Hostname: page-component-78c5997874-8bhkd Total loading time: 0 Render date: 2024-11-09T05:59:58.478Z Has data issue: false hasContentIssue false
  • English
  • Français

Expanding the Ethical Analysis of Biobanks

Published online by Cambridge University Press:  01 January 2021

Mark A. Rothstein
Get access Rights & Permissions [Opens in a new window]

Extract

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 33 , Issue 1 , Spring 2005 , pp. 89 - 101
Copyright
Copyright © American Society of Law, Medicine and Ethics 2005

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

Eiseman, E. and Haga, S. B., Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples (Rockville, Md.: RAND, 1999): p. xvii.Google Scholar
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).+(last+accessed+February+1,+2005).>Google Scholar
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.Google Scholar
Id. at B-12 to B-15.Google Scholar
See Campbell, C. S., “Research on Human Tissue: Religious Perspectives,” NBAC vol. II, at C-1 to C-22.Google Scholar
See Alpert, S., “Privacy and the Analysis of Stored Tissues,” NBAC vol. II, at A-20, A-28 to A-29.Google Scholar
See Johnson, K., “By Accident, Utah is Proving an Ideal Genetic Laboratory,” N.Y. Times, July 31, 2004, at A1, col. 5.Google Scholar
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.Google Scholar
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.Google Scholar
See Collins, F. S. and Watson, J. D., “Genetic Discrimination: Time to Act,” Science 302 (2003): 745.CrossRefGoogle Scholar
See Rothstein, M. A., “Genetic Privacy and Confidentiality: Why They Are So Hard to Protect,” Journal of Law, Medicine & Ethics 26 (1998):198–203.CrossRefGoogle Scholar
Berg, J. W. et al. , Informed Consent: Legal Theory and Clinical Practice, 2d ed. (New York: Oxford University Press, 2001).Google Scholar
The Nuremberg Code (1947), available at <http://www.ushmn.org/research/doctors/NurembergCode.htm> (last accessed February 1, 2005).+(last+accessed+February+1,+2005).>Google Scholar
The rules applicable to research under the Department of Health and Human Services appear at 45 C.F.R. Part 46, subpart A.Google Scholar
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).Google Scholar
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).Google Scholar
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.Google Scholar
45 C.F.R. § 46.102(f).Google Scholar
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).+(last+accessed+February+1,+2005).>Google Scholar
For a further discussion, see Clayton, E. W., “Informed Consent and Biobanks,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 15–21.CrossRefGoogle Scholar
45 C.F.R. §164.514(e).Google Scholar
OHRP, supra note 19.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
Clayton, E. W., supra note 20.Google Scholar
45 C.F.R. Parts 160, 164.Google Scholar
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).+(last+accessed+February+1,+2005).>Google Scholar
Research Repositories, Databases, and the HIPAA Privacy Rule, at <http://privacyruleandresearch.nih.gov/research_repositories.asp> (last accessed February 1, 2005).+(last+accessed+February+1,+2005).>Google Scholar
Id.Google Scholar
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.Google Scholar
45 C.F.R. § 164.508(c).Google Scholar
45 C.F.R. § 164.508(c)(1)(v).Google Scholar
45 C.F.R. § 164.528(a)(iv).Google Scholar
See supra note 23.Google Scholar
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).+(last+accessed+February+1,+2005).>Google Scholar
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.Google Scholar
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).CrossRefGoogle Scholar
Knoppers, B. M., “Biobanking: International Norms,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 7–14.CrossRefGoogle Scholar
See Merz, J. et al. , “Use of Human Tissues in Research: Clarifying Clinician and Researcher Roles and Information Flows,” Journal of Investigative Medicine 45 (1997): 252–257.Google Scholar
Winickoff, D. E. and Winickoff, R. N., “The Charitable Trust as a Model for Genomic Biobanks,” New Eng. J. Med. 349 (2003): 1180–1184.CrossRefGoogle Scholar
Of course, to the extent that medical research advances the state of the art, then patients and the public also benefit.Google Scholar
Partridge, A. H. and Winer, E. P., “Informing Clinical Trial Participants About Study Results,” JAMA 288 (2002): 363–365.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Beskow, L. M. et al. , “Informed Consent for Population-Based Research Involving Genetics,” JAMA 286 (2001): 2315–2321.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
See, e.g., Cahill, L. S., “Genetics, Commodification, and Social Justice in the Globalization Era,” Kennedy Institute of Ethics Journal 11 (2001): 221–238.CrossRefGoogle Scholar
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.Google Scholar
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).+(last+visited+February+1,+2005).>Google Scholar
See, e.g., Foster, M. W. et al. , “A Model Agreement for Genetic Research in Socially Identifiable Populations,” American Journal of Human Genetics 63 (1998): 696–702.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Andrews, L. B., “Harnessing the Benefits of Biobanks,” Journal of Law, Medicine & Ethics 33, no 1 (2005): 22–30.CrossRefGoogle Scholar
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).+(last+visited+February+1,+2005).>Google Scholar
See Andrews, supra note 52, at 30, n. 47.CrossRefGoogle Scholar
Greenberg v. Miami Children's Hosp., 264 F.Supp.2d 1064 (S.D. Fla. 2003).Google Scholar
Moore v. Regents of the Univ. of Cal, 793 P.2d 479 (Cal. 1990).Google Scholar
Greenberg v. Miami Children's Hosp., 264 F.Supp.2d 1064 (S.D. Fla. 2003).Google Scholar
Deschênes, M. and Sallée, C., “Accountability in Population Biobanking: Comparative Approaches,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 40–53.CrossRefGoogle Scholar
Williams, and Schroeder, , supra note 46.Google Scholar
Id. at 98 (emphasis in original).Google Scholar
See Rothstein, M. A., “The Role of IRBs in Research Involving Commercial Biobanks,” Journal of Law, Medicine & Ethics 30, no. 1(2002): 105–108.CrossRefGoogle Scholar
See Knoppers, B. M. et al. , “Commercialization of Genetic Research and Public Policy,” Science 285 (1999): 2277–2278.CrossRefGoogle Scholar
Malinowski, M. J., “Technology Transfer in Biobanking: Credits, Debits, and Population Health Futures,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 54–69.CrossRefGoogle Scholar
See Symposium, “Conflicts of Interest in Clinical Research,” Widener Law Journal 8 (2001).Google Scholar
See Winickoff, D. E., “Governing Population Genomics: Law, Bioethics, and Biopolitics in Three Case Studies,” Jurimetrics Journal 43 (2003): 187–228.Google Scholar
Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990).Google Scholar
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.Google Scholar
Greenberg v. Miami Children's Hosp., 264 F. Supp. 1064 (S.D. Fla. 2003).Google Scholar
For a description of the background of this pending case, see Dalton, R., “When Two Tribes Go to War,” Nature 430 (2004): 500–502.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Janger, E. J., “Genetic Information, Privacy and Insolvency,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 79–88.CrossRefGoogle Scholar