Primary Roles and Responsibilities of Institutional Ethics Committee (IEC/IRB) during Clinical Trials

In making decisions about health care, patients, families, and physicians and other health care professionals often face difficult, potentially life-changing situations. Such situations can raise ethically challenging questions about what would be the most appropriate or preferred course of action. Institutional Ethics committees (IEC), or Institutional Review Board (IRB), offer assistance in addressing ethical issues that arise in patient care and facilitate sound decision making that respects participants’ values, concerns, and interests. Ethics committees involve individuals from diverse backgrounds who support health care institutions with three major functions: providing clinical ethics consultation, developing and/or revising policies pertaining to clinical ethics and hospital policy (e.g., advance directives, withholding and withdrawing life-sustaining treatments, informed consent, organ procurement), and facilitating education about topical issues in clinical ethics. Ethics committees or select members often help resolve ethical conflicts and answer ethical questions through the provision of consultations.

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Ethics programs may provide ethics consultations in response to non-clinical ethics questions, identify and remedy systems-level factors that induce or exacerbate ethical problems and/or impede their resolution (often using quality improvement methods), and promote a positive ethics culture throughout the institution. Thus, the additional goals of expanded ethics programs include:

To be effective in providing the intended support and guidance in any of these capacities, ethics committees should have Following designated Person:-

Alternate members:

  • The IEC should nominate alternate Chairperson who can be selected from the non- institutional  IEC  members.  The  alternate  Chairperson  can  oversee  /  conduct  the meeting in the absence of the Chairperson.
  • Considering the fact that there may be conflict of interests when the Member Secretary is the Principal Investigator/ co-investigator or is absent from the meeting, the IEC may consider appointing alternate Member Secretary who should be the institutional IEC member.
  • The alternate member of required speciality (Legal Expert, Clinical Pharmacologist, Community Member) can be selected for fulfilling the quorum, in case the present member is not able to attend the meeting due to unprecedented prior commitments and the meeting is to be held on the same day.
  • Alternate members are suggested by the IEC and appointed by the Director/ Officer-in- Charge.
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Roles and Responsibilities of IEC members

  • Regularly attend and actively participate in the EC meetings
  • Review, discuss and consider research proposals submitted for evaluation. Reviewers for each proposal will review the study.  Later,  if any other issues the other IEC members can voice their comments/suggestions.
  • Discuss serious adverse event reports and recommend appropriate action(s) Review the progress reports and monitor ongoing studies as appropriate.
  • Evaluate final reports and outcomes
  • Maintain confidentiality of the documents and deliberations of IEC meetings. Declare any conflict of interest
  • Participate in  continuing  education  activities  in  biomedical  ethics  and  biomedical research
  • If deemed necessary, should suggest any changes that may be necessary to be included in the SOPs of the IEC.
  •  Conduct monitoring visits for any research proposal, if needed.

Quorum Requirements

  • A minimum of five members or one third of the total members must be present at a meeting besides Member Secretary and Chairperson in order to issue a valid advice and/or decision, provided quorum is met.
  • Professional qualifications of the quorum requirements should consist of:
  • One legal expert
  • One Clinician
  • One socio-behavioural scientist/ one basic scientist depending on the projects to be discussed
  • at least one member who is independent of the institution/research site.
  • at least one member whose primary area of expertise is in a non-scientific area i.e. lay person or community member

In order to integrate ethics throughout the institution and effect cultural change, ethics programs may include senior leaders in disparate services, such as fiscal, human resources, patient safety, quality improvement, and compliance and business integrity. At some institutions a special ethics council is formed to address ethical issues across the institution, providing a more integrated approach to addressing ethical issues.

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