Structuring the review of human genetics protocols: Gene localization and identification studies

IRB Ethics and Human Research

Volumn 18, Issue 4, 1996, Pages 1-9

  Glass, Kathleen Cranley ^a,b   Weijer, Charles ^c   Palmour, Roberta M ^b   Shapiro, Stanley H ^a,b   Lemmens, Trudo M ^a   Lebacqz, Karen ^a,d  

^a Clinical Trials Research Group

^b MCGILL UNIVERSITY   (Canada)

^c MEDICAL RESEARCH COUNCIL   (United Kingdom)

^d Pacific School of Religion   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL AND BEHAVIORAL RESEARCH; CONFIDENTIALITY; CONFLICT OF INTEREST; ETHICS; FAMILY; FREEDOM; GENETIC COUNSELING; GENETIC PRIVACY; GENETICS; GENETICS AND REPRODUCTION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; METHODOLOGY; MORALITY; NOMENCLATURE; PATIENT SELECTION; PEDIGREE; PERSONAL AUTONOMY; PERSONNEL; PERSUASIVE COMMUNICATION; PRACTICE GUIDELINE; PROBABILITY; PROFESSIONAL STANDARD; RESEARCH SUBJECT; REVIEW; RISK; RISK ASSESSMENT; SOCIAL BEHAVIOR; SOCIAL CHANGE; TECHNIQUE; UNCERTAINTY; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; GENETICS AND REPRODUCTION;

COERCION; CONFIDENTIALITY; CONFLICT OF INTEREST; DISCLOSURE; ETHICAL REVIEW; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FAMILY; FREEDOM; GENETIC COUNSELING; GENETIC PRIVACY; GENETIC RESEARCH; GENETICS; GUIDELINES; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; METHODS; MORAL OBLIGATIONS; PATIENT SELECTION; PEDIGREE; PERSONAL AUTONOMY; PROBABILITY; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; SOCIAL CHANGE; SOCIAL RESPONSIBILITY; TERMINOLOGY; TRUTH DISCLOSURE; UNCERTAINTY; UNITED STATES;

EID: 0030177270     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564004     Document Type: Article

References (69)

