Competencies and operations of research ethics committee members and the protection of research participants: A scoping review.

Ethical oversight is essential since clinical research involves animal and human participants. Despite being established to uphold moral standards, the effectiveness of ethics committees (ECs) in protecting participants remains uncertain. This scoping review examines EC members' competency and operational performance. We searched PubMed, Scopus, and Web of Science for papers assessing EC members' competence and operational performance from 2013 to May 2024 in compliance with PRISMA guidelines. After removing duplicates and irrelevant studies, 16 publications were reviewed. Findings were compared across countries and institutions to identify patterns and areas requiring improvements in EC. Out of 16 articles, 6 (37.5%) exclusively assessed the competency in knowledge, attitude, skills, and practices, while 10 (62.5%) papers evaluated the competencies related to EC members' structure, functioning, and procedural performance. The current study report shows that knowledge scores range from 11.3% to 62.5% across the six studies. Most studies suggested that standardized, periodic training should be for EC members. Proficiency in reviewing complex study designs ranged from 14% to 53%, and substantial gaps were noted in understanding ethical principles, particularly among ECs with heavier workloads despite accreditation. On-site monitoring identified frequent ethical breaches, including missing documentation and incomplete serious adverse event records. Access to formal ethics education was limited to approximately 25% of members, with 20% of ECs reporting inadequate staffing and limited resources. In addition, delays in the communication of EC decisions are observed. The findings highlight the need for standardized ethics training, national oversight mechanisms, and adequate resources to improve the effectiveness of ECs in making the right decisions and enhancing their competency in execution.