HRPP Policy & Guidelines


During 2019 and 2020, the NIH Intramural Program (IRP) transitioned from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies. (See General and Structural Changes to the NIH HRPP Policies for more information.) These policies are applicable to NIH clinical investigators, non-NIH clinical investigators when relying upon the NIH IRB, to the Office of IRB Operations (IRBO), 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. Additional supplemental educational materials are provided below each policy link to aid investigators and research teams with the implementation of these 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. 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 system). 

How to request an archived policy:

OHSRP is the official HRPP standard operating procedure (SOP) archive, these SOPs are no longer in effect and have been superseded by Manual Chapter (MC) 3014. To request a copy of an archived SOP email: irb@od.nih.gov

OMA is the policy archive for the HRPP policies (MC 3014). To request a copy of a HRPP policy (MC 3014) email: PolicyManual@nih.gov.

Please contact Heather Bridge for any questions or concerns.



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


102 - Investigator Conflict of Interest and Government Royalties

There are Currently No Attachments

COI Certifications and Guide

For the COI Certifications and Guide please navigate to this page. 


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 

There are Currently No Attachments


109 - Coverage Under the NIH FWA

109 - Policy - Coverage Under the NIH FWA (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


202 - Board Member Financial Conflict of Interest

202 - Policy - Board Member Conflict of Interest (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 

206 - Policy - Maintenance of Records (Printer friendly version available)

There are Currently No Attachments


207 - Public Health Emergency Research Review Board

There are Currently No Attachments





300 Series - Investigator Responsibilities


300 - Investigator Responsibilities

300 - Policy - Investigator Responsibilities (Printer friendly version available)

There are Currently No Attachments

There are Currently No Attachments


301 - Informed Consent

301 - Policy - Informed Consent (Printer friendly version available)

There are Currently No Attachments


302 - Recruitment and Compensation

302 - Policy - Subject Recruitment and Compensation (Printer friendly version available)

There are Currently No Attachments

303 - Intramural Research Program Telehealth Requirements

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

401- Policy - Research Involving Prisoners (Printer friendly version available)

There are Currently No Attachments


402 - Children in Research

402- Policy - Research Involving Children (Printer friendly version available)

There are Currently No Attachments


403 - Research with Subjects Lacking Capacity to Consent

There are Currently No Attachments


404 - Research Involving NIH Staff

404-Policy-Research Involving NIH Staff as Subjects  (Printer friendly version available)

There are Currently No Attachments





500 Series - FDA Requirements for Human Subjects Research and Data and Safety Monitoring


500 - Research Involving Drugs, Biological, and Nutritional Products

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)

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




Policy and Accreditation

For more information, please visit the OHSRP Policy and Accreditation page here.