A Snapshot Summary and Comparative Analysis of Selected Ethics Review Committees Reviewing Clinical Trials in Sri Lanka

Abstract

In Sri Lanka, and across the world, ethics is becoming an ever increasingly integral part of clinical practice and biomedical research. Comprehensible and transparent ethics standards are essential to public trust in scientific research studies. In the pursuit of ethical research, Ethics Review Committees play a momentous role in the review and monitoring of biomedical research, especially in the case of clinical studies. National legislation and specific legal guidelines which systematically regulate the establishment, functioning, registration, and/or accreditation of such committees in Sri Lanka are yet to be developed. The National Medicines Regulatory Authority, an independent authority within the Sri Lankan Ministry of Health, plays an important role in the regulation of clinical trials in Sri Lanka. This review, albeit briefly, highlights the history of bioethics, the current state of Ethics Review Committees in Sri Lanka, and the recent efforts taken to assess their operations to ensure they meet international standards. In addition, this manuscript critically analyzes the membership composition and quorum requirements of selected Ethics Review Committees in Sri Lanka, as well as the challenges faced by these committees today.