The Office of Research Integrity (ORI) is pleased to announce the publication of new guidance documents for the updated Final Rule. The updated regulation now applies to all institutions as of January 1, 2026. 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 March 2026 include:
- Confidentiality (pdf): This document is designed to assist institutions in understanding confidentiality requirements during research misconduct proceedings, including limits on disclosure, secure handling of records, and reporting to ORI.
- Interviews (pdf): This guidance document provides practical considerations involving interviews during research misconduct proceedings such as what interactions qualify and the requirements involving interviews in the updated regulation.
- Subsequent Use Exception (pdf): This document describes how the subsequent use exception in research misconduct proceedings is applied in the updated regulation.
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 documents that have not yet been released. Users can expect these guidance documents and others to be released in the near future.
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.
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.
