried Kreutz
p.000012: (formerly of the Council for International Organizations of Medical Sciences [CIOMS], Switzerland) , Laurence Lwoff (on
p.000012: behalf of Council of Europe, France), James Lavery (University of Toronto, Canada), Jacob Leveridge
p.000012: (Wellcome Trust, UK), Florencia Luna (National Scientific and Technical Research Council [CONICET], Argentina), Paul
p.000012: Ndebele (University of Botswana, Botswana), Aceme Nyika (African Malaria Network Trust [AMANET]), Muriel Socquet
p.000012: (Partnership for Appropriate Technology in Health, [PATH], France), Marjorie Speers (Association for the
p.000012: Accreditation of Human Research Protection Programs, Inc. [AAHR], USA), Christina Torres (Forum for Ethical Review
p.000012: Committees in the Asian and Western Pacific Region [FERCAP], Thailand), Douglas Wassenaar (University
p.000012: KwaZulu-Natal, South Africa), Hugh Whittall (Nuffield Council on Bioethics, UK), John Williams (formerly of
p.000012: the World Medical Association [WMA], France), Xiaomei Zhai (Peking Union Medical College, China).
p.000012: Collaboration with UNESCO in the development of these standards has been especially valuable, both in its
p.000012: representation at the WHO informal consultation, and later, in the critical comments received from the chief of the
p.000012: bioethics section of UNESCO, Dafna Feinholz.
p.000012: The feedback provided to earlier drafts of this document by the participants of the 8th Global Summit of
p.000012: National Bioethics Advisory Bodies (Singapore, July 2010), the 10th World Congress of Bioethics (Singapore,
p.000012: July 2010), the Third National Bioethics Conference (India, November 2010), the 5th National Meeting of Bioethics
p.000012: Commissions of Mexico (November 2010), the medical ethics conference: Is medical Ethics Really in the Best Interest of
p.000012: the Patient? (Sweden, June 2010), and the 10th FERCAP International Conference on Networking and Alliance
p.000012: Building for Ethical Health Research (China, November 2010) shaped the final version of this document.
p.000012:
p.000012:
p.000012: viii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: WHO gratefully acknowledges the contributions of the following reviewers, who provided a review and
p.000012: critical comments on an earlier draft of this document:
p.000012: Dieudonné Adiogo, M. Chi Primus Che, Nchangwi Syntia Munung, Odile Ouwe-Missi-Oukem-Boyer, Ludovic Reveiz,
p.000012: Godfrey B. Tangwa, and M. Jerome Mbih Tosam (on behalf of Cameroon Bioethics Initiative [CAMBIN]), Julian Rodriguez
p.000012: Alvarez and Martha M. Fors López (Centro Nacional Coordinador de Ensayos Clínicos, Cuba), Leslie Ball,
p.000012: Joanne Less, Kevin Prohaska, and Joseph Salewski (Food and Drug Administration [FDA], USA), Nika Berlic
p.000012: (Ministry of Health, Slovenia), Anne Buvé, Raffaella Ravinetto, Jef Verellen, and Bjorn Van Den Sande (Institute of
p.000012: Tropical Medicine, Belgium), Alistair Campbell and Donald Chalmers (University of Tasmania, Australia), Barbara
p.000012: DeCausey (Centers for Disease Control and Prevention [CDC], USA), Hans van Delden, Sev Fluss, Gunilla Sjölin
p.000012: Forsberg, and Rieke van der Graaf (on behalf of CIOMS, Switzerland), Christiane Druml (Ethics- Committee of the
p.000012: Medical University of Vienna, Austria), Gillian Fletcher (La Trobe University, Australia), Dirce Guilhem (on
p.000012: behalf of Foro Latinoamericano y del Caribe de Comités de Ética en Investigación para la Salud [FLACEIS]), Me
p.000012: Marie Hirtle (Biotika, Canada), Nuria Homedes (University of Texas, USA on behalf of Salud y Farmacos and
p.000012: Latin American Network on Clinical Trials and Ethics [RELEM]), Tawfik A. M. Khoja (Health Ministers Council for
p.000012: Cooperation Council, Kingdom of Saudi Arabia), Robert J. Levine, (Yale University, USA), Michael Makanga (European and
p.000012: Developing Countries Clinical Trials Partnership Secretariat Cape Town, S. Africa), Roli Mathur (Indian Council
p.000012: of Medical Research [ICMR], India), Joseph Millum (on behalf of the Fogarty International Center, National
p.000012: Institutes of Health, [NIH], USA), Keymanthri Moodley (University of Stellenbosch, South Africa), Mikkel Møller
p.000012: Rasmussen (Danish National Committee on Biomedical Research Ethics, Denmark), Fernando Andrade Narvaez,
p.000012: (State of Yucatan, Mexico), M. C. Dolores Delgado Ochoa, (Secretaria de la Comisión de Ética en Investigación,
p.000012: Mexico), M. Patrão Neves (Portugal), Susy Y. Olave Quispe (University of Seville and Spanish Medicines
p.000012: Agency, Spain—National Institute of Health, Peru), Harry Perlstadt (Michigan State University, USA), Peush
p.000012: Sahni (All India Institute of Medical Sciences, [AIIMS] India), Renu Saxena (AIIMS, India), Barry Smith
...
p.000007: proposed research;
p.000007: 3. senior decision-makers of the entity creating the REC, or of any organization that sponsors or conducts
p.000007: the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members
p.000007: of the REC or its Chair;
p.000007: 4. the entity that establishes the REC ensures that REC members are protected from retaliation based on positions
p.000007: taken with respect to REC-related matters or review of research projects.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: CHAPTER II
p.000008:
p.000008:
p.000008: Standard 5: Training the research ethics committee
p.000008: Training on the ethical aspects of health-related research with human participants, how ethical
p.000008: considerations apply to different types of research, and how the REC conducts its review of research, is provided
p.000008: to REC members when they join the committee and periodically during their committee service.
p.000008: The training provided to REC members, either directly by the appointing entity or through cooperative arrangements
p.000008: with other RECs and/or organizations that provide education on research ethics, focuses on:
p.000008: 1. the role and responsibilities of the REC, and its role vis-à-vis other relevant entities, according to relevant
p.000008: international guidelines (e.g. the Council for International Organizations of Medical Societies [CIOMS]
p.000008: International Ethical Guidelines for Biomedical Research, CIOMS International Ethical Guidelines for
p.000008: Epidemiological Research, International Council on Harmonization [ICH] Good Clinical Practice [GCP] guidelines
p.000008: in the case of clinical trials), national laws, and institutional policies;
p.000008: 2. the full range of ethical considerations relevant to research with human participants;
p.000008: 3. the application of such ethical considerations to different types of research;
p.000008: 4. basic aspects of research methodology and design (for members who lack such background);
p.000008: 5. the impact of different scientific designs and objectives on the ethics of a research study;
p.000008: 6. the various approaches for recognizing and resolving the tensions that can arise among different ethical
p.000008: considerations and modes of ethical reasoning.
p.000008:
p.000008: When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no
p.000008: control, direct or indirect, over the content of the training.
