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.
General and Structural Changes to the NIH HRPP Policies
100 Series
Institutional Authorities and Requirements
There are Currently No Attachments
300 Series
Investigator Responsibilities
There are Currently No Attachments
800 Series
Compliance and Research Event Reporting Requirements
There are Currently No Attachments
Active HRPP Policies (SOPs)
There are Currently No Attachments
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
Overview
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