New ethics guidelines for clinical trials involving humans

The Indian Council of Medical Research (ICMR) is set to renew its 10-year guidelines on clinical trials  using humans as research subjects, even as scientists continue to push the envelop on medical ethics with increasingly complex researches.

The apex council’s draft National Ethical Guidelines for Biomedical and Health Research involving human participants will be finalised after analysing the comments received till Saturday.

“Finalisation of the document may take a few more months as we have received hundreds of comments from within the country and outside. We carried out a consultation in Bengaluru last week and one more is planned in Delhi in November. All these inputs will go into the final document,” ICMR director general Soumya Swaminathan told DH.

The draft is a revised version of ICMR’s 2006 guidelines with new chapters on social and behavioural sciences, responsible for the conduct of research and new technologies like genetics. Other specialised areas like the informed consent process, biological materials, vulnerability, international collaboration and research during humanitarian emergencies and disasters have been elaborated in the new draft.

The process of obtaining informed consent from research subjects has been made more stringent following multiple instances of its violation of ethical norms, the most prominent of which was testing of the cervical cancer vaccine in Andhra Pradesh and Gujarat almost three years ago.

The informed consent forms will have to be approved by the ethics committee supervising the research.  According to the draft norms, one of the committee members will have to be a lay person, whose task will be to review the informed consent documents.

Once accepted, the new guideline will be a key part of the government’s initiatives to overhaul the existing clinical trial system, which came under sharp criticism from several courts.