NIH HRPP Policy & Guidelines
These policies are applicable to NIH Intramural Research Program clinical investigators, non-NIH clinical investigators when the NIH Institutional Review Board (IRB) is the Reviewing IRB, to the Office of Human Subjects Research Protections, and to the NIH IRB. These policies also apply when the NIH IRB is acting as the Public Health Emergency Research Review Board (PHERRB) for the United States. Additional supplemental educational materials are provided below each policy link to aid investigators and research teams with the implementation of these policies.
Showing 37 policies
001 Series - NIH Human Research Protection Program Policy Management
Specifies the management of the NIH HRPP policy series and includes the Policy Glossary.
100 Series - NIH Human Research Protection Program
Describes NIH institutional authorities and specifies requirements for the NIH HRPP.
200 Series - Institutional Review Board Requirements
Describes IRB authorities and specifies IRB requirements.
300 Series - Investigator Requirements
Specifies requirements for investigators conducting human subjects research.
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400 Series - Vulnerable Populations
Specifies regulatory requirements and policy protections for vulnerable populations participating in research.
405 - Policy- Research Involving American Indian/Alaska Native Persons, Their Data and Biological Materials
This policy describes the requirements that apply when the NIH Institutional Review Board (IRB) is reviewing, or when an NIH Investigator seeks to co…
500 Series - FDA Requirements and Data and Safety Monitoring
Specifies requirements for Food and Drug Administration regulated research and data and safety monitoring.
700 Series - International Research
Specifies the requirements for research conducted in international settings.
800 Series - Reporting Research Events and Non-Compliance
Specifies the requirements for reporting research events and non-compliance.