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Informed Consent and Biobanks

Published online by Cambridge University Press:  01 January 2021

Extract

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2005

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References

45 CFR §46.101(b)(4).Google Scholar
45 CFR §46.102(f)(emphasis added).Google Scholar
National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Vol. 1, (Rockville, MD: National Bioethics Advisory Commission, 1999).Google Scholar
Office for Human Research Protections (OHRP), and Department of Health and Human Services (HHS), Guidance on Research Involving Coded Private Information or Biological Specimens, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf> (last visited January 4, 2005).+(last+visited+January+4,+2005).>Google Scholar
Andrews, L. B., “My Body, My Property,” Hastings Center Report 16 (1986): 2838; Schwartz, M. N. Rothenberg, K. Joseph, L. et al. , “Consent to the Use of Stored DNA for Genetics Research: A Survey of Attitudes in the Jewish Population,” American Journal of Medical Genetics 98 (2001): 336–42.CrossRefGoogle Scholar
45 CFR § 164.514(a).Google Scholar
45 CFR § 164.514(b).Google Scholar
45 CFR § 164.512(i).Google Scholar
45 CFR § 164.514(e)(1).Google Scholar
45 CFR § 46.116(a).Google Scholar
21 CFR § 50.22.Google Scholar
45 CFR § 164.508(f).Google Scholar
45 CFR § 46.116(d).Google Scholar
45 CFR § 164.514 (1)(i)(2)(ii).Google Scholar
National Conference of State Legislatures, State Genetic Privacy Laws, available at <http://www.ncsl.org/programs/health/genetics/prt.htm> (last visited January 4, 2005); Health Privacy Project, Health Privacy Project 2004, available at <http://www.healthprivacy.org> (last visited June 8, 2004).+(last+visited+January+4,+2005);+Health+Privacy+Project,+Health+Privacy+Project+2004,+available+at++(last+visited+June+8,+2004).>Google Scholar
Colo. Rev. Stat. Ann. § 25-1-1201 (2004); Mass. Gen. L. Ann. Ch. 111, § 70G (2004); New Mex. Stat. Ann. § 24-21-3(C)(8&9) (2004); New York Civil Rts. L. § 79–1 (2004); N. Car. Gen. Stat. Ann. § 143–518 (2004); Ore. Rev. Stat. §§ 192.531–549 (2004); Utah Stat. § 63-2-202(8) (2004).Google Scholar
Hull, S. C. Gooding, H. Klein, A. P. et al. , “Genetic Research Involving Human Biological Materials: A Need to Tailor Consent Forms,” Institutional Review Board: Ethics and Human Research 26 (2004): 17.Google Scholar
McWilliams, R. Hoover-Fong, J. Hamosh, A. et al. , “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA 290 (2003): 360–66.CrossRefGoogle Scholar
National Institutes of Health, Research Repositories, Databases, and the HIPAA Privacy Rule, available at <http://privacyruleandresearch.nih.gov/research_repositories.asp> (last visited January 11, 2005).+(last+visited+January+11,+2005).>Google Scholar
Ehringhaus, S. H., AAMC Project to Document the Effects of HIPAA on Research, available at <http://www.aamc.org/advocacy/library/research/testimony/2004/033004.pdf> (last visited January 11, 2005).+(last+visited+January+11,+2005).>Google Scholar
Grody, W. W. and Sobel, M. E., “Update on Informed Consent for Stored Tissue Research,” Diagnostic Molecular Pathology 5 (1996): 7980; McQueen, M. J., “Ethical and Legal Issues in the Procurement, Storage, and Use of DNA,” Clinical Chemistry and Laboratory Medicine 36 (1998): 545–49.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 (1999): 737–66.Google Scholar
