A Trade Secret Model for Genomic Biobanking

Rothstein M. A. , “Expanding the Ethical Analysis of Biobanks,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 89–101 We use “biospecimens,” “samples,” and “human tissues” synonymously, and follow Eisman and Haga's capacious definition of “human tissue” as including both fluids, such as blood, and solids, such as muscle biopsies; see

Eiseman E. Haga S. B. , Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples (Santa Monica, CA: Rand Corporation, 1999): At 7.

Shickle D. , “The Consent Problem within DNA Biobanks,” Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 37, no. 3 (2006): 503–519.

In the U.S., the doctrine of informed consent began to take on its current form following reports in the 1960s and 1970s by Henry Beecher and others, who revealed the unethical treatment of research subjects in the U.S., most infamously in the 40-year Tuskegee Syphilis Study. Beecher H. , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354–60. These revelations punctured the illusion that researchers themselves, acting as moral agents, could be trusted as the arbiters of ethical research conduct. In response, the 1976 Belmont Report enshrined three ethical principles for human subjects research: Respect for persons, beneficence, and justice. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html>(last visited July 10, 2012). These principles were operationalized in the 1991 Common Rule, which (as implemented by Institutional Review Boards) governs nearly all federally funded research, with informed consent as its core premise. U.S. Department of Health and Human Services, Federal Policy for the Protection of Human Subjects (“Common Rule”), available at <http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html>(last visited November 1, 2011).

Greely H. T. , “The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks,” Annual Review of Human Genetics 8 (2007): 343–364, at 344.

Jacobs K. B. Yeager M. Wacholder S. Craig D. Kraft P. Hunter D. J. Paschal J. Manolio T. A. Tucker M. Hoover R. N. Thomas G. D. Chanock S. J. Chattterjee N. , “A New Statistic and Its Power to Infer Membership in a Genome-Wide Association Study Using Genotype Frequencies,” Nature Genetics 41, no. 11 (2009): 1253–1257.

Hayden E. C. , “Secrets of the Human Genome Disclosed,” Nature 478 (2011): 17.

See Rothstein, supra note 1, at99.

Greely H. T. , “Breaking the Stalemate: A Prospective Regulatory Framework for Unforseen Research Uses of Human Tissue Samples and Health Information,” Wake Forest Law Review 34, no. 3 (1999): 737–766;

see reely , supra note 4.

Caulfield T. Upshur R. Daar A. , “DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model,” BioMed Central Medical Ethics E1, 4 (2003), at <http://www.biomedcentral.com/1472–6939/4/1>;

Caulfied T. Knoppers B. M. Consent, Privacy & Research Biobanks, Policy Directions Brief Number 1, 2009–2010 Series on Genetic Information, Genome Canada (January 26, 2010): 1–10, at 4–5, available at <http://www.genomecanada.ca/medias/pdf/en/GPS-Policy-Directions-Brief.pdf>(last visited June 26, 2012).

U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (2011),” 76 Fed. Reg. 44512–44531 (July 26, 2011), available at <http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011–18792.htm>(last visited June 26, 2012).

The ANPRM treats a biospecimen and genotypic information derived from it as one unit and presumes that individuals who provide biospecimens can be identified (U.S. Department of Health and Human Services, supra note 10, at 44525). Given this inherent identifiability, the ANPRM proposes that no research on biospecimens – regardless of whether biospecimens were collected for a study or left over from clinical care – proceed without prospective written consent (U.S. Department of Health and Human Services, supra note 10, at 33515, 44519). Yet under the ANPRM, prospective consent may be broad and undefined regarding future uses and studies may be exempted from IRB review if researchers themselves view it as presenting minimal risk (U.S. Department of Health and Human Services, supra note 10, at 44515). The ANPRM thus strengthens oversight by expanding regulatory coverage, but simultaneously gives greater discretion to the research community whose original indiscretions led to the creation of the whole regulatory apparatus.

Winickoff D. E. Winickoff R. , “Charitable Trust as a Model for Genomic Biobanks,” New England Journal of Medicine 349, no. 12 (2003): 1180–1184.

Fullerton S. M. Anderson N. R. Guzauskas G. Freeman D. Fryer-Edwards K. , “Meeting the Governance Challenges of Next-Generation Biorepository Research,” Science Translational Medicine 2, no. 15 (2010): 15cm3, available at <http://stm.sciencemag.org/content/2/15/15cm3.full>(last visited July 11, 2012).

Hoeyer K. , “The Ethics of Research Biobanking,” Biotechnology and Genetic Engineering Reviews 25 (2008): 429–452, at 440.

Mitchell R. Conley J. Davis A. Cadigan J. Dobson A. Gladden R. , “Genomics, Biobanks, and the Trade-Secret Model,”Scienc e 332, no. 6027 (April 15, 2011): 309–310;

see also, “Letters and Response,” Science 333, no. 6051 (September 16, 2011): 1574–1576.

