Q. Can an ethics committee member become a subject in a clinical trial which is approved by the same ethics committee? What are the possible implications? How will an auditor / inspector view this?
● Anirudha Bhosle
If an Ethics Committee member becomes a trial subject on a trial that they were involved in approving then there has been a major conflict of interest. The following situations need to considered:
1) IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but thereafter it is suggested that the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore not advisable.
2) IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study).
ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid conflicts of interest.
Q. This is with respect to the constitution of ethics committee of our organization, for which I need your valuable guidance and suggestion in understanding the qualification of Chairperson of Ethics committee.
● S Gurunath
First you need to consider whether it is appropriate for your organization to form an Ethics Committee. If yours is an academic medical / research, institute, forming an EC is essential and justified.
Independence and competence are the two hallmarks of an IEC. If your organization is a private enterprise - a for-profit entity -, the independence of EC would be questioned by the auditors and regulatory inspectors.
There is no specific qualification prescribed for the chairperson in ICMR guidelines / Schedule Y. However, usually EC selects a chairperson who has achieved success and social recognition in life and work and who can understand the ethical issues related to research in human beings.
Q. Is it necessary to submit protocols of all BA/BE studies to IEC at least 3 weeks before the IEC meeting? I have learnt that as per Schedule Y it is must to submit protocols at least 3 weeks before the meeting for review.
● Divakar Kolli
IThis is Indian GCP recommendation applicable to all clinical studies including BA/BE.
Indian GCP 2.4.2.5. Submission of Application
The researcher should submit an appropriate application to the IEC in a prescribed format along with the study protocol at least three weeks in advance.
However, the submission depends on SOP of the EC. Most ECs have a submission date and a meeting date. If the EC submission date is shorter then 3 weeks, you can follow their SOP for submission.
Q. In a multicentric, multinational phase III trials, Principal Investigator (PI) of one site was changed. Does it require a site-specific amendment of protocol or general amendment of the protocol?
● Arulsingh Jayaraman
This is a site specific amendment which requires approval of IEC of the site.
Q. What is the difference between an IRB (Institutional Review Board) and IEC (Independent Ethics Committee)?
● Nilesh Vite
IRB is a US concept. IRB is a body which reviews both scientific and ethical aspects of a study.. In India, most institutions have 2 committees - 1 scientific committee for scientific review and 2 ethics committee.
Q. Is it necessary to have at least one female member in an IEC ?
● Nilesh Vite
One can not fix a number for female members . It all depends on the total number of members in IEC. If the number is large e.g. 11, EC should have proportionate number of female members.