HHS Announces Updates to Policies on Research Misconduct
The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on Sept. 12, 2024.
The Final Rule updates the 2005 regulation and is intended to respond to technological changes and clarify requirements for addressing research misconduct in PHS-funded research "to provide clarity, transparency, and a better streamlined process."
Policy Updates
Notably, the updates are intended to, among other things:
- clarify institutional confidentiality obligations
- identify areas of institutional discretion (e.g., notification to publications of corrections)
- better describe research misconduct investigation requirements, including with regard to investigating leads
- clarify permissible areas for institutional discretion
- extend the timeline for institutional inquiries from 60 days to 90 days
- provide a clearer appeal process
The Final Rule takes effect on Jan. 1, 2025, and becomes applicable on Jan. 1, 2026.
ORI will present a webinar providing details on the Final Rule on Sept. 20, 2024. To attend, please register online.
In addition, ORI plans to release sample policies and guidance in the coming months to help prepare PHS-funded entities.
A more detailed analysis from Holland & Knight is forthcoming. In the meantime, visit ORI's website for further details, and contact the authors with any questions.
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