Survey of ethics committee protocol approval letters: compliance with Schedule Y / ICMR Guidelines 2006

Abstract

A study was carried out to determine the extent to which ECs comply with format requirements given in guidelines and regulations. ECs were sent a written communication requesting them to permit investigators to study their approval letter for compliance with the ICMR Guidelines and Schedule Y using a pre-designed proforma. Of the 60 ECs approached, only 20 agreed to participate. Legal experts and social scientists were not present at the approval meetings of most of the ECs. Only 7 ECs had a quorum according to Schedule Y Several ECs did not state whether documents such as the clinical trial agreement and insurance policy were reviewed. Delays in sending approval letters could be shortened with efficacious operating of ECs. There is a need to train EC members and create a better awareness of regulatory requirements. There is also a need to evolve a mechanism to monitor EC functioning.

Ethics in clinical research in India: A survey of clinical research professionals′ perceptions

“…[12] These concerns have also been reflected in Indian literature and media stories, which have highlighted issues of vulnerability, consent deviations, compensation for patients, Ethics Committee (EC) training and functioning, placebo, post-trial access etc. [3–6] These individual opinions could have an impact in shaping the perceptions of clinical research professionals. This survey attempts to understand the overall perceptions of clinical research professionals about ethics of clinical research in India.…”

Evolution of ethics in clinical research and ethics committee

“…This highlights the gaps in education and training of IEC members. [20] With reports of IEC malfunction pouring in the media,[21] CDSCO has taken stern steps in streamlining the IEC functioning. The Schedule Y is amended by inserting a rule 122DD which specifies the detail procedures for the registration of ethics committee.…”

Indian clinical trials: Paradigm shift from speed to quality?

“…A recent survey of EC approval letters found deficiencies in composition, quorum, and review of insurance and clinical trial agreement, revealing gaps in education and training of EC members. [8] Although most Indian ECs have received some training in basic aspects, there are lacunae in awareness of ethical guidelines and changing regulations, competency of assessing risk:benefit of investigational products and study procedures in subjects who are economically disadvantaged or illiterate, and review of safety information.…”