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
- Federal Regulations for the Protection of Human Subjects
- Informed Consent Requirements
- Informed Consent Requirements in Emergency Research
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