The New Regulation on Establishment, Procedures, and Duties of the Research Ethics Committees in the Islamic Republic of Iran

More than two decades have passed since the establishment of research ethics committees in Iran. With many years of experience of research ethics committees, Iran Ministry of Health and Medical Education revised previous regulations and developed “Regulation on the Establishment, Leveling, and Duties of the Biomedical Research Ethics Committees”. Following publish and notification of “Regulation on the Establishment, Leveling, and Duties of the Biomedical Research Ethics Committees” in 2014, research ethics committees formed in national, academic, and organizational levels. In this regard, due to cooperation of the Iran Ministry of Health and Medical Education with the Iran Ministry of Science, Research and Technology, “the single article of the Act for Prevention and Combating Fraud in Scientific Publications” was approved in the Parliament of Iran in 2017; its executive bylaw was notified for implementation by the Cabinet of Ministers in 2019 and accordingly research ethics committees found a legal status in Iran. For promotion and update of the mentioned regulation and adaption to the Act, the secretariat of the national ethics committee proposed revised version of the regulation after obtaining opinions of stakeholders and several expert meetings. Then the new regulation entitled “Regulation on the Establishment, Procedures, and Duties of the Research Ethics Committees” was approved by the Iran National Committee for Ethics in Biomedical Research and the High Council of Medical Ethics of Iran in 2021. Structure of the committees in the new regulation includes “the National Committee for Ethics in Biomedical Research”, “Regional Research Ethics Committee”, “Institutional Research Ethics Committee”, “Biomedical Research Ethics Committee”, and “Specialized Committee”. This article introduces this new regulation.