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
100 Series - Institutional Authorities and Requirements
100 - NIH HRPP
103 - Education Program
105 - IRB Reliance
109 - FWA Coverage
800 Series - Compliance and Research Event Reporting Requirements
801 - Reporting Research Events
802 - Non-Compliance in HSR
Active HRPP Policies (SOPs)
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
Overview
Content Tools
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