Mauss M. , The Gift, trans. Halls W.D. (London: Routledge, 1954, orig. 1924).

Malinowski B. , Crime and Custom in Savage Society (Tonowa, NJ: Helix Books, 1985, orig. 1926): At 24–27.

Sykes K. , Arguing with Anthropology: An Introduction to Critical Theories of the Gift (London: Routledge, 2005): At 1.

Titmuss R. , The Gift Relationship: From Human Blood to Social Policy (London: Allen & Unwin, 1970).

Medical Research Council (MRC), Human Tissue and Biological Samples for Use in Research (London: MRC, 2001).

Tutton R. , “Gift Relationships in Genetics Research,” Science as Culture 11, no. 4 (2002): 523–542, at 526.

Rapport F. L. Maggs C. J. , “Titmuss and the Gift Relationship: Altruism Revisited,” Journal of Advanced Nursing 40, no. 5 (2002): 495–503;

see Tutton , supra note 21.

See, e.g., Leach E. , “The Heart of the Matter,” New Society 17, no. 434 (1971): 114–115;

Tutton , supra note 21;

Waldby C. Mitchell R. Tissue Economies: Blood, Organs, and Cell Lines in Late Capitalism (Durham, NC: Duke University Press, 2006).

See Leach, supra note 23, at 114.

See Tutton, supra note 21, at 528.

Blood can be fractionated and blood components stored for longer periods and distributed to geographically distant communities. Starr D. P. Blood: An Epic History of Medicine and Commerce (New York: Alfred A. Knopf, 1998): At101–121. However, the national publics that donate blood are often not aware of this fact. The emergence in the 1980s of HIV in the French donated blood supply, for example, revealed that blood components had been imported from the U.S., which caused a huge scandal among a French public that had been led to believe that its stored blood supply was derived entirely from indigenous sources. P. Rabinow, French DNA: Trouble in Purgatory (Chicago: University of Chicago Press, 1999): At 71–111.

See Tutton, supra note 21, at 538;

Waldby Mitchell supra note 23, at 19.

Rabinow P. , Essays on the Anthropology of Reason (Princeton, NJ: Princeton University Press, 1996): At 99.

Id., at 99.

Sommer M. , “DNA and Cultures of Remembrance: Anthropological Genetics, Biohistories and Biosocialities,” BioSocieties 5, no. 3 (2010): 366–390.

Id., at383.

Lindee M. S. Goodman A. H. Heath D. , “Anthropology in and Age of Genetics: Practice, Discourse, and Critique,” in Goodman A. H. Heath D. Lindee M. S. , eds., Genetic Nature/Culture (Berkeley, CA: University of California Press, 2003): 1–22, at 7.

See Luque J. S. Quinn G. P. Montel-Ishino F. A. Arevalo M. Bynum S. A. Noel-Thomas S. Wells K. J. Gwede C. K. Meade C. D. Tampa Bay Community Cancer Network Partners, “Formative Research on Perceptions of Biobanking: What Community Members Think,”Journal of Cancer Education 27, no. 1 (2012): 91–99;

Streicher S. A. Sanderson S. C. Wang Jabs E. Diefenbach M. Smirnoff M. Peter I. Horowitz C. R. Brenner B. Richardson L. D. “Reasons for Participating and Genetic Information Needs among Racially and Ethnically Diverse Biobank Participants: A Focus Group Study,”Journal of Community Genetics, 2, no. 3 (2011): 153–163;

Simon C. M. L'Heureux J. Murray J. C. Winokur P. Weiner G. Newbury E. Shinkunas L. Zimmerman B. “Active Choice But Not Too Active: Public Perspectives on Biobank Consent Models,” Genetics in Medicine 13, no. 9 (2011): 821–831. Some of this work, guided by the principles of “deliberative democracy,” has focused on the BC Biobank Deliberation, a four-day “public engagement event” held in British Columbia in 2007.

See Walmsley H. “Stock Options, Tax Credits or Employment Contracts Please! The Value of Deliberative Public Disagreement about Human Tissue Donation,” Social Science and Medicine 73, no. 2 (2011): 209–216;

Secko D. Preto N. Miemeyer S. Burgess M. “Informed Consent in Biobank Research: A Deliberative Approach to the Debate,” Social Science and Medicine 68, no. 4 (2009): 781–789.

Hoeyer K. , “Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?” Public Health Genomics 13, no. 6 (2010): 345–52, at 349.

Hoeyer K. , “The Power of Ethics: A Case Study from Sweden on the Social Life of Moral Concerns in Policy Processes,” Sociology of Health and Illness 28, no. 6 (2006): 785–801.

See Hoeyer, supra note 34, at 345.

See Hoeyer, supra note 35, at 797.

Id., at797.

See Hoeyer, supra note 14, at 440–441.

Id., at 442.

