Compensation for inadequate consent to genetic research

27 April 2010

A native American tribe, the Havasupai Indians, have been in the news recently following a payment from Arizona State University in compensation for the use of blood samples for genetic research. In addition to the out-of-court settlement of US$700,000 and return of the blood samples, the university is reportedly to provide additional assistance to the tribe such as scholarships. This decision was the result of legal actions brought by tribe members after it came to their attention that DNA samples provided for a specific research project in the 1990s had subsequently been used for a range of other studies, without the permission of the original subjects.
In fact, the original consent obtained had been quite broad, referring to research into causes of ‘behavioral/medical disorders’, but the study participants had been convinced particularly by the prospect of research into diseases of immediate relevance to their tribe, such as type 2 diabetes, which is unusually prevalent. They were displeased to discover that a much broader range of articles had been published based on studies of the DNA samples, including discussion of issues such as racial origins (see New York Times report).
Although no misconduct has been proven on the part of the researchers, the university had reportedly already spent US$1.7 million on legal costs and were no doubt disinclined to spend more. However, the move is potentially significant from a legal perspective since it recognises a lack of fully informed consent with respect to the scope of research conducted with donated samples as misuse (see the Genomics Law Report for more discussion of the legal implications of this case).
Comment: Whilst it seems very plausible that the Havasupai Indians who donated blood samples for research should have been angered and distressed on discovering uses to which they did not feel they had given consent, sympathies must also lie with the researchers. Suitable protection of research participants is crucial, but not to the point that research is stifled – and fears of legal action of this type could have just that effect; the original lawsuit reportedly sought US$75 million in damages (see Nature blog) – that is, damages of approaching US$2 million for each claimant, which is clearly ridiculous.
Robust consent procedures that allow for effective use of patient samples for different forms of research are essential; robust responses to claims of misuse may be more difficult to achieve in an increasingly litigious society.

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