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: CHAPTER II
p.000009:
p.000009:
p.000009: Standard 6: Transparency, accountability, and quality of the research ethics committee
p.000009: Mechanisms exist to make REC operations transparent, accountable, consistent, and of high quality.
p.000009: The entity establishing the REC employs reliable means to evaluate whether the staff and members of the REC
p.000009: routinely follow the REC’s policies, rules, and written procedures (see Standard 9), with special attention to
p.000009: whether the ethical considerations articulated in international guidelines and national standards are being
...
p.000022: authority the research is being conducted, the sponsor of the research, and any other applicable organizations.
p.000022: 5. Information to research participants
p.000022: Researchers have a responsibility to keep the research participants and their communities informed of the progress of
p.000022: research by appropriate means, at suitable time-frames in simple and non-technical language, for example, when:
p.000022: a. the research study is terminated or cancelled
p.000022: b. any changes occur in the context of the research study that alter the potential benefits or risks
p.000022: c. the research project is completed
p.000022: d. results of the research are available.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex 1. 2. 3.
p.000023: and Glossary
p.000023:
p.000023: ANNEX
p.000023:
p.000023:
p.000023: Annex 1
p.000023: Guidelines and codes of best practice
p.000023: 1. Nuremberg Code (Available at: http://ohsr.od.nih.gov/guidelines/ nuremberg.html, accessed 17 January
p.000023: 2009)
p.000023: 2. Declaration of Helsinki (Available at http://www.wma.net/
p.000023: en/30publications/10policies/b3/index.html, accessed 05 October 2011)
p.000023: 3. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
p.000023: (Available at http://www.cioms.ch/ publications/layout_guide2002.pdf, accessed 05 October 2011)
p.000023: 4. CIOMS: International Ethical Guidelines for Epidemiological Research Involving Human Subjects (2009) (For more
p.000023: information click http:// www.cioms.ch/frame_ethical_guidelines_2009.htm)
p.000023: 5. UNAIDS/WHO, Ethical Considerations in Biomedical HIV Prevention Trials (2007) (Available at
p.000023: http://data.unaids.org/pub/Report/2007/ JC1399_ethical_considerations_en.pdf , accessed 05 October 2011)
p.000023: 6. UNESCO Universal Declaration on Bioethics and Human Rights (2005) (Available at
p.000023: http://portal.unesco.org/en/ev.php-URL_ ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000023: 7. Nuffield Council on Bioethics: the Ethics of Research related to Healthcare in Developing
p.000023: Countries (2002) (Available at http:// www.nuffieldbioethics.org/sites/default/files/Ethics%20of%20
p.000023: research%20related%20to%20healthcare%20in%20developing%20 countries%20I.pdf)
p.000023:
p.000023:
p.000023: Statutes and regulations
p.000023: 1. The Universal Declaration of Human Rights Available at http://www. un.org/en/documents/udhr/ accessed on 05
p.000023: October 2011)
p.000023: 2. ICH Good Clinical Practice Guidelines (1996) (Available at http://www.
p.000023: ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E6_R1/Step4/E6_R1 Guideline.pdf
p.000023: 3. ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials (2000)
p.000023: (Available at http://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_
p.000023: Guideline.pdf , accessed 05 October 2011)
p.000023:
p.000023:
p.000026: 26
p.000026:
p.000026: ANNEX
p.000026:
p.000026:
p.000026: 4. Council of Europe. Convention on Human Rights and Biomedicine, 1997 (Available at
...
General/Other / common rule
Searching for indicator commonXrule:
(return to top)
p.000023:
p.000023:
p.000023: Statutes and regulations
p.000023: 1. The Universal Declaration of Human Rights Available at http://www. un.org/en/documents/udhr/ accessed on 05
p.000023: October 2011)
p.000023: 2. ICH Good Clinical Practice Guidelines (1996) (Available at http://www.
p.000023: ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E6_R1/Step4/E6_R1 Guideline.pdf
p.000023: 3. ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials (2000)
p.000023: (Available at http://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_
p.000023: Guideline.pdf , accessed 05 October 2011)
p.000023:
p.000023:
p.000026: 26
p.000026:
p.000026: ANNEX
p.000026:
p.000026:
p.000026: 4. Council of Europe. Convention on Human Rights and Biomedicine, 1997 (Available at
p.000026: http://conventions.coe.int/treaty/EN/Treaties/ Html/164.htm, accessed 05 October 2011)
p.000026: 5. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning
p.000026: Biomedical Research, 2005 (Available at http://conventions.coe.int/treaty/EN/Treaties/Html/195. htm , accessed
p.000026: on 05 October 2011))
p.000026: 6. Directive of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.000026: laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
p.000026: practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European
p.000026: Communities, 2001 : L121/34. (Available at http://www.eortc.be/Services/Doc/clinical-EU- directive-04-April-01.pdf ,
p.000026: accessed 05 October 2011)
p.000026: 7. The Common Rule (45 CFR Part 46) ( Available at http://www.hhs.gov/ ohrp/policy/ohrpregulations.pdf accessed 05
p.000026: October 2011)
p.000026: 8. United States Food and Drug Administration regulations for the protection of
p.000026: humansubjectsCFR—CodeofFederalRegulationsTitle21,Part50(Available at
p.000026: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=50, accessed 15 August 2011
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: ANNEX
p.000027:
p.000027:
p.000027: Annex 2
p.000027: Guidance for developing terms of reference for the Secretariat of the research ethics committee
p.000027: Institutions hosting RECs provide the RECs with a Secretariat that is adequately staffed to support them in
p.000027: their review and record keeping duties. At a minimum, the functions of the Secretariat include:
p.000027: 1. Informing and advising the principal investigators, sponsors, and new REC members of applicable regulations,
p.000027: guidelines, processes and procedures. In some cases the Secretariat maintains a website ensuring public access to this
p.000027: information.
p.000027: 2. Managing the timely progress of protocol review through initial and continuing contacts with
p.000027: Principal Investigators. This includes identifying and requesting missing documentation in applications and
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000022: notified of the suspension or termination and the plans for care and follow-up for the participants.
p.000022: d. If the REC terminates or suspends its approval of a study, the researcher informs the institution under whose
p.000022: authority the research is being conducted, the sponsor of the research, and any other applicable organizations.
p.000022: 5. Information to research participants
p.000022: Researchers have a responsibility to keep the research participants and their communities informed of the progress of
p.000022: research by appropriate means, at suitable time-frames in simple and non-technical language, for example, when:
p.000022: a. the research study is terminated or cancelled
p.000022: b. any changes occur in the context of the research study that alter the potential benefits or risks
p.000022: c. the research project is completed
p.000022: d. results of the research are available.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex 1. 2. 3.
