Registration of Ethics Committees reviewing Biomedical and Health Research with Department of Health Research
The New Drugs and Clinical Trials Rules, 2019
was notified by the Union Ministry for Health and Family Welfare on 19th March 2019.
Chapter IV of the “New Drugs and Clinical Trials Rules 2019” effective from 19th September 2019,
deals with the “Ethics Committee for Biomedical and Health Research”.
It states 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 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
Ethics Committees across the country reviewing Biomedical and Health research needs to abide by the “New Drugs and Clinical Trials Rules 2019”
and be registered with DHR. According to Chapter IV, it is also mandatory to follow the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017
for conduct and review of Biomedical and Health Research.