(As per the ICMR National Ethical Guidelines Section 4.1 and 4.4)
The head of the institution will appoint all Ethics Committee (EC) members, including the Chairperson.
The Term of reference for the EC and its members should be specified by the institution in the EC SOP.
Institutional Ethics Committee should have written SOPs according to which the committee should function.
The EC should refer to ICMR guidelines in preparing the SOPs for all biomedical and health research and to CDSCO guidelines for drug and device trials under the purview of the licensing authority.
The SOPs should be updated periodically to reflect changing requirements.
A copy of the latest version of SOPs should be made available to each member and they should be trained on the SOPs.
The SOPs should be available in the secretariat of the EC as both hard and soft copies. The EC should be registered with the relevant regulatory authorities
The appointment letter issued to all members should specify the TORs. The letter issued by the head of the institution should include, at the minimum, the following:
• Role and responsibility of the member in the committee
• Duration of appointment
• Conditions of appointment
Generally, the term of EC membership may be 2–3 years. The duration could be extended as specified in the SOPs. A defined percentage of EC members could be changed on a regular basis.
EC members may be given a reasonable honorarium for attendance at the meeting.
The members to be appointed to the IEC should be willing to fulfil the EC requirements as given below:
Every EC member must:
provide a recent signed Curriculum Vitae and training certificates on human research protection and good clinical practice (GCP) guidelines, if applicable;
either be trained in human research protection and/or GCP at the time of induction into the Ethics Committee (EC), or must undergo training and submit training certificates as per institutional policy;
be willing to undergo training or update their skills/knowledge during their tenure as an EC member;
be aware of relevant guidelines and regulations;
read, understand, accept and follow the Conflict of Interest (COI) policy of the EC and declare it, if applicable, at the appropriate time;
sign a confidentiality and conflict of interest agreement/s;
be willing to place her/his full name, profession and affiliation to the EC in the public domain; and
be committed and understanding to the need for research and for imparting protection to research participants in research.
The EC members should be made aware of their role and responsibilities as committee members. Any change in the regulatory requirements should be brought to their attention and they should be kept abreast of all national and international development in this regard.
Scope and purpose of the Ethics Committee: The committee shall review biomedical health research protocols involving human participants or involving data of human participants for the types like retrospective studies, disease and drug registries, case studies, epidemiological devices, studies involving pharmaceuticals, studies involving devices, in-vitro studies involving human samples, and other research protocols submitted within the scope of the institutional ethics committee.
