Lesbian, gay, bisexual and transgender (LGBT) people and sex workers should be part of an ethics committee that approves health research involving these communities to ensure informed consent and protect rights, India’s apex medical body has said.
The move is part of the Indian Council of Medical Research’s (ICMR) draft national guidelines for biomedical and health research and is the first time that a government body has included the marginalised sections in official policy.
The draft rules, which are open for public comments, include a separate section on dealing with sexual minorities because they are more vulnerable to stigma and discrimination than the general population.
Research on HIV, hepatitis B and other blood-borne diseases often requires participants to divulge their sexual orientation to get a fix on the possible source of infection, which can be through transfusions, sharing needles to inject drugs, unsafe syringes etc.
“We had a very extensive discussion, including a separate subcommittee, to define vulnerable people and for the first time, guidelines on research include how to take informed consent from sexual minorities to safeguard their interests,” said Dr Roli Mathur, senior scientist, ICMR, who is in-charge of drafting the updated guidelines.
The draft guidelines come a month after a proposed law got flak for banning unmarried and LGBT couples from having a surrogate baby. Homosexuality is criminalised in India under section 377 of the Indian Penal Code and a challenge to the British-era law is currently pending in the Supreme Court.
The need to include sexual minorities as a separate group was felt because of the unique challenges associated with research involving them, including the possibility of stigma, discrimination and exploitation. “Protection of their dignity and quality health care should be well addressed in the research proposal, preferably in consultation with the community before the proposal is finalised,” the draft guidelines say.
Mathur said a representative from the LGBT community can participate as a special invitee/ member in the meeting of the ethics committee that provides clearance for a research project. Each project will also set up a community advisory board to act as interface between the researcher(s) and the community.
“In HIV positive persons, for example, any research may be misconstrued as research on anti- HIV treatment and make them willing to participate; so the full implications must be explained to them in simple terms,” said Mathur. There could be inhibitions between groups within the community, so each group should be explained details of research separately.
Peer educators or champions among the community could be educated and sensitised first, and they would in turn explain the details to the potential participants from the community, to help them understand better.
While original time to accept suggestions was till September 15, ICMR has decided to extend the time limit by a month to accommodate more views.
“We have national-level consultations planned to get more expert comments as it is a sensitive topic. These guidelines will give researchers an idea on how to deal with a topic. These guidelines, however, are not the law but are admissible in the court of law, if required,” she said.