Expanding the Ethical Analysis of Biobanks

Eiseman E. and Haga S. B. , Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples (Rockville, Md.: RAND, 1999): p. xvii.

De Code Genetics, using a database of donated samples, has announced preliminary advances in discovering the genetics of cardiovascular disease, schizophrenia, osteoporosis, and other disorders. See <www.decode.com> (last accessed February 1, 2005).

See Buchanan A. , “An Ethical Framework for Biological Samples Policy,” in National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance [hereinafter cited asNBAC] vol. II, (Rockville, MD: U.S. Gov't Printing Office: 2000): At B-6 to B-12.

Id. at B-12 to B-15.

See Campbell C. S. , “Research on Human Tissue: Religious Perspectives,” NBAC vol. II, at C-1 to C-22.

See Alpert S. , “Privacy and the Analysis of Stored Tissues,” NBAC vol. II, at A-20, A-28 to A-29.

See Johnson K. , “By Accident, Utah is Proving an Ideal Genetic Laboratory,” N.Y. Times, July 31, 2004, at A1, col. 5.

See, e.g., Hall M. A. , “Legal Rules and Industry Norms: The Impact of Laws Restricting Health Insurers' Use of Genetic Information,” Jurimetrics Journal 40 (1999): 93–122.

In a nationwide interview survey of 2108 individuals, 83.1% said they were concerned about genetic discrimination. Rothstein M. A. and Hornung C. A. , “Public Attitudes,” in Genetics and Life Insurance: Medical Underwriting and Social Policy (Cambridge, MA: MIT Press, 2004). In a survey of genetic counselors, patients' concerns about genetic discrimination were overshadowed by psychological and other concerns. See Hall M. A. and Rich S. S. , “Genetic Privacy Laws and Patients' Fear of Discrimination by Health Insurers: The View From Genetic Counselors,” Journal of Law, Medicine & Ethics 28 (2000): 245–257.

See Collins F. S. and Watson J. D. , “Genetic Discrimination: Time to Act,” Science 302 (2003): 745.

See Rothstein M. A. , “Genetic Privacy and Confidentiality: Why They Are So Hard to Protect,” Journal of Law, Medicine & Ethics 26 (1998):198–203.

Berg J. W. , Informed Consent: Legal Theory and Clinical Practice, 2d ed. (New York: Oxford University Press, 2001).

The Nuremberg Code (1947), available at <http://www.ushmn.org/research/doctors/NurembergCode.htm> (last accessed February 1, 2005).

The rules applicable to research under the Department of Health and Human Services appear at 45 C.F.R. Part 46, subpart A.

There is some evidence that these broader issues related to research are being considered by researchers, IRBs, research sponsors, and regulators. See generally, Kahn J. P. Mastroianni A. C. , and Sugarman J. , eds., Beyond Consent: Seeking Justice in Research (New York: Oxford University Press, 1998).

See Weir R. F. and Olick R. S. , The Stored Tissue Issue: Biomedical Research, Ethics and Law in the Era of Genomic Medicine (New York: Oxford University Press, 2004); Caulfield T. Upshur R. E. G. , and Daar A. , “DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model,” BMC Medical Ethics 4 (2003): 1, available at <http://www.biomedcentral.com/1472-6939/4/1> (last visited February 1, 2005).

See Lowrance W. W. , “Learning from Experience: Privacy and the Secondary Use of Data in Health Research,” Journal of Biolaw and Business 6 (2003): 30–60, 44.

45 C.F.R. § 46.102(f).

Office for Human Research Protections, Department of Health and Human Services, Guidance on Research Involving Coded Private Information or Biological Specimens (August 10, 2004), available at <www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf> (last accessed February 1, 2005).

For a further discussion, see Clayton E. W. , “Informed Consent and Biobanks,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 15–21.

45 C.F.R. §164.514(e).

OHRP, supra note 19.

Unfortunately, allowing research subjects to treat research on mental illness, HIV/AIDS, and other sensitive conditions separately may lead to reinforcing the stigma of the conditions, but efforts to reduce stigma should be directed elsewhere and should not trump the autonomy of research subjects.

Another way of structuring a “menu” would be to focus on the outcome of the research, such as research that could result in prenatal testing and research on behavioral traits.

National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. 1 (Rockville, MD: U.S. Gov't Printing Office, 1999): at 64–66. See also Greely H. T. , “Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information,” Wake Forest Law Review 34 (1999): 737–66. The menu approach would require the use of information technology capable of tracking restrictions on the use of donated samples.

Clayton E. W. , supra note 20.

45 C.F.R. Parts 160, 164.

See Letter from Lumpkin John R. , Chair of the National Committee on Vital and Health Statistics to Tommy G. Thompson, Secretary of Health and Human Services, March 5, 2004, at <http://www.ncvhs.hhs.gov> (last accessed February 1, 2005).

Research Repositories, Databases, and the HIPAA Privacy Rule, at <http://privacyruleandresearch.nih.gov/research_repositories.asp> (last accessed February 1, 2005).

It is easy to imagine a situation in which a cancer patient consents to donate his or her surgically excised tumor to a biobank on the express condition that neither the biobank nor any researcher associated with the biobank will ever contact the individual again. Because current HIPAA rules would require additional authorizations for each research protocol, the biobank would have to violate the individual's express wishes or discard the sample.

