Untapped potential: IRB guidance for the ethical research use of stored biological materials

IRB Ethics and Human Research

Volumn 26, Issue 4, 2004, Pages 1-8

  Wolf, Leslie E ^a   Lo, Bernard ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CHILD; CONFIDENTIALITY; DONOR; DUTY TO RECONTACT; EMPIRICAL APPROACH; ETHICS; EVALUATION; GENETIC PRIVACY; GENETICS; GENETICS AND REPRODUCTION; HEALTH CARE FACILITY; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL SCHOOL; ORGANIZATION AND MANAGEMENT; POLICY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RESEARCH SUBJECT; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH; GENETICS AND REPRODUCTION;

ADULT; BIOLOGICAL SPECIMEN BANKS; CHILD; CONFIDENTIALITY; CONSENT FORMS; DATA COLLECTION; DISCLOSURE; DUTY TO RECONTACT; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; EVALUATION STUDIES; GENETIC PRIVACY; GENETIC RESEARCH; GUIDELINE ADHERENCE; GUIDELINES; HUMANS; INFORMED CONSENT; ORGANIZATIONAL POLICY; RESEARCH SUBJECTS; SCHOOLS, MEDICAL; TISSUE DONORS; UNITED STATES;

EID: 4644342620     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563696     Document Type: Review

References (94)

