The Office of Research Integrity (ORI), under the leadership of Director Sheila Garrity, oversees the enforcement and promotion of research integrity within institutions funded by the U.S. Department of Health and Human Services. The Division of Education and Integrity manages approximately 6,000 institutional assurances, reviews policies and procedures related to research misconduct, conducts compliance investigations, and develops resources to foster ethical research environments in accordance with federal regulations (42 CFR Part 93). Its responsibilities also include administering grant programs and responding to requests under the Freedom of Information and Privacy Acts. The Division of Investigative Oversight monitors allegations of research misconduct, provides guidance on compliance with Public Health Service regulations, and recommends sanctions where appropriate. Common types of research misconduct reported in recent years include falsification, fabrication, and plagiarism, with administrative actions ranging from supervision and mandatory corrections to multi-year debarment.
In 2023, the ORI has moved forward with a Notice of Proposed Rulemaking (NPRM) to update its core regulations, which have not been substantially revised since 2005. This process was informed by a public Request for Information (RFI), gathering feedback from institutions and individuals on which regulations should be revised, retained, or removed. Key topics for revision include clarifying investigation procedures, updating definitions, increasing transparency, and revising deadlines and penalties. The NPRM aims to address gaps in clarity and processes identified by the RFI, with further refinements to responsibilities, definitions, and guidance for institutions, as well as simplification of appeals processes. Stakeholders are encouraged to participate in the public comment period, highlighting ORI’s commitment to open dialogue as it modernizes research misconduct policy and oversight.
