The Office of Research Integrity (ORI) is excited to announce the release of the first phase of our updated Final Rule Guidance Documents! As we work toward fostering a culture of research integrity, these documents are designed to assist PHS-funded stakeholders in understanding and implementing the 2024 Final Rule, which will apply to all institutions on January 1, 2026.
"The release of these Guidance Documents marks a significant milestone in our commitment to supporting institutions with compliance in upholding research integrity," said ORI Director Sheila Garrity. "By providing clear, practical resources, we aim to empower stakeholders to navigate the updated regulations with confidence and integrity."
What Institutions Can Expect
The initial release includes valuable resources that will serve as practical tools for institutions as they align their policies and procedures with the updated regulations. These documents focus on several key areas of compliance and will help researchers navigate the complexities of the updated regulations.
Here's a brief overview of what's included in this first phase:
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 regulations, ensuring that institutions are well-prepared to transition smoothly.
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 honest error, levels of intent, and building the institutional record.
What Institutions Can Do
We encourage all institutions to take proactive steps to prepare for the updated Final Rule by reviewing the newly released documents and beginning the drafting of your 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 updated Guidance Documents and stay updated on our phased rollout plan, please visit ori.hhs.gov/guidance-documents or contact AskORI@hhs.gov for any inquiries. Look out for announcements of webinars to help answer your questions.
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.