1. Levine, RJ: Ethics and Regulation of Clinical Research. 2nd ed. Baltimore: Urban and Schwarzenberg, 1986.
2. National Institutes of Health, Office for Protection from Research Risks: Protecting Human Subjects: Institutional Review Board Guidebook. Washington: U.S. Government Printing Office, 1993.
3. Gelehrter, TD, and Collins, FS: Principles of Medical Genetics. Baltimore: Williams & Wilkins, 1990.
4. Lander, ES, and Shork, NJ: Genetic dissection of complex traits. Science 1994; 265: 2037-48.
5. Rosenthal, N: DNA and the genetic code, NEJM 1994; 331: 39-41.
6. Rosenthal, N: Tools of the trade - recombinant DNA. NEJM 1994; 331: 315-17.
7. Rosenthal, N: Stalking the gene - DNA libraries. NEJM 1994; 331(9): 599-600.
8. Sutherland, G, and Richards, RI: DNA repeats - a treasury of human variation. NEJM 1994; 331: 191-93.
9. Congress of the United States, Office of Technology Assessment: Mapping Our Genes - The Genome Projects: How Big, How Fast? Washington, D.C.: U.S. Government Printing Office, 1988.
10. For a thorough discussion, see Freedman, B: Scientific value and validity as ethical requirements for research: a proposed explanation. IRB 1987; 17(6): 7-10.
11. Feinstein, AR,and Lichtenstein, JL: Medical ethics and the architecture of clinical research. In The Belmont Report, Appendix, Volume I, pp. 9-1 to 9-39. as cited in Freedman, ref. 10.
12. Levine, RJ: Personal communication. 11 June 1996.
13. See, for example, Sodal Science and Humanities Research Council of Canada (SSHRC): Ethics: Guidelines for Research With Human Sub/ects. Ottawa: SSHRC, 1992.
14. American Anthropological Association: Professional Ethics: Statements and Procedures of a the American Anthropological Association. Washington, D.C.: American Anthropological Association, 1990.
15. A recent Canadian draft document takes this approach for genetics research. See Tri-Council Working Group: Code of Conduct for Research Involving Humans, Ottawa: Medical Research Council of Canada, 1996, Article 15.1.
16. Royal Commission on Aborignal Peoples: Ethioal guidelines for research. Ottawa: RCAP. 1993, Appendix B.
17. American Indian Law Center: Model Tribal Research Code, with Materials for Tribal Regulation for Research and Checklist for Indian Health Boards. Albuquerque, N.M.: AILC: 1994.
18. Maddocks, I: Ethics in Aboriginal research: A model for minorities or for all? Medical Journal of Australia 1992; 157(8): 553-55.
19. Council for International Organizations of Medical Sciences: International Guidelines for Ethical Review of Epidemiological Studies. Geneva: CIOMS, 1991.
20. Centre for Independent Living: Independent Living and Participation in Research: A Critical Analysis (Discussion Paper). Toronto: CILT, 1989.
21. Levine, C, Dubler, NN, and Levine, RJ: Building a new consensus: Ethical principles and policies for clinical research on HIV/AIDS. IRB 1991; 13(1-2): 1-17.
22. Weijer, C: Our bodies, our science. The Sciences 1995; 35(3): 41-45.
23. Wertz, DC and Ftetcher, JC: Privacy and disclosure in medical genetics examined in an ethics of care. Bioethics 1991; 5(3): 212-32.
24. Spinsanti, S: Obtaining consent from the family: A horizon for clinical ethics. Journal of Clinical Ethics 1992; 3(3): 188-92.
25. Hardwig, J: What about the family? Hastings Center Report, 1990; 20(2): 5-10.
26. Danish Council of Ethics: Ethics and Mapping of the Human Genome. Copenhagen: The Danish Council of Ethics, 1993.
27. Hayes, CV: Genetic testing for Huntington's disease - A family issue. NEJM 1992; 327: 1449-51.
28. Appelbaum, PS, Lidz, CW, and Meisel, A. Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 1987.
29. Parker, LS, and Lidz, CW: Familial coercion to participate in genetic family studies: Is there cause for IRB intervention? IRB 1994; 16(1,2): 6-12.
30. Capron, AM: Ethical implications of studies in molecular genetics: An emerging issue. In Ethics and Research on Human Subjects: International Guidelines (Proceedings of the XXVIth CIOMS Conference, Geneva, 5-7 February 1992) ed. Bankowski, Z and Levine, R.J. Geneva: CIOMS. 1993.
31. Glass, KC, and Somerville, MA: Informed consent to medical research on persons with Alzheimer's disease: Ethical and legal parameters. In Alzheimer's Disease Research: Ethical and Legal Issues, ed. Berg, J, Karlinsky, H, and Lowy, F. Toronto: Carswell, 1991, pp. 30-59.
