What is the current status of CDSCO guidelines on compensation?

The Drugs & Cosmetics Rules have been amended vide GSR no 53 (E) dated 30-01-2013 inserting a Rule 122DAB, and a new Appendix-XII in Schedule Y along with other amendments. The amendment specifies in detail the procedures for analysis of Serious Adverse Events (SAEs) including deaths occurring during clinical trial to arrive at the cause of death/injury to the subject,  and to determine the quantum of compensation, if any to be paid by the sponsor or his representative whosoever have obtained permission from CDSCO.

As per Appendix XII the Investigator shall report all serious and unexpected adverse events to the CDSCO, the sponsor or his representative and the Ethics Committee, within twenty four hours of their occurrence.

In case of SAE of death, the reports shall be examined by an independent Expert Committee constituted by DCG(I) to determine if the cause of death is a clinical trial related death and to give its recommendation to CDSCO. In case of clinical trial related death the committee shall also recommend the quantum of compensation to be paid by the sponsor or his representative, to CDSCO. The CDSCO shall consider the recommendations of the Expert Committee and shall determine the cause of death and also the quantum of compensation within three months of receiving the report of SAE of death.

In cases of an SAE other than death, CDSCO shall determine the cause of injury, and the quantum of compensation within three months of receiving the report of SAE.

In case of clinical trial related injury or death, the sponsor or his representative concerned shall pay the compensation as per the order of CDSCO within thirty days of the receipt of such order.

What should be the basic qualifications of chairman of IEC? Is it necessary that chairman should have qualifications of basic medical scientist only? In the absence of chairman anyone can be delegated as chairman like lay person or lawyer or clinician?

There is no qualification defined for the Chair. Any EC member one can serve as chairperson. However, chairperson of EC is a fixed designation defined by EC SOPs. Hence, you cannot change the chairperson for each meeting. EC should have SOPs to decide how to handle a meeting if chairperson is absent. e.g. In the absence of the chairperson, the co-chairperson will chair the meeting. In the absence of both, a member who is independent of the institution will chair the meeting as the acting chairperson.

Some of the well known IECs e.g. Tata Memorial Hospital define the chairperson's expertise as follows: The IRB chairperson should be a highly respected individual, who is 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 chairperson has to ensure that the EC is be perceived to be fair and impartial, immune from pressure either by  institute’s  administration, the investigators whose protocols are brought before it, or other professional and non-professional sources.

The EC chairperson will respect the diverse backgrounds, perspectives, and sources of expertise of all IRB members, especially the contributions of the non scientists, and must have the ability to foster such respect among the IRB members.

Is it necessary to replace 50% of the members periodically (3-5 yearly)? If yes what can be the approach; chairman or Institutional head would give formal suspension letter to half of members?

There is no statutory requirement about replacing 50% of members of EC. The authority of termination of membership is usually with the institutional Head.

We have the one ethics committee member list in which an MD in ayurveda medicine doing private practice is working as clinician in ethics committee. Is this acceptable as per Indian GCP?

As per the Gazette notification on registration of EC, the clinician should have postgraduate qualification and adequate experience in his/her field. This usually means a clinician with degree in Allopathic specialties - internist, cardiologist, oncologist etc.

It would be difficult for an MD ayurveda to review and give opinion of a clinical protocol from allopathic discipline.

We have an EC with 14 members. What would be quorum requirements?

If the EC has 14 members, 8 are required to fulfill the quorum i.e. half of the total number + 1. The quorum should also cover Schedule Y requirement of minimum 5 categories of representation. If 8 members were present for an EC meeting, and if one member was an investigator, whose study was under discussion, he cannot participate in voting process. Hence, the quorum would be lost. In such a situation, you would have to postpone the meeting to a later date and convene the meeting with full quorum.