To reduce the spread of the human immunodeficiency virus (HIV), Granich et al. 1 ( 2009 ) have proposed a new strategy for universal voluntary HIV testing immediately followed by antiretroviral therapy. Although this proposal is likely to benefit the partners of those affected and thus promote public health, it is by no means clear that it benefits the infected people themselves and indeed it may be harmful. Since the proposal involves an intervention that is not clinically indicated, it falls (...) foul of the normal ethical standards of clinical medicine, which is to act in the best interests of patients. Neither is it a measure that would be imposed under the protection of public health law on people who are seen as representing such danger to others that significant restrictions in liberty are appropriate. Thus, the proposal represents a third category of public health measure. We argue that a coherent ethical framework including a robust process is appropriate to proposals of this kind and that medical research offers a useful model since some research, like this proposal, is motivated not by the interests of the individual participants but by the common good. We outline some possible elements of such an ethical framework. (shrink)

In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. (...) But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. (shrink)

The American Journal of Bioethics, Volume 11, Issue 12, Page 48-50, December 2011.