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OHSRP is the official HRPP standard operating procedure (SOP) archive, these SOPs are no longer in effect and have been superseded by Manual Chapter (MC) 3014.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)

101-Presentation-Organizational Structure of OHSRP 09.14.2020.pptx

11.26 MB

102 - Investigator Conflict of Interest and Government Royalties

102 - Policy - Investigator Conflict of Interest and Government Royalties (Printer friendly version available)

102-Guideline-Royalties and investigator inventions 03.28.2023.pdf	288 kB
102-Guideline-Management of Investigator Royalties 03.29.2023.pdf	487 kB
102-Presentation-Investigator Conflict of Interest and Government Royalties 02.08.2021.ppsx	17.99 MB

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)

104-Presentation-Research-Related Subject Complaints 09.14.2020.pptx

11.55 MB

105 - IRB Reliance and Collaborative Research

105 - Policy - IRB Reliance and Collaborative Research (Printer friendly version available)

105-Guideline-NIH FWA 05.06.2020.pdf

931 kB

106 - Ancillary Reviews

106 - Policy - Ancillary Reviews (Printer friendly version available)

106-Presentation-Ancillary Reviews 10.06.2020.pptx

7.59 MB

107 - Privacy and Confidentiality

107 - Policy - Privacy and Confidentiality (Printer friendly version available)

107-Presentation-Privacy and Confidentiality 11.09.2020.ppsx

13.05 MB

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

109 - Policy - Coverage Under the NIH FWA (Printer friendly version available)

109-Guideline-Volunteers Serving as AIs on NIH Protocols 07.14.2022.pdf

174 kB

200 Series - IRB Authorities and Requirements

200 - IRB Scope and Authority

200 - Policy - IRB Scope and Authority (Printer friendly version available)

200-Presentation-IRB Scope and Authority 09.14.2020.pptx

12.62 MB

201 - IRB Membership and Composition

201 - Policy - IRB Membership and Composition (Printer friendly version available)

201-Presentation-IRB Membership and Composition 11.09.2020.ppsx

20.75 MB

202 - Board Member Financial Conflict of Interest

202 - Policy - Board Member Conflict of Interest (Printer friendly version available)

202-Presentation-Managing IRB Member COI Clearance IC DECs 04.05.2021.ppsx	21.56 MB
202-Presentation-Board Member Conflict of Interest 04.08.2021.ppsx	10.76 MB

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)

Common Rule Bulletin #2: Exemptions

205 - Requirements for IRB Submissions

205 - Policy - Requirements for IRB Submissions (Printer friendly version available)

205-Presentation-Requirements for IRB Submissions 10.06.2020.pptx

8.70 MB

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

207 - Policy - Public Health Emergency Research Review Board (Printer friendly version available)

There are Currently No Attachments

300 Series - Investigator Responsibilities

300 - Investigator Responsibilities

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

300-Presentation-Investigator Responsibilities 01.26.2022.pptx

300-Guideline-Investigator Responsibilities When Conducting Exempt Research 06.09.2022.pdf

300-Guideline-Investigators Leaving the NIH 10.27.2021.pdf

300-Guideline-Investigator Responsibilities When Conducting NON-FDA-Regulated Research & NIH is the Reviewing IRB 09.14.2021.pdf

300-Guideline-Investigator Responsibilities when Conducting FDA-Regulated Research and NIH is the Reviewing IRB 09.14.2021.pdf

301 - Informed Consent

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

301-Guideline-Enrolling Non-English Speaking Subjects 01.31.2024.pdf	203 kB
301-Presentation-QAPAC Informed Consent Questions 04.14.2021.ppsx	31.76 MB

302 - Recruitment and Compensation

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

302-Guideline-Payment to Peer Recruiters 11.28.2023.pdf	122 kB
302-Guideline-Recruitment Plan, Recruitment Materials and Screening Plan, for NIH Intramural Research Program Protocols 07.24.2023.pdf	285 kB
302-Guideline-Investigators Regarding Paying Subjects for Research Participation 08.07.2023.pdf	241 kB
302-Guideline-Use of 3rd Party Vendors for Recruitment and Screening rev 05.10.2022.pdf	122 kB

303 - Intramural Research Program Telehealth Requirements

303 - Intramural Research Program Telehealth Requirements (Printer friendly version available)

303-Presentation-IRP Telehealth Presentation Narrated 04.26.2021.ppsx

15.12 MB

400 Series - Regulatory Protections for Vulnerable Populations

400 - Research Involving Pregnant Women, Fetuses, and Neonates

400 - Policy - Research Involving Pregnant Women, Fetuses, and Neonates (Printer friendly version available)

400-Guideline-Inclusion-Exclusion of Pregnant Persons and Information about Pregnancy Testing 10.17.2022.pdf	171 kB
400-Presentation-Research Involving Pregnant Women 08.24.2020.pptx	13.86 MB

401 - Research Involving Prisoners

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

401-Guideline-FAQ Involving Prisoners in Research 8.10.2022.pdf	354 kB
401-Presentation-Research Involving Prisoners 08.24.2020.pptx	14.75 MB

402 - Children in Research

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

402-Guideline-Enrolling Children as Participants in Research 09.07.2021.pdf	161 kB
402-Presentation-Research Involving Children 08.24.2020.pptx	20.14 MB

403 - Research with Subjects Lacking Capacity to Consent

403 - Policy - Research with Subjects Lacking Capacity to Consent (Printer friendly version available)

403-Guideline-Research with Adults who Lack Capacity to Consent to Research Participation 04.11.2023.pdf	208 kB
403-Presentation-Research Involving Adults Who Lack Capacity to Consent 08.24.2020.pptx	15.60 MB

404 - Research Involving NIH Staff

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

404-Guideline- FAQs for Research Involving NIH Staff 09.14.2020.pdf	224 kB
404-Presentation-Research Involving NIH Staff 08.24.2020.pptx	17.20 MB

500 Series - 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)

500-Presentation-Research Involving FDA Regulated Drugs 10.13.2020.pptx

13.64 MB

501 - Research Involving FDA Regulated Devices

501 - Policy - Research Involving FDA Regulated Devices (Printer friendly version available)

501-Guideline-FAQs for Humanitarian Use Devices 4.29.2023.pdf	261 kB
501-Guideline-Device Classification for Protocols using MRI in the NMR Center 03.27.2023.pdf	175 kB
501-Presentation-Research Involving FDA Regulated Devices 10.13.2020.pptx	13.29 MB

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)

Humanitarian Use Device FAQs

For Humanitarian Use Device (HUD) FAQs please navigate to this page

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)

700-Guideline-International Research - Protocol Document 09.08.2021.pdf	97 kB
700-Guideline-International Research - IRB Review and Consent Document 09.08.2021.pdf	204 kB
700-Presentation-International Research 11.02.2020.ppsx	20.21 MB

800 Series - Compliance and Research Event Reporting Requirements

801 - Reporting Research Events

801 - Policy - Reporting Research Events (Printer friendly version available)

801-Guideline - Reporting Research Events and Non-compliance 06.09.2023.pdf

496 kB

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.