Responsible Conduct of Research

By Adil E. Shamoo; David B. Resnik | Go to book overview

Appendix 2
Resources

CODES AND REGULATIONS

Code of Federal Regulations

21 CFR 50. 1997. Food and Drug Administration: Protection of Human Subjects.

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: Additional Protections Relating to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization.

45 CFR 46, part C. 1991. Department of Health and Human Services: Additional Protections Pertaining to Biomedical and Behavioral Research Involving 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. Declaration 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

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