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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.
001- Policy - NIH Human Research Protection Program (HRPP) Policy Development General and Structural Changes to the NIH HRPP Policies NIH IRP Human Research Protection Program (HRPP) Policy Glossary |
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. 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). How to request an archived policy: OHSRP is the official HRPP standard operating procedure (SOP) archive, these SOPs are no longer in effect and have been superseded by Manual Chapter (MC) 3014. To request a copy of an archived SOP email: irb@od.nih.gov OMA is the policy archive for the HRPP policies (MC 3014). To request a copy of a HRPP policy (MC 3014) email: PolicyManual@nih.gov Please contact Heather Bridge for any questions or concerns. |
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For more information, please visit the OHSRP Policy and Accreditation page here. |
