NHRC seeks Health Ministry views on clinical trial guidelines
New Delhi: The National Human Rights Commission has written to Union Health Ministry seeking their views on draft guidelines on clinical trials including compensation and risks involved.
The guidelines, framed by an expert committee of NHRC, has suggested that ethics committees should be set up in all institutions undertaking studies on human subjects and should be registered as per the Act.
The NHRC`s expert committee also suggested that standard operating procedures (SOPs) should be written down and followed in all clinical trials based on prevailing good clinical practices (GCP) guidelines for biomedical research on human participants and there should be an effective mechanism for monitoring the implementation of the SOPs.
Ethics committees should be constituted as per the Act and all ethics committee members should familiarise themselves with various aspects of ethics guidelines and provisions of Act, rules etc for clinical trials, it said.
Information given to patients should include details of risks involved as per the current knowledge and it should also inform about the rights of the participants for compensation in case of injury or death during the study as per the prevailing provisions of Acts and regulations.
Procedure for recruitment of participants and volunteers for the trial should be documented in the SOP. Guidelines for the procedure should be framed with due deliberation and should be in consonance with ethical guidelines for biomedical research.
Participants of the clinical trial should be provided medical care from the time of enrolment in the study, for the duration of study and for the period of follow up as specified in the protocol, the guidelines on clinical trials suggested.
The Commission in a statement said that it has also decided to file an affidavit before the Supreme Court and intervene in the pending matter related to clinical drug trials.
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