p.000023: and Glossary
p.000023:
p.000023: ANNEX
p.000023:
p.000023:
p.000023: Annex 1
p.000023: Guidelines and codes of best practice
p.000023: 1. Nuremberg Code (Available at: http://ohsr.od.nih.gov/guidelines/ nuremberg.html, accessed 17 January
p.000023: 2009)
p.000023: 2. Declaration of Helsinki (Available at http://www.wma.net/
p.000023: en/30publications/10policies/b3/index.html, accessed 05 October 2011)
p.000023: 3. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
p.000023: (Available at http://www.cioms.ch/ publications/layout_guide2002.pdf, accessed 05 October 2011)
p.000023: 4. CIOMS: International Ethical Guidelines for Epidemiological Research Involving Human Subjects (2009) (For more
p.000023: information click http:// www.cioms.ch/frame_ethical_guidelines_2009.htm)
p.000023: 5. UNAIDS/WHO, Ethical Considerations in Biomedical HIV Prevention Trials (2007) (Available at
p.000023: http://data.unaids.org/pub/Report/2007/ JC1399_ethical_considerations_en.pdf , accessed 05 October 2011)
p.000023: 6. UNESCO Universal Declaration on Bioethics and Human Rights (2005) (Available at
p.000023: http://portal.unesco.org/en/ev.php-URL_ ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000023: 7. Nuffield Council on Bioethics: the Ethics of Research related to Healthcare in Developing
p.000023: Countries (2002) (Available at http:// www.nuffieldbioethics.org/sites/default/files/Ethics%20of%20
p.000023: research%20related%20to%20healthcare%20in%20developing%20 countries%20I.pdf)
p.000023:
p.000023:
p.000023: Statutes and regulations
...
Orphaned Trigger Words
p.000011: expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any
...
p.000012: of the Research Ethics Review Committee, and focal points for WHO’s Strategy on Research for Health - Robert Terry
p.000012: - and the Global Strategy and Plan of Action on public health, innovation and intellectual property (GSPA -
p.000012: PHI ) – Precious Matsoso. This work was accomplished with the support of three WHO Directors, namely Rüdiger Krech
p.000012: (ETH/WHO), Tikki Pang (IER/ WHO), and Robert Ridley (TDR/WHO).
p.000012: The support provided by the Research Ethics Review Committee (WHO ERC), particularly the Chair of the Committee,
p.000012: Ronald Johnson, is gratefully acknowledged.
p.000012: The support provided by the regional offices of WHO in dissemination of the document for review purposes was invaluable
p.000012: and is gratefully acknowledged. We would also like to thank the various interns and volunteers at WHO, namely
p.000012: Lindsay Heck, Nola Tomaska, Ning Wong, and Yeyang Su, who over time have made important contributions to the project.
p.000012: Special thanks are due to the members of the WHO informal consultation noted below, who provided comments on the first
p.000012: draft of this document. Their detailed review and comments have shaped the development of the Standards:
p.000012:
p.000012: Clement Adebamowo (University of Ibadan, Nigeria), David Borasky (RTI International, USA), Ingrid Callies
p.000012: (Institut Pasteur, France), Alexander M. Capron (University of Southern California, USA), Julie
p.000012: Chaumont (Partnership for Appropriate Technology in Health,
p.000012:
p.000012:
p.000012:
p.000012: vii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: France), Julius Ecuru (National Council for Science and Technology, Uganda), David G. Forster (Western
p.000012: Institutional Review Board, USA), Dirceu Greco, (Federal University of Minas Gerais, Brazil), Nouzha Guessous
p.000012: (Independent Researcher and Consultant, Morocco), Reva Gutnick (Independent Consultant), Samia Hurst (University
p.000012: of Geneva, Switzerland), Carel IJsselmuiden (Council on Health Research for Development [COHRED],
p.000012: Switzerland), Amar Jesani (Anusandhan Trust, India), Irakli Khodeli (United Nations Educational, Scientific
p.000012: and Cultural Organization [UNESCO], France), Otmar Kloiber (World Medical Association [WMA], France), Gottfried Kreutz
p.000012: (formerly of the Council for International Organizations of Medical Sciences [CIOMS], Switzerland) , Laurence Lwoff (on
p.000012: behalf of Council of Europe, France), James Lavery (University of Toronto, Canada), Jacob Leveridge
p.000012: (Wellcome Trust, UK), Florencia Luna (National Scientific and Technical Research Council [CONICET], Argentina), Paul
p.000012: Ndebele (University of Botswana, Botswana), Aceme Nyika (African Malaria Network Trust [AMANET]), Muriel Socquet
p.000012: (Partnership for Appropriate Technology in Health, [PATH], France), Marjorie Speers (Association for the
p.000012: Accreditation of Human Research Protection Programs, Inc. [AAHR], USA), Christina Torres (Forum for Ethical Review
p.000012: Committees in the Asian and Western Pacific Region [FERCAP], Thailand), Douglas Wassenaar (University
p.000012: KwaZulu-Natal, South Africa), Hugh Whittall (Nuffield Council on Bioethics, UK), John Williams (formerly of
p.000012: the World Medical Association [WMA], France), Xiaomei Zhai (Peking Union Medical College, China).
p.000012: Collaboration with UNESCO in the development of these standards has been especially valuable, both in its
p.000012: representation at the WHO informal consultation, and later, in the critical comments received from the chief of the
p.000012: bioethics section of UNESCO, Dafna Feinholz.
p.000012: The feedback provided to earlier drafts of this document by the participants of the 8th Global Summit of
p.000012: National Bioethics Advisory Bodies (Singapore, July 2010), the 10th World Congress of Bioethics (Singapore,
p.000012: July 2010), the Third National Bioethics Conference (India, November 2010), the 5th National Meeting of Bioethics
p.000012: Commissions of Mexico (November 2010), the medical ethics conference: Is medical Ethics Really in the Best Interest of
p.000012: the Patient? (Sweden, June 2010), and the 10th FERCAP International Conference on Networking and Alliance
p.000012: Building for Ethical Health Research (China, November 2010) shaped the final version of this document.
p.000012:
p.000012:
p.000012: viii
p.000012:
p.000012: ACKNOWLEDGEMENTS
p.000012:
p.000012:
p.000012: WHO gratefully acknowledges the contributions of the following reviewers, who provided a review and
p.000012: critical comments on an earlier draft of this document:
p.000012: Dieudonné Adiogo, M. Chi Primus Che, Nchangwi Syntia Munung, Odile Ouwe-Missi-Oukem-Boyer, Ludovic Reveiz,
p.000012: Godfrey B. Tangwa, and M. Jerome Mbih Tosam (on behalf of Cameroon Bioethics Initiative [CAMBIN]), Julian Rodriguez
p.000012: Alvarez and Martha M. Fors López (Centro Nacional Coordinador de Ensayos Clínicos, Cuba), Leslie Ball,
p.000012: Joanne Less, Kevin Prohaska, and Joseph Salewski (Food and Drug Administration [FDA], USA), Nika Berlic
p.000012: (Ministry of Health, Slovenia), Anne Buvé, Raffaella Ravinetto, Jef Verellen, and Bjorn Van Den Sande (Institute of
p.000012: Tropical Medicine, Belgium), Alistair Campbell and Donald Chalmers (University of Tasmania, Australia), Barbara
p.000012: DeCausey (Centers for Disease Control and Prevention [CDC], USA), Hans van Delden, Sev Fluss, Gunilla Sjölin
p.000012: Forsberg, and Rieke van der Graaf (on behalf of CIOMS, Switzerland), Christiane Druml (Ethics- Committee of the
p.000012: Medical University of Vienna, Austria), Gillian Fletcher (La Trobe University, Australia), Dirce Guilhem (on
p.000012: behalf of Foro Latinoamericano y del Caribe de Comités de Ética en Investigación para la Salud [FLACEIS]), Me
p.000012: Marie Hirtle (Biotika, Canada), Nuria Homedes (University of Texas, USA on behalf of Salud y Farmacos and
...
p.000012: disseminated, and used by RECs in more than 100 countries.
