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

Active HRPP Policies (SOPs)

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Guidance

Regulations and Ethical Guidance

• 45 CFR 46 - The Common Rule
• The Belmont Report
• Search for Federalwide Assurances
• HHS Regulations and Policies Guidance

Food and Drug Administration (FDA)

• 21 CFR 50-Informed Consent and Children
• 21 CFR 56- Institutional Review Boards
• 21 CFR 312-INDs
• 21 CFR 812- IDEs
• FDA IND Toolbox - Emergency INDs

Other Guidance Documents

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