Rights commission frames guidelines for clinical trials

To ensure poor and illiterate Indians did not end up as guinea pigs in clinical trials, investigators have been asked by the National Human Rights Commission (NHRC) to prepare an audio-visual clip on risks and benefits of the medical intervention, which would need to be shown to the subjects before recruiting them.

The investigators would need to keep a record of people watching and listening to the clips, which would be needed for submission to the authorities in the event of a dispute.

The new measure would be in addition to the existing official procedure of obtaining informed consent from people before they opted for participating in the trial.

The rights body has called for the informed consent procedure, to be standardised and simplified. The patient would need to be given information, including details of risks involved.

The rights body has referred to the union health ministry to seek its view on the guidelines prepared by it. The guidelines framed by an expert committee of NHRC call for the setting up of ethics committees in all institutions undertaking studies on human subjects and their registration as per the Act.

The NHRC's expert committee also calls for the writing down of all standard operating procedures (SOPs) and following them in all clinical trials based on prevailing good clinical practices (GCP) guidelines for biomedical research on human participants. The guidelines also call for an effective mechanism for monitoring the implementation of the SOPs.

The NHRC said the ethics committees would need to be constituted as per the Act and all ethics committee members familiarising themselves with various aspects of ethics guidelines and provisions of Act, rules etc for clinical trials.

Information needed to be given to patients would include details of risks involved as per the current knowledge, along with information 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.

Recruitment procedure of participants and volunteers for the trials would need to be documented in the SOP, with guidelines for the procedure framed with due deliberation in consonance with ethical guidelines for biomedical research.

Participants in the clinical trial would need to be provided medical care spanning the time of enrolment in the study, the duration of study as also the period of follow-up as specified in the protocol, the guidelines on clinical trials suggested.