Table 2.
1. | Preferably, 50% of the ethics committee members should be non-affiliated or from outside the institution.[2] |
2. | The total number of members in an EC should preferably be between 7 and 15.[2] |
3. | The head of the institution should appoint all EC members, including the chairperson. The chairperson should be a non-affiliated member, whereas the member secretary should be affiliated with the institute.[2] |
4. | Constitution of the Ethics Committee for Clinical Trials[2] The Ethics Committee should have a minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least (i) One layperson; (ii) One woman member; (iii) One legal expert; (iv) One independent member (such as a social scientist or representative of a non-governmental organization, a philosopher or ethicist, or theologian). |
5. | The committee should include at least one member whose primary area of interest or specialization is nonscientific and at least one member who is independent of the institution. |
6. | The medical scientists and clinicians on the ethics committee should have post graduate qualifications and adequate experience in their respective areas of specialization. |
7. |
Quorum requirements[2]
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8. | Independent Ethics Committee[3] Researchers who have no institutional attachments can apply for ethics committee approval from Independent Ethics Committees (Ind EC). The Ind EC should be a registered legal entity. The individuals who govern the Ind EC should not be members of the proposed EC, and will oversee and monitor the functioning of the Ind EC. |