Human subject protections in genetic research

Genetic Testing

Volumn 8, Issue 2, 2004, Pages 209-213

  Coffey, M Justin ^a   Ross, Lainie ^b,c  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CERTIFICATION; CONFIDENTIALITY; DOCUMENTATION; ETHICS; FAMILIAL DISEASE; GENETIC ANALYSIS; GENETICS; HUMAN CLONING; INFORMED CONSENT; MEDICAL RESEARCH; PRIVACY; PROTECTION;

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

CONFIDENTIALITY; CONSENT FORMS; DATA COLLECTION; ETHICS COMMITTEES, RESEARCH; GENETIC RESEARCH; HUMANS; PERIODICALS; RESEARCH SUBJECTS;

EID: 4143069050     PISSN: 10906576     EISSN: None     Source Type: Journal    
DOI: 10.1089/gte.2004.8.209     Document Type: Article

References (27)

1. AMERICAN SOCIETY OF HUMAN GENETICS. (1996). ASHG Report: Statement on Informed Consent for Genetic Research. Am. J. Hum. Genet. 59, 471-474.
2. AMERICAN SOCIETY OF HUMAN GENETICS. (1998). Social Issues Subcommittee on Familial Disclosure. Professional disclosure of familial genetic information. Am. J. Hum. Genet. 62, 474-483.
3. ANDREWS, L.B., FULLARTON, J.E., HOLTZMAN, N.A., and MOTULSKY, A.G. (eds.) for Institute of Medicine. (1994). Assessing genetic risks: implications for health and social policy. National Academy Press, Washington, DC.
4. BAUCHNER, H., and SHARFSTEIN, J. (2001). Failure to report ethical approval in child health research: review of published papers. Br. Med. J. 323, 318-319.
5. CLAYTON, E.W. (2003). Ethical, legal and social implications of genomic medicine. N. Engl. J. Med. 349, 562-569.
6. COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970. Pub. L. No. 91-513, 3(a) 84 Stat. 1241.
7. DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) 45 CFR 46 Subpart A. (1991). Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects. Fed. Reg. 46 (January 26, 1991), 8366-8391; revised 56 (June 18, 1991), 28003-28032.
8. DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) 45 CFR 46 Subpart A. (1991). Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects. Fed. Reg. 46 (January 26, 1991), 8366-8391; revised 56 (June 18, 1991), 28003-28032.
9. EARLEY, C.L., and STRONG, L.C. (1995). Certificates of confidentiality: a valuable tool for protecting genetic data. Am. J. Hum. Genet. 57, 727-731.
10. FEDDER, R.S. (2000). To know or not to know: legal perspectives on genetic privacy and disclosure of an individual's genetic profile. J. Leg. Med. 21, 557-592.
11. HUDSON, K.L., ROTHENBERG, K.H., ANDREWS, L.B., KAHN, M.J., and COLLINS, F.S. (1995). Genetic discrimination and health insurance: an urgent need for reform. Science 270, 391-393.
12. INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS. (1993). Uniform requirements for manuscripts submitted to biomedical journals. J. Am. Med. Assn. 269, 2282-2286.
13. INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS. (2001). Uniform requirements for manuscripts submitted to biomedical journals-updated 2001. http://www.icmje.org.
14. KARLAWISH, J.H.T., HOUGHAM, G.W., STOCKING, C.B., and SACHS, G.A. (1999). What is the quality of the reporting of research ethics in publications of nursing home research? J. Am. Geriatr. Soc. 47, 76-81.
15. MYLES, P.S., and TAN, N. (2003). Reporting of ethical approval and informed consent in clinical research published in leading anesthesia journals. Anesthesiology 99, 1209-1213.
16. NATIONAL INSTITUTES OF HEALTH. (2003). Certificates of confidentiality kiosk. http://grants1.nih.gov/grants/policy/coc/?Display= Graphics.
17. Nuremberg Code, 1946, principle 1. Reprinted 1978 in Encyclopedia of Bioethics. W.T. Reich (ed.). The Free Press, New York, p. 1764.
18. PUBLIC HEALTH SERVICE ACT, §301(d), 42 U.S.C.A. §241(d). 1988. West 1991, Supp. 1999.
19. RENNIE, D., and YANK, V. (1997). Disclosure to the reader of institutional review board approval and IC. J. Am. Med. Assn. 277, 922-923.
20. RIKKERT, M., TEN HAVE, H., and HOEFNAGELS, W. (1996). IC in biomedical studies on aging: survey of four journals. Br. Med. J. 313, 1117-1120.
21. ROGGIN, K.K., CHWALS, W.J., and TRACY, T.F. (2001). Institutional review board approval for prospective experimental studies on infants and children. J. Pediatr. Surg. 36, 205-208.
22. ROTHENBERG, K., FULLER, B., ROTHSTEIN, M., DUSTER, T., ELLIS KAHN, M.J., CUNNINGHAM, R., et al. (1997). Genetic information and the workplace: legislative approaches and policy changes. Science 275, 1755-1757.
23. ROTHSTEIN, M. (ed.). (1997). Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era. Yale University Press, New Haven.
24. RUIZ-CANELA, M., MARTINEZ-GONZALEZ, M.A., GOMEZ-GRACIA, E., and FERNANDEZ-CREHUET, J. (1999). Informed consent and approval by institutional review boards in published reports on clinical trials. N. Engl. J. Med. 340, 1114-1115.
25. WEIL, E., NELSON, R.M., and ROSS, L.F. (2002). Are research ethics standards satisfied in pediatric journal publications? Pediatrics 110, 364-370.
26. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI. (1964). Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th World Medical Association (WMA) General Assembly Helsinki Finland, June, 1964.
27. nd WMA General Assembly, Edinburgh Scotland, October 2000, and the WMA General Assembly, Washington 2002.