Welcome to ORI’s 2024 Final Rule Guidance

The Office of Research Integrity (ORI) is dedicated to promoting the responsible conduct of research and preserving the integrity of public health advancements. As we prepare for the upcoming 2024 Final Rule on Public Health Service (PHS) Policies on Research Misconduct, we encourage all PHS-funded institutions to stay informed and engaged. In June 2025, ORI began releasing comprehensive guidance documents designed to aid institutions in developing compliant policies and procedures. The rollout will equip institutions with essential resources, including sample policies, implementation guidance, and key topic areas, to ensure effective adherence to the updated regulation. 

Key Dates to Remember: 

• Effective Date of the Final Rule: January 1, 2025
• Applicable Date of the Final Rule: January 1, 2026
• Next Annual Report Submission Due: April 30, 2026 

The effective date is when using the updated regulation is not mandatory and requires agreement with all parties involved in research misconduct matters. The applicable date is when all PHS-funded institutions must use the updated regulation. The annual report is an institutional report of all research misconduct activity from the prior year and an annual assurance of institutional research misconduct policies and procedures.

Here is a short description of the first group of guidance documents:

1. Writing Policies and Procedures (pdf): This document emphasizes the importance of compliance, providing guidance for institutions to develop their own research misconduct policies that align with PHS regulations.
    
2. 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.
    
3. Small Institution Guidance (pdf):This document provides specialized resources to assist smaller institutions in aligning their policies with the PHS regulations.
    
4. 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.

The second group of documents are topic-specific and are intended to clarify key issues:

5. 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.

6. 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.

7. Pursuing Leads Guidance (pdf): This document provides details on how to pursue leads during an institutional research misconduct investigation.

8. 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.

9. 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. 

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

Join us in fostering a culture of compliance and research integrity. Stay tuned for our upcoming guidance materials and webinars that will provide essential insights and support throughout the implementation of the 2024 Final Rule.

To view the 2024 Final Rule, visit https://ori.hhs.gov/blog/ori-final-rule. For inquiries about the implementation of the 2024 Final Rule, stakeholders can reach out to ORI-ComplianceReviews@hhs.gov or AskORI@hhs.gov.