...
p.000012: language that establishes specific outcomes or characteristics against which achievements can be benchmarked.
p.000012: The standards put forward in this document do not represent new ideas for REC functioning. Rather, they are based on
p.000012: requirements for RECs delineated in existing international guidance documents. Their purpose is to underscore essential
p.000012: considerations relevant to the ethical review of research, not to take a substantive position on how specific ethical
p.000012: dilemmas should be resolved. Accompanying the standards are a series of “operational guidance” points (set forth in
p.000012: regular type), which reflect commonly used strategies for implementing and fulfilling each of the standards.
p.000012: In addition to delineating standards for the research ethics system, three other changes have been made in this
p.000012: edition. First, the title has been changed to reflect the purpose of the document. Second, the importance of a systems
...
p.000003: the manner in which members and the Chair will be appointed. The appointing entity ensures that the REC
p.000003: has a multidisciplinary and multisectoral membership, that its composition is gender balanced, that it reflects the
p.000003: social and cultural diversity of the communities from which research participants are most likely to be drawn,
p.000003: and that it includes individuals with backgrounds relevant to the areas of research the committee is most likely to
p.000003: review.
p.000003: The entity establishing the REC takes the following factors into consideration when appointing
p.000003: members.
p.000003: 1. Members include individuals with scientific expertise, including expertise in behavioural or social
p.000003: sciences; health care providers; members who have expertise in legal matters and/or ethics; and lay people
p.000003: whose primary role is to share their insights about the communities from which participants are likely to be drawn.
p.000003: 2. Lay people and other members, whose primary background is not in health research with human participants, are
p.000003: appointed in sufficient numbers to ensure that they feel comfortable voicing their views.
p.000003: 3. In order to enhance independence, committee membership includes members who are not affiliated with organizations
p.000003: that sponsor, fund, or conduct research reviewed by the REC (see also Standard 4).
p.000003: 4. Committees are large enough to ensure that multiple perspectives are brought into the discussion. To this end,
p.000003: quorum requirements provide that at least five people, including at least one lay member and one non-affiliated member,
p.000003: are present to make decisions about the proposed research.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000006: 6
p.000006:
p.000006: CHAPTER II
p.000006:
p.000006:
p.000006: Standard 3: Research ethics committee resources
p.000006: The entity establishing the REC supports it with adequate resources, including staffing, facilities, and financial
p.000006: resources to allow the REC to effectively carry out its responsibilities.
p.000006: As an integral part of a health research institution or health system, an REC receives:
p.000006: 1. support staff, adequate in number and training to enable the REC to carry out its technical and administrative
p.000006: responsibilities;
p.000006: 2. adequate resources for the staff to fulfil its assigned functions, including office space and equipment
p.000006: and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct
p.000006: administrative business, to store committee files, and to keep documents secure and confidential;
p.000006: 3. access to appropriate space for the committee to meet and adequate means for members to communicate as needed
p.000006: between meetings;
p.000006: 4. adequate financial resources to permit the committee to produce high-quality work;
p.000006: 5. if considered necessary by the entity establishing the REC, resources necessary to compensate REC members,
p.000006: unless they are already being compensated for their time and effort on the REC through other means.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: CHAPTER II
p.000007:
p.000007:
p.000007: Standard 4: Independence of research ethics committees
p.000007: Policies governing the REC include mechanisms to ensure independence of the REC’s operations, in order to
p.000007: protect decision- making from influence by any individual or entity that sponsors, conducts, or hosts the
p.000007: research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove
p.000007: themselves from the review of any research in which they or close family members have a conflicting interest.
p.000007: To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws,
p.000007: policies and/or procedural rules of the REC provide that:
p.000007: 1. the REC’s membership includes at least one person with no connection to the organization that sponsors
p.000007: or conducts the research under review;
p.000007: 2. researchers, sponsors, and funders may attend an REC meeting to answer questions about their
p.000007: research protocols and associated documents, but they are not present when the REC reaches decisions about their
p.000007: proposed research;
p.000007: 3. senior decision-makers of the entity creating the REC, or of any organization that sponsors or conducts
p.000007: the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members
p.000007: of the REC or its Chair;
p.000007: 4. the entity that establishes the REC ensures that REC members are protected from retaliation based on positions
p.000007: taken with respect to REC-related matters or review of research projects.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: CHAPTER II
p.000008:
p.000008:
p.000008: Standard 5: Training the research ethics committee
p.000008: Training on the ethical aspects of health-related research with human participants, how ethical
p.000008: considerations apply to different types of research, and how the REC conducts its review of research, is provided
p.000008: to REC members when they join the committee and periodically during their committee service.
p.000008: The training provided to REC members, either directly by the appointing entity or through cooperative arrangements
p.000008: with other RECs and/or organizations that provide education on research ethics, focuses on:
p.000008: 1. the role and responsibilities of the REC, and its role vis-à-vis other relevant entities, according to relevant
p.000008: international guidelines (e.g. the Council for International Organizations of Medical Societies [CIOMS]
p.000008: International Ethical Guidelines for Biomedical Research, CIOMS International Ethical Guidelines for
p.000008: Epidemiological Research, International Council on Harmonization [ICH] Good Clinical Practice [GCP] guidelines
p.000008: in the case of clinical trials), national laws, and institutional policies;
p.000008: 2. the full range of ethical considerations relevant to research with human participants;
p.000008: 3. the application of such ethical considerations to different types of research;
p.000008: 4. basic aspects of research methodology and design (for members who lack such background);
p.000008: 5. the impact of different scientific designs and objectives on the ethics of a research study;
p.000008: 6. the various approaches for recognizing and resolving the tensions that can arise among different ethical
p.000008: considerations and modes of ethical reasoning.
p.000008:
p.000008: When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no
p.000008: control, direct or indirect, over the content of the training.
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: CHAPTER II
p.000009:
p.000009:
p.000009: Standard 6: Transparency, accountability, and quality of the research ethics committee
p.000009: Mechanisms exist to make REC operations transparent, accountable, consistent, and of high quality.
p.000009: The entity establishing the REC employs reliable means to evaluate whether the staff and members of the REC
p.000009: routinely follow the REC’s policies, rules, and written procedures (see Standard 9), with special attention to
p.000009: whether the ethical considerations articulated in international guidelines and national standards are being
p.000009: considered and applied consistently and coherently.
p.000009: 1. Such evaluations are conducted by knowledgeable and unbiased people at regular, pre-defined intervals
p.000009: using a pre-defined format; internal assessments are supplemented periodically by independent external
p.000009: evaluations.
p.000009: 2. The entity establishing the REC is committed to consider and, when appropriate, follow up on the findings and
p.000009: recommendations of the internal and external evaluations.
p.000009: 3. The results of the evaluation are of a type that can aid the REC in reviewing its practice and
p.000009: appraising performance (rather than apportioning blame), while also assuring the public that research is being
p.000009: reviewed according to established standards.
p.000009: 4. Researchers, research participants, and other interested parties have a means of lodging complaints about the
p.000009: REC; such complaints should be reviewed by an entity other than the REC itself, and appropriate follow-up actions
p.000009: should be taken.
p.000009: 5. Researchers have a means of discussing concerns with REC members, both on general matters and in response to REC
p.000009: decisions on particular research studies.
p.000009: 6. REC decisions, excluding confidential information, are made publicly available, through
p.000009: mechanisms such as clinical trial registries, web sites, newsletters, and bulletin boards.
