1. Explanation of Material Transmitted: This policy describes the scope and authority of the NIH intramural Institutional Review Board (IRB) and the Research Compliance Review Committee (RCRC) which is also a duly constituted IRB. This policy partially supersedes the Introduction to the NIH Human Research Protection Program (HRPP) and fully supersedes SOPs 1 Human Subjects Research and the NIH IRB System and 2 IRB Membership and Structure. Partial Revision 02/06/2025: Incidents of undue influence upon an IRB member may also be reported to the NIH IRB Executive Chair in addition to the IRBO Director or OHSRP Director.
2. Filing Instructions:
   • Insert: NIH Manual Chapter 3014-200, dated 12/09/2019
   • Implementation Date: 09/21/2020
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: 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. This policy describes the requirements for research involving adults who lack the decision-making capacity to consent to research participation.  Upon implementation, this policy fully supersedes SOP 14E – Research Involving Adults Who Are or May Be Unable to Consent and partially supersedes SOP 14A – Research Involving Vulnerable Subjects (General Considerations). Partial Revision 12/18/2024: This revision clarifies requirements, for seeking assent  from adults who lack capacity to consent, when appropriate.
2. Filing Instructions:

• Insert: NIH Manual Chapter 30-403, dated 05/13/2020
• Implementation Date: 09/14/2020

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 organizational structure of the NIH Office of Human Subjects Research Protections (OHSRP) and the functions of the established offices located within OHSRP. Partial Revision 06/07/2021: Sections E.1.b and E.2.b. are revised to describe the assessment of resources by the OHSRP Director. Partial Revision 11/21/2022: This revision specifies that the OHSRP office of Policy and Accreditation establish and maintain a Continuity of Operations Plan (COOP) and HRPP Mission Essential Function (MEF) in case of an emergency that impacts the NIH IRP HRPP and the rights, safety or welfare of its research subjects. Partial Revision 12/06/2024: This revision specifies responsibilities of the NIH Intramural Research Program (IRP) Institutional Officials (IOs) consistent with the updated Delegation of Authority, General No. 44.
2. Filing Instructions:

• Insert: NIH Manual Chapter 3014-101, dated 07/09/2019, Partial Revision Date: 06/07/2021; Partial Revision Date: 11/21/2022; Partial Revision Date: 12/06/2024
• Implementation Date: 09/21/2020

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 Management Support, 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 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 alteration 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. Partial Revision 02/13/2024: This revision includes updated requirements for informed consent for non-English speaking subjects which takes effect March 1, 2024, and recommendations from the recent consolidated FDA guidance on informed consent. In addition, this revision incorporates regulatory changes at 21 CFR 50.22 for waiver or alteration of informed consent elements or waiver to obtain informed consent for FDA-regulated minimal risk research which took effect January 22, 2024. Partial Revision 10/02/2024: This revision includes requirements for the consent of persons who are blind/illiterate at E.2.i.
2. Filing Instructions:
   Insert: NIH Manual Chapter 3014-301, Dated 03/23/2021
   Implementation Date: 03/30/2021
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 chapter provides guidelines and requirements for handling all requests for leave for family responsibilities. This transmittal provides updates to formatting, hyperlinks, and references. A Scope section has replaced the former Coverage section. Within the Scope and Policy sections, updates have been made to include Paid Parental Leave and Parental Bereavement leave policy guidelines. The Records Retention and Disposal section and the Internal Controls section have been removed as they are no longer required.
2. Filing Instructions: 
   
   Remove: NIH Manual 2300-630-5, dated 04/04/2016
   Insert: NIH Manual 2300-630-5, dated 09/18/2024

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.