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Year : 2016  |  Volume : 7  |  Issue : 1  |  Page : 1-3

Ethics committee minutes: Heart of ethics committee quality

President, Clininvent Research Private Limited, Mumbai, Maharashtra, India

Date of Web Publication12-Jan-2016

Correspondence Address:
Arun Bhatt
Clininvent Research Private Limited, A - 302, Everest Chambers, Marol Naka, Andheri, Andheri (E), Kurla Road, Mumbai - 400 059, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.173774

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How to cite this article:
Bhatt A. Ethics committee minutes: Heart of ethics committee quality. Perspect Clin Res 2016;7:1-3

How to cite this URL:
Bhatt A. Ethics committee minutes: Heart of ethics committee quality. Perspect Clin Res [serial online] 2016 [cited 2023 Mar 29];7:1-3. Available from: http://www.picronline.org/text.asp?2016/7/1/1/173774

Ethics committee (EC) is responsible for safeguarding the rights, safety, and well-being of all clinical trial participants.[1] The EC review of research is also essential to ensure public accountability and to minimize the influence of research investigator's conflicts of interest.[2] The requirement of a review of research by EC is overarching as the review covers other ethical principles-social and scientific value of clinical research; risk:benefit, informed consent, fair selection of clinical research participants, and scientific validity of protocol. Independent review by an EC is vital for ethical conduct of clinical research. The EC has to comply with the regulations and guidelines to ensure the quality of the ethical review.

There are several literature reports about deficiencies in EC functioning [3] for example, inappropriate composition and functioning, inadequate training, conflict of interest, and lack of standard operating procedures (SOPs). In our survey of ethics in clinical research, the major concern was independence and competence of EC, contribution of lay person in EC meeting, and safety review.[4] A study of EC approval letters revealed deficiencies in composition, quorum, and review of insurance as well as clinical trial agreement.[5] These deficiencies in EC functioning need a deeper analysis of how ECs function. As the EC decisions are taken in the meetings, EC minutes provide good evidence of how the ECs carry out their responsibilities.

During inspections of Institutional Review Board (IRB), United States Food and Drug Administration (FDA) inspectors focus on IRB minutes to review (1) recent practices (2) violative procedures and (3) approval and follow-up on tracked studies.[6] Office for Human Research Protections (OHRP), as part of its compliance oversight activities, evaluates compliance of IRBs to regulations.[7] IRBs have been cited in OHRP determination letters and FDA warning letters for failing to prepare and maintain adequate minutes. This is also one of the common findings in FDA inspection of IRBs. The citation in the warning letter is a failure to have minutes of IRB meetings in sufficient detail to show attendance at the meetings. Examples of noncompliance related to minutes include:[8]

  • Minutes are missing
  • Minutes lack sufficient detail to show the vote on actions taken by the IRB, including the number of members voting for, against, and abstaining
  • Minutes are incomplete and only describe voting actions as “passed unanimously”
  • Minutes do not clearly indicate, or contain discrepancies about, what the IRB approved
  • The IRB maintains multiple sets of minutes with different information for the same meeting
  • Minutes fail to include a summary of the discussion of controverted issues.

Recently, the US FDA and OHRP have issued draft guidance for institutions and IRBs on the type and amount of information to include in minutes to help IRBs meet the regulatory requirements for minutes.[8] The FDA expects an IRB to prepare and maintain adequate documentation of its activities, including minutes in sufficient detail to show:

  • Attendance at the meetings

    • Members, alternates, consultants, and guests
    • Quorum present throughout the meeting.

  • Actions taken by the IRB

    • Approve, require modifications to secure approval, disapprove
    • Suspension or termination of approval
    • Other regulatory determinations and review responsibilities
    • Criteria for approval of research
    • Informed consent
    • Studies involving children
    • Studies involving pregnant women, human fetuses, and neonates
    • Studies involving prisoners
    • Medical device studies
    • Expedited review activities
    • Unanticipated problems, serious or continuing noncompliance, suspension or termination of approval

  • Vote on these actions, including the number of members voting for, against, and abstaining
  • Basis for requiring changes in or disapproving research
  • Written summary of the discussion of controverted issues and their resolution.

