Ethical issues in genetic research: Disclosure and informed consent

Nature Genetics

Volumn 15, Issue 1, 1997, Pages 16-20

  Reilly, Philip R ^a   Boshar, Mark F ^b   Holtzman, Steven H ^b  

^a UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE PREDISPOSITION; EMOTIONAL STRESS; GENE MAPPING; GENETIC RISK; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL RESEARCH; PRIORITY JOURNAL; REVIEW;

BIOMEDICAL AND BEHAVIORAL RESEARCH; CONSENT FORMS; DNA DATA BANKS; FAMILY MEMBERS; FEDERAL GOVERNMENT; GENETIC INFORMATION; GENETIC RESEARCH; GENETICS AND REPRODUCTION; GOVERNMENT REGULATION; HUMAN GENOME PROJECT; INCIDENTAL FINDINGS; OFFICE FOR PROTECTION FROM RESEARCH RISKS; PROPERTY RIGHTS; RESEARCH SUBJECTS; SOCIAL DISCRIMINATION; UNITED STATES;

ADULT; CHILD; CHROMOSOME MAPPING; CONSENT FORMS; DATABASES, NUCLEIC ACID; DISCLOSURE; ETHICS COMMITTEES, RESEARCH; ETHICS, MEDICAL; FEDERAL GOVERNMENT; GENETIC PRIVACY; GENETIC RESEARCH; GENETICS, MEDICAL; GOVERNMENT REGULATION; GUIDELINES; HUMANS; INCIDENTAL FINDINGS; INFORMED CONSENT; PREJUDICE; RESEARCH; RESEARCH SUBJECTS; TRUTH DISCLOSURE; UNITED STATES;

EID: 0031012303     PISSN: 10614036     EISSN: None     Source Type: Journal    
DOI: 10.1038/ng0197-16     Document Type: Review

References (29)

1. NIH-DOE Working Group on the Ethical, Legal, and Social Implications of Human Genome Research. Genetic information and health insurance: report of the task force on genetic information and insurance. (National Center for Human Genome Research NIH Publication No. 93-3686, 1993).
2. Andrews, L., Holtzman, A., Fullarton, J. & Motulsky, A. (eds). Assessing Genetic Risk (National Academy Press, Washington D.C., 1994).
3. House of Commons, Science and Technology Committee. Human Genetics: The Science and its Consequences (HMSO, London, 1995).
4. American Society of Human Genetics. Statement of the American Society of Human Genetics on genetic testing for breast and ovarian cancer predisposition. Am. J. Hum. Genet. 55, i-iv (1994).
5. National Action Plan on Breast Cancer. Position Paper: Heriditary Susceptibility Testing for Breast Cancer (NAPBC, Washington, D.C., 1996).
6. "The Health Insurance Portability and Accountability Act of 1996" US Public Law 104-191.
7. Hudson, K., Rothenberg, K. Andrews, L., Kahn, M. & Collins, F. Genetic discrimination and health insurance: an urgent need for reform. Science 270, 391-393 (1995).
8. U.S. Equal Employment Opportunity Commission. Directives Transmittal Number 915.002. March 14, 1995.
9. AAAS Directorate for Science and Policy Programs. Report of a Conference on Ethical and Legal Aspects of Pedigree Research. (AAAS, Washington, D.C., 1993).
10. Knoppers, B. & Laberge, C. Research and stored tissues: persons as sources, samples as persons? J. Am. Med. Assoc. 274, 1806-1807 (1995).
11. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Protecting Human Subjects (U.S. Government Printing Office, Washington D.C., 1981).
12. Health and Human Services Regulations on Protection of Human Subjects. 45 Code of Federal Regulations, 46; 46 Federal Register, 8386 (1981).
13. Health and Human Services Regulations on Protection of Human Subjects. 45 Code of Federal Regulations, 46; 46 Federal Register, 8386 (1981).
14. Bloch, M. & Hayden, M. Predictive testing for Huntington's Disease in childhood: challenges and implications. Am. J. Hum. Genet. 46, 1-4 (1990).
15. Biesecker, B. et al. Genetic counseling for families with inherited susceptibility to breast and ovarian cancer. J. Am. Med. Assoc. 269, 1970-1974 (1993).
16. NIH Office of Protection from Research Risks. in Human Genetic Research. Protecting Human Research Subjects: Institutional Review Board Guidebook. Chapter 5H. (U.S. Government Printing Office, Washington, D.C., 1993).
17. Juengst, E. The ethics of prediction: genetic risk and the physician-patient relationship. Genome Sci. Technol. 1, 21-36 (1995).
18. Blatt, R. & Weiss, J., Informed consent: participation in genetic research studies. Genet. Resour. 7, 32-36 (1993).
19. 45 Code of Federal Regulations 46.116.
20. Annas, G., Glantz, L. & Roche, P. The Genetic Privacy Act and Commentary (Health Law Department, Boston University School of Public Health, Boston, 1995).
21. Clayton, E. et al. Informed consent for genetic research on stored tissue samples. J. Am. Med. Assoc. 274, 1786-1792 (1995).
22. The American Society of Human Genetics. ASHG Report: Statement on informed consent for genetic research. Am J. Hum. Genet. 59, 471-474 (1996)
23. Oregon Stat. 659.036, 659.277 (1995).
24. New York Senate Bill 4239. Signed by Governor Pataki on August 8, 1996.
25. Moore v. Regents of the University of California 793 P. 2d 479 (1990).
26. Earley, C. & Strong, L. Certificates of confidentiality: a valuable tool for protecting genetic data. Am J. Hum. Genet. 57, 727-731 (1995).
27. The American Society of Human Genetics Board of Directors and The American College of Medical Genetics Board of Directors. Points to consider: ethical, legal and psychosocial implications of genetic testing in children and adolescents. Am. J. Hum. Genet. 57, 1233-1241 (1995).
28. 45 Code of Federal Regulations 46.408(a) (1991).
29. 45 Code of Federal Regulations 46.116(d) (1991).