About Us

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects who participate in research. The Office of IRB Operations (IRBO) manages the NIH Institutional Review Board (IRB), which meets four times per week to review research submissions for ethical and regulatory considerations.

Our key responsibilities include:

• Determining whether an activity constitutes human subjects research (HSR)
• Determining whether human subjects research activities are exempt from IRB review
• Performing limited IRB review
• Determining whether NIH, through its staff, is engaged in HSR
• Supporting high-quality, compliant research pre-review of protocols
• Staffing NIH IRB convened meetings
• Communicating IRB determinations to investigators 

The Office of Compliance and Training oversees the review and management of Reportable Events in the IRP during the conduct of the study. We provide information on event reporting and completing Reportable New Information (RNI) forms in PROTECT. 

Our key responsibilities include: 

• Managing tasks for the Research Compliance Review Committee (RCRC), an NIH IRB reviewing potential noncompliance events 
• Reporting IRB determinations—like unanticipated problems, noncompliance, or research suspensions/terminations—to the HHS Office for Human Research Protections (OHRP) and the FDA 
• Conducting noncompliance investigations 
• Performing QA/QI reviews of NIH IRB activities 
• Addressing training-related inquiries for NIH IRB investigators 
• Developing educational materials and coordinating/delivering the OHSRP Education Series and NIH Investigator Seminar Series to the research community 

The Office of Policy and Accreditation is responsible for establishing and maintaining HRPP policies and educational materials and ensuring accreditation of the NIH IRP HRPP by AAHRPP.

Our key responsibilities include:

• Establishing Human Research Protection Program (HRPP) policy for the IRP, maintaining the HRPP Policy Glossary, and developing educational materials.
  • The HRPP policies are part of the OMA policy System (Manual Chapter 3014 - NIH Intramural Human Research Protection Program) and can be found by clicking on the HRPP policy title below along with the educational materials about the policy series.
• Maintaining accreditation of the NIH IRP HRPP. NIH is accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP), showing our commitment to quality and excellence in protecting research participants.