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Appendix 2
Resources

CODES AND REGULATIONS

Code of Federal Regulations

21 CFR 50. 1997. Food and Drug Administration: Protection of Human Sub-
jects.

21 CFR 54. Food and Drug Administration: Financial Disclosure by Clinical
Investigators.

21 CFR 56. 1996. Food and Drug Administration: Institutional Review
Boards.

45 CFR 46, part A. 1991. Department of Health and Human Services: Basic
Policy for Protection of Human Research Subjects.

45 CFR 46, part B. 1991. Department of Health and Human Services: Addi-
tional Protections Relating to Research, Development, and Related Activ-
ities Involving Fetuses, Pregnant Women, and Human In Vitro Fertiliza-
tion.

45 CFR 46, part C. 1991. Department of Health and Human Services: Addi-
tional Protections Pertaining to Biomedical and Behavioral Research In-
volving Prisoners as Subjects.

45 Code of Federal Regulations 46, part D. 1991. Department of Health and
Human Services: Additional Protections for Children Involved as Subjects
in Research.


Federal Register

56 Federal Register 28012. 1991. The Common Rule.

59 Federal Register 14508. 1994. NIH Guidelines on the Inclusion of Women
and Minorities in Research.

60 Federal Register 35810. 1995. Objectivity in Research.


Medical Associations

Council of the International Organization of Medical Sciences (CIOMS).
1993. International Ethical Guidelines for Biomedical Research Involving
Human Subjects. Geneva: CIOMS.

World Medical Association (WMA). 1964, 1975, 1983, 1989, 1996, 2000. De-
claration of Helsinki: Recommendations Guiding Physicians in Biomedical
Research Involving Human Subjects. Ferney-Voltaire Cedex, France:
WMA.


Books and Articles

Association of Academic Health Centers (AAHC). 1994. Conflicts of Interest
in Institutional Decision-Making. Washington, DC: AAHC.
Cape, R. 1984. Academic and Corporate Values and Goals: Are They Really

-312-

Questia, a part of Gale, Cengage Learning. www.questia.com

Publication Information: Book Title: Responsible Conduct of Research. Contributors: Adil E. Shamoo - author, David B. Resnik - author. Publisher: Oxford University Press. Place of Publication: New York. Publication Year: 2003. Page Number: 312.
    
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