Johnstone B. , “Discourse Analysis and Narrative,” in Schiffrin D. Tannen D. Hamilton H. E. , eds., The Handbook of Discourse Analysis (Malden, MA: Blackwell Publishing, 2001): 635–649;

Conley J. O'Barr W. Just Words: Law, Language, and Power (Chicago: University of Chicago Press, 1998).

Foucault M. , Discipline and Punish: The Birth of the Prison (London: Allen Lane, 1977);

Foucault M. , The History of Sexuality (New York: Random House, 1978).

See, e.g., Goodwin C. Conversational Organization: Interaction between Speakers and Hearers (New York: Academic Press, 1982).

Shuy R. , “Discourse Analysis in the Legal Context,” in Schiffrin, Tannen, and Hamilton, supra note 41, at437–452.

Ainsworth-Vaughn N. , “The Discourse of Medical Encounters,” in Schiffrin, Tannen, and Hamilton, supra note 41, at453–469.

Fleischman S. , “Language and Medicine,” in Schiffrin, Tannen, and Hamilton, supra note 41, at 470–502.

Hamilton H. E. , “Discourse and Aging,” in Schiffrin, Tannen, and Hamilton, supra note 41, at 568–589.

Id., at 573.

Goffman E. , The Presentation of Self in Everyday Life (Garden City, NY: Doubleday, 1959).

Garfinkel H. , Studies in Ethnomethodology (Englewood Cliffs, NJ: Prentice-Hall, 1967).

Atkinson J. M. Drew P. , Order in Court: The Organisation of Verbal Interaction in Judicial Settings (Atlantic Highlands, NJ: Humanities Press, 1979): At18–22.

See Hoyer, supra note 35, at795–798 for an application of this approach to medical ethics.

National Conference of Commissioners on Uniform State Laws, Uniform Trade Secrets Act, available at <http://www.law.upenn.edu/bll/archives/ulc/fnact99/1980s/utsa85.htm>(last visited July 10, 2012).

Black's Law Dictionary, Abridged Sixth Edition (St. Paul, MN: West Publishing, 1991): At 211.

In Washington University v. Catalona, 437 F. Supp. 2d 985 (E.D. Mo. 2006), aff'd, 490 F.3d 667 (8th Cir. 2007), cert. denied, 128 S. Ct. 1122 (2008), the United States Court of Appeals for the Eighth Circuit held that neither a former Washington University researcher nor the donors of biospecimens he had collected had any property rights in the biospecimen and therefore could not compel transfer of the biospecimens to the researcher in his new position. Applying Missouri state law, the court found that the biospecimens had been a gift to Washington University.

In Greenberg v. Miami Children's Hospital Research Institute, Inc., 264 F. Supp. 2d 1064 (S.D. Fl. 2003), a federal trial court in Miami held under Florida law that donors had no property right in biospecimens they had contributed. The Greenberg court cited Moore v. Regents of University of California, 51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479 (1990), in which the California Supreme Court reached a similar result under California law.

National Cancer Institute, Office of Biorepositories and Biospecimen Research, Custodianship and Ownership Issues in Biospecimen Research, Symposium – Workshop (2008), available at <http://biospecimens.cancer.gov/resources/publications/workshop/cow.asp>(last visited June 26, 2012).

See Catalona and Greenberg, supra note 55.

Grimes v. Kennedy Krieger Institute, 366 Md. 29, 782 A. 2d 807 (2001).

See Catalona, supra note 55.

See Conley J. Cadigan J. Davis A. Dobson A. Edwards E. Fortson R. Mitchell R. , “The Discourse of DNA: Giving Informed Consent to Genetic research,” in Heffer C. Rock F. Conley J. , eds., Lay-Legal Communication: Textual Travel in the Legal Process (Oxford, UK: Oxford University Press, forthcoming).

Dove E. S. Joly Y. Knoppers B. M. , “Trade-Secret Model: Legal Limitations,” Science 333, no. 6051 (2011): 1575, at 1575.

See Hoeyer, supra note 34, and Hoeyer, supra note 35.

U.S. Department of Health and Human Services, Draft Guidance on Exculpatory Language in Informed Consent (September 2011), available at <http://www.hhs.gov/ohrp/news*-room/rfc/exculpatorydraft2011.html>(last visited June. 25, 2012).

Kauffman Foundation, Facilitating the Commercialization of University Innovation: The Carolina Express License Agreement (April 2010), available at <http://www.kauffman.org/uploadedFiles/UNCagreements_4-19-10.pdf>(last visited June 25, 2012).

Office of Technology Development, University of North Carolina at Chapel Hill, Carolina Express User Guide, at 2, available at <http://otd.unc.edu/documents/CarolinaExpressLicenseUserGuide.pdf>(last visited June 26, 2012).

See National Cancer Institute, supra note 56.

See Winickoff and Winickoff, supra note 12.

See Fullerton, supra note 13.

See Office of Human Subjects Research, National Institutes of Health, supra note 3.