Ethics Committees in India: Past, present and future

Abstract

Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward.The Past:The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency.The Present:A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen.Way Forward:A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future.Conclusions:Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.

Review of Scientific Self-Experimentation: Ethics History, Regulation, Scenarios, and Views Among Ethics Committees and Prominent Scientists

“…Other countries working toward inclusion in this harmonization include Russia, Ukraine, Eastern Europe, Central Asia, 33 China, 34 and India. 35 GCP did not jettison Helsinki as some think. ''Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance'' of 1996, release 1 (R1), and the 2015 draft release 2 (R2), are built on Helsinki.…”

Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases

“…[3] It was believed that the accreditation of ECs would play a pivotal role in improving the protection of research participants. [45] The CDSCO has tasked the National Accreditation Board For Hospitals And Healthcare Providers (NABH) to accredited ECs in India.…”

Future of Indian clinical trials: Moving forward from hyped potential to human protection

“…However, in the last 5 years, Indian media began highlighting safety issues and ethical deviations in clinical trials. The underlying factors were: (1) Sponsors' focus on potential for rapid recruitment of patients and cost savings; (2) the investigators' interest in commercial benefits[ 1 ]; (3) inadequately functioning ECs[ 2 ], and (4) lack of effective regulatory oversight. It became obvious that the roots were not stable and wings were not strong enough to support the growing field of clinical trials.…”

“…These actions impacted the functioning of ECs, whose responsibility and workload increased enormously. [ 2 ] The institutions and the investigators lost interest in the conduct of clinical trials as the increased burden of regulatory compliance activities far outweighed the perceived benefits of conducting clinical trials. [ 1 ] The number of new trials plummeted as India lost its attractiveness as a cost-effective clinical destination for global sponsors.…”

“…However, there are still significant gaps in their functioning and standard operating procedures. [ 2 ] It was expected that the Central Drugs Standard Control Organisation would inspect the registered ECs and ask them to correct deficiencies. [ 5 ] However, in 2016, the ECs have been allowed to apply for reregistration, without any need for regulatory inspection.…”