Ethics committees and the changed clinical research environment in India in 2016: A perspective!

Abstract

Introduction:Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013–2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism.Methodology:The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs.Results:Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies.Discussion:Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC.Conclusion:Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

The difference in views of various researchers about changes in the new drugs and clinical trial rules in India

“…This was the irst study that surveyed the differences in views of various researchers about the changes in NDCT Rules. Previous surveys have reported the views of investigators and the ethics committees on the earlier regulatory changes (Davis et al, 2017;Kadam et al, 2016;Parikh et al, 2011).…”

“…Because their views are necessary to decide whether the trials are being conducted as per the NDCT Rules, moreover, these professionals perform an indispensable role in documenting and reporting unethical clinical trials, notably on vulnerable peoples (Shivayogi, 2013). Some earlier studies have detailed the awareness and opinions of investigators and the members of the ethics committee about the past rules (Davis et al, 2017;Kadam et al, 2016;Parikh et al, 2011). However, no study surveyed the views of various researchers about the NDCT Rules.…”

Monitoring of approved studies: A difficult tightrope walk by Ethics Committees

“…Lack of administrative infrastructure, lack of a clear framework for undertaking monitoring,[ 15 ] difficulty in motivating members to conduct audits of ongoing studies,[ 16 ] lack of workforce, lack of training of EC members on how to conduct monitoring and inadequate funds are identified as major hurdles for conducting active site monitoring. [ 17 ] Most IECs spend a substantial amount of time in reviewing and approving protocols and reserve some time for passive monitoring but almost none for site visits.…”

Ethics committee meetings – Online or face to face?

“…Competencies of EC members have been brought into question repeatedly, and their familiarity with technology is a serious concern [ 4 ] Members of some ECs are not proficient enough and inappropriate functioning has been identified as a leading challenge in the work ECs. [ 5 ] The need for improving EC functioning has been voiced by many [ 6 7 ] EC review is an important function, and it should be given due importance by physical meetings. …”

“…Members of some ECs are not proficient enough and inappropriate functioning has been identified as a leading challenge in the work ECs. [ 5 ] The need for improving EC functioning has been voiced by many [ 6 7 ]…”