DUHS IRB Policy Updates

The DUHS IRB continues to update its policies in support of AAHRPP re-accreditation process and to improve usability for the research community.  Building on the initial policy updates announced over the last 9 months, several additional policies have transitioned to the enhanced template format and will be effective 09/01/2026, and will be available on our website on August 13, 2026 in preparation:

1. IRB-1400 Promptly Reportable Information
   1. Version 1.0, Effective Date 09/01/2026:  This revision combines and replaces “Non-Compliance with the Requirements of the Human Research Protection Program (03/25/2021)”, “Problems or Events That Require Prompt Reporting to the IRB (11/20/2023)”and “The Review of Problems, Complaints, Comments, Concerns, or Allegations of Noncompliance from Investigators or Research Participants (11/22/2023)”. Timelines have been revised for consistency, and provided additional information is provided on SUSAR’s based on “Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices (December 2025-FDA)
2. IRB-1450 IRB Review and Reporting of Promptly Reportable Information
   1. Version 1.0, Effective Date 09/01/2026:  This revision combines and replaces “Non-Compliance with the Requirements of the Human Research Protection Program (03/25/2021)”, “Problems or Events That Require Prompt Reporting to the IRB (11/20/2023)”and “The Review of Problems, Complaints, Comments, Concerns, or Allegations of Noncompliance from Investigators or Research Participants (11/22/2023)” and “Reporting to DUHS Officials and Federal Agencies (11/20/2023).  This document is intended to supplement IRB 1400 and specifically the IRB review and reporting responsibilities, ensure timely reporting to federal agencies, and provide additional information on SUSAR’s based on “Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices (December 2025-FDA)

The DUHS IRB will be conducting “Promptly Reportable Information Training” during DOCR Research Wednesday Series on September 23, 20206 to review policy 1400 and 1450 and Promptly Reportable Information, the revisions, and answer questions.

 Several additional policies have also received minor updates.  These revisions address immediate guidance and operational needs and will be incorporated into the enhanced template during future policy revisions as applicable.

1. Reliance on an External Institutional Review Board (IRB Policy)
   1. Version 2.1: Effective Date 06/30/2026- Minor revision to clarify when DUHS will rely on an external IRB and clarification on DUHS responsibilities and oversight.
2. Investigator Conflicts of Interest Managed by the Duke University School of Medicine Conflict of Interest Committee
   1. The policy was revised to include how the DUHS IRB will have ongoing oversight and monitoring of Conflicts of Interest through the IRB’s standard review processes, such as review of updated management plans at time of continuing review, incorporation into consent forms as applicable, and monitoring by the Office of Audit, Risk, and Compliance as requested. (06/27/2026)
3. On-Going Training for IRB Office Staff, Chairs, and IRB Members
   1. This policy was revised to include additional information on what type of training the IRB may provide its members, and how often they may be repeated (06/24/2026)
4. Department of Defense (DoD) Research
   1. This policy was revised to replace direct regulatory citations with both the citation and referenced DoD language per AAHRPP’s standards (06/22/2026) 
5. Research Involving Drugs or Biologics
   1. This policy was revised to explicitly state that DUHS IRB will not accept investigator brochures (IB’s) as the sole documentation of an IND per AAHRPP’s standards (06/18/2026)
6. HRPP Emergency Preparedness Plan
   1. This policy was revised to include a reassessment period as required per AAHRPP’s standards (06/12/2026)
7. Research for Which Review by the DUHS HRPP is required
   1. This policy was revised for consistency with OHRP regulatory language related to exemption categories, and to include references for ongoing oversight and reportable information (06/10/2026)