The Department of Health and Human Services (HHS) Public Health Service (PHS) finalized its Policies on Research Misconduct in May 2005, establishing comprehensive guidelines and procedures for institutions receiving PHS support and for PHS itself to address allegations of research misconduct. The policy, codified in 42 CFR Part 93 and effective June 16, 2005, aligns PHS regulations with the Federal Policy on Research Misconduct, clearly defining misconduct as fabrication, falsification, or plagiarism, and specifying the need for intentional action and significant departure from accepted practices, as proven by a preponderance of evidence. Institutions are assigned explicit responsibilities, including managing conflicts of interest in investigations, maintaining records for seven years, and guarding the integrity of research records, which now may include physical or electronic data from scientific instruments.
The policy’s scope is broad, covering all institutions applying for or receiving PHS support, and extends to related activities such as maintaining data banks or sharing research findings. It introduces a six-year limitation on allegations, with exceptions for ongoing use of research records, and emphasizes the role of the PHS Office of Research Integrity (ORI) in oversight and coordination, especially in multi-agency cases. Respondents retain the right to a hearing before an Administrative Law Judge (ALJ), though the lack of required scientific or technical advice at this stage remains a concern among research organizations. The policy also refines expectations regarding the burden of proof, affirmative defenses, and the treatment of missing documentation. Institutions are advised to review and update their internal policies and procedures to ensure alignment with the new federal requirements, paying particular attention to definitions, reporting obligations, record retention, and the handling of possible admissions or settlements in misconduct proceedings.
