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Many resources are available to researchers interested in learning more about the protection of human subjects in research and the role of the IRB. Listed below are some of the source documents of interest to IRB members and researchers. Outside links will open in a new windos.
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OHRP
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The Office of Human Research Protections. As of June 2000,
the federal office now responsible for implementing the U.S.
Department of Health and Human Services regulations governing
research involving human subject, as codified in 45 CFR Part
46. Formerly know as OPRR (the Office for the Protection from
Research Risks).
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OHRP's
International Compilation |
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The 2007 International Compilation of Human Research Protections
lists the human subjects research legislation, regulations,
or guidelines for 79 countries, two confederations, and several
international organizations.
This Compilation was developed for IRBs/Ethics Committees,
researchers, funding agencies, and others who are involved
in international research. Its purpose is to help these groups
familiarize themselves with the laws, regulations, and guidelines
where the research will be conducted, to assure that those
standards are followed appropriately.
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OHRP's
IRB Guidebook |
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Hypertext version of the federal handbook Protecting Human
Research Subjects: Institutional Review Board Guidebook.
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Nuremburg
Code |
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A list of ethical principles for human research used at
the Nuremberg Military Tribunal to judge Nazi experiments.
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Declaration
of Helsinki |
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The World Medical Association Recommendations Guiding Medical
Doctors in Biomedical Research Involving Human Subjects. Adopted
by the 18th World Medical Assembly, in Helsinki, Finland,
1964 and as revised by the World Medical Assembly in Tokyo,
Japan in 1975, in Venice, Italy in 1983, in Hong Kong in 1989,
in Somerset West, Republic of South Africa in 1996, and in
Edinburgh, Scotland in 2000.
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The
Belmont Report |
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Ethical Principles and Guidelines for the Protection of
Human
Subjects of Research from The National Commission for the
Protection of Human Subjects of Biomedical and Behavioral
Research (April 18, 1979)
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45
CFR 46 |
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The Code of Federal Regulations which governs the use of
human subjects in research projects. |
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Protection
of Human Subjects in Social Behavioral Science Research
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This document from the National Institutes of Health defines
the role of the Institutional Review Board and the types of
review it conducts and also includes information on privacy
and confidentiality.
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