1. 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. Partial Revision 09/10/2024: Addition of the Tribal Health Research Office as a component of the NIH IRP HRPP and the newly established Human Fetal Tissue Review Committee as an ancillary review committee for IRP research.
2. Filing Instructions:

• Insert: NIH Manual Chapter 3014-100, dated 11/19/2020, Partial Revision Date: 11/07/2022, Partial Revision Date: 09/10/2024

• Implementation Date: 11/24/2020

3. PLEASE NOTE:

• The current policies can also be found at: https://irbo.nih.gov/confluence/display/ohsrp/Policy.

• 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 enter this URL:  https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx

1. Explanation of Material Transmitted: This policy describes the requirements for NIH investigators for expanded access to, including emergency use of, investigational drugs, biologics and medical devices (test articles), and to the NIH IRB when it is reviewing expanded access and emergency use submissions. Upon implementation, this policy partially supersedes the following HRPP Standard Operating Procedure (SOP), SOP 15A - Research Regulated by the Food and Drug Administration (FDA): Information and Policies Specific to Research Involving Investigational New Drugs (Including Biological Products and partially supersedes SOP 15B  Research Regulated by the Food and Drug Administration (FDA): Information and Policies for Investigational Device Exemption (IDE) Applications. Partial Revision 09/10/2024: To clarify ancillary reviews are required by policy for intermediate-size patient population and treatment IND expanded access protocols.
2. Filing Instructions:
   • Insert: NIH Manual Chapter 3014-502, dated 4/20/2020; Partial Revision: 09/10/2024
   • Implementation Date: 10/26/2020

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  

1. Explanation of Material Transmitted:  This policy describes how financial and non-financial conflicts of interest in human subjects research are managed to assure the protection of human subjects and the scientific integrity of the research; and describes how institutional conflicts of interest arising from government royalty rights are managed to assure the protection of human subjects and the scientific integrity of human subjects research at the NIH. Upon implementation, this policy fully supersedes the SOP 21 Conflict of Interest Requirements for Researchers and Research Staff. Partial Revision Date 12/21/2022: This policy is revised to indicate that there is only one Conflict of Interest (COI) Certification to be signed by any NIH investigator or statistician working on a Covered Research Protocol (CRP) who is not an NIH ethics filer. This policy is also revised to reflect process changes brought about by the implementation of the PROTECT electronic IRB system. Partial Revision Date 09/09/2024: This policy is revised 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 under review. Investigators are reminded to consult OHSRP for questions about whether the protocol is a Covered Research Protocol.
2. Filing Instructions:

• Insert: NIH Manual Chapter 3014-102, dated 11/06/2020, Partial Revision Date: 12/21/2022, Partial Revision Date: 09/09/2024
• Implementation Date: 3/1/2021

3. 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

1. Explanation of Material Transmitted: This Manual Chapter pertains to the direct acquisition of printing requirements, as well as printing that is a supplementary deliverable in a contract for a larger purpose. This Manual Chapter is being revised to establish the HHS Program Support Center (PSC) as the servicing entity for NIH printing requirements; to reflect current office titles and acronyms; to revise dates; and to update provisions as necessary, including updated links and procedures to be utilized in preparing and submitting forms needed to acquire printing services at NIH.
2. Filing Instructions:

          Remove: NIH Manual Chapter 6308, dated 01/05/2015
          Insert: NIH Manual Chapter 6308, dated 07/31/2024

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

1. 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.
2. 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
3. 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