Women’s health and HIV research ethics

A short review published this week in the Lancet, written by two US researchers, Daniel Fitzgerald and Frieda Behets, raises serious ethical issues. It challenges international researchers on HIV prevention in developing countries to engage more deeply with the communities they work with, before starting such research. Particular problems arise from much-needed research on microbicides and on preventing mother-to-child transmission. This increasingly has to recruit women of reproductive age as clinical trial volunteers in settings where their basic human rights, including access to health care, are often not met.

The article highlights extremes of social injustice and vulnerability experienced by women at risk from HIV. Examples are given of:

• physical and sexual abuse of women who lack legal redress against their partners or independent economic support
• lack of access to healthcare for non-HIV-related conditions such as breast and cervical cancer
• the consequences of restricted access to abortion (or, indeed, pressure to have abortions)
• lack of support for women in childbirth.

The researchers are at pains to stress that these issues don’t go away, regardless of the position that people take, for example, on the ethics of abortion.

In one case, a US-based research ethics committee severely reprimanded a researcher for offering US $10 to pay for antibiotics to try and save the life of a woman trial volunteer after a disastrous childbirth. This was judged as “coercive” – an unfair inducement to volunteers to take part in research, which might compromise their ability to participate (or withdraw) on a truly voluntary basis.

As the authors say, “there are no easy answers” to the problems they describe. To remedy all the defects they describe, not only of healthcare systems but also economic inequality and deficient legal systems within countries, would take more resources than researchers will ever have. However, if these issues are not discussed, and some action taken in advance of clinical trials being launched, then the risk is that researchers will be seen by affected communities as inhuman monsters, and future research that could genuinely improve their situation will be blocked.

Comment: the challenges of ‘partnership’

Calling for partnerships with affected communities echoes calls by other groups that have considered international research ethics, including UNAIDS (in its ethical guidelines on HIV vaccine trials) and the Nuffield Council on Bioethics (in its recent report on international clinical research). However, the likelihood that affected communities will have the resources and will to enter freely into partnerships, unless given specific outside funding to do so, is a problem in itself. Once community-based agencies accept such funding, even if it is independent of the researchers themselves, who are they really accountable to?

Another conclusion might be that the possibility of ethical research rests on the commitment of government and other institutions to counter poverty and gender inequality. In countries with grossly oppressive or negligent governments, does there come a point where researchers should stay away? Where and by whom should such lines be drawn?