The Office of Research Integrity (ORI) is pleased to announce the release of the second phase of updated Final Rule Guidance Documents. As we approach the applicable date of the 2024 Final Rule on Public Health Service Policies (PHS) on Research Misconduct, ORI is dedicated to guiding institutions in successfully complying with regulatory requirements. Our aim is to ensure a clear understanding of the updated regulation and to foster environments that prioritize research integrity. The updated regulation will apply to all institutions on January 1, 2026.
What Institutions Can Expect
This next 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.
The second group of documents are topic-specific and are intended to clarify key issues:
- Honest Error Guidance (pdf): This document describes the role of honest error and how making a determination of honest error influences a research misconduct proceeding.
- Admissions Guidance (pdf): This document explains the components of a respondent admission statement, the accompanying statement from an institution, and carrying institutional research misconduct proceedings to completion in the event of an admission.
- Pursuing Leads Guidance (pdf): This document provides details on how to pursue leads during an institutional research misconduct investigation.
- Sub-Awardee Assurances Guidance (pdf): This document explains how all recipients of PHS support, including sub-awardees, must establish and maintain an active research integrity assurance with ORI.
- Assessments Guidance (pdf): This document describes the assessment (the first phase of institutional research misconduct proceedings) including how to document assessments and distinguishing them from institutional inquiries.
As we continue to roll out additional guidance documents in phases throughout 2025 and 2026, stakeholders can look forward to more resources focusing on priority areas including institutional and administrative records, levels of intent, multiple institutions, interviews, subsequent use exception, confidentiality, and other topics.
Please note: Some of the newly released guidance cross-reference other guidance documents that have not yet been released. Users should expect these 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 closely read 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 on 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 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.
