A large number of biomedical and health research studies are being conducted across the country at various research centres/medical institutions/ universities etc. Ethics Committees (EC) are entrusted with the responsibility to undertake the ethical review of research proposals prior to initiation, and also have a continuing responsibility to regularly monitor the approved research to ensure ethical compliance during the conduct of research and to ensure that the rights, safety and well-being of research participants is protected. These Ethics committee reviewing biomedical and health research shall be constituted and are required to function in accordance with the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

Therefore, an Office for Ethics Committee Registration is set up under DHR for coordinating and monitoring Ethics committee registrations and related activities that can bring about the much needed transparency, accountability and structure to regulate and monitor biomedical & health research in India. This office will receive applications for registration of EC, review and make decisions on the EC registrations/re-registrations. This office will closely work with DHR and ICMR accomplishing its activities. All Ethics Committees conducting biomedical and health research shall make an application with the office along with necessary documents as specified in New Drugs and Clinical Trials and Rules for registration and renewal of registration. The provisional registration will remain valid for two years and the final registration granted by DHR shall remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the designated authority at DHR.