Ethics Committee

It is necessary for all research proposals on biomedical, social and behavioural science research for health involving human participants, their biological material and data to be reviewed and approved by an appropriately constituted EC to safeguard the dignity, rights, safety and well-being of all research participants.

The institution is responsible for establishing an EC to ensure an appropriate and sustainable system for quality ethical review and monitoring. The EC is responsible for scientific and ethical review of research proposals. ECs are entrusted with the initial review of research proposals prior to their initiation, and also have a continuing responsibility to regularly monitor the approved research to ensure ethical compliance during the conduct of research. The EC should be competent and independent in its functioning.

Every EC should have written SOPs according to which the committee should function. The EC can refer to ICMR guidelines in preparing the SOPs for all biomedical and health research.

ECs should be multi-disciplinary and multi-sectoral.

There should be adequate representation of age and gender.

Preferably 50% of the members should be non-affiliated or from outside the institution.

The number of members in an EC should preferably be between seven and 15 and a minimum of five members should be present to meet the quorum requirements.

The EC should have a balance between medical and non-medical members/technical and non-technical members, depending upon the needs of the institution.

A minimum of five members present in the meeting room.

The quorum should include both medical, non-medical or technical or/and non-technical members.

Minimum one non-affiliated member should be part of the quorum.

Preferably the lay person should be part of the quorum.

No decision is valid without fulfilment of the quorum.

The head of the institution should appoint all EC members, including the Chairperson.

Generally, the term of EC membership may be 2–3 years.

Members should be selected in their personal capacities based on their qualifications, experience, interest, commitment and willingness to volunteer the required time and effort for the EC.

Members should undergo initial and continued training in human research protection, EC functions and SOPs, and should be conversant with ethical guidelines, GCP guidelines (if applicable) and relevant regulations of the country.

EC has to ensure protection of the dignity, rights, safety and well-being of the research participants

EC must ensure ethical conduct of research by the investigator team

EC is responsible for declaration of conflicts of interest to the Chairperson

EC should perform its function through competent initial and continuing review of all scientific, ethical, medical and social aspects of research proposals received by it in an objective, timely and independent manner

EC should assist in the development and education of the research community in the given institute

EC should ensure that privacy of the individual and confidentiality of data including the documents of EC meetings is protected

EC reviews progress reports, final reports and AE/SAE and gives needful suggestions

Regarding care of the participants and risk minimization procedures, if applicable

EC should recommend appropriate compensation for research related injury, wherever required

EC should carry out monitoring visits at study sites as and when needed

Independent ECs (Ind EC) that function outside institutions can be used by researchers who have no institutional attachments. For these committees, the following essential conditions should be met:

The Ind EC must be established as a registered legal entity, governed by individuals who are not members of the proposed EC and who will oversee and monitor the functioning of the Ind EC.

It should function according to SOPs that follow the national guidelines for functioning of ECs.

It should not accept research proposals from investigators affiliated to institutions that have their own ECs unless there is an MoU.

It will have rights and responsibilities related to the projects submitted to it.

It should have access to all research records, including the source documents and research participants.

It should undertake continuing review of the implemented project including site visits.

It should familiarize itself with local socio-cultural norms that may help to ensure protection of rights and well-being of research participants.