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
There are Currently No Attachments
103 - Education Program
There are Currently No Attachments
105 - IRB Reliance
There are Currently No Attachments
109 - FWA Coverage
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
100 Series
Institutional Authorities and Requirements
There are Currently No Attachments
200 Series
IRB 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
Common Rule Bulletins
- Common Rule Bulletin #1: Key Information
- Common Rule Bulletin #2: Exemptions
- Common Rule Bulletin #3: Biospecimens/Data REquirements in ICF
- Common Rule Bulletin #4: Reasonable Person Standard in ICF
- Common Rule Bulletin #5: Posting of ICFs
- Common Rule Bulletin #6: Broad Consent
Human Subjects Research vs. Not Human Subjects Research (NHSR)
There are Currently No Attachments
Other Guidance Documents
There are Currently No Attachments