Informed Consent and Biobanks

45 CFR §46.101(b)(4).

45 CFR §46.102(f)(emphasis added).

National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Vol. 1, (Rockville, MD: National Bioethics Advisory Commission, 1999).

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).

Andrews L. B. , “My Body, My Property,” Hastings Center Report 16 (1986): 28–38; Schwartz M. N. Rothenberg K. Joseph L. , “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.

45 CFR § 164.514(a).

45 CFR § 164.514(b).

45 CFR § 164.512(i).

45 CFR § 164.514(e)(1).

45 CFR § 46.116(a).

21 CFR § 50.22.

45 CFR § 164.508(f).

45 CFR § 46.116(d).

45 CFR § 164.514 (1)(i)(2)(ii).

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).

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).

Hull S. C. Gooding H. Klein A. P. , “Genetic Research Involving Human Biological Materials: A Need to Tailor Consent Forms,” Institutional Review Board: Ethics and Human Research 26 (2004): 1–7.

McWilliams R. Hoover-Fong J. Hamosh A. , “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA 290 (2003): 360–66.

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).

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).

Grody W. W. and Sobel M. E. , “Update on Informed Consent for Stored Tissue Research,” Diagnostic Molecular Pathology 5 (1996): 79–80; McQueen M. J. , “Ethical and Legal Issues in the Procurement, Storage, and Use of DNA,” Clinical Chemistry and Laboratory Medicine 36 (1998): 545–49.

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.

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): 1–16.

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 , supra note 5

Andrews , supra note 5.

Anderlik M. R. and Rothstein M. A. , “Canavan Decision Favors Researchers Over Families,” Journal of Law, Medicine, and Ethics 31 (2003): 450–54.

Coghlan A. , “Crisis of Confidence: Britain's Body Parts Scandal Still Haunts the Health Service,” New Science 173 (2002): 14–15; 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.

Ornstein C. , “Sale of Body Parts at UCLA Alleged,” LA Times, 6 March 2004.

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).

Rothstein M. A. , “The Role of IRBs in Research Involving Commercial Biobanks,” Journal of Law, Medicine, and Ethics 30 (2002): 105–8.

National Bioethics Advisory Commission, supra note 3.

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. , “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.

Clayton E. W. Steinberg K. K. Khoury M. J. , “Informed Consent for Genetic Research on Stored Tissue Samples,” JAMA 274 (1995): 1786–92.

National Bioethics Advisory Commission, supra note 3; Greely , supra note 20.

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).

National Bioethics Advisory Commission, supra note 3.

Partridge A. H. Hackett N. Blood E. , “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.

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): 12–19; 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).

45 CFR § 164.524(a).