NEW -  Important Information for Investigators with International Collaborations

Regulations

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)

Website: http://www.hhs.gov/ohrp/

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

Food and Drug Administration (FDA)

Website: http://www.fda.gov/

Regulations:​

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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