Q. ICMR guidelines recommend that the member secretary generally belongs to the same institution. Schedule Y recommends that the member secretary signs the letter of approval. As the member secretary belongs to same institution and signs or gives decision for the approval, does it affect the study at that particular site? If not then, does he have any rights for voting in the meeting?
● Nilesh Vite

The word institution refers to an academic research setting such as a medical hospital - public or private. The objective of having the member secretary from the institution is administrative convenience. A person from outside the institute would not be able to coordinate the meetings, correspondence and archival of documents. He does not give decision. He only conveys the decision of EC to the investigator. If he is an investigator whose protocol is discussed, he should not take part in the deliberations and should not vote.


Q. If there is a phase I data available from a foreign country, can we submit this to DCGI to obtain permission to conduct phase I concurrently in India with other countries?
● Sunil Kumar

At a recent meeting held on 17 Oct 2006 in Mumbai, CDSCO officials have clarified this issue. The repeat phase I can also be permitted to the company. As regards request for permitting phase I studies on repeat dose, in which the total single dose is limited to the maximum total tolerated dose in foreign studies, the foreign data will be examined in consultation with CDSCO experts and decision will be taken on the basis of discussions.

Q. How can people who do not understand science (lay people in EC) take a judgment on something they don't understand, or people who know science (technical people evaluating the study) take a judgment on something that is very low on their priority lists?
● Paresh Patel

In EC, the decision is a collective one and does not depend on one person or his/her experience as a technical / lay person. Each member has a specific responsibility in the EC. The technical person usually focuses on scientific issues, the lay person looks at the trial protocols from a community perspective. The non-scientific person is essential for providing a layperson's viewpoint and concerns about the risk to study subjects. The medical experts may underestimate the risks as they are used to dealing with such risks as professionals. In absence of a non-scientific person, the decisions of the committee are likely to be biased towards the project.

Some of the roles, which non-scientific members can play, are:
● They are an ethical conscience because they are in the best position to analyse the informed consent document for clarity and ease of understanding.
● They are invaluable in discussion of the risks and benefits of a proposed study.
● They help restore public trust in research through their experiences with the EC
● According to US FDA, the quorum is complete only if one non-scientific member is present.

Q. Is it possible to seek the approval of EC of other institutions for conducting a research programme at a facility, where there is no EC?
● S. Gurunath?

Schedule Y allows this. Relevant excerpt is give below in section on clinical trial.
(1) Approval for clinical trial
(i) The trial site(s) may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an independent ethics committee (constituted as per Appendix VIII), provided that the approving ethics committee(s) is/are willing to accept their responsibilities for the study at such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the protocol version is same at all trial sites.

You will have to obtain 1) letter from the institute that they will accept the approval/oversight of independent ethics committee and 2) a letter from an independent ethics committee should accept the responsibility / review / oversight / SAE etc for the institution

Q. If one pharma is going for clinical evaluation of one molecule at multiple sites in same city, then do we need separate copy of protocol with Investigator's details for each centre? Or one protocol copy with multiple CVs of Principal Investigators will suffice? It is important to know about it for us it has got finance implications and payment to members accordingly?
● Dr D R Joshi

This is an issue of EC requirement. The protocol has to be reviewed by EC of each site. Each EC has to receive all required documents including CV of investigators (Ref Schedule Y). Each member of each EC must receive a copy of all relevant documents for review. If there are financial implications, the sponsor should be ready to provide required number of copies of documents to each EC.