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Good Clinical Practices
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EC review should focus on all potential ethical issues

Dr Arun Bhatt
Thursday, May 4, 2023, 08:00 Hrs  [IST]

Can the chairperson of 1 Ethics Committee for clinical trial also become the chairperson of 2 Ethics Committee for Biomedical and Health Research (BHR) simultaneously in the same Institute? Both ECs are registered separately, and one chairperson has resigned recently.
Dr Sreevatsa

None of the regulations or guidelines discuss such operational issues of ethics committee composition. Some institutes have one ethics committee for both the purposes – review of clinical trials of new drugs or Biomedical and Health Research.

Same person can serve as 1) Ethics committee for also become the chairperson of 2) Ethics Committee for (BHR) simultaneously in the same Institute.

However, the person cannot automatically become chair of second Ethics Committee. The appointment of a person to chair a committee should as per 1) the terms of reference, 2) the requirements of composition and 2) the SOP for replacement of chair in case of resignation of chair.

What are the ethics review requirements for the studies in India that don’t involve any new/investigational product or that are non-drug studies?  
Nirmallya Das

None of the regulations or guidelines specifically discuss Ethics Committee clearance requirements for non-drug studies. However, we can make following conclusions:
  • Main risk for such non-drug studies is not just safety but ensuring privacy and confidentiality of patient’s data.
  • NDCTR 19 includes non-interventional studies on new drugs for post marketing surveillance. These require Central Drugs Standard Control Organisation (CDSCO) and Ethics Committee approvals.
  • Non-interventional studies of new drugs for generating RWE for effectiveness would require Ethics Committee approval. It would be important to notify CDSCO for such studies as safety could be one of the outcome measures.  
  • Non-interventional studies with old drugs for academic purpose should comply with ICMR ethics guidelines for observational studies. Such studies will require Ethics Committee approval.
  • Non-interventional studies with old drugs for commercial/marketing purpose sponsored by a company, would require review by Ethics Committee regarding risk benefit and consent requirements. So, Ethics Committee approval is essential.
  • Ethics Committee review should focus on all potential ethical issues - benefit: risk considerations, patient awareness about purpose of data collection, data ownership, data sharing, protection of privacy, ensuring confidentiality, informed consent, waiver of informed consent, anonymization etc.
A participant complained of headache during screening period before the investigational product (IP) was administered? Do we capture this as an adverse event (AE)?
Ninad Satam

As per the GCP definition, since the investigational product is not administered, it is not an adverse event.

However, following situation suggest that it is prudent to record such events as adverse events.
  • If a participant in a clinical trial is in wash out period of a therapy, such a symptom could be due to uncontrolled disease. Monitoring such symptoms would be critical from the view of safety of participant.
  • Some of the common symptoms such as headache is prevalent in patients. If you don’t capture these as adverse event, and if such symptoms occur after administration of investigational product, they could be considered Adverse Drug Reaction (ADR) if a causality assessment suggests a link between investigational product and symptom.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 
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