What is the Final Rule?
On October 6, 2023, ORI proposed revisions (“NPRM”) to the current research misconduct regulations at 42 C.F.R. Part 93 that were promulgated May 17, 2005. The NPRM was open for public comment and on September 12, 2024, HHS released a final rule formally published in the Federal Register on September 17, 2024, at 89 Fed. Reg. 76280-76309 (“Final Rule”). The final rule is effective January 1, 2025, but will not be applicable until January 1, 2026. During the ARIO Conference in September, ORI stated that they will be issuing draft policy guidance as well as additional resources to assist institutions in updating their policies and maneuvering the final rule. A full breakdown of changes can be found in the table below.
Currently Northeastern is working to update related Research Misconduct policies and procedures ahead of the implementation date of January 1, 2026.
| Assessment | Final Rule formalizes the pre-inquiry assessment. The RIO or other designated institutional official is required to evaluate, determine, and document whether the allegation 1) meets the definition of research misconduct, 2) is within the jurisdiction of Part 93, and 3) is credible such that evidence of research misconduct may be identified. |
| Inquiry | An inquiry committee is no longer necessary. Per the Final Rule the RIO or another designated institutional official may conduct the inquiry. |
| Inquiry Report | Final Rule expands the required components of the inquiry report: The composition of the inquiry committee (if a committee is used) Inventory of sequestered research records and evidence and description of how sequestration was conducted. Transcripts of any transcribed interviews Timeline and procedural history Any scientific or forensic analyses conducted. Basis on which any allegations do not merit investigation. Any institutional actions implemented, including communications with journals or funding agencies |
| Investigation Report | Final Rule expands the required components of the investigation report: Composition of the investigation committee Inventory of sequestered research records and evidence, except records not relied upon, and description of how sequestration was conducted. Transcripts of all interviews conducted. Identification of publications, manuscripts, PHS funding applications, progress reports, presentations, research records, etc., containing material linked to the alleged research misconduct. Any scientific or forensic analyses conducted |
| Institutional Record | Final Rule now requires institutions to transmit a full institutional record to ORI after a final determination in research misconduct proceedings, including: All records compiled or generated and relied upon in the proceedings. Documentation of the assessment stage Inquiry report (if inquiry stage was reached) Transcripts of all transcribed interviews Record of any institutional appeal Index listing all research records and evidence that the institution compiled during the proceeding. General description of records that were sequestered but not considered or relied on |
| Investigation Timeframe | Final Rule extends the investigation time limit from 120 days to 180 days. If investigation exceeds 180 days, institutions must still request an extension from ORI. |
| Definitions Added | Intentionally – to act with the aim of carrying out the act Knowingly – to act with awareness of the act Recklessly – to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism |
| Plagiarism | Final Rule clarifies the definition of plagiarism, including stating that self-plagiarism and authorships disputes do not constitute plagiarism – therefore do not constitute research misconduct |
| Subsequent Use Exception | Final Rule narrows the subsequent use exception, stating it only applies “when the respondent uses, republishes or cited to the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized,…within six years of when the allegations were received.” |
| Confidentiality | Final Rule states that the confidentiality restriction applies until the institution has made its final determination int eh research misconduct process. Concept of “need to know” clarified – may now include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions |
| Respondent Record Retention | If a respondent claims to possess records documenting the questioned research is evidence of research misconduct – final rule permits such evidentiary finding only if the respondent claims to possess the records but refuses to provide them upon request |
| Interview Transcripts | Interviews in the investigation stage must be transcribed and the respondent must have access to interview transcripts. Materials shown to interviewees must also be numbered as exhibits and referred by exhibit number during the interview and included in the institutional record along with the exhibits. |
| Sequestration | Final Rule clarifies that 1) when original research records cannot be obtained, copies of records that are “substantially equivalent in evidentiary value” will fulfill the sequestration requirement and 2) subsequent or interim sequestration should occur whenever new records become known |
| Finality of Institutional Decisions | Final Rule clarifies that institutional determinations are final |
| Multiple Respondents | Final Rule adds clarification that new inquires are not necessary if new respondents are added to a proceeding |
| Multiple Institutions | Final Rule adds guidelines for multi-institutional proceedings |