In paediatric clinical studies EC should include paediatrician

Is it mandatory to have DCGI approval and CTRI registration before reviewing sponsored proposals submitted in MNS studies? Can EC give approval if these documents are still pending?
Dr Sreevatsa

It is not mandatory for EC to have DCGI approval and CTRI registration prior to review of the proposal. The EC can give a letter of provisional/conditional approval listing requirements for final approval. The provision approval letter would mention that the EC will give final approval after the applicant submits DCGI approval letter and CTRI number.

Also, the EC can ask the investigator to give an undertaking, as part of submission documents, that the research project (including collection of blood or tissues samples for research) will not be started until the final approval of the EC has been obtained.

One member of our EC has undergone a surgery and will not be able to attend EC meetings for 6 months. How do we handle this situation?
Dr Mahendra Yadav

The EC should have written SOPs as to how an IRB member can be replaced if needed. This insures the integrity of the membership and maintaining a quorum to vote. The SOP usually includes following conditions:

An EC member may be relieved his/her membership in case of a) inability to participate in the meetings on any grounds or b) if a regular member fails to attend more than 3 meetings of ECc) Relocation to another town or any such matter.

In all such situations/circumstances, the relevant authority - Head of Institution -  or chairperson of EC can send a letter of termination of membership. This should be documented in the minutes of the next duly constituted EC meeting and EC membership roster will be revised. The relevant authority would then appoint a new member, falling in the same category of membership.

This situation could be avoided if EC has an SOP describing the appointment and function of alternate members for appointing alternate members. The EC roster should identify the primary member(s) for whom each alternate member may substitute. To ensure an appropriate quorum, the alternate member’s qualifications should be comparable to the primary member to be replaced. The EC minutes should document when an alternate member replaces a primary member. When alternates substitute for a primary member, the alternate member should have received and reviewed the same material that the primary member received or would have received.

If there is an amendment in study, do we need to reconsent all subjects?
Yogini Mehta

Whether a reconsent is required depends upon the nature of the amendment in the study protocol or information about the study that lead to the change.

If the informed consent document was amended because new adverse events (AE) were detected at some study sites, it is essential to convey that information to all study subjects. Depending upon the nature and/or severity of the AEs, some enrolled subjects may decide to discontinue their participation in the study. Therefore, obtaining the reconsent of those who choose to remain in the study is also significant.

In contrast, if the change is due to a new test or, procedure, that was added to the study protocol and only new study subjects will undergo these tests/procedures, then it would not be necessary to inform ongoing study subjects.

During reconsenting, the subject has an opportunity of refreshing his/her responsibilities in the trial will entail, the risks involved, who to contact in case he/she has any AEs adverse experiences, etc., and to ask any questions that he/she may have.

In one of our studies, the age criterion for inclusion is 16 yrs to 60 yrs. Does the EC require a paediatrician during the review process?
Dr Sachin Bhgnani

Participants who are younger than 18 yrs. fall in paediatric category.
Schedule Y in the section on paediatric studies stipulates as follows:
(viii) For clinical trials conducted in the paediatric population, the reviewing ethics committee should include members who are knowledgeable about paediatric, ethical, clinical and psychosocial issues. Hence, for your study the EC should include a paediatrician.