Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India.

OBJECTIVES

Appropriate constitution of ethics committees (EC) is crucial to ensure a high quality review of research proposals. We studied the profile and role of EC members of Pune-based health and research organisations.

METHOD

52 ethics committee members representing 12 health and bio-medical research institutions in Pune city completed the structured questionnaires.

RESULTS

The respondents represented ECs of hospitals (67%), research organisations (23%) and NGOs (10%). The attendance of members at EC meetings was significantly associated with higher qualification (p=0.004), more than 20 years of research experience (p=0.023) and more experience of working with ECs (p=0.032). Most of the chairpersons or secretaries had a medical background (p=0.027), and were more likely to be formally trained in ethics compared to other members (p=0.049) and had more research experience (0.043). Overall, 62% had doctorate degrees and 38% were post-graduates or graduates. Forty four percent had the correct knowledge of ethical principles. A majority (79%) of EC members felt that formal training was necessary and 84% said that there should be networking of the various ECs to share thoughts and experiences.

CONCLUSIONS

EC members were generally senior in age, highly educated and well-experienced in research. Representation of lawyers, ethicists and non-scientific members needs to be increased. Even with an appropriate EC constitution, the members had sub-optimal understanding of ethical issues and ethical principles. Formal training of EC members in ethics, and networking of ECs, is crucial. The scope of the role of EC members needs to be clearly recognised and understood by the constituting institutes.