32. Shaw, MW: Testing for the Huntington gene: A right to know, a right not to know, or a duty to know? American Journal of Medical Genetics 1987; 26: 243-46.
33. Reilly, P: When should an investigator share raw data with the subjects? IRB 1980; 2(6): 4-5, 12.
34. Chapman, MA: Canadian experience with predictive testing for Huntington disease: Lessons for genetic testing centers and policy makers. American Journal of Medical Genetics 1992; 42(4): 491-98.
35. Collins, FS: BRCA1 - lots of mutations, fots of dilemmas. NEJM 1996; 334: 186-88.
36. Narod, S: Hereditary breast-ovarian cancer. How can we use the new DNA markers to improve patient management? Clinical and Investigative Medicine 1993; 16(4): 314-17.
37. Kodish, E, Murray, TH, and Shurin, S: Cancer risk research: What should we tell subjects? Clinical Research 1994; 42(3): 396-402.
38. Wiggins, S et al.: The psychological consequences of predictive testing for Huntington's disease. NEJM 1992; 327: 1401-5.
39. Huggins, M et al.: Predictive testing for Huntington disease in Canada: Adverse effects and unexpected results in those receiving a decreased risk. American Journal of Medical Genetics 1992; 42(4): 508-15.
40. Bloch, M et al.: Predictive testing for Huntington disease: The experience of those receiving an increased risk. American Journal of Medical Genetics 1992; 42(4): 499-507.
41. MacKay, CR: Developing a test to detect carriers of Huntington's disease. IRB 1984; 6(4): 1-5.
42. Chertkow, H et al.: Protocol for the evaluation of apolipoprotein E genotype and heme oxygenase-1 expression in subjects with memory impairment. 24 November 1994.
43. Hyman, BT, and Tanzi, R: Molecular epidemiology of Alzheimer's disease. NEJM 1995; 333: 1283-84.
44. Polvikoski, T et al.: Apolipoprotein E, dementia, and cortical deposition of beta-amyloid protein. NEJM 1995; 333: 1242-47.
45. 45 CFR 46.111(a)(1)(i).
46. Medical Research Council of Canada (MRC): Guidelines on Research Involving Human Subjects, sec. IIC: Methodology and Ethics. Ottawa: MRC. 1987.
47. Shapiro, SH, and Louis, TA, eds.: Clinical Trials: Issues and Approaches. New York: Marcel Dekker, Inc., 1983.
48. Weir, RF, and Horton, JR: DNA Banking and Informed Consent, Parts 1,2. IRB 1995; 17(4): 1-4;
49. Weir, RF, and Horton, JR: IRB (5-6): 1-8.
50. Clayton, EW et al.: Informed consent for genetic research on stored tissue samples. JAMA 1995; 274(22): 1786-92.
51. Knoppers, BM and Laberge, CM: Research and stored tissues: Persons as sources, samples as persons. JAMA 1995; 274: 1806-8.
52. Harper, P: Research samples from families with genetic diseases: a proposed code of conduct. British Medical Journal 1993; 306: 1391-94.
53. MacKay, C: Discussion points in research related to the human genome. Human Gene Therapy 1993; 4: 447-95.
54. 45 CFR 46.111(a)(7).
55. National Council on Bioethics in Human Research: Research Involving Children. Ottawa: NCBHR, 1992.
56. 45 CFR 46.111(a)(4); 45 CFR 46.408(a).
57. Keyserlingk, EW, Glass, KC, Kogan, S, and Gauthier, S: Proposed guidelines for the participation of persons with dementia as research subjects. Perspectives in Biology and Medicine 1995; 32(2): 319-62.
58. Guteil, TG, Bursztajn, HJ, Brodsky, A, and Alexander, V, eds.: Decision Making in Psychiatry and the Law. Baltimore: Williams & Wilkins, 1991.
59. 45 CFR 46.111(a)(2).
60. Freedman, B, Fuks, A, and Weijer, C: Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research. Clinical Research 1992; 40(4): 653-60.
61. 45 CFR 46.111(a)(1).
62. Wertz, D, and Fletcher, J: Communicating genetic risks. Science, Technology, and Human Values 1987; 3,4: 60-66.
63. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Screening and Counseling for Genetic Conditions. Washington, D.C.: U.S. Government Printing Office, 1983.
64. Kass, N: Participation in pedigree studies and the risk of impeded access to health insurance. IRB 1993; 15(5): 7-10.
65. Powers, M: Publication-related risks to privacy: Ethical implications of pedigree studies. IRB 1993; 15(4): 7-10.
66. 45 CFR 46.116.
67. 45 CFR 46.116(a)(8).
68. 45 CFR 46.116(b)(3).
69. Levine, RJ: Research that could yield marketable products from human materials: The problem of informed consent. IRB 1986; 16(1): 6-7.