Federal and State Regulations & Guidance Materials for Human Subjects Research and Institutional Review Board (IRB)
- (“The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.”)
- – Federal Policy for the Protection of Human Subjects
Office for Human Research Protections (OHRP)
- – Federal Regulations for the Protection of Human Subject – applies to ALL human subjects studies
National Institutes of Health (NIH)
- : Frequently asked questions (FAQs) regarding the NIH Education Requirement
- Special Topics:
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National Science Foundation (NSF)
- – NSF Policy for human subjects research (HSR)
- – NSF interpretation of Common Rule and Behavioral and Social Science Research
Food and Drug Administration (FDA)
Studies using investigational drugs, devices or biologics
- – FDA Regulations for Protection of Human Subjects
- – FDA Regulations for Institutional Review Boards