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Policies & Guidance

During 2019 and 2020, NIH is transitioning from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies. These policies are applicable to NIH clinical investigators, non-NIH clinical investigators when relying upon the NIH IRB, to NIH IRB operations, 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. These pages contain the currently implemented policies of the NIH Intramural Research Program. Also contained within these pages are supplemental guidelines and tools to aid investigators and research teams with the implementation of these policies.

Policies

The NIH Human Research Protection Program (HRPP) Policies are under development. The implemented policies appear below under policy groupings organized by topic. Upon implementation the remaining policies will appear below in under the topic groupings. Until the policies are implemented, the HRPP Standard Operating Procedures (SOPs) remain in effect. Please view the overview of General and Structural Changes to the NIH HRPP Policies if you are so inclined.

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. Note that we are in the process of replacing the policy PDFs with links to the published policies within MC 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). The HRPP policy glossary is also published in MC 3014 and each policy lists the defined terms in Section D and a link to the policy glossary is provided there.