The finalized Department of Health and Human Services (HHS) Public Health Service (PHS) Policies on Research Misconduct, effective June 16, 2005, delineate the responsibilities of institutions seeking or receiving PHS support, as well as those of the PHS Office of Research Integrity (ORI), in responding to allegations of research misconduct. The rule, codified at 42 CFR part 93, aligns the PHS policy with the federal definition of research misconduct—fabrication, falsification, and plagiarism—and retains a two-stage inquiry and investigation process for handling allegations. Institutions are required to adopt detailed procedures to guard against conflicts of interest, manage and retain research records (including relevant data stored on scientific equipment) for seven years, and report certain actions to ORI. Notable changes from previous rules include refined definitions, explicit burden-of-proof assignments, limited application scope, a six-year statute of limitations modified by ongoing use of research, and the clarification that missing documentation does not automatically indicate misconduct unless intentional destruction is proven.
The document also addresses institutional and HHS-specific responsibilities in misconduct proceedings, including inter-agency coordination and the hearing process for respondents, now overseen by an Administrative Law Judge without mandatory scientific consultation—a point of concern within the research community. The scope of the policy requires institutions to closely examine any potential linkage with PHS-supported research or activities and to ensure that internal policies, definitions, and evidence handling comply with the updated federal standards. Institutions must also be mindful of the nuanced handling of affirmative defenses like honest error and the new conditions surrounding case closures due to admission or settlements. Overall, these policy updates necessitate careful review and possible revision of institutional research misconduct procedures to ensure full alignment with federal requirements and best practices for research integrity.
