Clinical trials, genetic add-ons, and the question of benefit-sharing

Discussion of benefit-sharing has become common in the sphere of human genetic research. Roughly, this term means that individuals or organisations who could reap financial rewards from research into human genetics have some obligation to share the benefits of this research, perhaps with the people who made the research possible in the first place, or with humankind more broadly. This idea has met with some acceptance, finding its way into policy recommendations and statements of several prominent groups. However, the issue of benefit-sharing is generally raised in the context of large-scale population-based genetic studies. Other sources of human DNA are often ignored. In particular, little attention has been paid to the increasingly common practice of collecting genetic samples as addons to clinical drug trials. Generally such trials do not specify a use for these samples, which are collected for purposes of potential future research. We argue that if a case for benefit-sharing can be made for genetic studies in general, it can be made for add-on studies as well. We suggest some ways in which benefit-sharing might be implemented for genetic add-on studies.