Knowledge, attitude, and practices regarding assessment of risks and benefits of clinical research studies by ethics committee members in India: A questionnaire-based study

Abstract Purpose: Balancing risks to research participants against benefits to science or future patients is the most challenging part of the Ethics Committee (EC) review process. Explicit guidance to conduct risk–benefit assessment (RBA) of research studies is not available in the guidelines and existing regulations. RBA, while reviewing research studies by ECs, is largely based on long-term clinical experience and tends to be subjective. This study was undertaken to capture knowledge, attitude, and practices (KAP) among ECs across India about the RBA of clinical research proposals. Materials and Methods: A cross-sectional, observational questionnaire-based study was conducted after obtaining approval from the Institutional EC. Members of registered ECs across India with a minimum 1-year of experience were approached to respond to a validated questionnaire regarding assessment of KAP of EC members about RBA; through direct contact or by sending Google Forms. Data were analyzed using descriptive statistics. Results: Of 114 participants, 90% agreed on the need to carry out RBA for every study. Eighty-nine percent stated that studies with vulnerable participants need more attention for RBA. Fifty-five percent of participants considered payment received for research as a benefit. Regarding types of potential risks in research, 35 (31%) precisely selected all five types of risks. For conducting RBA, five participants reported using a specific checklist, while others mentioned reference to the Indian Council for Medical Research, ICH-GCP, and EC SOPs. Conclusion: EC members were aware of concepts of risks and benefits and the need for RBA in clinical research. A few gaps were identified in the awareness and approaches followed.