Federal and State Guidelines

	Department of Health and Human Services (DHHS)
	Code of Federal Regulations (45 CFR § 46)
	Office for Human Research Protection (OHRP)
	OHRP International Compilation of Human Subject Protections
	National Institutes of Health (NIH)
	NIH Public Access Policy
	Food and Drug Administration (FDA)
	FDA Regulations for Drugs and Devices FDA Regulations on the Protection of Human Subjects (21 CFR § 50) FDA Regulations for Institutional Review Boards (21 CFR § 56) FDA Information Sheet Guidance for IRBs, Investigators and Sponsors

Additional Information
CHS Policies and Procedures
Harvard University Guidelines

Updated: 17-Jun-2008

Office for Research Subject Protection
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For questions or comments about this website, please email: orsp@hms.harvard.edu