45 C.F.R. § 164.508(c).

45 C.F.R. § 164.508(c)(1)(v).

45 C.F.R. § 164.528(a)(iv).

See supra note 23.

Biobank UK, Protocol for the UK Biobank: A Study of Genes, Environment and Health, available at <http//www.ukbiobank.ac.uk/documents/draft_protocol.pdf> (last accessed February 1, 2005).

For a discussion of several studies dealing with public opinion about informed consent for research, see Weir and Olick , supra note 16, at 26–31.

See Rothstein M. A. and Hornung C. A. , “Public Attitudes About Pharmacogenomics,” in Pharmacogenomics: Social, Ethical, and Clinical Dimensions, Rothstein M. A. , ed., (Hoboken, NJ: Wiley-Liss, 2003).

Knoppers B. M. , “Biobanking: International Norms,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 7–14.

See Merz J. , “Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows,” Journal of Investigative Medicine 45 (1997): 252–257.

Winickoff D. E. and Winickoff R. N. , “The Charitable Trust as a Model for Genomic Biobanks,” New Eng. J. Med. 349 (2003): 1180–1184.

Of course, to the extent that medical research advances the state of the art, then patients and the public also benefit.

Partridge A. H. and Winer E. P. , “Informing Clinical Trial Participants About Study Results,” JAMA 288 (2002): 363–365.

See Fernandez C. V. Skedgel C. , and Weijer C. , “Considerations and Costs of Disclosing Study Findings to Research Participants,” Canadian Medical Association Journal 170 (2004): 1417–1419.

Beskow L. M. , “Informed Consent for Population-Based Research Involving Genetics,” JAMA 286 (2001): 2315–2321.

See Austin M. A. Harding S. E. , and McElroy C. E. , “Monitoring Ethical, Legal, and Social Issues in Developing Population Genetics,” Genetics in Medicine 5 (2003): 451–457, 453; Williams G. and Schroeder D. , “Human Genetic Banking: Altruism, Benefit & Consent,” New Genetics and Society 23 (2004): 89–103, 93.

See, e.g., Cahill L. S. , “Genetics, Commodification, and Social Justice in the Globalization Era,” Kennedy Institute of Ethics Journal 11 (2001): 221–238.

See Greely H. T. , “The Control of Genetic Research: Involving the ‘Groups Between”’ Houston Law Review 33 (1997): 1397–1430; Khan Z. Q. , “Colonialism Revisited: Insights into the Human Genome Diversity Project,” Journal of Law & Social Challenges 3 (1999): 89–115.

See NIH News Advisory, Background on Ethical and Sampling Issues Raised by the International HapMap Project, available at <http://genome.gov/page.efm?pageID=10005337> (last visited February 1, 2005).

See, e.g., Foster M. W. , “A Model Agreement for Genetic Research in Socially Identifiable Populations,” American Journal of Human Genetics 63 (1998): 696–702.

See Anderlik M. R. and Rothstein M. A. , “Canavan Decision Favors Researchers Over Families,” Journal of Law, Medicine & Ethics 31, no. 3 (2003): 450–454.

Andrews L. B. , “Harnessing the Benefits of Biobanks,” Journal of Law, Medicine & Ethics 33, no 1 (2005): 22–30.

HUGO Ethical, Legal, and Social Issues Committee Report to HUGO Council, Statement on the Principled Conduct of Genetics Research, Recommendation 9, March 21, 1996, at <http://www.gene.ucl.ac.uk/hugo/conduct.htm> (last visited February 1, 2005).

See Andrews, supra note 52, at 30, n. 47.

Greenberg v. Miami Children's Hosp., 264 F.Supp.2d 1064 (S.D. Fla. 2003).

Moore v. Regents of the Univ. of Cal, 793 P.2d 479 (Cal. 1990).

Greenberg v. Miami Children's Hosp., 264 F.Supp.2d 1064 (S.D. Fla. 2003).

Deschênes M. and Sallée C. , “Accountability in Population Biobanking: Comparative Approaches,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 40–53.

Williams and Schroeder , supra note 46.

Id. at 98 (emphasis in original).

See Rothstein M. A. , “The Role of IRBs in Research Involving Commercial Biobanks,” Journal of Law, Medicine & Ethics 30, no. 1(2002): 105–108.

See Knoppers B. M. , “Commercialization of Genetic Research and Public Policy,” Science 285 (1999): 2277–2278.

Malinowski M. J. , “Technology Transfer in Biobanking: Credits, Debits, and Population Health Futures,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 54–69.

See Symposium, “Conflicts of Interest in Clinical Research,” Widener Law Journal 8 (2001).

See Winickoff D. E. , “Governing Population Genomics: Law, Bioethics, and Biopolitics in Three Case Studies,” Jurimetrics Journal 43 (2003): 187–228.

Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990).

In 1951, Henrietta Lacks died of ovarian cancer, and without her knowledge or consent her tissue was made into a cell line that has been used by researchers for over 50 years. See Washington H. A. , “Henrietta Lacks – An Unsung Hero,” Emerge, Oct. 1994, at 29.

Greenberg v. Miami Children's Hosp., 264 F. Supp. 1064 (S.D. Fla. 2003).

For a description of the background of this pending case, see Dalton R. , “When Two Tribes Go to War,” Nature 430 (2004): 500–502.

Palmer L. I. , “Should Liability Play a Role in the Social Control of Biobanks?” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 70–78.

Janger E. J. , “Genetic Information, Privacy and Insolvency,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 79–88.