Chapters Icon Recently Released Chapters
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the requirements for reporting research-related events to the Institutional Review Board (IRB). Partial Revision Date 6/3/2021: This revision specifies reporting requirements to the OHSRP office of Compliance and Training when a PI receives a 483 from the Food and Drug Administration. Partial Revision Date 8/9/2021: This revision specifies reporting requirements to the OHSRP office of Compliance and Training when an external reviewing IRB suspends or terminates research activities at an NIH site; adds IRB responsibilities when reviewing reportable events and includes minor edits for clarity and consistency. Partial Revision Date 02/15/2024: This revision is to provide the requirement to report short-form consent use to the NIH IRB via the Reportable New Information (RNI) form in the electronic IRB (eIRB) system. Partial Revision 7/21/2024: This revision clarifies the authorities of the OHSRP Director, IRBO Director and/or IRB Chair to immediately suspend, or have the PI take additional actions necessary to protect the health, safety or welfare of subjects in response to a Reportable event, or refer it for review by the RCRC or IRB.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-801, dated 5/14/2019, Partial Revision Date: 6/3/2021, 8/9/2021, 02/15/2024, 7/21/2024
- Implementation Date: 7/1/2019
- 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, DCM, 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 process for the investigation and resolution of allegations of non-compliance the requirements for reporting research-related events to the Institutional Review Board (IRB). Partial Revision 5/19/2021: This partial revision clarifies the requirements for non-compliance for closed protocols or activities never under IRB review. Sections C.10 and E.4, and E.5.e were revised to address that the OHSRP will investigate, and the Research Compliance Review Committee (RCRC) will review, non-compliance related to closed protocols or for activities that were never under IRB review. Partial Revision 7/05/2024: This revision clarifies the authorities of the OHSRP Director, IRBO Director and/or IRB Chair to immediately suspend, or have the PI take additional actions necessary to protect the health, safety or welfare of subjects in response to an allegation of non-compliance, or refer it for review by the RCRC.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-802, dated 5/14/2019, Partial Revision: 7/05/2024.
- Implementation Date: 7/1/2019.
- 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, DCM, 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 chapter provides guidance in determining the appropriate funding mechanism when issuing NIH grants, cooperative agreements, and contracts.
- 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.
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.
- 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.
Transmittal Notice
- Explanation of Material Transmitted: This Chapter, 2300-550-1, is established to state the NIH policy for the payment of premium pay to the employees at the NIH under Title 38 United States Code, Chapter 74. This revision provides updates to formatting, hyperlinks, and references. The requirement to verify part-time and intermittent employees on non-holidays meet the basic overtime requirement to receive on-call pay was removed. Clarification was added to specify compensatory time-off may only be authorized when it is voluntarily requested in writing by an employee.
- Filing Instructions:
Remove: Manual Issuance 2300-550-1, dated 12/13/2018.
Insert: Manual Issuance 2300-550-1, dated 05/28/2024.
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
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 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.
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.
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
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
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 1500-04. 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 1500-04 dated 05/01/2004.
- 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