The Office for Human Research Protections (OHRP) is the federal lead office overseeing the system that protects the rights, welfare, and well-being of subjects involved in research and helps ensure that such research is carried out in accordance with the regulations described at 45 CFR part 46 or equivalent at other agencies.
OHRP provides leadership in human subjects research by providing interpretation and guidance, developing educational programs and materials, and maintaining regulatory oversight. The OHRP focus is compliance, education, regulation, and policy setting.
Office for Human Research Protections (OHRP)
Regulations/Policies
La Oficina para la Protección de los Seres Humanos en la Investigación (OHRP En Español)
Federal Policy for the Protection of Human Rights (45 CFR 46), Subparts A, B, C, & D
Informed Consent Requirements in Emergency Research
Exempt and Expedited Categories
Expedited Categories 45 CFR 46.110, Categories #1-9
Exemption Categories 45 CFR 46.101, Categories (b)(1) thru (b)(6)
Guidance/Resources
Office for Human Research Protection Policy Guidance by topic
OHRP Compliance Activities: Common Findings and Guidance (7/10/2002) (PDF)
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
The Institutional Review Board Guidebook (IRB Guidebook - revised 1993)
Guidance on Research Involving Coded Private Information or Biological Specimens
Research with Vulnerable Populations
Research with Children
Research with Prisoners