Chapters Icon Recently Released Chapters
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. Partial Revision 09/01/2026: This MC has been partially revised to implement policy updates from the NIH Staff Policy: Avoiding the Perception of Bias Created by Co-Authorship for NIH Extramural Staff issued by the Deputy Director for Extramural Research on August 12, 2026.
- Filing Instructions:
- Remove: NIH Policy Manual, Chapter 54815, dated 8/17/2009
- Insert: NIH Policy Manual, Chapter 4202-203, dated 7/01/2024; Partial Revision Date: 09/01/2026
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, [email protected], or: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Transmittal Notice
Explanation of Material Transmitted: This chapter states the basic requirements for the closeout of assistance awards following expiration of support from the National Institutes of Health (NIH).
Filing Instructions:
Insert: NIH Policy Manual, Chapter 4304-205, dated 08/27/2026
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, [email protected], or: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Transmittal Notice
- Explanation of Material Transmitted: This issuance updates information regarding the management, scheduling, maintenance, and operation of the Lister Hill Center (LHC) Auditorium within the National Library of Medicine.
- Filing Instructions:
Remove: NIH Manual Chapter 1363-1, dated 03/20/2019
Insert: NIH Manual Chapter 1363-1, dated 06/18/2026
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.
Transmittal Notice
1. Explanation of Material Transmitted:
The Office of Human Resources developed this policy to document and communicate temporary changes to NIH General Administration Delegations of Authority (DOAs) and ensure the continued efficient operations of NIH business functions during any transition of the NIH administration in the NIH Office of the Director. The issuance of this new NIH Policy Manual, Chapter 1131 will rescind the temporary NIH Policy Manual, Chapter 0007 to establish a permanent framework for managing NIH business functions during temporary transitions in NIH leadership.
2. Filing Instructions:
Remove: NIH Policy Manual, Chapter 0007, dated 04/03/2024
Insert: NIH Policy Manual, Chapter 1131, dated 06/18/2026
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.
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the requirements for submissions to the NIH IRB by investigators, to NIH IRB members when reviewing IRB submissions, and to IRBO staff when reviewing research that may be exempt under 45 CFR 46. This policy fully supersedes the following HRPP Standard Operating Procedures (SOPs): SOP 5 Research Activities with Human Data/Specimens, SOP 6 Determinations, Including Exemptions Made by the Office of Human Subjects Research Protections (OHSRP), SOP 8 Procedures and Required Documentation for Submission and Initial Review of Protocols, SOP 9 Continuing Review by the Convened IRB, SOP 10 Amendments to IRB-approved Research, SOP 11 Suspensions and Terminations of IRB Approval and Administrative Holds and SOP 11A Closure of an IRB-approved protocol. In addition, this policy partially supersedes SOP 16 Reporting Requirements for Unanticipated Problems, Adverse Events and Protocol Deviations. Partial Revision Date: 11/30/2022 These revisions update terminology to comport with the implementation of Huron PROTECT electronic IRB system. Partial Revision 02/18/2025: This revision is to remind investigators to disclose to the IRB when they are listed as an inventor for any intellectual property that is being evaluated in the research study. This revision also removes the requirement for submission of a high-level summary of events at time of Continuing Review. Partial Revision 06/02/2026: The revision at E.1.C.V. clarifies that any data and safety monitoring reports with findings that were not previously reported to the IRB must be reported at time of Continuing Review.
Filing Instructions:
Insert: NIH Manual Chapter 3014-205, dated 10/01/2020, Partial Revision Date: 06/02/2026
Implementation Date: 10/12/2020
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
Chapters Icon Frequently Accessed Chapters
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
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
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
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
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
Transmittal Notice
- Explanation of Material Transmitted: This chapter is being rescinded and reissued as a Grants Administration Manual. See NIH GAM Part 4.01.20.
- Filing Instructions:
Remove: NIH Manual 5805 dated 02/16/00
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://nih.sharepoint.com/sites/OD-OMA-DCM/PolicyManual/NIH.
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
Transmittal Notice
1. Explanation of Material Transmitted:
The Office of Human Resources developed this policy to document and communicate temporary changes to NIH General Administration Delegations of Authority (DOAs) and ensure the continued efficient operations of NIH business functions during any transition of the NIH administration in the NIH Office of the Director. The issuance of a new NIH Policy Manual, Chapter 1131 will rescind this temporary NIH Policy Manual, Chapter 0007 to establish a permanent framework for managing NIH business functions during temporary transitions in NIH leadership.
2. Filing Instructions:
Remove: NIH Policy Manual, Chapter 0007, dated 04/03/2024
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, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
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.
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.