Research ethics

I have been primarily interested in ethical issues raised by research sponsored by rich countries in resource poor countries. The issue started to get international attention in the mid-1990s, when WHO/UNAIDS decided to endorse a trial of an HIV vaccine candidate that was rejected in the US. According to the guidelines in effect at that time, this was not permissible: Trials that could be done in both rich and poor countries should primarily be done in resource rich countries, and as a minimum be done simultaneously in both settings. The justification for this prohibition against doing trials only in research poor settings was to avoid exploitation of poor countries. Many representatives from these countries, such as Thailand, argued that this standard was inherently paternalistic and unjustifiable. As a result a process of discussion of the international guidelines was initiated by UNAIDS. I had been interested in this issue in relation to Brazil, and was asked by UNAIDS to produce a working paper.

At the same time as this deliberation was going on, the controversy erupted over the perinatal HIV transmission trials with the publication of a Sounding board article and editorial in the New England Journal of Medicine. This controversy was about whether it sometimes would be justifiable to allow trials in resource poor settings that would be unacceptable in rich countries. I have argued in several articles that under certain very specific conditions this should be acceptable. In an article I published with Seema Shaw we argue that standard of care may change as a research project progresses and this creates challenges for the conduct of clinical trials.



As a result of these discussions, I was part of a group that developed what has been called the Fair Benefits Framework. This framework rejects the requirement that a particular type of benefit should be required in international collaborative research. Specifically, it rejects the requirement that reasonable availability should always be required. Some have interpreted this to be that only the amount of benefits matters, and no restrictions should be placed on the types of benefits, and that there are no independent standards by which benefit agreements can be evaluated: whatever parties to the negotiations agree is fair should be accepted. I have rejected this interpretation of the Framework.