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HRPP Policies

During 2019 and 2020, the NIH Intramural Program (IRP) transitioned from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies. (See General and Structural Changes to the NIH HRPP Policies for more information.) These policies are applicable to NIH clinical investigators, non-NIH clinical investigators when relying upon the NIH IRB, to the Office of IRB Operations (IRBO), and to the NIH IRB when it is the Reviewing IRB. These policies also apply when the NIH IRB is acting as the Public Health Emergency Research Review Board (PHERRB) for the United States. Additional supplemental educational materials are provided below each policy link to aid investigators and research teams with the implementation of these policies.


Policy 001 - NIH Human Research Protection Program (HRPP) Policy Development

General and Structural Changes to the NIH HRPP Policies


Policy page update

The official repository for the HRPP policies is in the OMA Manual Chapter (MC) system. Manual Chapter 3014 is a chapter within the Intramural Policy Series 3000. The MC 3014 contains the HRPP policies which can be found here: https://policymanual.nih.gov/3014. In MC 3014, you will notice a slight difference in the policy numbering to reflect the MC under which the policies fall, (e.g., Policy 100, will be listed as Policy 3014-100 in the MC system). The HRPP policy glossary is also published in MC 3014 and each policy lists the defined terms in Section D with a link to the policy glossary is provided there.

OMA is the official HRPP standard operating procedure (SOP) and policy archive for the HRPP policies. To request a copy of an archived SOP or policy email a request to: PolicyManual@nih.gov.



100 Series - Institutional Authorities and Requirements


100 - NIH HRPP


101 - Organizational Structure of OHSRP


102 - Investigator Conflict of Interest and Government Royalties


103 - Education Program

Formerly Policy number 201


104 - Research-Related Subject Complaints


105 - IRB Reliance and Collaborative Research


106 - Ancillary Reviews


107 - Privacy and Confidentiality 


108 - OHSRP Quality Assurance and Quality Improvement Program 


109 - Coverage Under the NIH FWA Assurance





200 Series - IRB Authorities and Requirements


200 - IRB Scope and Authority


201 - IRB Membership and Composition


202 - Board Member Financial Conflict of Interest


203 - Support of IRB Operations


204 - Levels of IRB Review and Criteria for IRB


205 - Requirements for IRB Submissions


206 - Maintenance of Records 


207 - Public Health Emergency Research Review Board

There are Currently No Attachments





300 Series - Investigator Responsibilities










500 - FDA Requirements for Human Subjects Research and Data and Safety Monitoring










HRPP Policy Memoranda




Guidance