Chapters Icon Recently Released Chapters
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 (IRP). 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. Upon implementation, 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.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-201, dated 11/19/2020 Partial Revision Date: 05/04/2022
- 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://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx
Transmittal Notice
- Explanation of Material Transmitted: This revised chapter establishes responsibility for humane care and use of animals within the intramural program of NIH. Minor changes have been provided to the main document to include further defining individual responsibilities, and the Animal Study Proposal form has streamlined needed information for some sections. Partial Revision Date 03/18/2022: Revised Section B. Scope for clarity, updated Section F. Responsibilities for IC-ACUC to revise animal activities frequency of required reviews from annually to triennially (see F.13.b.xix) based on revisions to 9 CFR 2.31(d)(5), and corrected links, references, and citations.
- Filing Instructions:
- Remove: NIH Manual Chapter 3040-2, dated 02/27/2008.
- Insert: NIH Manual Chapter 3040-2, dated 04/22/2014; Partial Revision: 03/18/2022
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: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Transmittal Notice
- Explanation of Material Transmitted: This policy establishes responsibilities and procedures for registration and results information reporting of clinical trials and natural history or observational clinical studies (“NH/O studies”) to ClinicalTrials.gov when the clinical trial or NH/O clinical studies are conducted or supported by the Intramural Research Program (IRP) of the National Institutes of Health (NIH), consistent with the requirements of NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) (hereinafter referred to as “the NIH Policy”), Section 801 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 282(j)) (hereinafter referred to as “FDAAA”), and the Final Rule for Clinical Trials Registration and Results Information Reporting (42 CFR Part 11) (hereinafter referred to as “the regulation”).
- Filing Instructions:
- Remove: N/A
- Insert: NIH Manual Chapter 3007, dated 01/14/2022
- PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Management Operations Branch, 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.
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 (IRP). This policy describes the levels of ethical review and criteria for approval of human subjects research by the National Institutes of Health (NIH) Institutional Review Board (IRB) (i.e., review by the convened IRB, expedited procedures, limited IRB procedures, or exempt procedures). Partial Revision 1/04/2022: This policy has been revised to remove the requirements for a fixed anniversary date for NIH IRB-approved protocols, consistent with IRBO practice, and provides examples of when the NIH IRB may require continuing review more often than annually.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-204, dated 10/01/2020 Partial Revision Dated: 01/04/2022
- 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, 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 revised chapter incorporates by reference as Appendix 1 the current edition of the NIH Intramural Research Program Policies & Procedures for Research Misconduct Proceedings (hereinafter “IRP RM Policy”). This chapter’s former title and content have been updated to ensure consistency with the current policies and procedures set forth in the IRP RM Policy.
- Filing Instructions:
- Remove: 3006 – Policies and Procedures Relating to Possible Scientific Misconduct in the IRP at NIH, dated 02/15/1991
- Insert: 3006 – NIH IRP Research Misconduct Proceedings, dated 12/28/2021
- PLEASE NOTE:
- For inquiries regarding the content of this chapter contact the Agency Intramural Research Integrity Officer (AIRIO), Office of Intramural Research (OIR), Office of the Director, NIH: AIRIO@nih.gov or 301-451-7764. Additional information on the handling of research misconduct allegations in the intramural research program (IRP) is located at the following URL: https://oir.nih.gov/sourcebook/ethical-conduct/research-misconduct
- For inquiries regarding the NIH Policy Manual contact the Management Operations Branch (MOB), Division of Compliance Management (DCM), Office of Management Assessment (OMA) at 301-496-4606, or navigate to the following 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: 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
Transmittal Notice
1. Explanation of Material Transmitted: The material transmitted contains amended language in order to reflect recent changes to the FTR and corresponding HHS policies and procedures, as well as other necessary edits. Specifically, the more important changes include: 1) information inclusive of a web site address for the GSA Federal Premier Lodging Program facilities; 2) clarification regarding policy on temporary duty (TDY) travel and annual leave; 3) guidance on emergency travel, i.e., when an employee is injured or becomes ill while in TDY travel status; 4) additional guidance on the authorization and approval of an Actual Expense Allowance; 5) new HHS policy on reimbursement for laundry/dry cleaning expenses; 6) clarification regarding NIH policies and procedures on mechanisms used to pay for registration fees; 7) information on the use of a cell phone to make a personal call home while in TDY travel status; and 8) the rescinding of the GSA Conference Planning regulation that permitted the use of appropriated funds for light
Partial Revisions: 9/5/06*, 4/29/08**, 4/23/12***, 6/04/12****, 11/04/13*****, 01/30/14******, and 02/10/15*******
* NIH Manual 1500-04-07 Section E was revised 9/5/06 to reflect recent changes in HHS policy.
** NIH Manual 1500-04-07 Section E(5) was revised 4/29/08 to update requirements surrounding the reimbursement for personal phone calls home while in TDY travel status, in a foreign location. As long as an estimate of the costs for such phone calls is displayed on the Travel Authorization, there will no longer be a stipulation that the reimbursement is only to be limited to the international transmitting costs plus not to exceed the first three minutes of conversation.
*** NIH Manual 1500-04, the following Chapters are revised/added on 4/23/12:
- Revised 1500-04-06, Section F(3) and G(3) was revised to no longer require an AEA memo for in-kind sponsor lodging.
- Revised 1500-04-07, Section A was revised involving reimbursement for checked baggage, internet fees, GPS for a rental car, and laundry, cleaning and pressing of clothing.
- Added 1500-04-10, NEW NIH Policy for Compensatory Time for Travel (CTT) is issued prescribing use of new NIH Form 2920-1, NIH Compensatory Time for Travel (CTT) Request and Approval Form.
****NIH Manual 1500-04, the following Chapters are revised on 6/04/12:
- 1500-04-03, Section B to update the Meal Reduction Table for CONUS Locations
- 1500-04-04 and 1500-04-05, Sections A and C are completely revised to bring these sections of the NIH Manual Chapter in agreement with the HHS Travel Manual (January 2012)
*****NIH Manual 1500-04, the following are partially revised/rescinded on 11/04/13 as a result of the Conference Lodging Allowance being abolished:
- 1500-04-06 – “Actual Expense Allowance (AEA),” Section F(1) revised to delete paragraph regarding Conference Lodging Allowance
- 1500-04-09 – “Conference Planning - Conference Lodging Allowance,” rescinded in its entirety
******NIH Manual 1500-04, the following Chapter is partially revised on 1/30/14:
- 1500-04-07, Section D is revised to capture current HHS Efficient Spending Policy that requires approval of conference attendance prior to the obligation of registration fees.
*******NIH Manual 1500-04, the following Chapter is rescinded on 2/10/15:
- 1500-04-10 – "NIH Policy for Compensatory Time for Travel (CTT)" is rescinded, NIH CTT policy can be found in NIH Policy Manual, Chapter 2300-550-3, “Compensatory Time off for Travel.”
2. Filing Instructions: This revised version of Chapter 04 is to replace the previously issued version of this chapter.
PLEASE NOTE: For information on:
- Content of this chapter, contact the Office of Financial Management on 301-496-4379 or 301-402-8831.
- NIH Manual System, contact the Office of Management Assessment, OM on 301-496-2832, or enter this URL: http://oma.od.nih.gov/public/MS/manualchapters/Pages/default.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: 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
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 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.
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.
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.
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.
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.