Clin Genet. 2013 May 10. doi: 10.1111/cge.12190. [Epub ahead of print]
Funding considerations for the disclosure of genetic incidental findings in biobank research.
Black L, Avard D, Zawati MH, Knoppers BM, Hébert J, Sauvageau G; on behalf of the Leucegene Project (see Acknowledgments for the list of contributors).
Centre of Genomics and Policy, Department of Human Genetics, Faculty of Medicine, McGill University. Montreal, Quebec, Canada.
The use of biobanks in biomedical research has grown considerably in recent years. As a result of the increasing analysis of tissue samples stored in biobanks, there has also been an increase in the probability of discovering-in addition to the research target-incidental findings (IF). We identified 23 laws, policies and guidelines from international, regional and national organizations that provide guidance or identify the need for the disclosure of IF to research participants. We analyzed these instruments to determine their contemplation of the funding considerations for the disclosure of IF, examining their guidance for who discloses and the extent of researcher responsibilities. We found that the available normative documents provide little guidance to researchers and biobanks for how they should address cost and funding concerns associated with IF disclosure. It is therefore essential that the research and policy communities think through the financial implications of imposing an ethical responsibility to disclose IF. Concerted efforts should be made by policymakers, ethicists, researchers, clinicians and research institutions to develop detailed funding recommendations, potentially universal in application, to aid in the disclosure of IF, and we provide recommendations on steps that can be taken to ensure full consideration of these issues.
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