NEW -  Important Information for Investigators with International Collaborations


Sponsor Agency Regulations

Department of Health and Human Services Federal Register notice of the revised Rules and Regulations effective August 25, 2011 

Non-PHS agencies that have adopted the DHHS regulations

National Science Foundation Grant Policy Manual 

Federal Regulations

Department of Health and Human Services (DHHS)/Office for Human Research Protections (OHRP)


Regulations: DHHS: 45 CFR Part 46 DHHS -- Protection of Human Subjects

Food and Drug Administration (FDA)



FDA: 21 CFR Part 50 FDA - Protection of Human Subjects​

FDA: 21 CFR Part 54 FDA - Financial Disclosure by Investigators<

FDA: 21 CFR Part 56 FDA - Institutional Review Boards

FDA: 21 CFR Part 312 FDA - Investigational New Drug Application

FDA: 21 CFR Part 812 FDA - Investigational Device Exemptions

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