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

Intro to NIH HRPP policies and Policy 100, 105, and 109

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

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