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 human subjects protection educational requirements for NIH investigators, NIH IRB members, and the Office of Human Subjects Research Protections (OHSRP). Upon implementation, this policy fully supersedes the SOP 25 – Training Requirements for the NIH Human Research Protection Program (HRPP). Partial Revision 11/07/2022: Addition of new training requirements for Associate Investigator post-doctoral Intramural Research Training Awardees (IRTAs)/Cancer Research Training Awardees (CRTAs) and post-doctoral Visiting Fellows (VFs) who obtain informed consent of subjects.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-103, dated 05/07/2019, Partial Revision Date: 11/07/2022
- Implementation Date: 06/01/2019
- 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, 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 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. Partial Revision 11/7/2022: This revision distinguishes coverage under the NIH Federalwide Assurance (FWA) between Intergovernmental Personnel Act (IPA) appointees and detailees. This revision also specifies the requirement for a continuity plan in case of an emergency that impacts the NIH IRP HRPP and the rights, safety or welfare of its research subjects, for the OHSRP and the NIH IRB.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-100, dated 11/19/2020, Partial Revision Date: 11/07/2022
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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.
-
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
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 investigators regarding informed consent for non-exempt and certain exempt human subjects research. This policy also describes the requirements for the NIH Institutional Review Board, as the Reviewing IRB when reviewing and approving informed consent documents and procedures, or for waiver or alternation of consent, including waiver or alteration of documentation of informed consent. Technical Revision 5/20/2021: Updated links to the new Telehealth policies 3014-301 and M20-1 and added reference to the FDA guidance on planned emergency research. Partial Revision 11/7/22: This revision clarifies the educational and supervisory requirements for post-doctoral Intramural Research Training Awardees (IRTAs)/Cancer Research Training Awardees (CRTAs) and Visiting Fellows (VFs) when obtaining informed consent.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-301, dated 03/23/2021
- Implementation Date: 03/30/2021
- 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
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 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.
- Filing Instructions:
- Insert: NIH Manual Chapter 3014-300, dated 3/23/2021, Partial Revision 11/7/2022, Technical Revision Date: 8/5/2021
- 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
Transmittal Notice
- Explanation of Material Transmitted: This chapter provides guidance for restricting and/or removing individuals from the NIH grounds or facilities for inappropriate conduct or threatening and/or disruptive behavior. This policy defines the roles, responsibilities, and procedures for the restriction and/or removal of an offending individual and in determining the length of time of the restriction. This chapter has been revised to include the role of National Institutes of Health (NIH) Civil Program throughout, current records retention schedule, emergency information for Bayview/Baltimore, Maryland, and the appeals process for individuals with medical limitations.
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 2300-752-3, dated 03/07/2014
Insert: NIH Policy Manual, Chapter 2300-752-3, dated 10/17/2022
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 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: 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, NIH 2300-600-1 - NIH Telework Policy, is hereby rescinded in its entirety since it has been superseded by HHS policy guidance regarding Workplace Flexibilities. Please refer to HHS Instruction 990-1, Workplace Flexibilities, dated March 22, 2022 for guidance, as well as the NIH OHR Workplace Flexibilities (WPF) website for WPF program requirements. The HHS Instruction can be found at: https://www.hhs.gov/about/agencies/asa/ohr/hr-library/990-1/index.html, and the OHR Workplace Flexibilities website at: https://hr.nih.gov/working-nih/workplace-flexibilities.
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 2300-600-1 dated 10/30/2003
Insert: None
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above.
- 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: This chapter, NIH 1965 –NIH Evaluation Set-Aside Program, is hereby rescinded in its entirety. The program was suspended in February 2015. In the Consolidated and Further Continuing Appropriations Act, 2015, Congress substantially changed the distribution of Public Health Service (PHS) Evaluation Funds. As a result of these changes, HHS decided not to make any PHS Evaluation Funds available for internal use activities at NIH in FY 2015. Consequently, the program was unable to accept applications from ICs and OD offices for evaluations and evaluation-related activities in the absence of funds. Congress and HHS have followed this general course of action in FY 2016 and beyond; thus, the program is discontinued permanently.
- Filing Instructions:
Remove: NIH Policy Manual, Chapter 1965, dated 02/27/2017
Insert: None
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above.
- NIH Policy Manual, contact the Division of Compliance Management (DCM), OMA on 301-496-4606, or: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
Transmittal Notice
- Explanation of Material Transmitted: The FEORP information in this manual chapter is obsolete. FEORP is now managed internally through the Office of Human Resources (OHR). For further FEORP information please contact OHR/Client Services Division, Corporate Recruitment Unit information at https://hr.nih.gov/about/organizational-chart/client-services-division-csd.
- Filing Instructions:
Remove: Manual Issuance 2203, dated 05/14/93
PLEASE NOTE: For information on:
- Content of this chapter, contact Frances Davis at 301-451-1785 or email at Frances.Davis@nih.gov or Kyle Hartwig at 301-435-7276 or e-mail at Kyle.Hartwig@nih.gov.
- 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: 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:
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Remove: NIH Policy Manual, Chapter 26101-26-37, dated 2/28/1994
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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: 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
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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.