1. Lengauer C, Kinzler KW, Vogelstein B. Genetic instability in colorectal cancers. Nature 1997;386:623-627;
2. Haraldsdottir R, Iceland's central database of health records. Science 1999;283:487;
3. Hall JM, et al. Linkage of early onset breast cancer to chromosome 17q21. Science 1990;250:1684-1689;
4. Greely H, Iceland's plan for genomics research: Facts and implications. Jurimetrics 2000;40:153-191;
5. National Institute of Mental Health. Human Genetics Intiative, http://www.nimh.nih.gov/research/geneticsinitiative.cfm (Last accessed 6/19/2003).
6. Herbst AL, Scully RE. Adenocarcinoma of the vagina in adolescence. Cancer 1970;25:745-757;
7. Herbst AL, Ulfelder H, Poskanzer, DC. Adenocarcinoma of the vagina. NEJM 1971;284:878-881;
8. Herbst AL et al. Clear-cell adenocarcinoma of the vagina and cervix in girls: Analysis of 170 registry cases. American Journal of Obstetrics and Gynecology 1974;119:713-724.
9. Abbott A. DNA study deepens rift over Iceland's genetic heritage. Nature 2003;421:678;
10. Skloot R. Henrietta's dance. Johns Hopkins Magazine. 2000;
11. Skloot R. Cells that save lives are mother's legacy. New York Times 2001, A15;
12. National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Vol. I. Rockville, MD, 1999.
13. Wolf C, Smith G, Smith R. Science, medicine, and the future: Pharmacogenetics. BMJ 2000;320;987-990;
14. Meyer U. Pharmacogenetics and adverse drug reactions. Lancet 2000;356:1667-1671.
15. Otto MA. Informed consent: Failure to obtain consent derails bone marrow research repository. Medical Research Law & Policy 2003;2(6):206.
16. Dalton R. Tribe blasts 'exploitation' of blood samples. Nature 2003;420:111.
17. See ref. 3, NBAC 1999;
18. Kowalczyk L. $50m plan by Partners for centers on genetics. Boston Globe 2000;
19. Kaiser J. Population databases boom, from Iceland to the U.S. Science 2002;298(5596):1158.
20. 45 CFR 46.101(b)(4) (2001).
21. American College of Medical Genetics. Statement on storage and use of genetic materials. American Journal of Human Genetics 1995;57(6):1499-1500;
22. American Society of Human Genetics. Statement on informed consent for genetic research. American Journal of Human Genetics 1996;59:471-474;
23. Clayton EW, et al., Informed consent for genetic research on stored tissue samples. JAMA 1995;274(22):1786-1792;
24. Grizzle W, et al., Ad Hoc Committee on Stored Tissues. College of American Pathologists. Recommended policies for uses of human tissue in research, education, and quality control. Archives of Pathological Laboratory Medicine 1997;123(4):296-300;
25. Human Genome Organization Ethics Committee (HUGO). Statement on DNA sampling: Control and access. HUGO: London, 1998.
26. See ref. 3, NBAC 1999.
27. See ref. 3, NBAC 1999;
28. ref. 9, Clayton et al. 1995;
29. Schwartz MD, 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 2001;98:336-342;
30. NIH. National Heart, Lung, and Blood Institute (NHLBI) Report of the Special Emphasis Panel: Opportunities and Obstacles to Genetic Research in NHLBI Clinical Studies. Bethesda, MD, 1997.
31. See ref. 3, NBAC 1999;
32. ref. 9, Clayton et al. 1995,
33. Grizzle et al. 1997;
34. ref. 11, NHLBI 1997.
35. See ref. 9, American Society of Human Genetics 1996.
36. See ref. 3, NBAC 1999;
37. ref. 9, American College of Medical Genetics 1995;
38. Clayton et al. 1995;
39. ref. 11, NHLBI 1997.
40. See ref. 3, NBAC 1999.
41. See ref. 3, NBAC 1999;
42. ref. 9, Clayton et al. 1995.
43. See ref. 3, NBAC 1999;
44. ref. 9, Clayton et al. 1995;
45. Annas GJ. The limits of state laws to protect genetic information. NEJM 2001;345(5):385-8;
46. Annas GJ, Glanz LH, Roche PA. The Genetic Privacy Act and Commentary. Boston: Boston University School of Public Health, 1995;
47. Annas GJ, Glantz LH, Roche PA. Drafting the genetic privacy act: Science, policy, and practical considerations. Journal of Law and Medical Ethics 1995;23:360-366.
48. See ref. 9, Grizzle et al. 1997.
49. See ref. 3, NBAC 1997;
50. ref. 9, American College of Medical Genetics 1995, American Society of Human Genetics 1996, Clayton et al. 1995, Grizzle et al. 1997;
51. ref. 17, Annas 2001;
52. Fuller BP, et al. Privacy in genetics research. Science 1999;285(5432):1359-1361;
53. Greely H. Informed consent, stored tissue samples, and the human genome diversity project: Protecting the rights of research participants. In: Weir R ed. Stored Tissue Samples: Ethical, Legal, and Public Policy Implications. Iowa City: University of Iowa Press, 1998, p. 99-108;
54. Holtzman N, Andrews L. Ethical and legal issues in genetic epidemiology. Epidemiologic Reviews 1997;19(1):22-33;
55. Hustead J, Cunningham A, Goldman, J. Genetics and privacy: A patchwork of protections. Health Privacy Project. Institute for Health Care Research and Policy, Georgetown University: Washington D.C., 2002.
56. See ref. 3, NBAC 1999;
57. ref. 19, Hustead et al. 2002;
58. Merz JF, Sankar P. DNA banking: An empirical study of a proposed consent form. In: Weir R, ed. Stored Tissue Samples: Ethical, Legal, and Public Policy Implications. Iowa City: University of Iowa Press, 1998, p. 198-225;
59. Naser C. Researcher obligations to tissue and DNA sample sources. In: Weir R, ed. Stored Tissue Samples: Ethical, Legal, and Public Policy Implications. Iowa City: University of Iowa Press, 1998, p. 160-181;
60. Taylor H. Harris Poll. #34. New York: Louis Harris and Associates, 1995;
61. Wertz D, Society and the not-so-new genetics. Journal of Contemporary Health Law and Policy 1997;13(2):299-346.
62. See ref. 3, NBAC, 1999;
63. ref. 19, Fuller et al. 1999,
64. Holtzman 1997;
65. See ref. 20, Naser 1998.
66. See ref. 3, NBAC 1999.
67. See ref. 19, Fuller et al. 1999,
68. Holtzman 1997;
69. See ref. 20, Naser 1998.
70. See ref. 9, Clayton et al. 1995;
71. Knoppers BM, et al., Science and society: children and incompetent adults in genetic research: Consent and safeguards. Nature Review Genetics 2002;3(3):221-225.
72. See ref. 24, Knoppers et al. 2002;
73. Robertson S, Savulescu J. Is there a case in favour of predictive genetic testing in young children? Bioethics 2001;15(1):26-49;
74. Clayton EW. Removing the shadow of the law from the debate about genetic testing of children. American Journal of Medical Genetics 1995;57:630-634.
75. NIH Awards to Medical Schools by Rank - Fiscal Year 2001 (Revised April 17, 2002), Available at http://grants1.nih.gov/grants/award/rank/medttlnod.htm.
76. See ref. 3, NBAC 1999;
77. ref. 19, Greely 1998;
78. Therrell BL, et al. Guidelines for the retention, storage, and use of residual dried blood spot samples after newborn screening analysis: Statement of the Council of Regional Networks for Genetic Services. Biochemical and Molecular Medicine 1996;57(2):116-24.
79. See ref. 3, NBAC 1999;
80. ref. 9, Clayton et al. 1995;
81. ref. 20, Taylor 1995;
82. Goodson ML, Vernon BG. A study of public opinion on the use of tissue samples from living subjects for clinical research. Journal of Clinical Pathology 2004;57:135-138.
83. See ref. 3, NBAC 1999;
84. ref. 9, Clayton et al. 1995.
85. See ref. 8.
86. National Institutes of Health. Research on human specimens: Are you conducting research using human subjects?. http://www.cdp.ims.nci.nih.gov/ policy.html (Last accessed 2/5/04);
87. Office for Human Research Protections. Human Subject Regulations Decision Charts. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm (Last accessed 2/5/04).
88. 45 CFR 46.110 (2001);
89. 45 CFR 46.109 (2003);
90. 45 CFR 46.116 (2003).
91. 45 CFR 46.116(a)(8) (2001).
92. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York: Oxford University Press, 1994.
93. Institute of Medicine. Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection. Protecting Data Privacy in Health Services Research. Washington, D.C.: National Academy Press, 2000;
94. Institute of Medicine. Committee on Quality of Health Care in America. To Err Is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, 2000.