Ethics panel to monitor bio-medical research

Guidelines on conducting bio-medical research on humans in India, awaiting clearance from the Union Health and Family Welfare Ministry, provide for setting up a 'National Ethics Committee' with which all private or public ethics committees in the country will have to register.

Speaking at a symposium on 'Bioethics, Biosafety and IPR' organised by the T John Group of Institutions here on Wednesday, Dr Nandini Kumar, deputy director general, ICMR, said, "When the ministry clears the ethical guidelines for biomedical research on human participants, they will be tabled in Parliament for final approval."

The guidelines attach importance to informed consent, maximisation of public interest and distributive justice.

"In a country like India where illiteracy is very high, taking informed consent poses a major constraint. However, as stated in the guidelines, even if a person is incompetent to give consent, it should be given by someone empowered to act on his or her behalf," she added.

Violation of these guidelines will be liable for penal provision equivalent to violation of human rights.

The guidelines will set in place checks like proving safety before implementation or practice.

These will also help medical colleges in the country and should form part of the undergraduate and post-graduate medical curriculum.