White, M. T. and Gamm, J., “Informed Consent for Research on Stored Blood and Tissue Samples: A Survey of Institutional Review Board Practices,” Accountability in Research 9 (2002): 116.CrossRefGoogle Scholar
Goodson, M. L. and Vernon, B. G., “A Study of Public Opinion on the Use of Tissue Samples From Living Subjects for Clinical Research,” Journal of Clinical Pathology 57 (2004): 135–38; Andrews, , supra note 5; Schwartz, et al. , supra note 5CrossRefGoogle Scholar
Andrews, , supra note 5.Google Scholar
Anderlik, M. R. and Rothstein, M. A., “Canavan Decision Favors Researchers Over Families,” Journal of Law, Medicine, and Ethics 31 (2003): 450–54.CrossRefGoogle Scholar
Coghlan, A., “Crisis of Confidence: Britain's Body Parts Scandal Still Haunts the Health Service,” New Science 173 (2002): 1415; Mayor, S., “Inquiry Finds Brains Were Removed Without Consent,” British Medical Journal 326 (2003): 1051; Mason, K. and Laurie, G., “Consent or Property? Dealing with the Body and its Parts in the Shadow of Briston and Alder Hey,” Modern Law Review 64 (2001): 710–29.Google Scholar
Ornstein, C., “Sale of Body Parts at UCLA Alleged,” LA Times, 6 March 2004.Google Scholar
Lumpkin, J. R., Letter to Secretary Thompson — Recommendations on the Effect of the Privacy Rule from the National Committee on Vital and Health Statistics, available at <http://www.hipaadvisory.com/news/newsarchives/2001/1121ncvhs.htm> (last visited January 11, 2005).+(last+visited+January+11,+2005).>Google Scholar
Rothstein, M. A., “The Role of IRBs in Research Involving Commercial Biobanks,” Journal of Law, Medicine, and Ethics 30 (2002): 105–8.CrossRefGoogle Scholar
National Bioethics Advisory Commission, supra note 3.Google Scholar
National Action Plan for Breast Cancer, Consent Form for Use of Tissue for Research, available at <http://www.4woman.gov/napbc/catalog/wci/napbc/consent.htm> (last visited January 11, 2005); Knoppers, B. M. and Laberge, C., “DNA Sampling and Informed Consent,” Canadian Medical Association Journal 140 (1989): 1023–28; Knoppers, B. M. Hirtle, M. Lormeau, S. et al. , “Control of DNA Samples and Information,” Genomics 50 (1998): 385–401; Weir, R. F. and Horton, J. R., “DNA Banking and Informed Consent — Part 1,” Institutional Review Board 17 (1995): 1–4.Google Scholar
Clayton, E. W. Steinberg, K. K. Khoury, M. J. et al. , “Informed Consent for Genetic Research on Stored Tissue Samples,” JAMA 274 (1995): 1786–92.CrossRefGoogle Scholar
National Bioethics Advisory Commission, supra note 3; Greely, , supra note 20.Google Scholar
Committee on Human Subjects Research, UCSF, Laboratory Test Results: CLIA Compliance 2003, available at <http://www.research.ucsf.edu/chr/Guide/chrCLIA.asp> (last visited January 4, 2005).+(last+visited+January+4,+2005).>Google Scholar
National Bioethics Advisory Commission, supra note 3.Google Scholar
Partridge, A. H. Hackett, N. Blood, E. et al. , “Oncology Physician and Nurse Practices and Attitudes Regarding Offering Clinical Trial Results to Study Participants,” Journal of the National Cancer Institute 96 (2004): 629–32.CrossRefGoogle Scholar
Committee on Human Subjects Research, supra note 33; Fernandez, C. V. Kodish, E., and Weijer, C., “Informing Study Participants of Research Results: An Ethical Imperative,” Institutional Review Board 25 (2003): 1219; Fernandez, C. V. Skedgel, C., and Weijer, C., “Considerations and Costs of Disclosing Study Findings to Research Patients,” Canadian Medical Association Journal 170 (2004): 1417–19; Veatch, R. M., A Theory of Medical Ethics (New York: Basic Books, 1981).Google Scholar
45 CFR § 164.524(a).Google Scholar