Chapters Icon Recently Released Chapters
IRB Membership and Composition
3014-201
11/19/2020, Partial Revision: 4/21/2026
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the requirements for the membership and composition of the NIH Institutional Review Board (IRB) for the NIH Intramural Research Program (IRP) based on federal regulation and policy, including NIH policy. This policy fully supersedes the SOP 2 IRB Membership and Structure and partially supersedes SOP 26 Evaluation of NIH IRB Chairs, Vice Chairs and Members, IRB Administrative Staff and IRB Committee Activities. Partial Revision 05/04/2022: This policy has been revised to add the requirement to share the results of the annual IRB member evaluations with IRB members. Partial Revision 04/21/2026: This policy has been revised to specify that no NIH IRB shall be comprised solely of one sex consistent with the requirements of 45 CFR 46.107 and 21 CFR 56.107.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-201, dated 11/19/2020 Partial Revision Date: 04/21/2026
- Implementation Date: 12/07/2020
PLEASE NOTE: For information on:
- The current policies can also be found at: https://irbo.nih.gov/confluence/display/ohsrp/Policy.
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA, on (301) 496-4606, or enter this URL: https://nih.sharepoint.com/sites/OD-OMA-DCM/PolicyManual/NIH
NIH Intramural Research Program’s Human Research Protection Program
3014-100
11/19/2020, Partial Revision: 4/17/2026
Transmittal Notice
- Explanation of Material Transmitted: This Manual Chapter describes the NIH Human Research Protection Program (HRPP) of the NIH Intramural Research Program (IRP). The Office of Human Subjects Research Protections(OHSRP) is the lead office for the NIH HRPP. This manual chapter describes the structure and components of the NIH HRPP and the OHSRP. This chapter has been revised to include coverage of Visiting Fellows (VFs) under the NIH FWA without a separate Agreement, and to include VFs in the definition of “NIH Investigator.” This manual chapter taken together with the HRPP Policies, will fully supersede Manual Chapter 3014 and the Introduction to the NIH Human Research Protection Program. Effective December 2019, the NIH HRPP completed a reorganization and consolidation resulting in the centralization of IRB operations and transition to a centralized and flexible IRB system. Partial Revision 8/10/2021: This revision adds overarching statements regarding NIH inclusion policies for research involving human subjects. Partial Revision 11/7/2022: This revision distinguishes coverage under the NIH Federalwide Assurance (FWA) between Intergovernmental Personnel Act (IPA) appointees and detailees. This revision also specifies the requirement for a continuity plan in case of an emergency that impacts the NIH IRP HRPP and the rights, safety or welfare of its research subjects, for the OHSRP and the NIH IRB. Partial Revision 09/10/2024: Addition of the Tribal Health Research Office as a component of the NIH IRP HRPP and the newly established Human Fetal Tissue Review Committee as an ancillary review committee for IRP research. Partial Revision 04/17/2026: This policy has been revised to update the description of CC Office of Patient Recruitment Services at Section E.3.h.VIII. and to clarify that OPR conducts periodic evaluation of the effectiveness of its outreach activities in accordance with NIH CC requirements.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-100, dated 11/19/2020, Partial Revision Date: 04/17/2026
- Implementation Date: 11/24/2020
PLEASE NOTE:
- The current policies can also be found at: https://irbo.nih.gov/confluence/display/ohsrp/Policy.
- For information on content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA, on (301) 496-4606, [email protected] or enter this URL: https://nih.sharepoint.com/sites/OD-OMA-DCM/PolicyManual/NIH/
Reorganization Management
0001
4/09/2026
Transmittal Notice
- Explanation of Material Transmitted: This temporary chapter is being revised due to a change in department guidance. This chapter contains the policy for requesting NIH organizational changes and explains the reorganization processes and requirements.
- Filing Instructions:
Insert: NIH Manual 0001 dated 04/09/2026.
Expiration: This temporary policy expires within 2 years of publication.
