1. Explanation of Material Transmitted: This policy describes the responsibilities of NIH Investigators, non-NIH Investigators, NIH Sponsors, and the NIH Institutional Review Board (IRB) when conducting or reviewing human subjects research (HSR) that involves the use of drugs, biological products, or nutritional products (e.g., dietary supplements or foods) that are under the oversight of the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). 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. Partial Revision 10/30/2023: This revision adds flexibility at E.1.a.V.ii. for notifying the IRB of updates to the Investigator Brochure (IB) if the changes do not adversely impact the risk-benefit assessment. Partial Revision 8/02/2025: This revision clarifies that NIH PIs must report to the IRB when the Sponsor has withdrawn the IND.
2. Filing Instructions:

• Insert: NIH Manual Chapter 3014-500, dated 04/20/2020, Partial Revision Date: 08/02/2025
• Implementation Date: 10/26/2020

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 chapter outlines the NIH policy for determining General Schedule (GS) salaries for employees. It covers the process for setting pay above the minimum step based on exceptional qualifications, special needs, using the highest previous rate, the maximum payable rate, etc. This revision incorporates the final pay setting guidance published by the Office of Personnel Management (OPM) in January 2024, added sections of Scope and Responsibility, and includes updates to the issuing office information.
2. Filing Instructions:

Remove: NIH Manual 2300-531-2, dated 11/25/2014.
Insert: NIH Manual 2300-531-2, dated 06/16/2025.

PLEASE NOTE: For information on:

• Content of this chapter, contact the issuing office listed above.
• NIH Manual System, contact the Division of Compliance Management, OMA on 301-496-2832, or enter this URL:  https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx 

1. Explanation of Material Transmitted: 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. Partial Revision 07/21/2024: Revisions including grammatical corrections, formatting to bring this very old policy into our more current structure, and removing inline external links so that external links reside only in References which should make the policy links easier to manage. Partial Revision 04/28/2025:  To revise the policy to add needed flexibility for unaffiliated IRB members.
2. Filing Instructions:
   • Insert: NIH Manual Chapter 3014-103, dated 05/07/2019, Partial Revision Date: 04/28/2025
   • Implementation Date: 06/01/2019
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, 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 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.
2. 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

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 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.
2. Filing Instructions:

• Insert: NIH Manual Chapter 3014-106, dated 08/03/2020; Partial Revision: 09/09/2024
• Implementation Date: 10/12/2020

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