Policies & Guidance
During 2019 and 2020, NIH is transitioning from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies. These policies are applicable to NIH clinical investigators, non-NIH clinical investigators when relying upon the NIH IRB, to NIH IRB operations, and to the NIH IRB when it is the Reviewing IRB. These policies also apply when the NIH IRB is acting as the Public Health Emergency Research Review Board (PHERRB) for the United States. These pages contain the currently implemented policies of the NIH Intramural Research Program. Also contained within these pages are supplemental guidelines and tools to aid investigators and research teams with the implementation of these policies.
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
101 - Organizational Structure of OHSRP
103 - Education Program
Formerly Policy number 201
104 - Research-Related Subject Complaints
105 - IRB Reliance
106 - Ancillary Reviews
107 - Privacy and Confidentiality NEW
108 - OHSRP Quality Assurance and Quality Improvement Program
109 - FWA Coverage
200 Series - IRB Authorities and Requirements
200 - IRB Scope and Authority
203 - Support of IRB Operations
204 - Levels of IRB Review and Criteria for IRB
205 - Requirements for IRB Submissions
206 - Maintenance of Records
207 - PHERRB NEW
300 Series - Investigator Responsibilities
302 - Recruitment Compensation
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400 Series - Regulatory Protections for Vulnerable Populations
400 - Research Involving Pregnant Women, Fetuses, and Neonates
401 - Research Involving Prisoners
402 - Children in Research
403 - Research with Subjects Lacking Capacity to Consent
404 - Research Involving NIH Staff
500 - FDA Requirements for Human Subjects Research
500 - Research Involving FDA
501 - Research Involving FDA Regulated Devices
502 - Expanded Access Emergency Use
503 - Data and Safety Monitoring
700 Series - International Research Requirements
700 - International Research Requirements NEW
800 Series - Compliance and Research Event Reporting Requirements
801 - Reporting Research Events
802 - Non-Compliance in HSR
Active HRPP Policies (SOPs)
Active
Guidance
Regulations and Ethical Guidance
Food and Drug Administration (FDA)
Common Rule Bulletins
Other Guidance Documents
Overview
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