Chapters Icon Recently Released Chapters
Research Involving NIH Staff or Immediate Family Members of the Study Team as Subjects
3014-404
5/08/2020, Partial Revision: 3/12/2025
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the requirements for research involving NIH staff participating in NIH Research. This policy partially supersedes SOP 14A Research Involving Vulnerable Subjects (General Considerations) and fully supersedes SOP 14F- Research Involving Staff as Subjects. Partial Revision 02/11/2025: This revision clarifies the applicability of NIH Manual Chapter: 2300-630-3 - Leave Policy for NIH Employees Participating in NIH Intramural Research Program (IRP) Biomedical Research Studies. In addition, we clarify who may not obtain informed consent of immediate family members of the study team at C.9.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-404, dated 05/08/2020
- Implementation Date: 09/14/2020
- 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
Requirements for IRB Submissions
3014-205
10/01/2020, Partial Revision: 2/21/2025
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.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-205, dated 10/01/2020, Partial Revision Date: 11/30/2022, Partial Revision Date: 02/18/2025
- 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
Investigator Responsibilities
3014-300
3/23/2021, Partial Revision: 2/14/2025
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the mandates and requirements of all NIH investigators, which includes NIH Principal Investigators (PIs), NIH Investigators, and NIH trainee Investigators, when conducting human subjects research (both exempt and non-exempt human subject research); and describes the responsibilities and requirements of non-NIH investigators when the NIH IRB is the Reviewing IRB. Partial Revision 6/3/2021: This revision specifies the requirement for NIH PIs to report any and all FDA Form 483s to the OHSRP Office of Compliance and Training consistent with Policy 3014-801 Reporting Research Events. Technical Revision 8/5/2021: This revision adds the definition, “Engaged in Human Subjects Research,” to clarify when research staff must be designated as investigators by the PI. Partial Revision 11/7/22: This revision further clarifies who can or cannot be a Principal Investigator and revises the conditions upon which certain trainees can obtain consent for research. Partial Revision 2/14/25: This revision is to remind investigators to disclose to the IRB when a study staff member is listed as an inventor for any intellectual property that is being evaluated in the research study.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-300, dated 3/23/2021, Partial Revision: 2/14/2025
- Implementation Date: 3/30/2021
- 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
Ancillary Reviews
3014-106
8/03/2020, Partial Revision: 2/14/2025
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the NIH institutional reviews (referred to as “ancillary reviews”) that are required for human subjects research activities, in addition to Institutional Review Board (IRB) review. Upon implementation, this policy partially supersedes SOP 8 Procedures and Required Documentation for Submission. Partial Revision 09/09/2024: To clarify that ancillary reviews are required for intermediate-size patient population and treatment Investigational New Drug (IND) expanded access protocols. To add the requirement for Intramural researchers to obtain prospective approval from the Human Fetal Tissue (HFT) Review Committee, and human subjects review, before use or acquisition of HFT. This includes research involving HFT that may be considered to be not human subjects research (NHSR). To add information about review by the NIH Protocol Royalty Analysis Committee (PRAC) when the NIH IRB is informed that an investigator is listed as an inventor for any intellectual property that is being evaluated in the research under review. . Partial Revision 2/14/2025: This revision specifies that investigators should consult the Biological Safety Officer for any new product used in an expanded access protocol at the NIH that has not previously been reviewed by the NIH IBC.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-106, dated 08/03/2020; Partial Revision: 09/09/2024
- 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
IRB Reliance and Collaborative Research
3014-105
5/15/2020, Partial Revision: 2/13/2025
Transmittal Notice
- Explanation of Material Transmitted: This policy describes the requirements for IRB reliance, collaborative research and multi-site research that requires Single IRB review. This policy fully supersedes the following Standard Operating Procedures (SOPs): SOP 20 – NIH HRPP Requirements for Collaborative Research, SOP 20A – Obtaining a Reliance (Authorization) Agreement at the NIH, SOP 20B – NIH IRB Responsibilities When Reviewing Local Context Considerations for Offsite Research and SOP 20C – Responsibilities When the NIH Intramural Research Program Serves as a Coordinating Center for a Multisite Trial or as the IRB of Record for a Non-NIH Coordinating Center. Partial Revision 2/13/2025: These revisions include minor clarifications for consistency with the eIRB system and for multisite research studies consistent with current practice. This revision also reminds NIH Investigators to submit to IRBO external IRB approvals and approved documentation no later than 2 weeks following receipt of the approval letter.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-105, dated 05/15/2020
- Implementation Date: 07/06/2020
- 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
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: NIHRecordsManagement@nih.gov 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 : nihrecordsmanagement@nih.gov 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: policymanual@nih.gov 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
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, policymanual@nih.gov, 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, policymanual@nih.gov, 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, dape@od.nih.gov, 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
Per Diem and Other Allowable Expenses
1500-04
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 1500-04. 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