ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects

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Policies, Reports, and Policy Statements
Directives for Human Experimentation: Nuremberg Code. 1949. (Link)
World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, Helsinki, Finland: World Medical Association, 1964, 2002. (Link)
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Washington, DC: DHHS, 1979. (Link)
United States. Congress, 99th Congress. Health Research Extension Act of 1985, PL 99-158, 1985. (Link)
National Institutes of Health. Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health, 1995. (Link)
———. Required Education in the Protection of Human Research Participants, National Institutes of Health, 2000. (Link)
Federal Policy for the Protection of Human Subjects, 45 CFR 46, Subpart A (2001). (Link)
General Information Web Sites
Food and Drug Administration. Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators, 1998. (Link)
National Institutes of Health. Standards for Clinical Research within the NIH Intramural Research Program, 2000. (Link)
National Institutes of Health. Bioethics Resources on the Web, 2003. (Link)
———. IRB Review Standards, OHSR Infosheets, Forms, Etc., nd. (Link)
National Institutes of Health, Office of Human Subjects Research. Home Page, nd. (Link)
Office for Human Research Protections, HHS. Home Page, 2003. (Link)
Additional Reading
Eckstein, S, King’s College (University of London). Centre of Medical Law and Ethics. Manual for Research Ethics Committees, 6th ed. Cambridge, UK; New York: Cambridge University Press, 2003.
Federman, DD, Hanna, KE, Rodriguez, LL. Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Participants. Responsible Research: A Systems Approach to Protecting Research Participants, Washington, D.C.: National Academies Press, 2002.
Gallin, JI. Principles and Practice of Clinical Research, San Diego, CA: Academic Press, 2002.
Jensen, E. Not Just Another GCP Handbook: A Practical Guide to FDA/DHHS Requirements, New York, NY: PJB Publications Ltd., 2003. (Link)
Loue, S. Textbook of Research Ethics: Theory and Practice, New York, N.Y.: Kluwer Academic/Plenum Pub. Corp., 2000.
Penslar, RL, National Institutes of Health (U.S.). Office for Protection from Research Risks. Protecting Human Research Subjects: Institutional Review Board Guidebook, 2nd ed. Bethesda, MD; Washington, DC: GPO, 1993.
Shamoo, AE, Khin-Maung-Gyi, FA. Ethics of the Use of Human Subjects in Research: Practical Guide, London; New York: Garland Science, 2002.

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