The Office of Research Integrity (ORI) is pleased to announce the publication of new guidance documents for the updated Final Rule. These documents provide institutions with practical resources tailored to meet the complexities of the updated regulation. Each document acts as a roadmap of best practices to help institutions align their processes with ORI’s regulatory compliance expectations.
What Institutions Can Expect
This release includes guidance documents that focus on key topic areas described in the Public Health Service Policies on Research Misconduct (42 CFR Part 93) to assist institutions in complying with the updated regulation.
New topic-specific guidance documents released in May 2026 include:
- State of Mind (pdf): This document is designed to clarify how to determine the state of mind of the respondent when evaluating if the evidence supports a finding of research misconduct.
- Respondents (pdf): This document provides guidance for institutions about respondents, including multiple respondents as outlined in the updated regulation.
- Institutional Record Best Practices (pdf): This document highlights best practices to help institutions compile and organize the institutional record during research misconduct proceedings.
ORI will continue to release guidance documents throughout 2026, and 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 so they can appropriately address research misconduct proceedings. 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.
The effective implementation of the updated Final Rule is vital to upholding the integrity of research conducted under PHS funding. The phased release of ORI’s guidance documents will ensure that institutions are well-equipped to meet the updated regulatory landscape.
