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The investigator has notified a protocol to Ethics Committee (EC) that the site didn’t do Echocardiogram in 3 patients, as the Echo cardiogram instrument was not working. What should EC review before accepting this as protocol deviation?
Dr Durgesh Mundekar
Echocardiogram is done to evaluate the structure and function of the heart. In a clinical trial could be an investigation to assess efficacy or safety endpoints. The EC should review the notification vis-à-vis the protocol requirements for Echocardiogram.
A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol, e.g., missing a visit window because the subject is traveling. In contrast, protocol violation is any deviation of the approved protocol version or the clinical trial regulation that is likely to affect the safety, rights of trial participants or the reliability and robustness of the data generated in the clinical trial. is serious and should be notified (Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 30 Jun 2023).
In view of the above, this notification should be considered a protocol violation as non-performance of Echocardiogram posing risk for the participants.
The EC should ask the investigator to stop the enrolment of the participants till the hospital echo machine becomes functional. In case the investigator plans to send the participants to an external imaging centre, he/she should ensure that the participants are not inconvenience and given travel/other expenses. This would require amendments to the informed consent document. The EC should review the amendments to the informed consent document and approve, before the investigator can restart the enrolment.
During the review of a clinical trial on vaccine, the paediatrician left the EC meeting because of conflict-of-interest? Can the EC review the protocol?
Dr Aravind Kanakia
The EC should consider what was the reason for conflict-of-interest. As this was a vaccine trial, the paediatrician could be a co-investigator.
The regulations/guidelines for clinical trials conducted in the paediatric population are:
• New Drugs and Clinical Trials Rules19 mandates that 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.
• ICMR Guidelines for Research Involving Children Ethics Committees recommend that EC should have member/s, with paediatric expertise. The expert or experts may be permanent members of the EC or invited as subject experts to provide advice and consulted on an ad hoc basis.
As the paediatrician was not present during the deliberations of EC, the quorum was incomplete. So, the EC should postpone the discussion to next meeting, in which an expert who is knowledgeable about paediatric, ethical, clinical and psychosocial issues should be invited to participate.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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