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 add-ons 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.

Benefit sharing in smaller markets: the case of Newfoundland and Labrador.

This case report describes recent efforts in the Canadian province of Newfoundland and Labrador to establish an appropriate benefit-sharing model for human genetic research conducted there. The relatively homogeneous population of this island province has proven to be attractive to the drug development industry. However, unlike large-scale national projects that include broad benefit-sharing arrangements from the outset such as those proposed for places like Iceland and Estonia, there are no plans in Newfoundland and Labrador to establish a large gene bank. Hence a benefit-sharing protocol that will assess individual genetic studies on a case by case basis has been proposed. The province is moving toward legislation to establish a Provincial Health Research Ethics Board (PHREB) that will ensure that all human health research conducted in the province receives local ethics review. The proposed benefit-sharing protocol calls for the establishment of a Standing Committee on Human Genetic Research (SCHGR) that will operate in concert with the PHREB and will ensure that research sponsors enter into appropriate benefit-sharing arrangements with the province.