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:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Chapter III
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Standards and guidance for members of the research ethics committees
p.000010:
p.000010: CHAPTER III
p.000010:
p.000010:
p.000010: The primary task of an REC is the ethical review of research protocols and their supporting documents. Approval or
p.000010: disapproval is based on the ethical acceptability of the research, including its social value and scientific
p.000010: validity, an acceptable ratio of potential benefits to risks of harm, the minimization of risks, adequate
p.000010: informed consent procedures (including cultural appropriateness and mechanisms to ensure
...
p.000012: 3. Selection of study population and recruitment of research participants
p.000012: Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens
p.000012: of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research;
p.000012: these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is
p.000012: designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear
p.000012: the risks of participating in the research is likely to benefit from the knowledge derived from the research. In
p.000012: addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the
p.000012: purpose of the research, the risks and potential benefits of participating in the research, and other
p.000012: relevant details.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: CHAPTER III
p.000013:
p.000013:
p.000013: 4. Inducements, financial benefits, and financial costs
p.000013: It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated
p.000013: with participation in research, including transportation, child care, or lost wages. Many RECs also believe
p.000013: that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or
p.000013: free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to
p.000013: participate in the research against their better judgement or to compromise their understanding of the research.
p.000013: 5. Protection of research participants’ privacy and confidentiality
p.000013: Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss
p.000013: of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or
p.000013: lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard
p.000013: participants’ privacy and confidentiality.
p.000013: 6. Informed consent process
p.000013: The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled
p.000013: to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what
p.000013: the research entails. Decisions for children or adults who lack the mental capacity to provide informed
p.000013: consent should be made by an authorized surrogate decision-maker.
p.000013: RECs should examine the process through which informed consent will occur, as well as the information that will be
p.000013: provided. RECs may waive the requirement of informed consent only when doing so is consistent with international
p.000013: guidelines and national standards.
p.000013: While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to
p.000013: research does not, in itself, mean that the research is ethically acceptable.
p.000013: 7. Community considerations
p.000013: Research has impacts not only on the individuals who participate, but also on the communities where the research occurs
p.000013: and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as
p.000013: far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local
p.000013: capacity, and
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: CHAPTER III
p.000014:
p.000014:
p.000014: promoting, as relevant, positive effects on communities, including those related to health effects or capacity
p.000014: development. Researchers should actively engage with communities in decision-making about the design and conduct of
p.000014: research (including the informed consent process), while being sensitive to and respecting the communities’ cultural,
p.000014: traditional and religious practices.
p.000014:
p.000014: Standard 8: Decision-making procedures for research ethics committees
p.000014: Decisions on research protocols designated for review by the convened REC are based on a thorough and inclusive process
p.000014: of discussion and deliberation. Protocols involving no more than minimal risk and burden to research
p.000014: participants may be reviewed on an expedited basis by one or more members (rather than the full committee), if
p.000014: the REC has established written procedures permitting such a procedure.
p.000014: 1. During meetings of the REC, members engage in discussions to elicit all concerns and opinions
p.000014: related to the protocols and the associated documents under consideration. The REC’s rules ensure that the
p.000014: discussions are respectful of all opinions and allow for varied beliefs to be aired. The Chair fosters a respectful and
p.000014: inclusive tone and allows adequate time for deliberation, during which only REC members participate and decisions are
p.000014: made only by those who were present during the entire discussion. The Chair is responsible for the
p.000014: decision-making process, in particular for determining when consensus is needed to achieve the decision.
p.000014: Researchers, funders, or others directly associated with the protocol in question are not present during committee
p.000014: deliberations.
p.000014: 2. REC members recognize the limitations of their knowledge and seek external input when necessary, particularly in
p.000014: relation to research that involves people whose life experiences may differ significantly from those of the committee
p.000014: members.
p.000014: 3. Decisions are arrived at through either a vote or consensus. Consensus does not require that all REC
p.000014: members support the decision, but that all members consider the decision at least acceptable and no member
p.000014: considers the decision unacceptable. A pre-defined method determines when votes will be taken and how many favourable
p.000014: votes will be needed for a proposed research to be approved.
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
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p.000015:
p.000015:
p.000015:
p.000015: Chapter IV
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Standards and guidance for the secretariat, staff, and administration of
p.000015: the research ethics committees
p.000015:
p.000015: CHAPTER IV
p.000015:
p.000015:
p.000015: Standard 9: Written policies and procedures
p.000015: Written policies and procedures specify the REC’s membership, committee governance, review procedures,
p.000015: decision-making, communications, follow-up, monitoring, documentation and archiving, training,
p.000015: quality assurance, and procedures for coordination with other RECs.
p.000015: The entity that creates the REC has a responsibility to establish the necessary policies to govern the REC. The REC
p.000015: adopts its rules of procedure and— with the secretariat/staff—promulgates comprehensive, written procedures, which are
p.000015: distributed to all committee members and made publicly available. To the fullest extent possible, the hosting
p.000015: institution provides RECs with a Secretariat whose staff have the necessary knowledge, expertise and
p.000015: training to support the REC in performing its review and record keeping function (for further guidance on the
p.000015: Secretariat function, see Annex 2) . To ensure efficient operation, the policies, rules, and written procedures are
p.000015: reviewed periodically in the light of ongoing assessment of performance and outcomes to determine whether any revisions
p.000015: are needed. REC policies and rules typically address the following topics.
p.000015: 1. Membership of the committee
p.000015: The REC’s policies and procedures delineate the authority, the terms, and the conditions of appointment. Staggered,
p.000015: finite terms of appointment should be considered, allowing continuity of some members when other members are newly
p.000015: appointed. Having limited terms also promotes the development of research ethics expertise and greater knowledge
p.000015: of REC procedures among the larger community of individuals who may rotate through committee service, and allows for
p.000015: input of fresh ideas and approaches to committee deliberations.
p.000015: 2. Committee governance
p.000015: The REC’s policies and procedures define how the REC will establish its offices (e.g. Chair, Vice-Chairs).
p.000015: The Chair is someone respectful of divergent views, able to encourage and help achieve consensus, and with the time to
p.000015: prepare adequately for meetings. The Chair is not a person who has a supervisory relationship toward other members of
p.000015: the committee.
p.000015: 3. Independent consultants
p.000015: The REC’s policies and procedures define the circumstances under which an REC may call upon independent
p.000015: consultants to provide special
p.000015:
p.000015:
p.000015:
p.000018: 18
p.000018:
p.000018: CHAPTER IV
p.000018:
p.000018:
p.000018: expertise to the REC on specific research protocols, populations, or topics.