Please Note: For information on:
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, Office of Management Assessment, OMA on 301-496-4606 or enter this URL: https://nih.sharepoint.com/sites/OD-OMA-DCM/PolicyManual/NIH/.
IRB Scope and Authority
3014-200
12/09/2019, Partial Revision: 3/08/2026
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the scope and authority of the NIH intramural Institutional Review Board (IRB) and the Research Compliance Review Committee (RCRC) which is also a duly constituted IRB. This policy partially supersedes the Introduction to the NIH Human Research Protection Program (HRPP) and fully supersedes SOPs 1 Human Subjects Research and the NIH IRB System and 2 IRB Membership and Structure. Partial Revision 02/06/2025: Incidents of undue influence upon an IRB member may also be reported to the NIH IRB Executive Chair in addition to the IRBO Director or OHSRP Director. Partial Revision 03/08/2026: The role of the Institutional Official has been added to the list of NIH leadership who can disapprove research that has previously been approved by the IRB.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-200, dated 12/09/2019
- Implementation Date: 09/21/2020
- PLEASE NOTE: For information on:
- The current policies can also be found at: https://irbo.nih.gov/confluence/display/ohsrp/Policy.
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA, on (301) 496-4606, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
NIH Non-Intramural Special Volunteer Program Temporary Policy
0009
3/06/2026
Transmittal Notice
- Explanation of Material Transmitted: This document is a temporary NIH Policy Manual Chapter establishing a policy for the use and management of Non-Intramural Special Volunteers. Issued by the NIH Deputy Director for Management, it outlines the administrative framework, purpose, scope, background, policy, responsibilities, procedures, references, definitions, and appendices associated with the program.
- Filing Instructions:
Insert: NIH Policy Manual, Chapter 0009, dated 03/06/2026
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA on
301-496-4606, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Chapters Icon Frequently Accessed Chapters
Managing Federal Records
1743
12/24/2020, Partial Revision: 5/07/2021
Transmittal Notice
- Explanation of Material Transmitted: This chapter was updated to include requirements stipulated in OMB-M-19-21 and the HHS Records Management Policy. Partial Revision: 5/7/2021 – This policy was partially revised to move the procedures for Departing Staff Requesting to Remove Copies of NIH Records from the Policy section into Appendix 5: Process for Departing Staff Requesting to Remove Copies of NIH Records.
Please refer to NIH Manual Chapter 1743-2 to review NIH’s responsibilities related to the NIH Litigation Hold Policy.
Please refer to NIH Manual Chapter 1742 to review NIH’s responsibilities related to transfer, withdrawal and destruction of Records at the Washington National Records Center.
Please refer to NIH Manual Chapter 1744 to review NIH’s responsibilities related to the Vital Records Program.
- Filing Instructions:
- Remove: 1743 – Keeping and Destroying Records, dated 10/01/2015
- Insert: 1743 – Managing Federal Records, dated 12/24/2020, Partial Revision: 5/7/2021
- PLEASE NOTE:
- For inquiries regarding the content of this chapter contact the Information Management Branch (IMB), Division of Compliance Management (DCM), Office of Management Assessment (OMA), Office of Management (OM), Records Management Program: [email protected] or 301-496-4606. Additional information on NIH records is located at the following URL:https://oma.od.nih.gov/DMS/Pages/Records-Management.aspx
- For inquiries regarding the NIH Policy Manual contact the Management Operations Branch (MOB), DCM, OMA, at 301-496-4606, or navigate to the following URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Intramural Research Training Award (IRTA) Program
2300-320-7
2/24/2021
Transmittal Notice
- Explanation of Material Transmitted: This issuance describes the policies and procedures for implementing the Intramural Research Training Award (IRTA) Program. This revision updates the manual chapter to address all levels of IRTA trainees, clarification of the renewal policies (Section C.7), leave policy (C.24), tort claims (C.30). In addition, this version eliminates the technical IRTA and adds the academic student IRTA (C.5); and revises and clarifies the roles and responsibilities (Section D).
