Hostname: page-component-7c8c6479df-fqc5m Total loading time: 0 Render date: 2024-03-27T13:48:22.375Z Has data issue: false hasContentIssue false

A Trade Secret Model for Genomic Biobanking

Published online by Cambridge University Press:  01 January 2021

Extract

The current ethical norms of genomic biobanking creating and maintaining large repositories of human DNA and/or associated data for biomedical research have generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself be directly involved in research, instead banking the biospecimens and associated data for other researchers. Moreover, the future uses of biospecimens may be unknown, if not unknowable, at the time of collection. Biobanking may thus stretch the meanings of inform and consent to their breaking point: if you cannot inform subjects about what their biospecimens will be used for (because you do not know), what can they consent to? Given that informed consent by individual subjects is the ethical gold standard, the seeming dilution of the concept in the context of biobanking is a profound problem.

Type
Independent
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Rothstein, M. A., “Expanding the Ethical Analysis of Biobanks,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 89101 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.CrossRefGoogle Scholar
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): 503519.CrossRefGoogle Scholar
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): 135460–135460. 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).CrossRefGoogle Scholar
Greely, H. T., “The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks,” Annual Review of Human Genetics 8 (2007): 343364, at 344.CrossRefGoogle Scholar
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): 12531257.CrossRefGoogle Scholar
Hayden, E. C., “Secrets of the Human Genome Disclosed,” Nature 478 (2011): 17.CrossRefGoogle Scholar
See Rothstein, supra note 1, at 99.Google Scholar
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): 737766; see reely, , supra note 4.Google Scholar
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): 110, at 4–5, available at <http://www.genomecanada.ca/medias/pdf/en/GPS-Policy-Directions-Brief.pdf>(last visited June 26, 2012).;+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+(last+visited+June+26,+2012).>Google Scholar
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).(last+visited+June+26,+2012).>Google Scholar
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.Google Scholar
Winickoff, D. E. Winickoff, R., “Charitable Trust as a Model for Genomic Biobanks,” New England Journal of Medicine 349, no. 12 (2003): 11801184.CrossRefGoogle Scholar
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).CrossRefGoogle Scholar
Hoeyer, K., “The Ethics of Research Biobanking,” Biotechnology and Genetic Engineering Reviews 25 (2008): 429452, at 440.CrossRefGoogle Scholar
Mitchell, R. Conley, J. Davis, A. Cadigan, J. Dobson, A. Gladden, R., “Genomics, Biobanks, and the Trade-Secret Model,”Science 332, no. 6027 (April 15, 2011): 309310; see also, “Letters and Response,” Science 333, no. 6051 (September 16, 2011): 1574–1576.Google Scholar
Mauss, M., The Gift, trans. Halls, W.D. (London: Routledge, 1954, orig. 1924).Google Scholar
Malinowski, B., Crime and Custom in Savage Society (Tonowa, NJ: Helix Books, 1985, orig. 1926): At 2427.Google Scholar
Sykes, K., Arguing with Anthropology: An Introduction to Critical Theories of the Gift (London: Routledge, 2005): At 1.Google Scholar
Titmuss, R., The Gift Relationship: From Human Blood to Social Policy (London: Allen & Unwin, 1970).Google Scholar
Medical Research Council (MRC), Human Tissue and Biological Samples for Use in Research (London: MRC, 2001).Google Scholar
Tutton, R., “Gift Relationships in Genetics Research,” Science as Culture 11, no. 4 (2002): 523542, at 526.CrossRefGoogle Scholar
Rapport, F. L. Maggs, C. J., “Titmuss and the Gift Relationship: Altruism Revisited,” Journal of Advanced Nursing 40, no. 5 (2002): 495503; see Tutton, , supra note 21.CrossRefGoogle Scholar
See, e.g.,Leach, E., “The Heart of the Matter,” New Society 17, no. 434 (1971): 114115; Tutton, , supra note 21; Waldby, C. Mitchell, R. Tissue Economies: Blood, Organs, and Cell Lines in Late Capitalism (Durham, NC: Duke University Press, 2006).Google Scholar
