Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) is the federal office overseeing the system that protects the rights, welfare, and well-being of subjects involved in research and helping to ensure that research is carried out in accordance with regulations 45 CFR part 46.

OHRP provides leadership in human subjects research by providing interpretation and guidance of regulations, and maintaining regulatory oversight.

Regulations/Policies

Review Categories

Expedited Categories 45 CFR 46.110, Categories #1-9
Exemption Categories 45 CFR 46.101, Categories (b)(1) thru (b)(6)

Guidance/Resources

OHRP Policy Guidance by Topic
OHRP Compliance Oversight Activities: Determinations of Noncompliance
Financial Relationships and Interests in Research Involving Human Subjects
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

Educational Materials

Educational Videos