Bioequivalence and Bioavailability Forum

Dear Hitesh Shah,

I will try and clarify what I mean to say. Sorry if the wording in my message was a bit clumsy.

Indeed ICH GCP (and Schedule Y in India) allow the IEC/IRB to have direct links with the institution/CRO. But if this is the case independence of the IEC/IRB should be maintained, and there should be no doubt regarding this independence.

This is quite clear and easier to demonstrate with the system we have in place in a number of European countries, where IECs are established at a regional or even national level and are independent from any CRO/institution. Of course you still have to make sure that the investigator is not a member of the IEC , or that if he is, he didn't participate in the discussion and vote on this particular project (which should be clear from the minutes of the meeting).

It is much more difficult for an outside eye (sponsor, auditor, regulatory agency inspector) to be sure of the independence of the IEC/IRB when it is attached to an institution/CRO.

❝ I do not see that independency is question at least in INDIA if you have very well written procedure.

That's precisely the point. My experience of visits of a dozen CROs in India is that some CROs have well written procedures, but others don't. When the investigator himself or members of his team involved in the trial are members of the CRO's IEC/IRB and the minutes don't show that they did not vote on the project, there is a problem. When new members of the IEC/IRB, working for the CRO, are appointed by the managers of the CRO on the day before the meeting, participate in the meeting and vote, without any particular training, there is a problem. And if the IRB/IEC meets on the CRO's premises and use SOPs written by the CRO it is more difficult to make their independence clear to the outside eye. Of course the institution/CRO may provide assistance and advice to the IRB/IEC but according to ICH GCP §3.3 it is the IRB/IEC's responsibility to establish and write their procedures.

Once again, this issue is not specific to India and I have come across similar concerns in other countries. Don't misunderstand what I mean, I certainly don't mean to say that this is a general issue specific to Indian institutions/CROs !

There certainly are cultural differences in the approach to this issue. US sponsors/auditors/inspectors are used to IRBs, attached to the institution/CRO. The situation is different in some European countries where IECs are totally independent from any institution.

Regards
Ohlbe

❝ As per the ICH guidelines, the IEC/IRB should composed of the following

❝

❝ a. At least five members.

❝ b. At least one member whose primary area of interest is in a nonscientific area.

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

But as per the Schedule Y of India specifies :

The number of persons in an Ethcis Committee should have at least seven members. Ethics Committee should appoint, from among its members, a Chairperson (who is from outside the institution) and a Member Secretary. Other members should be a mix of medical/non-medical, scientific and non-scientific persons, including lay public, to reflect the different viewpoints.

For review of each protocol the quorum of Ethics Committee should be at least 5 members with the following representations:

1. basic medical scientists (preferably one pharmacologist).
   
2. clinicians
   
3. legal expert
   
4. social scientist / representative of non-governmental voluntary agency / philosopher / ethicist / theologian or a similar person
   
5. lay person from the community.

Regards
Sasi