OHRP Guidance

OHRP Guidance

Office for Human Subjects Protections (OHRP) Regulations & Guidance

Click on the following link for the Office for Human Research Protections (OHRP) webpage

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

Code of Federal Regulations - 45 CFR 46

45 CFR 46 consists of Sub-parts A, B, C and D. Sub part A is also known as the "Common Rule".

The text of this Rule was agreed upon by seventeen government agencies and published in the Federal Register on June 18, 1991.

Expedited Categories of Research
Categories of research that may be reviewed by the Institutional Review Board (IRB) through Expedited review procedures.
OHRP Guidance by Topic

OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations. These include guidance documents and frequently asked questions (FAQs) addressing various topics, findings in the form of OHRP letters addressing regulatory issues, and other media including decision tree graphics and educational videos.   

Policies and Guidance webpage

OHRP Commonly Used Links