NOTE: A Technical Revision has been made to index the subsections that were previously included in Section C: Policy. Users may now easily navigate and reference these sections of the policy using the left hand navigation pane. - Filing Instructions:
Remove: NIH Manual 2300-320-7 dated 02/24/2009
Insert: NIH Manual 2300-320-7 dated 2/24/2021.
- PLEASE NOTE: For information on:
- For information on content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management (DCM), Office of Management Assessment (OMA) on 301-496-4606, or enter this url: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Travel Policies and Procedures
1500
8/03/2023
Transmittal Notice
- Explanation of Material Transmitted: The Office of Financial Management (OFM), Office of Management (OM), Office of the Director (OD) is rescinding this Chapter, including all Appendices within NIH Manual Chapter 1500. Superseding this chapter is the Temporary NIH Manual Chapter 0005: NIH Travel Policy. This temporary chapter provides updated travel policy and requirements while the HHS Travel Policy Manual dated September 10, 2018 (Edition #: 2018-Q4) undergoes revision. The HHS Travel Policy Manual is available here.
- Filing Instructions:
- Remove: NIH Manual Chapter 1500 dated 08/20/1999 including all Appendices.
- Insert: Temporary NIH Manual Chapter 0005: NIH Travel Policy dated 08/03/2023.
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above
- NIH Policy Manual, contact the Division of Compliance Management, Office of Management Assessment, OM on 301-496-4606 or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
NIH Litigation Hold Policy
1743-2
6/26/2020
Transmittal Notice
- Explanation of Material Transmitted: This policy applies to document preservation related to civil litigation, often referred to as “litigation holds”. This policy does not address records retention under the Federal Records Act, the Freedom of Information Act (FOIA), or preservation obligations imposed by other federal laws. This NIH Litigation Hold Policy identifies the process for preserving potentially relevant information in the possession, custody, or control of the National Institutes of Health (NIH), an Operating Division (OpDiv) of the U.S. Department of Health and Human Services (HHS) when civil litigation has commenced or is reasonably anticipated.
- Filing Instructions:
- Insert: NIH Manual 1743-2 – NIH Litigation Hold Policy, dated 11/12/2020, Partial Revision: dated 06/26/2020
- PLEASE NOTE:
- To the extent that a new HHS Policy for Litigation Holds is put in place after the effective date of this policy; and if the HHS policy provides more stringent requirements, the new HHS Litigation Hold Policy will control and supersede existing NIH policy. To the extent that the NIH Litigation Hold Policy provides more stringent controls than the HHS Policy, the NIH Litigation Hold Policy controls.
- For questions, comments, or concerns regarding Records Management content within this Manual Chapter, contact the Records Management Program, Division of Management Support (DMS), Office of Management Assessment (OMA), Office of Management (OM), Office of the Director(OD) at : [email protected] or via 301-496-2832. Additional information on the NIH Records Management Program is found at: https://oma.od.nih.gov/DMS/Pages/Records-Management.aspx
- For questions, comments, or concerns regarding NIH Policy Manual repository and official records policy, contact the Manual Chapter Program, DMS, OMA, OM, OD at: [email protected] or via 301-496-4606. Additional information on the NIH Policy Manual Program is found at: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Introduction to NIH Human Research Protection Program (HRPP) Policy Development
3014-001
6/03/2020
Transmittal Notice
- Explanation of Material Transmitted: NIH Human Research Protection Program (HRPP) policies have been revised to comport with the revised DHHS Common Rule (45 CFR 46) and to reflect the newly consolidated IRB structure within the NIH Intramural Research Program. This Manual Chapter describes the policy development and structure for the NIH Human Research Protection Program (HRPP) policies of the NIH Intramural Research Program (IRP). This manual chapter will partially supersedes the Introduction to the NIH Human Research Protection Program.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-100, dated 06/03/2020
- Implentation Date: 07/28/2020
- PLEASE NOTE
- The current policies can also be found at: https://irbo.nih.gov/confluence/display/ohsrp/Policy.
