A trade secret model for genomic biobanking.
Genomic biobanks present ethical challenges that are qualitatively unique and quantitatively unprecedented. Many critics have questioned whether the current system of informed consent can be meaningfully applied to genomic biobanking. Proposals for reform have come from many directions, but have tended to involve incremental change in current informed consent practice. This paper reports on our efforts to seek new ideas and approaches from those whom informed consent is designed to protect: research subjects. Our model emerged from semi-structured interviews with healthy volunteers who had been recruited to join either of two biobanks (some joined, some did not), and whom we encouraged to explain their concerns and how they understood the relationship between specimen contributors and biobanks. These subjects spoke about their DNA and the information it contains in ways that were strikingly evocative of the legal concept of the trade secret. They then described the terms and conditions under which they might let others study their DNA, and there was a compelling analogy to the commonplace practice of trade secret licensing. We propose a novel biobanking model based on this trade secret concept, and argue that it would be a practical, legal, and ethical improvement on the status quo.
University of North Carolina at Chapel Hill.
John M
JM
Conley
Robert
R
Mitchell
R Jean
RJ
Cadigan
Arlene M
AM
Davis
Allison W
AW
Dobson
Ryan Q
RQ
Gladden
D001294:Attitude to Health; D018070:Biological Specimen Banks / Q000941:ethics* / Q000331:legislation & jurisprudence*; D003219:Confidentiality / Q000941:ethics / Q000331:legislation & jurisprudence; D015894:Genome, Human; D037921:Gift Giving; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D008004:Licensure / Q000331:legislation & jurisprudence; D008962:Models, Theoretical; D010067:Ownership / Q000331:legislation & jurisprudence; D014019:Tissue Donors; D014481:United States