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
Policy page update
The official repository for the HRPP policies is in the OMA Manual Chapter (MC) system. Manual Chapter 3014 is a chapter within the Intramural Policy Series 3000. The MC 3014 contains the HRPP policies which can be found here: https://policymanual.nih.gov/3014. Note that we are in the process of replacing the policy PDFs with links to the published policies within MC 3014. In MC 3014, you will notice a slight difference in the policy numbering to reflect the MC under which the policies fall, (e.g., Policy 100, will be listed as Policy 3014-100 in the MC). The HRPP policy glossary is also published in MC 3014 and each policy lists the defined terms in Section D and a link to the policy glossary is provided there.
100 Series - Institutional Authorities and Requirements
100 - NIH HRPP
100 - Policy - NIH HRPP (Printer friendly version available)
There are Currently No Attachments
101 - Organizational Structure of OHSRP
101 - Policy - Organizational Structure of OHSRP (Printer friendly version available)
There are Currently No Attachments
103 - Education Program
Formerly Policy number 201
103 - Policy - Education Program (Printer friendly version available)
There are Currently No Attachments
104 - Research-Related Subject Complaints
104 - Policy - Research-Related Subject Complaints (Printer friendly version available)
There are Currently No Attachments
105 - IRB Reliance and Collaborative Research
105 - Policy - IRB Reliance and Collaborative Research (Printer friendly version available)
There are Currently No Attachments
106 - Ancillary Reviews
106 - Policy - Ancillary Reviews (Printer friendly version available)
There are Currently No Attachments
107 - Privacy and Confidentiality
107 - Policy - Privacy and Confidentiality (Printer friendly version available)
There are Currently No Attachments
108 - OHSRP Quality Assurance and Quality Improvement Program
108 - Policy - OHSRP Quality Assurance and Quality Improvement Program (Printer friendly version available)
There are Currently No Attachments
109 - Coverage Under the NIH FWA Assurance
109 - Policy - Coverage Under the NIH FWA Assurance (Printer friendly version available)
There are Currently No Attachments
200 Series - IRB Authorities and Requirements
200 - IRB Scope and Authority
200 - Policy - IRB Scope and Authority (Printer friendly version available)
There are Currently No Attachments
201 - IRB Membership and Composition
201 - Policy - IRB Membership and Composition (Printer friendly version available)
There are Currently No Attachments
203 - Support of IRB Operations
203 - Policy - Support of IRB Operations (Printer friendly version available)
There are Currently No Attachments
204 - Levels of IRB Review and Criteria for IRB
204 - Policy - Levels of IRB Review and Criteria for IRB (Printer friendly version available)
There are Currently No Attachments
205 - Requirements for IRB Submissions
205 - Policy - Requirements for IRB Submissions (Printer friendly version available)
There are Currently No Attachments
206 - Maintenance of Records
There are Currently No Attachments
207 - Public Health Emergency Research Review Board
207 - Policy - Public Health Emergency Research Review Board (Printer friendly version available)
There are Currently No Attachments
300 Series - Investigator Responsibilities
300 - Investigator Responsibilities
There are Currently No Attachments
301 - Informed Consent
There are Currently No Attachments
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
500 - FDA Requirements for Human Subjects Research and Data and Safety Monitoring
500 - Research Involving Drugs, Biological, and Nutritional Products
500 - Policy - Research Involving Drugs, Biological, and Nutritional Products (Printer friendly version available)
There are Currently No Attachments
501 - Research Involving FDA Regulated Devices
501 - Policy - Research Involving FDA Regulated Devices (Printer friendly version available)
There are Currently No Attachments
502 - Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles)
502 - Policy - Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles) (Printer friendly version available)
There are Currently No Attachments
503 - Data and Safety Monitoring
503 - Policy - Data and Safety Monitoring (Printer friendly version available)
There are Currently No Attachments
700 Series - International Research Requirements
700 - International Research
700 - Policy - International Research (Printer friendly version available)
There are Currently No Attachments
800 Series - Compliance and Research Event Reporting Requirements
801 - Reporting Research Events
801 - Policy - Reporting Research Events (Printer friendly version available)
There are Currently No Attachments
802 - Non-Compliance in HSR
802 - Policy - Non-Compliance in HSR (Printer friendly version available)
There are Currently No Attachments
Active HRPP Policies (SOPs)
Active
There are Currently No Attachments
Guidance
Regulations and Ethical Guidance
Food and Drug Administration (FDA)
Common Rule Bulletins
Other Guidance Documents
There are Currently No Attachments
Overview
Content Tools
ThemeBuilder