p.000018: 4. Submissions, documents required for review, review procedures, and decision-making
p.000018: The REC’s policies and procedures describe the requirements for submitting an application for review, including
p.000018: the forms to be completed and the documents to be submitted. They also specify the process and procedure
p.000018: for review, process for coordinating review with other committees, process for setting up meetings, circulating
p.000018: documentation for the meetings, inviting non-members of the REC, approving the meeting minutes, and any related process
p.000018: issues. Procedures for deliberation and decision-making are clearly established and described. Specific quorum
p.000018: requirements for reviewing and making decisions or taking actions are clearly established in the standard operating
p.000018: procedures.
p.000018: 5. Communicating a decision
p.000018: The REC’s policies and procedures describe procedures for communicating the decisions of the
p.000018: REC and specify the maximum amount of time between the decision about the application and when the applicant is
p.000018: informed.
p.000018: 6. Follow-up reviews and monitoring of proposed research
p.000018: Standard operating procedures describe the process by which RECs will follow up the progress of all approved
p.000018: studies—from the time that the approval decision is taken until the termination or completion of the
p.000018: research.
p.000018: 7. Documentation and archiving
p.000018: All of the REC’s documentation and communication is dated, filed, and archived according to the committee’s
p.000018: written procedures. Records may be kept either in hard copy or electronically. In either case, sufficient
p.000018: safeguards are established (e.g. locked cabinets for hard copy files, password protection and encryption
p.000018: for electronic files) to maintain confidentiality. Members of staff are sufficiently trained to understand
p.000018: their responsibilities related to record-keeping, retrieval, and confidentiality. Procedures outline who is authorized
p.000018: to access committee files and documents.
p.000018: Further guidance on REC written procedures is provided in Annex 3.
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
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p.000019:
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p.000019:
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p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Chapter V
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Standards and guidance
p.000019: for researchers
p.000019:
p.000019: ANNEX
p.000019:
p.000019:
p.000019: Standard 10: Researchers’ responsibilities
p.000019: Research is performed only by persons with scientific, clinical, or other relevant qualifications
p.000019: appropriate to the project, who are familiar with the ethical standards applicable to their research, who submit
p.000019: the necessary information to the REC for review (including both the research protocol and disclosures of
p.000019: any conflicting interests), and who carry out the research in compliance with the requirements established by the
p.000019: REC.
p.000019: The person conducting research fulfils the following criteria in the conduct of ethical research.
p.000019: 1. Submitting an application for review
p.000019: a. An application or review of the ethics of proposed health-related research is submitted by a
p.000019: researcher qualified to undertake the particular study, who is directly responsible for the ethical and
p.000019: scientific conduct of the research. In certain jurisdictions, the sponsor of a study is responsible for submitting the
p.000019: research protocol to the REC.
p.000019: b. Student applications are submitted under the responsibility of a qualified advisor / faculty member
p.000019: involved in the oversight of the student’s work or in the student’s name, co-signed by the qualified faculty
p.000019: supervisor.
p.000019: c. All information required for a thorough and complete review of the ethics of proposed research is submitted,
p.000019: including disclosures about researchers’ conflicting interests, if any.
p.000019: 2. Conduct of research
p.000019: a. The research is conducted in compliance with the protocol approved
p.000019: by the REC.
p.000019: b. No deviation or changes are made to the approved protocol or in following it, without prior
p.000019: approval of the REC, except where immediate action is necessary to avoid harm to research participants. In such a
p.000019: case, the REC is informed promptly of the changes/deviations made, and the justification for doing so.
p.000019: c. The REC is informed of any changes at the research site that significantly affect the conduct of
p.000019: the trial, and/or reduce the protections or decrease the benefits provided or increase the risk to
p.000019: participants (e.g. closing down of a health facility at the
p.000019:
p.000019:
p.000019:
p.000022: 22
p.000022:
p.000022: ANNEX
p.000022:
p.000022:
p.000022: research site or other impediments to obtaining access to health care that was originally available).
p.000022: 3. Safety reporting
p.000022: a. All serious, unexpected adverse events related to the conduct of the study/study product or unanticipated
p.000022: problems involving risks of harm to the participants or others are promptly reported to the REC and/or other relevant
p.000022: authorities, as required by REC policies and applicable laws.
p.000022: b. Any recommendations provided by the REC in response to such reporting are immediately implemented.
p.000022: 4. Ongoing reporting and follow-up
p.000022: a. The researcher submits written summaries of the research status to
p.000022: the REC annually, or more frequently, if requested by the REC.
p.000022: b. Researchers inform the REC when a study is completed or prematurely suspended/terminated.
p.000022: c. In the case of the early suspension/termination by the researcher or sponsor, the researcher notifies the
p.000022: REC of the reasons for suspension/termination; provides a summary of results obtained prior to prematurely
p.000022: suspending or terminating the study; and describes the manner by which enrolled participants will be
p.000022: notified of the suspension or termination and the plans for care and follow-up for the participants.
p.000022: d. If the REC terminates or suspends its approval of a study, the researcher informs the institution under whose
p.000022: authority the research is being conducted, the sponsor of the research, and any other applicable organizations.
p.000022: 5. Information to research participants
p.000022: Researchers have a responsibility to keep the research participants and their communities informed of the progress of
p.000022: research by appropriate means, at suitable time-frames in simple and non-technical language, for example, when:
p.000022: a. the research study is terminated or cancelled
p.000022: b. any changes occur in the context of the research study that alter the potential benefits or risks
p.000022: c. the research project is completed
p.000022: d. results of the research are available.
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
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p.000023:
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p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Annex 1. 2. 3.
p.000023: and Glossary
p.000023:
p.000023: ANNEX
p.000023:
p.000023:
p.000023: Annex 1
p.000023: Guidelines and codes of best practice
p.000023: 1. Nuremberg Code (Available at: http://ohsr.od.nih.gov/guidelines/ nuremberg.html, accessed 17 January
p.000023: 2009)
p.000023: 2. Declaration of Helsinki (Available at http://www.wma.net/
p.000023: en/30publications/10policies/b3/index.html, accessed 05 October 2011)
p.000023: 3. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
p.000023: (Available at http://www.cioms.ch/ publications/layout_guide2002.pdf, accessed 05 October 2011)
p.000023: 4. CIOMS: International Ethical Guidelines for Epidemiological Research Involving Human Subjects (2009) (For more
p.000023: information click http:// www.cioms.ch/frame_ethical_guidelines_2009.htm)
p.000023: 5. UNAIDS/WHO, Ethical Considerations in Biomedical HIV Prevention Trials (2007) (Available at
p.000023: http://data.unaids.org/pub/Report/2007/ JC1399_ethical_considerations_en.pdf , accessed 05 October 2011)
p.000023: 6. UNESCO Universal Declaration on Bioethics and Human Rights (2005) (Available at
p.000023: http://portal.unesco.org/en/ev.php-URL_ ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000023: 7. Nuffield Council on Bioethics: the Ethics of Research related to Healthcare in Developing
p.000023: Countries (2002) (Available at http:// www.nuffieldbioethics.org/sites/default/files/Ethics%20of%20
p.000023: research%20related%20to%20healthcare%20in%20developing%20 countries%20I.pdf)
p.000023:
p.000023:
p.000023: Statutes and regulations
p.000023: 1. The Universal Declaration of Human Rights Available at http://www. un.org/en/documents/udhr/ accessed on 05
p.000023: October 2011)
p.000023: 2. ICH Good Clinical Practice Guidelines (1996) (Available at http://www.
