The Office of Research Integrity (ORI) is pleased to announce the release of new guidance documents for the updated Final Rule. The updated regulation will apply to all institutions on January 1, 2026. As we approach the applicable date of the 2024 Final Rule on Public Health Service (PHS) Policies on Research Misconduct, ORI is dedicated to guiding institutions in successfully complying with regulatory requirements. Our aims are to ensure a clear understanding of the updated regulation and to foster environments that prioritize research integrity. 

What Institutions Can Expect

This release includes guidance documents that focus on key topic areas described in the Public Health Service Polices on Research Misconduct (42 CFR Part 93) to assist institutions in complying with the updated regulation.

New topic-specific guidance documents released in December 2025 include:

1. Institutional Records (pdf): This document is designed to assist institutions in producing a complete institutional record including reports, interviews, research records, and other documents and information compiled during a research misconduct proceeding.

2. Research Records (pdf): This document describes the wide range of research records and other evidence that may be needed to complete a research misconduct proceeding.

3. Multiple Institutions (pdf): This guidance document is intended to help institutions navigate research misconduct proceedings involving multiple institutions.

As we continue to roll out additional guidance documents in phases throughout 2026, stakeholders can look forward to more resources focusing on priority areas.

Please note: Some of the newly released guidance documents cross-reference other guidance areas that have not yet been released. Users should expect referenced guidance documents to be released in the near future. Additionally, some guidance documents refer to new and updated forms. ORI expects to release these updated forms shortly. 

What Institutions Can Do

We encourage all institutions and their counsel to read closely the newly released guidance documents in order to ensure appropriate handling of research misconduct proceedings. ORI also urges institutions to take proactive steps to prepare for the updated Final Rule by reviewing the newly released documents and beginning to develop specific policies and procedures. Remember, institutions must submit their updated assurance of research misconduct policies and procedures as part of the 2025 Annual Report due by April 30, 2026.

To access the new Guidance Documents and stay updated on our phased rollout plan, please visit our website at https://ori.hhs.gov/guidance-documents or contact  AskORI@hhs.gov for any inquiries.

Let's work together to institutionalize research integrity and accountability! Stay tuned for more updates from ORI as we continue to support institutions with compliance and in building a culture of research integrity. Your commitment to maintaining the highest standards of research integrity is vital for advancing science and our nation's health.