Chapters Icon Recently Released Chapters
Medical Qualifications Determinations
2300-339-2
10/15/2020, Partial Revision: 8/10/2021
Transmittal Notice
- Explanation of Material Transmitted: The revisions to this Manual Chapter pertain to guidelines, requirements and procedures for Medical Qualification Determinations at the National Institutes of Health (NIH). Partial Revision 8/10/2021: This partial revision removes language that will alleviate an administrative burden of seeking an exemption for selections that should be exempt by default.
- Filing Instructions:
- Remove: NIH Manual 2300-339-2, dated 05/13/09
- Insert: NIH Manual 2300-339-2, dated 10/15/2020, Partial Revision Dated: 08/10/2021
- 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 496-4606, or enter this URL https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
NIH Intramural Research Program’s Human Research Protection Program
3014-100
11/19/2020, Partial Revision: 8/10/2021
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, and for equity, diversity and inclusion.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-100, dated 11/19/2020, Partial Revision Date: 8/10/2021
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Implementation Date: 11/24/2020
- PLEASE NOTE:
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The current policies can also be found at: https://irbo.nih.gov/confluence/display/ohsrp/Policy.
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For information on content of this chapter, contact the issuing office listed above.
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NIH Policy Manual, contact the Division of Compliance Management, OMA, on (301) 496-4606, policymanual@nih.gov or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Reporting Research Events
3014-801
5/14/2019, Partial Revision: 8/09/2021
Transmittal Notice
- Explanation of Material Transmitted: NIH Human Research Protection Program (HRPP) policies have been revised to comport with the revised HHS Common Rule (45 CFR 46) and to reflect the newly consolidated IRB structure within the NIH Intramural Research Program. 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.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-801, dated 5/14/2019, Partial Revision Date: 6/3/2021, 8/9/2021
- 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
Maintenance of Records
3014-206
6/10/2020, Partial Revision: 6/09/2021
Transmittal Notice
- Explanation of Material Transmitted: NIH Human Research Protection Program (HRPP) policies have been revised to comport with the revised HHS Common Rule (45 CFR 46) and to reflect the newly consolidated IRB structure within the NIH Intramural Research Program (IRP). This policy describes the requirements for maintaining adequate documentation of the human subjects protection activities of the Office of Human Subjects Research Protections (OHSRP) and the NIH Institutional Review Board (IRB) within the NIH Intramural Research Program (IRP) Human Research Protection Program (HRPP); and describes the requirements for the content of IRB Minutes. Partial Revision: 6/9/2021: Revision to E.3. to update Minutes requirements.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-206, dated 06/10/2020, Partial Revision: 6/9/2021
- Implementation Date: 11/02/2020
- 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
Privacy and Confidentiality
3014-107
5/22/2019, Partial Revision: 6/07/2021
Transmittal Notice
- Explanation of Material Transmitted: NIH Human Research Protection Program (HRPP) policies have been revised to comport with the revised HHS Common Rule (45 CFR 46) and to reflect the newly consolidated Institutional Review Board (IRB) structure within the NIH Intramural Research Program (IRP). This policy describes the NIH requirements for privacy and confidentiality and ensures that the National Institutes of Health’s (NIH) Intramural Research Program (IRP) research activities comply with Federal standards for privacy and confidentiality in the collection, use and disclosure of research subjects’ information). Partial Revision 6/07/2021: This partial revision clarifies the meaning of privacy of subjects and their interest in controlling the access by others to themselves during research procedures. Section E.1.c. was revised to describe privacy in the context of protections an investigator would describe in the protocol and consent. Section E.1.d. was revised to split confidentiality protections away from privacy protections that would be described in the protocol and the consent.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-107, dated 05/22/2019, Partial Revision: 06/07/2021
- Implementation Date: 11/16/2020
- 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
NIH Privacy and Information Security Incident and Breach Response Policy
1745-2
2/23/2016
Transmittal Notice
- Explanation of Material Transmitted: This policy outlines the requirements of National Institutes of Health (NIH) employees, contractors, researchers, grantees, trainees, and other non-Government personnel affiliated with NIH for complying with the policy, and ensuring the protection of personally identifiable information (PII) and sensitive information (SI) contained in all NIH information technology (IT) systems as well as paper record systems. This policy also applies to electronic and paper-based systems that are developed, operated and/or maintained by contract personnel on behalf of NIH.
This policy shall be used in conjunction with Appendix A, NIH Privacy and Information Security Incident Supplemental Guidance.
- Filing Instructions:
Remove: None.
Insert: NIH Manual Chapter 1745-2 dated 02/23/2016.
Additional Information:
For information concerning the content of this Chapter, please contact the NIH issuing offices. On-line resources include:
- NIH Office of the Chief Information Officer (OCIO) Websites:
http://ocio.nih.gov
https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/index.aspx - NIH Office of Management Assessment (OMA) Websites:
http://oma.od.nih.gov/
https://oma.od.nih.gov/DMS/Pages/Privacy-Program.aspx
- NIH Manual System: Contact the Division of Management Support (DMS), OMA, on 301-496-2832 or enter this URL:
https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
NIH Remote Access Policy
2810
1/28/2019, Partial Revision: 7/30/2019
Transmittal Notice
- Explanation of Material Transmitted: This policy sets forth requirements for ensuring that NIH information technology (IT) resources and data are appropriately protected when authorized users remotely access NIH information and information systems.
The policy is being revised to require the use of a Personal Identity Verification (PIV) card for remote access in accordance with Homeland Security Presidential Directive 12 (HSPD-12) 1, NIH Manual Chapter 2811, NIH Policy for Access to Information Technology Systems and Networks, and other related federal requirements and directives. It is being revised for clarity and to remove outdated information.