p.000023: ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E6_R1/Step4/E6_R1 Guideline.pdf
p.000023: 3. ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials (2000)
p.000023: (Available at http://www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_
p.000023: Guideline.pdf , accessed 05 October 2011)
p.000023:
p.000023:
p.000026: 26
p.000026:
p.000026: ANNEX
p.000026:
p.000026:
p.000026: 4. Council of Europe. Convention on Human Rights and Biomedicine, 1997 (Available at
p.000026: http://conventions.coe.int/treaty/EN/Treaties/ Html/164.htm, accessed 05 October 2011)
p.000026: 5. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning
p.000026: Biomedical Research, 2005 (Available at http://conventions.coe.int/treaty/EN/Treaties/Html/195. htm , accessed
p.000026: on 05 October 2011))
p.000026: 6. Directive of the European Parliament and of the Council of 4 April 2001 on the approximation of the
p.000026: laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
p.000026: practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European
p.000026: Communities, 2001 : L121/34. (Available at http://www.eortc.be/Services/Doc/clinical-EU- directive-04-April-01.pdf ,
p.000026: accessed 05 October 2011)
p.000026: 7. The CommonXRule (45 CFR Part 46) ( Available at http://www.hhs.gov/ ohrp/policy/ohrpregulations.pdf accessed 05
p.000026: October 2011)
p.000026: 8. United States Food and Drug Administration regulations for the protection of
p.000026: humansubjectsCFR—CodeofFederalRegulationsTitle21,Part50(Available at
p.000026: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=50, accessed 15 August 2011
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: ANNEX
p.000027:
p.000027:
p.000027: Annex 2
p.000027: Guidance for developing terms of reference for the Secretariat of the research ethics committee
p.000027: Institutions hosting RECs provide the RECs with a Secretariat that is adequately staffed to support them in
p.000027: their review and record keeping duties. At a minimum, the functions of the Secretariat include:
p.000027: 1. Informing and advising the principal investigators, sponsors, and new REC members of applicable regulations,
p.000027: guidelines, processes and procedures. In some cases the Secretariat maintains a website ensuring public access to this
p.000027: information.
p.000027: 2. Managing the timely progress of protocol review through initial and continuing contacts with
p.000027: Principal Investigators. This includes identifying and requesting missing documentation in applications and
p.000027: preparing the completed file for committee review.
p.000027: 3. Preparing the meetings of the REC, including the distribution of relevant documentation to the members, scheduling
p.000027: the meetings, and ensuring the quorum.
p.000027: 4. In close collaboration with the chair of the REC, preparing applications that will be evaluated through expedited
p.000027: review.
p.000027: 5. Following-up with tasks that the REC requests the principal investigators to perform such as progress
p.000027: reports, final reports, corrective actions, amendment of the approved protocol or consent documents etc.
p.000027: 6. In close collaboration with the Chair of the REC, preparing reports of REC meetings and annual reports of REC
p.000027: activities. The annual report includes information about sources of funding and expenses of the REC.
p.000027: 7. Record keeping, including maintaining research protocols and all correspondence in relation to their
p.000027: review, as well as records of any continuing oversight that may be required after approval. The Secretariat
p.000027: ensures that the confidentiality of REC records is maintained.
p.000027: 8. Facilitating access to literature and educational programmes useful to the members of REC.
p.000027:
p.000027: 9. Up dating information about REC membership, including declarations of potential conflicts of interests.
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: ANNEX
p.000028:
p.000028:
p.000028: Additional responsibilities may be delegated to the Secretariat staff by the entity creating the REC and/or
p.000028: the REC Chair, as appropriate in light of the Secretariat’s training, expertise, capacity, and resources;
p.000028: such responsibilities may include keeping abreast of developments in research ethics and regulation,
p.000028: engaging in community outreach and education, serving as a liaison between the REC and the research community,
p.000028: facilitating implementation of quality improvement and quality assurance programs etc.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: ANNEX
p.000029:
p.000029:
p.000029: Annex 3
p.000029: Guidance for developing written procedures for the research ethics committee
p.000029: REC written procedures address the following issues:
p.000029: I. Membership of the Committee
p.000029: a) Authority for appointment of committee members specifying the name or description of the entity responsible
p.000029: for making appointments and the procedures for:
p.000029: 1. selecting and appointing the REC Chair and members, including the method by which new members and the Chair are
p.000029: selected (e.g. by consensus or majority vote of existing members, by direct appointment of the Chair or other
p.000029: official)
p.000029: 2. managing conflicts of interest in making appointments (see Standard 4).
p.000029: b) Terms of appointment, including:
p.000029: 1. the duration of an appointment
p.000029: 2. the policy for the renewal of an appointment
p.000029: 3. the disqualification procedure
p.000029: 4. the resignation procedure
p.000029: 5. the replacement procedure.
p.000029: c) Conditions of appointment, including:
p.000029: 1. that an REC member shall agree to publicize his/her full name, profession and affiliations
p.000029: 2. whether a member receives any reimbursement for travel expenses and/or lost wages and that such
p.000029: reimbursements, if any, shall be recorded and information about such reimbursements made available to the public
p.000029: 3. that REC members and staff shall sign confidentiality agreements regarding sensitive aspects of protocols,
p.000029: meeting deliberations and related matters (e.g. information about trade secrets or personal information about
p.000029: research participants).
p.000029:
p.000029: II. Committee governance
p.000029: The REC establishes clearly defined offices for the good functioning of ethical review. The REC’s policies and
p.000029: procedures define how the REC will establish its officers (e.g. Chair, Vice-Chairs, etc.). Terms of reference are
p.000029: established for officers that outline:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030: ANNEX
p.000030:
p.000030:
p.000030: 1. procedures for selecting and appointing officers
p.000030: 2. the requirements for holding the office
p.000030: 3. the terms and conditions of each office
p.000030: 4. the duties, responsibilities, and authority of each officer (e.g. running a meeting, setting the agenda,
p.000030: notifying decisions to applicants).
p.000030:
p.000030: III. Independent consultants
p.000030: Written procedures define the circumstances under which an REC may call upon independent consultants to provide special
p.000030: expertise to the REC on specific research projects, populations, or topics. Such consultants could include
p.000030: experts in ethics, law, or specific medical specialties or procedures, or they might be representatives of communities,
p.000030: patients, or other groups relevant to the deliberations required. Written procedures require terms of reference for
p.000030: independent consultants and confidentiality agreement, and clarify that—because consultants are not members of the
p.000030: REC—they do not have any voting or decision-making authority.
