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
100 Series - Institutional Authorities and Requirements
100 - NIH HRPP
There are Currently No Attachments
103 - Education Program (Formerly Policy number 201)
There are Currently No Attachments
105 - IRB Reliance
There are Currently No Attachments
109 - FWA Coverage
There are Currently No Attachments
300 Series - Investigator Responsibilities
302 - Recruitment Compensation
There are Currently No Attachments
400 Series - Regulatory Protections for Vulnerable Populations
400 - Research Involving Pregnant Women, Fetuses, and Neonates
There are Currently No Attachments
401 - Research Involving Prisoners
There are Currently No Attachments
402 - Children in Research
There are Currently No Attachments
403 - Research with Subjects Lacking Capacity to Consent
There are Currently No Attachments
404 - Research Involving NIH Staff
There are Currently No Attachments
800 Series - Compliance and Research Event Reporting Requirements
801 - Reporting Research Events
There are Currently No Attachments
802 - Non-Compliance in HSR
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
Other Guidance Documents
There are Currently No Attachments
Overview
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