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA, on (301) 496-4606, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Chapters Icon Recently Rescinded Chapters
Office of Equity Diversity and Inclusion (EDI) Affiliation with NIH Employee Resource Groups
2207
7/03/2025
Transmittal Notice
- Explanation of Material Transmitted: This policy is rescinded because it does not align with department priorities.
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 2207, dated 06/17/2022
Insert: None
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above.
- NIH Manual System, contact the Division of Compliance Management, OMA on 301-496-4606, or enter this URL: http://oma.od.nih.gov/public/MS/manualchapters/Pages/default.aspx.
Implementation of Cooperative Agreements
54815
7/01/2024
Transmittal Notice
- Explanation of Material Transmitted: This chapter establishes the NIH policy for initiation, award, and administration of cooperative agreements for conducting extramural research and development projects as well as management of bias by NIH staff in the administration of cooperative agreements. NIH Policy Manual, Chapter 54815 is rescinded by the release of Chapter 4202-203 - Implementation of Cooperative Agreements.
- Filing Instructions:
- Remove: NIH Policy Manual, Chapter 54815, dated 8/17/2009
- Insert: NIH Policy Manual, Chapter 4202-203, dated 7/01/2024
PLEASE NOTE: For information on:
- Content of this chapter contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA on 301-496-4606, [email protected], or: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Selection Of Extramural Award Instrument – Grant, Cooperative Agreement, or Contract
1820
7/01/2024
Transmittal Notice
- Explanation of Material Transmitted: This chapter provides guidance in determining the appropriate funding mechanism when issuing NIH grants, cooperative agreements, and contracts. NIH Policy Manual, Chapter 1820 is rescinded by the release of Chapter 4202-202 Determining Appropriate Award Instrument.
- Filing Instructions:
- Remove: NIH Policy Manual, Chapter 1820, dated 2/22/1985
- Insert: NIH Policy Manual, Chapter 4202-202, dated 7/01/2024
PLEASE NOTE: For information on:
- Content of this chapter contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management, OMA on 301-496-4606, [email protected], or: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Hotel Fire and Safety Act
6323
12/22/2023
Transmittal Notice
- Explanation of Material Transmitted:
This Manual Chapter is rescinded due to the following:- It was merely a recitation of the underlying statute and is covered in the Federal Travel Regulations.
- This Manual Chapter was issued when this requirement was new in 2006; now the requirement is fully integrated in solicitations and contracts as set forth in the NIH Document Generation System (DGS).
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 6323, dated 02/01/2006.
Insert: None.
PLEASE NOTE: For information on:
- Content of this chapter, contact the OD/OM/OALM/DAPE, [email protected], 301- 496-6014.
- NIH Policy Manual, contact the Division of Compliance Management, OMA on 301-496-4606, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Introduction to Official Government Travel
1500-01
8/03/2023
Transmittal Notice
- Explanation of Material Transmitted: The Office of Financial Management (OFM), Office of Management (OM), Office of the Director (OD) is rescinding Manual Chapter 1500-01. Superseding this chapter is the Temporary NIH Manual Chapter 0005: NIH Travel Policy. This temporary chapter provides updated travel policy and requirements while the HHS Travel Policy Manual dated September 10, 2018 (Edition #: 2018-Q4) undergoes revision. The HHS Travel Policy Manual is available here.
- Filing Instructions:
- Remove: NIH Manual Chapter 1500-01 dated 01/05/2004.
- Insert: Temporary NIH Manual Chapter 0005: NIH Travel Policy dated 08/03/2023.
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above
- NIH Policy Manual, contact the Division of Compliance Management, Office of Management Assessment, OM on 301-496-4606 or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx