Bioethics Blogs

Whose risk/benefit ratio is this, anyway?

It’s a good question. An analysis of risks and benefits for study participants is considered central to the ethics of research, but how risks and benefits are determined remains tricky. Part of the job description of research ethics committees is to make such determinations, and the Belmont Report encourages use of quantitative risk data whenever possible, but it is unclear how often that actually happens. Anecdotally, there is a lot of eyeballing and back-of-the-envelope estimation of risks, if not outright speculation and magnification. And as for benefits, there is much disagreement as to what should count as a benefit in the risk/benefit assessment. Compensation and inducements are traditionally thought to be inadmissible; benefits that come with study participation (‘inclusion benefits’) are permitted in the mix by some, ruled out by others.

The problem of risk/benefit determination is not just a problem about how, but also about who. Traditionally, the work of making such judgments is something reserved for experts: bioethicists, researchers, research ethics committees, policy makers. This is one area in which the whiff of paternalism in research ethics is particularly strong. If anything, the perspectives of research participants and communities are regarded as ethically dangerous and problematic, particularly in cases where communities are poor and the prospective participants are hoping to gain medical benefits by joining research studies. An article in a recent edition of Tropical Medicine and International Health suggests that local communities make their own risk/benefit calculations about particular studies, which go far beyond whatever risks and benefits may be directly connected to study interventions.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.