Produced by the U.S. Department of Health & Human Services (HHS) Office of Research Integrity (ORI), this video series introduces key topics and ethical dilemmas in the responsible conduct of research: https://ori.hhs.gov/integrity-scientific-research-videos
Current research misconduct regulations at 42 C.F.R. Part 93 (“Part 93”) were promulgated May 17, 2005, at 70 Fed. Reg. 28370–28400.
White House Office of Science and Technology Policy (“OSTP”) Federal Research Misconduct Policy, issued on December 6, 2000 the “2000 OSTP Policy”:
“Applies to federally funded research and proposals submitted to Federal agencies for research funding” and required that all “Federal agencies that conduct or support research . . . implement this policy.”
Defines “research misconduct” as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results,” which represent a “significant departure from accepted practices”; have been “committed intentionally, or knowingly, or recklessly”; and be “proven by a preponderance of evidence.”
Sets forth three phases to reviewing allegations:
- “an inquiry—the assessment of whether the allegation has substance and if an investigation is warranted;
- an investigation—the formal development of a factual record, and the examination of that record leading to dismissal of the case or to a recommendation for a finding of research misconduct or other appropriate remedies;
- adjudication— during which recommendations are reviewed and appropriate corrective actions determined.”
ORI regulations must be consistent with this policy; a primary purpose of the ORI Part 93 regulations issued in 2005 was to bring the ORI regulations into compliance with the 2000 OTSP Policy.– ORI’s changes to Part 93 cannot vary from the structure/definitions outlined under the OSTP Policy.
Office of Research Integrity (ORI) proposed revisions on October 6, 2023, at 88 Fed. Reg. 69583–69604 (“NPRM”).
HHS released a final rule September 12, 2024, that was formally published in the Federal Register on September 17, 2024, at 89 Fed. Reg. 76280–76309 (“Final Rule”).
Compliance with this rule is required effective January 1, 2026, and institutions are required to submit revised policies and procedures to ORI in annual reports beginning April 30, 2026.
Please note that the MaineHealth Research Misconduct Policy will be updated to be compliant with the HHS final rule.