p.000030:
p.000030: IV. Submissions, documents required for review, review pro- cedures, and decision-making
p.000030: a) Submission procedures
p.000030: The written procedures describe the requirements for submitting a research project for review. Submission
p.000030: requirements and required forms should be readily available to prospective applicants. Application
p.000030: instructions generally include at least the following:
p.000030: 1. the name(s) and address(es) of the REC secretariat, officers, or member(s) to whom the application material
p.000030: should be submitted
p.000030: 2. all written documentation to be submitted as part of the application
p.000030: 3. the format for submission
p.000030: 4. the language(s) in which (core) documents are to be submitted
p.000030: 5. the number of copies to be submitted
p.000030: 6. the deadlines for submission of the application in relation to review dates
p.000030: 7. the means by which applications will be acknowledged and by which notices about the incompleteness
p.000030: of an application package will be communicated
p.000030: 8. the expected time for notification of the decision following review
p.000030: 9. the time-frame to be followed in cases where the REC requests supplementary information or changes to documents
p.000030: from the applicant
p.000030: 10. a fair and transparent fee structure, if any, for reviewing a research project
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: ANNEX
p.000031:
p.000031:
p.000031: 11. the procedure for seeking amendments to the protocol, or its related documents
p.000031: 12. the required format for recruitment material, information to be given to prospective research participants,
p.000031: and the informed consent form
p.000031: 13. if appropriate and necessary, a check list for the above procedures.
p.000031: b) Documents required for review
p.000031: All documents required for a thorough and complete review of the proposed research project should be submitted by the
p.000031: applicant, in the REC’s working language. As applicable, this may include, but is not limited to:
p.000031: 1. signed and dated application form, including signatures of listed co-applicants and institutional
p.000031: officials (e.g. heads of departments) where relevant
p.000031: 2. the protocol for the proposed research project, clearly identified and dated, together with supporting documents
p.000031: and annexes
p.000031: 3. a project summary or synopsis in non-technical language
p.000031: 4. a description (which may be included in the protocol) of the ethical considerations involved in the
p.000031: proposed research
p.000031: 5. background information on previous research in the same area of work that justifies and/or supports the proposal
p.000031: 6. when the research involves an experimental product (such as a pharmaceutical or medical device
p.000031: under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and
p.000031: toxicological data available on the study product, together with a summary of clinical experience with the study
p.000031: product to date (e.g. recent investigator’s brochure, published data, a summary of the product’s characteristics)
p.000031: 7. current curricula vitae of the principle investigators
p.000031: 8. all data collection forms to be used in the research project, including but not limited to case report
p.000031: forms, diary cards, questionnaires, interview schedules, etc., clearly identified and dated
p.000031: 9. all forms, documents, advertisements to be used in recruitment of potential participants
p.000031: 10. a detailed description of the recruitment process and strategies
p.000031: 11. informed consent form(s) (with date and version number) in languages understood and at a reading
p.000031: level appropriate for the potential research participants and when required, in other languages
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: ANNEX
p.000032:
p.000032:
p.000032: 12. a description of the process that will be used to obtain and document informed consent
p.000032: 13. a description of measures that will be taken to ensure the protection of participants’ privacy and the
p.000032: confidentiality of data
p.000032: 14. a statement describing any remuneration or other goods or services to be provided to study
p.000032: participants, including reimbursement of expenses and access to medical care
p.000032: 15. a description of arrangements for insurance coverage for research participants, if applicable
p.000032: 16. disclosure of all previous decisions (including those leading to a negative decision or modified
p.000032: proposal) by other RECs or regulatory authorities for the proposed study, whether in the same location or
p.000032: elsewhere, and indication of the reasons for previous negative decisions and modification(s) to the proposal
p.000032: made on that account
p.000032: 17. a statement that the researcher(s) agree to comply with ethical principles set out in relevant guidelines.
p.000032: c) Review procedures
p.000032: The REC’s written procedures specify the process by which the REC will decide which projects should be reviewed by the
p.000032: full convened committee and which projects may be reviewed through an expedited procedure. The written procedures
p.000032: address who will have the responsibility of making this determination, as well as the number of reviewers required for
p.000032: expedited review and how those reviewers will be selected. The Chair regularly notifies the REC members of expedited
p.000032: reviews that have been conducted between convened REC meetings. The REC’s written procedures state the procedures for
p.000032: coordinating with and/or relying on the reviews and decisions of other domestic RECs or RECs in other countries.
p.000032: d) REC meetings
p.000032: RECs should meet regularly as a committee on dates that are announced in advance. The written procedures should
p.000032: describe the process for setting up meetings, circulating documentation for the meetings, inviting non-members of the
p.000032: REC, approving the meeting minutes, and any related process issues. The following issues are outlined in the written
p.000032: procedures:
p.000032: 1. the frequency of meetings, which should be based on committee workload and regular enough to avoid undue delay
p.000032: 2. the maximum time-frame for review after receipt of complete applications, and a process or mechanism which
p.000032: provides justification if the time-frame is exceeded.
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: ANNEX
p.000033:
p.000033:
p.000033: 3. mechanisms to ensure that REC members receive all relevant documents in advance of the meetings with
p.000033: enough time to adequately review meeting materials
p.000033: 4. standards and procedures for inviting the researcher and/or sponsor of a particular project to
p.000033: present or comment on the project in question or on specific issues that relate to it during the meeting, at the
p.000033: discretion of the committee
p.000033: 5. standards and procedures for taking and approving meeting minutes.
p.000033: e) Quorum requirements
p.000033: Specific quorum requirements for reviewing and making decisions or taking actions on an application are clearly
p.000033: established in the written procedures, including:
p.000033: 1. the minimum number of members required to compose a quorum (e.g. half of the members, a simple majority—see
p.000033: Standard 2)
p.000033: 2. the distribution of committee composition requirements across the quorum; a quorum should consist of at least
p.000033: five members, including at least one lay member and one non-affiliated member (see Standard 2)
p.000033: f) Deliberation and decision-making.
p.000033: Procedures for deliberation and decision-making are clearly established and describe:
p.000033: 1. the ethical guidelines on which the REC will rely to make its decisions
p.000033: 2. the manner in which the project documents will be presented to the committee for discussion
...
Appendix
Indicator List
Indicator | Vulnerability |
HIV | HIV/AIDS |
access | Access to Social Goods |
authority | Relationship to Authority |
child | Child |
children | Child |
cioms | cioms guidelines |
commonXrule | common rule |
disability | Mentally Disabled |
drug | Drug Usage |
education | education |
educational | education |
emergency | Public Emergency |
employees | employees |
ethnic | Ethnicity |
family | Motherhood/Family |
gender | gender |
hazard | Natural Hazards |
helsinki | declaration of helsinki |
homeless | Homeless Persons |
incapable | Mentally Incapacitated |
influence | Drug Usage |
language | Linguistic Proficiency |
literacy | Literacy |
minority | Racial Minority |
nomads | nomad |
officer | Police Officer |
opinion | philosophical differences/differences of opinion |
property | Property Ownership |
religious | Religion |
single | Marital Status |
stigma | Threat of Stigma |
student | Student |
undue influence | Undue Influence |
unemployed | Unemployment |
union | Trade Union Membership |
volunteers | Healthy People |
vulnerable | vulnerable |
women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Indicator | Peers |
child | ['children'] |
children | ['child'] |
drug | ['influence'] |
education | ['educational'] |
educational | ['education'] |
influence | ['drug'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input