Schedule Y defines list of member who should have to review the protocol e.g. legal...few more names are there. Does this mean that Legal person must be present in the EC meeting otherwise it will not be considered a quorum completion or it means that protocol can be reviewed by him but it is not mandatory to be present in meeting, discussion and then vote for the trial?
Darshu Darshana
The quorum is the count of the number of members present.
The quorum means: The minimal number of officers and members of a committee or organization, usually a majority, who must be present for valid transaction of business Schedule Y requires that Legal expert is must for Quorum.
For review of each protocol the quorum of Ethics Committee should be at least 5 members with the following representations:
■basic medical scientists (preferably one pharmacologist).
■clinicians
■legal expert
■social scientist/ representative of nongovernmental voluntary agency/philosopher/ethicist/ theologian or a similar person
■lay person from the community.
Hence, presence of legal expert is a must to satisfy quorum requirements of the Schedule Y.
Is it necessary to get DCGI permission for investigator initiated trial funded by an academic Institution outside India having institutional collaboration with an Indian academic Institute and the trial taken at Indian site or only the HMSC and IRB clearance is enough the initiate the trial?
J Vijayakumar
It depends on 1) the drug to be studied and 2) objective of the trial. If the drug falls into new drug as per Drugs & Cosmetics 122 E, DCGI permission is essential. If the objective of trial is to support drug development for registration of a new indication / use, the DCGI permission is essential.
Can a single impartial witness sign the ICD for more than one or multiple subjects?
Dr Sathish Kumar
The important issue is the GCP definition of impartial witness.
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
If a person signs multiple consent forms, the question is why he is doing this? Is he impartial or is he trying to comply with formalities for the CRO / investigator. This would be an audit / inspection issue. Hence, asking one witness to sign on multiple consents is not an ethical practice.
Can a member of Ethics Committee perform dual roles? Mr. XXX is a Social Scientist as per representation in IEC member list. Can he also perform or act as a Lay Person along with Social Scientist representation.
Vamsi Krishna Kota
As per Schedule Y, social scientist and lay person are distinct categories of membership. Both are required for quorum to complete. Hence, social scientist cannot serve as a lay person on the EC.
How long the term of the EC Member/ Chairman/ Member Secretary can be extended?
Sreevatsa
The term of EC members depends on EC Terms of Reference and SOPs. If the extension of term is covered in SOP, the EC has to follow the term.
Is it necessary for the EC to give comment /clear Retrospective studies?
Sreevatsa
If the term retrospective means an observational study of previous patient data, it may require EC review depending on what ethical issues study poses for the patient population. If the term retrospective study means that a completed study is submitted to EC for approval, the EC cannot review the same.
Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd, Mumbai.
Readers can send their queries at: arunbhatt@clininvent.com