Over-burdened ECs

Ethics Committees for clinical research are struggling to comply with new regulations and lagging in competence

Over-burdened ECs

A Review of clinical research by an ethics committee (EC) is the foundation of good clinical research conduct. The prime responsibility of an EC is to ensure the protection of the rights, safety and the well-being of research participants. However, the functioning of ECs has become onerous, with increasing expectations from the society, the media and the regulators. Frequent and multiple amendments to clinical trial (CT) rules have also added new challenges for ECs.

The critical responsibility of the EC is to review scientific aspects, ethical concerns and regulations applicable to a CT proposal. This includes the evaluation of the study’s design and methodology and the assessment of risks and benefits, the competence of the clinical researcher, the review of informed consent documents, the determination of the relationship and compensation for clinical research related serious adverse events – injury or death. New rules also mandate ECs to provide continued oversight on the conduct of the approved studies via ongoing review of the CTs based on periodic progress reports from the researcher, via monitoring and internal audit reports from the sponsor, or by visiting the study sites. No EC members having a conflict of interest can participate in the review and oversight of the CT. ECs now require dual registration – from the regulatory authorities set up for the review of CTs and from Department of Health Research for Biomedical and Health Research. ECs must provide robust documentation – training records, standard operating procedures (SOPs), agenda, minutes, decisions, actions, letters, correspondence – to provide evidence for registration and re-registration, for assessment visits for accreditation and re-accreditation, and for regulatory inspections.

However, ECs are struggling to comply with regulatory and quality requirements. This is reflected in many deficiencies found in EC functioning during audits, which could be due to inadequate training. EC members can be disqualified if they are not trained.

EC members should have relevant knowledge and skills to conduct a comprehensive review of research projects. They should be trained in local regulations, good clinical practice (GCP), national and international ethical guidelines, human subject protection, vulnerability, clinical research methodology and designs, therapeutic modalities, benefit-risk analysis, drug safety, SOPs and develop relevant skills such as critical thinking, analytical skills, an eye-for-detail etc. Unfortunately, most EC members just fulfill the need for getting a training certificate by taking a short online course or attending a 1-day GCP workshop.

Regulators expect the EC to fulfill the role of an ethical watchdog at the research site. Hence, ECs should invest time and effort in educating their members. EC members should undergo an induction training followed by ongoing updates and annual refresher programmes. As the regulatory and ethical environment is dynamic, members should receive regular updates. However, such efforts of individual ECs will not be enough to achieve a uniform standard in the EC’s functioning. We need a central organization, like US Office for Human Research Protections (OHRP), which can offer regular online training, webinars, videos, tutorials, workshops and ethics case studies and answer questions and provide guidance on human subject protection. Such comprehensive training will make Indian ECs competent and empowered to meet the challenges of ensuring human research protection in a complex and dynamic research environment.

Writer is a consultant on clinical research & development from Mumbai. arun_dbhatt@hotmail.com

 

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