• Open Access

Funding considerations for the disclosure of genetic incidental findings in biobank research

Authors

  • L Black,

    Corresponding author
    1. Department of Human Genetics, Faculty of Medicine, Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada
    • Corresponding author: Lee Black, JD LLM, Centre of Genomics and Policy, McGill University, 740 Dr. Penfield Avenue, Room 5209, Montreal, Quebec H3A 0G1, Canada.

      Tel.: +1 514 952 4599;

      fax: +1 514 398 8954;

      e-mail: lee.black@mcgill.ca

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  • D Avard,

    1. Department of Human Genetics, Faculty of Medicine, Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada
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  • MH Zawati,

    1. Department of Human Genetics, Faculty of Medicine, Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada
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  • BM Knoppers,

    1. Department of Human Genetics, Faculty of Medicine, Centre of Genomics and Policy, McGill University, Montreal, Quebec, Canada
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  • J Hébert,

    1. Institute for Research in Immunology and Cancer, Université de Montréal, Montreal, Quebec, Canada
    2. Leukemia Cell Bank of Quebec and Division of Hematology-Oncology, Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
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  • G Sauvageau,

  • on behalf of the Leucegene Project

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    • See Appendix for the list of contributors.


  • The authors declare that they have no conflicts of interest.

Abstract

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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