No rules against a person becoming chairman of two ECs

Can chairman of EC of one institute also become the chairman of EC of another institute?

There is nothing in the rules against a person becoming chairman of two ECs. However, in the new scenario the chairperson's role has become vital.

As per the EC registration requirements, he/she has to sign an undertaking on behalf of the EC. Ultimately overall responsibility for the EC function rests with the chairperson. There are also issues of conflict of interest and time requirement to be considered.  Another challenge would be - If in 1 EC members want to approve the study and another they want to reject the study, how will she/he manage? Will she/he pressurize the members to follow his bias/decision? Also, one of the important responsibility of the chairperson of EC is to make the EC a respected body.

See Tata Hospital EC requirement for the chairperson described below:

The EC chairperson should be a highly respected individual from outside the institution, fully capable of managing the EC and the matters brought before it with fairness and impartiality. The task of making the EC a respected part of the institutional community will fall primarily on the shoulders of this individual. The EC must be perceived to be fair and impartial, immune from pressure either by the institution’s administration, the investigators whose protocols are brought before it, or other professional and nonprofessional sources.

If the person is aware of such high expectations of chairmanship of EC and is willing to shoulder responsibility of chairing two ECs, he/she can do so.

What is the difference between an Institutional Ethics Committee and an Independent Ethics Committee?

The responsibilities of the two ECs are as per Schedule Y and GCP. However, since 2013, the CDSCO has made it mandatory for ECs to be registered. As per the registration letters, the institutional EC can review and approve all types of clinical studies - clinical trials. However, the independent ECs can only review and approve BA/BE studies.

If you are planning a clinical trial, you have to approach an institutional EC registered with CDSCO.

For bio equivalence study on a molecule which has not been approved in India, whose approval is required - an Independent EC or an Institutional EC?

In the recent BA/BE checklist effective 1 Feb, for the category application for BE NOC for export of a new molecule not approved in India but approved by other countries, Copy of registration of Independent/Institutional Ethics Committee (IEC) under Rule-122DD from the Office of Drugs Controller General (India), New Delhi, is acceptable to CDSCO. Hence, approval from whichever EC – institutional or independent – which is overseeing the bio equivalence study site seems acceptable.

We plan to conduct clinical study with an ayurvedic product. Do we require any approval from Dept of Ayush for these studies?

At present, Dept of Ayush does not have any guidance on seeking their approval for clinical studies, In the Ayurvedic industry the current accepted practice is to (1) obtain state FDA approval for the formulation and (2) EC approval before conducting a clinical trial.

In the pre-screening checklist of global clinical trial, there is a requirement for a declaration to be given  by the sponsor regarding subject’s receiving standard care. Can a declaration on sponsor’s letter head, duly signed be acceptable?

As the term used is declaration, a statement on the letter head declaring the statement prescribed by CDSCO is adequate. This is current industry practice.