GCP Queries

Understanding the overall issues in GCP and adopting procedural norms as per national and international guidelines becomes imperative in present times, especially for India which is turning out to be the hub of clinical research activities. There are many imponderables, both for the sponsors and investigators. Doubts and queries, even in the simplest of procedures which could have been taken for granted in the past, can arise. To enlighten readers on such issues, Dr Arun D Bhatt, well known clinical pharmacologist from Mumbai answers queries raised on this subject.

What is the minimum number of members for an Independent Ethics Committee (IEC)? Is it mandatory to have a legal person, a layperson and a theologian/religious person on IEC?

Dr Krishna Pandey, Lucknow

No. It is not mandatory. According to the good clinical practices guidelines for clinical studies in India prepared by central drugs standard control organisation (2.4.2.2), the composition may be as follows:

• Chairperson
• One or two basic medical scientists (preferably one pharmacologist).
• One or two clinicians from various Institutes
• One legal expert or retired judge
• One social scientist/ representative of non-governmental voluntary agency
• One philosopher/ ethicist/ theologian
• One lay person from the community
• Member Secretary

It is recommended that the number of persons in IEC be kept fairly small (5-7 members). The maximum recommended number is 12 to 15.

If the number is small (5-7), it will be difficult to have all the members listed above. However, if the number is 12-15, it would be possible to have all members listed above.

According to ICH-GCP 3.2.1, the IRB/IEC should include:

(a) At least five members.

(b) At least one member whose primary area of interest is in a non-scientific area.

(c) At least one member who is independent of the institution/ trial site.

In general there should be adequate representation of age, gender, community etc in IEC to safeguard the interests and welfare of all sections of the community/ society. Members should be aware of local, social and cultural norms, as this is the most important social control mechanism.

What is the quorum for Ethics Committee?

Dr Jayant Acharya, Manipal

According to the good clinical practices guidelines for clinical studies in India prepared by central drugs standard control organisation (2.4.2.2), a minimum of five persons is required to compose a quorum. However, care must be taken to ensure that the quorum has adequate representation of independent members, not affiliated to the institute.

Our recent IEC meeting had 5 members including the investigator whose protocol was discussed. The committee unanimously approved the protocol. However, the sponsor did not accept the IEC approval. What could be the reason?

Dr Kishore Kumar Ganguly, Kolkata

According to ICH-GCP 3.2.1, only those IRB/ IEC members who are independent of the investigator and the sponsor of the trial should vote/ provide opinion on a trial-related matter.

According to the good clinical practices guidelines for clinical studies in India prepared by central drugs standard control organisation (2.4.2.6):

• A member must voluntarily withdraw from the IEC while making a decision on an application which evokes a conflict of interest
• If one of the members has her/ his own proposal for review, then the member should not participate when the project is discussed.

As the investigator was present and voted, the approval is not in compliance with ICH-GCP/ Indian guidelines. It will be necessary to reconvene the meeting with adequate quorum, taking care to see that the investigator or any member with conflict of interest does not participate in the decision making process.