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ICMR Bioethics Unit

Updates

Registration of Ethics Committees reviewing Biomedical and Health Research with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research

The Union Ministry for Health and Family Welfare notified the “New Drugs and Clinical Trials Rules, 2019” on 19th March 2019. Chapter IV of the “New Drugs and Clinical Trials Rules 2019” deals with the “Ethics Committee for Biomedical and Health Research” and will be effective from 19th September 2019. It has been notified in the new rules that all Ethics Committees reviewing biomedical & health research studies shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research.

  • The Ethics Committee shall make an application for registration with the designated authority. On receipt of application the authority designated shall grant provisional registration which shall remain valid for a period of two years
  • After the grant of provisional registration, the authority shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of “New Drugs and Clinical Trials Rules 2019” have been complied with, will grant final registration to Ethics Committee. If not satisfied, the application will be rejected with reason provided in writing. The final registration shall supersede the provisional registration granted.
  • The final registration shall remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the authority designated, after which the Ethics Committee shall make an application for renewal of registration.
  • The function, proceedings of ethics committee and maintenance of records shall be as per the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

Registration of an EC with the designated authority for the conduct of Biomedical and Health research, becomes mandatory. Ethics Committees across the country reviewing Biomedical and Health research needs to be updated with the “New Drugs and Clinical Trials Rules 2019” especially Chapter IV, which deals with the Ethics Committees for Biomedical Research and ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017

More details regarding Registration of Ethics Committee related to biomedical and health research available from

https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/ http://ethics.ncdirindia.org/Other_Guidelines_Acts_and_Policies.aspx