A Trade Secret Model for Genomic Biobanking

Abstract

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.

A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States

“…A total of 51 publications comprising 48 studies were included in this review. 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 Most studies involved surveys ( n = 23), followed by focus groups ( n = 8), mixed methods ( n = 14), interviews ( n = 1), and analyses of consent forms ( n = 2) ( Supplementary Table S3 online). Two publications used a mixed-methods approach that included qualitative studies that informed the development and implementation of a survey.…”

Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

“…However, researchers make every effort to ensure that such documents are not treated as contracts, courts have usually not treated them as contracts, and they are also written so as to minimize any duties owed to subjects. 73 …”

Biobank Economics and the “Commercialization Problem”

“…More pragmatically, the ethico-legal problems of commercialization have been constructed as questions about "what social and legal norms will shape and constrain the commercial activity" (Anderlik 2003, 206; see also: Martin and Kaye 2000). Conley (2012) describes two broad approaches that have been proposed in response to the dangers of commercialization: (1) redefining notions of consent and refining regulation, as illustrated by shis to "open" or "broad" consent and ethical oversight by IRBs (Institutional Review Boards) (Greely 2007;Greely 1999;Caulfield, Upshur, and Daar 2003;Merz et al 2002;Rothstein 2002); or (2) the creation of innovative ethico-legal frameworks for benefit sharing, which re-imagine the relationship between biobanks, participant and commercial activity; examples of which include a "charitable trust model" (Winickoff and Winickoff 2003;see also: Oen, Wyle, and Phelps 2004;Winickoff and Winickoff 2004), a "trade secret model" (Conley et al 2012), and a "stewardship model" (Fullerton et al 2010).…”