The Office of Research Integrity (ORI) is dedicated to promoting the responsible conduct of research and preserving the integrity of public health advancements. The guidance on this webpage is intended to help institutions adapt to the updated Final Rule on Public Health Service (PHS) Policies on Research Misconduct released in 2024. In 2025, ORI began releasing comprehensive guidance documents designed to aid institutions in developing compliant policies and procedures. ORI will continue to equip institutions with essential resources, including sample policies and templates, guidance on key topics, and policies on emerging topics. ORI’s aim is to ensure effective adherence to the updated regulation. ORI’s guidance documents are divided into several key areas:
Institutional Infrastructure and Policy Foundations
These guidance documents focus on the structural setup, formal policies, and key administrative roles required of institutions under 42 CFR Part 93:
Implementation Guidance (pdf): This document provides clarity on the difference between the effective date and applicable date of the updated regulation, ensuring that institutions are well-prepared to transition smoothly.
Writing Policies and Procedures Guidance (pdf): This document emphasizes the importance of compliance, providing guidance for institutions to develop their own research misconduct policies that align with PHS regulations.
Sample Policies and Procedures (pdf): Designed to be customizable, this document offers template policies and procedures to facilitate compliance with PHS standards and enable institutions to implement effective frameworks.
Small Institution Guidance (pdf): This document provides specialized resources to assist smaller institutions in aligning their policies with the PHS regulations. See also the Small Institution Statement (PDF fillable form).
RIOs and Institutional Officials Guidance (pdf): This document highlights the different responsibilities of institutional roles including the Research Integrity Officer, the Institutional Deciding Official, and the Institutional Certifying Official.
Institutional Committees Guidance (pdf): This guidance document describes some considerations for institutions as they draw upon committee members’ expertise to support research misconduct proceedings.
Handling Allegations
These guidance documents cover the active, step-by-step phases of handling an allegation, from initial receipt through formal proceedings:
Confidentiality Guidance (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.
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.
Conflicts of Interest Guidance (pdf): This guidance document describes how institutions can take precautions to ensure that officials and members honestly and impartially carry out their duties and do not have unresolved personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
Subsequent Use Exception Guidance (pdf): This document describes how the subsequent use exception in research misconduct proceedings is applied in the updated regulation.
Respondents Guidance (pdf): This document provides guidance for institutions about respondents, including multiple respondents as outlined in the updated regulation.
Pursuing Leads Guidance (pdf): This document provides details on how to pursue leads during an institutional research misconduct investigation.
Interviews Guidance (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.
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.
Evidence, Records, and Jurisdictional Boundaries
These guidance documents address the management of physical and digital research evidence, confidentiality, and complex jurisdictional scenarios:
Research Records Guidance (pdf): This document describes the wide range of research records and other evidence that may be needed to complete a research misconduct proceeding.
Institutional Record Guidance (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.
Institutional Record Best Practices Guidance (pdf): This document highlights best practices to help institutions compile and organize the institutional record during research misconduct proceedings.
Multiple Institutions Guidance (pdf): This guidance document is intended to help institutions navigate research misconduct proceedings involving multiple institutions.
Standards of Proof and Exceptions
These guidance documents focus on the legal and scientific standards used to determine misconduct, alongside modern regulatory challenges:
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.
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.
State of Mind Guidance (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.
Emerging Issues
These guidance documents focus on emerging issues in research integrity and research misconduct as they arise:
Generative Artificial Intelligence Guidance (pdf): This document provides guidance to institutions as they navigate research misconduct proceedings involving generative AI.
Please note: Some of the newly released guidance may cross-reference other guidance documents that ORI has not yet released. Users can expect these referenced guidance documents to be released by ORI in the near future.
Join us in fostering an environment of research integrity. This webpage will be updated with new guidance documents as they are prepared for release.
The updated regulation can be viewed here. For inquiries about the implementation of the updated Final Rule, stakeholders can reach out to AskORI@hhs.gov.