- Filing Instructions:
Remove: NIH Manual Chapter 2810, dated 01/28/2019
Insert: NIH Manual Chapter 2810, dated 07/30/2019
PLEASE NOTE: For information on:
- Content of this chapter, contact the NIH Information Security Program, OCIO on 301-496-1168 or enter this URL: https://ocio.nih.gov/
- NIH Policy Manual, contact the Division of Management Support, OMA on 496-4606 or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
1]Homeland Security Presidential Directive/HSPD-12: https://csrc.nist.gov/Topics/Laws-and-Regulations/executive-documents/HSPD-12. A list of other related Federal requirements and directives is available upon request.
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
8/20/1999
Transmittal Notice
Explanation of Material Transmitted: Chapters and Appendices within NIH Manual 1500 have been issued and dated individually as listed below, beginning 8/20/99*. Since that time, some chapters/appendices have been completely revised, while others have had partial revisions. The most recent revision/partial revision date is reflected below next to each respective chapter/appendix.
*Note: Partial Revision Dates Listed by Corresponding Chapters/Appendices Below
FTR Links: GSA has recently modified its Web site display of FTR Chapters 300-304. As a result, a new GSA Portal page is available at: http://www.gsa.gov/portal/content/104790.
The chapters within NIH Manual 1500 are as follows:
Chapter 1500-01: Introduction to Official Government Travel
Chapter 1500-02: Traveler Responsibilities
Chapter 1500-03: Transportation
Chapter 1500-04: Per Diem and Other Allowable Expenses
Chapter 1500-05: Advance of Funds/Government-Issued Charge Card
Chapter 1500-07: International Travel
Chapter 1500-09: Relocation Allowances
Chapter 1500-10: Temporary Duty (TDY) Travel and Relocation of Non-FTE Persons
Chapter 1500-11: Use of NIH Official Travel Management Center
Chapter 1500-12: Travel for Consultants, Experts, Private Citizens and Foreign Visitors
Chapter 1500-13: Premium-Class Airline Accommodations
Chapter 1500-15: Travel and Transportation Reform Act of 1998 Requirements
Chapters Icon Recently Rescinded Chapters
Use of Official Telegraph Services
26101-35-1
8/05/2021
Transmittal Notice
- Explanation of Material Transmitted: This chapter is rescinded. Manual Chapter 26101-35-1 is obsolete since faster, less expensive, and more convenient technologies such as cell phones, email, etc. have largely replaced the use of telegraph/telex services. Questions related to this can be directed to the NIH Service Desk at https://itservicedesk.nih.gov/support/.
-
Filing Instructions:
-
Remove: NIH Policy Manual, Chapter 26101-35-1, dated 2/28/1994
-
Insert: NIH Policy Manual, Chapter 26101-35-1, dated 8/5/2021
- 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.
Updating The NIH Telephone And Service Directory
1757
8/05/2021
Transmittal Notice
- Explanation of Material Transmitted: This chapter is rescinded. Manual Chapter 1757 is obsolete since the published personnel listings and the NIH Telephone Operator’s Locator Database are now sourced from the NIH Enterprise Directory (NED). NIH Employees and contractors can update their NED information at: http://ned.nih.gov (Click on “Update” at this site for detailed instructions). For deletions, contact your Administrative Officer (AO). Questions related to this can be directed to the NIH Service Desk at https://itservicedesk.nih.gov/support/.
- Filing Instructions:
- Remove: NIH Policy Manual, Chapter 1757, dated 10/1/1994
- Insert: NIH Policy Manual, Chapter 1757, dated 8/5/2021
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.
Cable Television Services
26101-26-37
8/05/2021
Transmittal Notice
- Explanation of Material Transmitted: This chapter is rescinded. Manual Chapter 26101-26-37 is obsolete since the use of faster, less expensive, and more convenient Internet technologies has largely replaced the dedicated-use television services. Questions and service requests related to this can be directed to the NIH Service Desk at https://itservicedesk.nih.gov/support/.
- Filing Instructions:
-
Remove: NIH Policy Manual, Chapter 26101-26-37, dated 2/28/1994
-
Insert: NIH Policy Manual, Chapter 26101-26-37, 8/5/2021
- 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.
Change of Grantee Institution
55201
6/11/2020
Transmittal Notice
- Explanation of Material Transmitted: Content previously contained in this Chapter is purely procedural and will be relocated into a grants management procedural document referred to as a “How-To’s and linked to an appropriate Grants Administration Manual under the 5000 series.” Therefore, this Chapter is rescinded.
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 55201, dated 12/15/2000
Insert: OPERA will maintain the How-To document.
PLEASE NOTE: For information on:
- Content of this chapter, contact the Division of Grants Policy (DGP) within the Office of Extramural Research Policy Administration (OPERA) at the phone number listed above, or at GrantsPolicy@od.nih.gov ; or
- NIH Policy Manual, contact the Division of Management Support, OMA on 301-496-4606, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Notification to Unsuccessful Applicants and Inactivation of Favorably Recommended but Unfunded Applications
54502
6/11/2020
Transmittal Notice
- Explanation of Material Transmitted: Content previously contained in this Chapter is purely procedural and will be relocated into a grants management procedural document referred to as a “How-To’s and linked to an appropriate Grants Administration Manual under the 5000 series.” Therefore, this Chapter is rescinded.
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 54502, dated 4/10/1987
Insert: OPERA will maintain the How-To document.
PLEASE NOTE: For information on:
- Content of this chapter, contact the Division of Grants Policy (DGP) within the Office of Extramural Research Policy Administration (OPERA) at the phone number listed above, or at GrantsPolicy@od.nih.gov ; or
- NIH Policy Manual, contact the Division of Management Support, OMA on 301-496-4606, or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.