Whose risk/benefit ratio is this, anyway?
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. For example, the thought "How could my participation in this study possibly benefit my family?" is a consideration unlikely to appear in your standard risk/benefit discussions. What could be a benefit for participants may, from the perspective of an ethics committee, be literally invisible.
The authors state that much more research is needed into the complex links between socio-economic vulnerability, access to health care and the freedom to decide on participation in medical research. Seems reasonable. But whether such research will lead to a participant perspectives being more determinative of 'official' assessments of the risks and benefits of health research remains to be seen.