See Leach, supra note 23, at 114.Google Scholar
See Tutton, supra note 21, at 528.Google Scholar
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): At101121. 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.Google Scholar
See Tutton, supra note 21, at 538; Waldby, Mitchell, supra note 23, at 19.Google Scholar
Rabinow, P., Essays on the Anthropology of Reason (Princeton, NJ: Princeton University Press, 1996): At 99.Google Scholar
Id., at 99.Google Scholar
Sommer, M., “DNA and Cultures of Remembrance: Anthropological Genetics, Biohistories and Biosocialities,” BioSocieties 5, no. 3 (2010): 366390.CrossRefGoogle Scholar
Id., at383.Google Scholar
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): 122, at 7.Google Scholar
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): 9199; 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.CrossRefGoogle Scholar
Hoeyer, K., “Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?” Public Health Genomics 13, no. 6 (2010): 34552–34552, at 349.CrossRefGoogle Scholar
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): 785801.CrossRefGoogle Scholar
See Hoeyer, supra note 34, at 345.Google Scholar
See Hoeyer, supra note 35, at 797.Google Scholar
Id., at797.Google Scholar
See Hoeyer, supra note 14, at 440–441.Google Scholar
Id., at 442.Google Scholar
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): 635649; Conley, J. O'Barr, W. Just Words: Law, Language, and Power (Chicago: University of Chicago Press, 1998).Google Scholar
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).Google Scholar
See, e.g.,Goodwin, C.Conversational Organization: Interaction between Speakers and Hearers (New York: Academic Press, 1982).Google Scholar
Shuy, R., “Discourse Analysis in the Legal Context,” in Schiffrin, Tannen, and Hamilton, supra note 41, at437452.CrossRefGoogle Scholar
Ainsworth-Vaughn, N., “The Discourse of Medical Encounters,” in Schiffrin, Tannen, and Hamilton, supra note 41, at453469.CrossRefGoogle Scholar
Fleischman, S., “Language and Medicine,” in Schiffrin, Tannen, and Hamilton, supra note 41, at 470–502.CrossRefGoogle Scholar
Hamilton, H. E., “Discourse and Aging,” in Schiffrin, Tannen, and Hamilton, supra note 41, at 568–589.CrossRefGoogle Scholar
Id., at 573.Google Scholar
Goffman, E., The Presentation of Self in Everyday Life (Garden City, NY: Doubleday, 1959).Google Scholar
Garfinkel, H., Studies in Ethnomethodology (Englewood Cliffs, NJ: Prentice-Hall, 1967).Google Scholar
Atkinson, J. M. Drew, P., Order in Court: The Organisation of Verbal Interaction in Judicial Settings (Atlantic Highlands, NJ: Humanities Press, 1979): At1822.CrossRefGoogle Scholar
See Hoyer, supra note 35, at795798 for an application of this approach to medical ethics.Google Scholar
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).(last+visited+July+10,+2012).>Google Scholar
Black's Law Dictionary, Abridged Sixth Edition (St. Paul, MN: West Publishing, 1991): At 211.Google Scholar
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.Google Scholar
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).(last+visited+June+26,+2012).>Google Scholar
See Catalona and Greenberg, supra note 55.Google Scholar
Grimes v. Kennedy Krieger Institute, 366 Md. 29, 782 A. 2d 807 (2001).Google Scholar
See Catalona, supra note 55.Google Scholar
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).Google Scholar
Dove, E. S. Joly, Y. Knoppers, B. M., “Trade-Secret Model: Legal Limitations,” Science 333, no. 6051 (2011): 1575, at 1575.CrossRefGoogle Scholar
See Hoeyer, supra note 34, and Hoeyer, supra note 35.Google Scholar
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).(last+visited+June.+25,+2012).>Google Scholar
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).(last+visited+June+25,+2012).>Google Scholar
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).(last+visited+June+26,+2012).>Google Scholar
See National Cancer Institute, supra note 56.Google Scholar
See Winickoff and Winickoff, supra note 12.Google Scholar
See Fullerton, supra note 13.Google Scholar
See Office of Human Subjects Research, National Institutes of Health, supra note 3.Google Scholar