Office for Human Subjects Protections (OHRP) Regulations & Guidance
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing 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.
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.
Categories of research that may be reviewed by the Institutional Review Board (IRB) through and Expedited review.
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.
- 'Engaged in Research', OHRP Guidance document
- Human Subjects Regulations, Decision Chart
- Information: Special Protections for Children in Research Information
- OHRP (45 CFR 46) FAQ page OHRP (45 CFR 46) FAQ page
- Research Involving Coded Private Information or Biological Specimens
- Research Use of Stored Data or Tissues Research Use of Stored Data or Tissues, OHRP
- Reviewing and Reporting unanticipated Risks to Subjects or others