In India, at present, there is no regulatory inspection of ECs. However, National Accreditation Board for Hospitals and Healthcare Providers process of accreditation of ECs requires qualified assessors to review EC functioning.[9] The objectives of these standards are to confirm that the EC is adequately qualified, experienced, and knowledgeable in ethical issues and applicable rules and regulations for conduct of clinical trials ensuring scientific integrity and protection of subject rights, safety, and well-being. Accreditation of EC includes 10 standards and 49 objective elements, which would be checked by the assessors to verify whether (a) EC competently assesses risk and scientific validity of trials, (b) EC has appropriate measures to ensure protection of subject rights, safety, and well-being and (c) there is transparency in EC functioning and (d) procedures are followed for all essential activities. The list of mandatory EC SOPs includes several procedures for ethical evaluation-review and decision making, vulnerable population, risk: Benefit analysis, informed consent document-which would require review of minutes. Assessment of compliance to some of the standards-protection of subject rights, safety and well-being, review process, decision making and postmeeting activities, and monitoring – would require detailed review of EC minutes.

The Indian ECs should develop practice of preparing detailed minutes. The FDA guidance document would be of immense help in documenting the EC review and decision making. The EC minutes should document, review and decision making at all stages of a clinical trial. (a) before initiation of the trial (b) during the trial conduct and (c) after completion of the trial.

Before initiation the EC has to review the project proposal to give its opinion. This would require thorough evaluation [10] of (1) scientific design and conduct of the study (2) evaluation of risks and potential benefits (3) selection and recruitment of research participants (4) inducements, financial benefits, and financial costs (5) protection of research participants' privacy and confidentiality (6) informed consent process and (7) community considerations. During the clinical trial conduct, the EC review would focus on protocol deviations, protocol amendments, serious adverse reactions, compensation, and noncompliance by the investigator, study progress reports, complaints from participants, continuing oversight and monitoring. After the completion of trial, the EC has to review the completed study report. The EC also has to review issues related to premature termination/suspension/discontinuation of clinical trial.

World Health Organization recommends that EC may use a checklist to ensure that all important criteria are deliberated during the EC meeting.[10] The FDA and OHRP also recommend that IRBs decide who is responsible for preparing and maintaining minutes and outline the process in the IRB's SOPs. IRBs may consider developing a standard template to help in the preparation of the minutes.[8] IRBs may also decide to audio/video taping of the meetings to assist in the preparation of written minutes.

The purpose of EC minutes is to provide a summary of what transpired during a meeting and to document the EC's findings and decisions. The minutes also provide information to institution authorities and regulatory agency about the EC decisions and provide documentation of the EC's compliance with regulatory requirements. The EC minutes are core documentation to assess the functioning of ECs to meet quality and accreditation standards. Indian ECs should make efforts to have procedures and practices in place to prepare quality minutes to meet requirements of accreditation, and national and international guidelines and regulations.

   References Top

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice E6; 1996. Available from: http://www.ich.org/LOB/media/MEDIA482.pdf. [Last accessed on 2010 Dec 10].  Back to cited text no. 1
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-11.  Back to cited text no. 2
Kuyare MS, Taur SR, Thatte UM. Establishing institutional ethics committees: Challenges and solutions – A review of the literature. Indian J Med Ethics 2014;11:181-5.  Back to cited text no. 3
Jadhav M, Bhatt A. Ethics in clinical research in India: A survey of clinical research professionals' perceptions. Perspect Clin Res 2013;4:4-8.  Back to cited text no. 4
[PUBMED]  Medknow Journal  
Taur SR, Bavdekar SB, Thatte UM. Survey of ethics committee protocol approval letters: Compliance with schedule Y/ICMR guidelines 2006. Indian J Med Ethics 2011;8:214-6.  Back to cited text no. 5
Food and Drug Administration Compliance Program Guidance Manual: Institutional Review Boards. Available from: http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133768.pdf. [Last accessed on 2012 Mar 26].  Back to cited text no. 6
Division of Compliance Oversight Office for Human Research Protections (OHRP) OHRP Compliance Oversight Activities: Determinations of Noncompliance. Available from: http://www.hhs.gov/ohrp/compliance/findings/findings.pdf. [Last accessed on 2011 Nov 14].  Back to cited text no. 7
U.S. Department of Health and Human Services Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm. [Last accessed on 2015 Nov 30].  Back to cited text no. 8
National Accreditation Board for Hospitals and Healthcare Providers (NABH). Accreditation Standards for Clinical Trial in India Ethics Committee, Investigator and Clinical Trial Site. Available from: http://www.cdsco.nic.in/writereaddata/finalAccreditation%20Standards.pdf. [Last accessed on 2015 Dec 11].  Back to cited text no. 9
World Health Organization Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Available from: http://www.who.int/ethics/publications/9789241502948/en/. [Last accessed on 2013 Feb 15].  Back to cited text no. 10


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