An evaluation of university research ethics oversight in Islamic Republic of Iran

Regular evaluation of the performance of research ethics committees is vital to ensure their effectiveness in protecting the rights of research subjects and increasing public trust in biomedical research.

To evaluate the performance of research ethics committees (RECs) at Tehran University of Medical Sciences and identify key challenges in carrying out their functions.

Using the WHO ethics oversight benchmarking tool, we interviewed 18 secretaries of research ethics committees, 7 bioethics experts and 14 researchers at Tehran University of Medical Sciences and reviewed relevant documents. We performed a content analysis of the text and interview transcripts to identify key operational mechanisms and challenges.

Of the 26 indicators for structure and composition, resources, procedures, mechanisms to promote transparency and accountability, and mechanisms to monitor self-performance, only 8 were fully implemented, 8 were partially implemented, and 4 were not implemented by all the 18 RECs. There were variations in implementation of the remaining 6 indicators. The most prominent challenges in implementation were absence of post-approval monitoring of research, inadequate conflict of interest management and inconsistent adherence to procedures. The RECs had limited ethics training and there were no policy and procedures for managing conflict of interest.

The WHO tool effectively identified strengths and weaknesses in the performance of RECs at Tehran University of Medical Sciences. A tiered oversight system is recommended to enhance support for, and harmonization among, RECs. Key improvements should focus on post-approval monitoring, conflict of interest management, and institutional accountability. Addressing these gaps will strengthen ethics oversight and increase trust in biomedical research.