Oct 6, 2023 - Health

HHS overhauling how it handles research misconduct allegations

Illustration of a gavel hovering over a block with an image of a red cross.

Illustration: Gabriella Turrisi/Axios

Federal health officials are preparing their first major update to guidelines for handling allegations of research misconduct in nearly 20 years.

Why it matters: The evolution of research and technology since the policy was finalized in 2005, along with gaps in regulation, have made research institutions eager for new guidelines, said Minal Caron, a lawyer at Ropes & Gray who advises universities, hospitals and other organizations on scientific research and development regulations.

  • Recent high-profile incidents involving research misconduct, including the investigation leading to former Stanford University president Marc Tessier-Lavigne's resignation, have brought renewed attention to the issue.

Driving the news: The federal health department's Office of Research Integrity (ORI) on Thursday proposed revamped regulations that streamline the appeals process for misconduct findings and require subrecipients of federal funding to comply with the rules, among other changes.

  • If finalized, the updates will apply to all institutions receiving Public Health Services funding from the U.S. government, including National Institutes of Health grants.
  • Misconduct allegations for NIH-funded research have risen sharply since 2016, according to an agency report published earlier this year that partly attributed the increase to its increased communication with researchers about the importance of flagging suspected misconduct.
  • NIH handled 169 claims related to research fabrication, falsification or plagiarism in 2022, up from 46 in 2016.

Zoom in: ORI wants the ability to make other institutions' separate misconduct findings public. The agency may want to do this when it comes to a different conclusion from the institution, Caron said.

  • "I think [institutions] will be very skeptical of the idea that their own findings would be reported in the public record, as opposed to provided confidentially to the federal government for the federal government's own review," he said.
  • Institutions would also have to make full interview transcripts from misconduct investigations available to the person accused of misconduct. This could also prove controversial, as "a lot of these cases involve very senior people who are in positions of influence and power over some of the junior scientists" who may be interviewed about their bosses, Caron said.
  • The proposed rule would also clarify that self-plagiarism doesn't meet the ORI definition of research misconduct and should be handled at the institutional level.

What's next: The proposal is open for public comment until Dec. 5. Officials aim to finalize the new standards by summer 2024, with a target effective date of Jan. 1, 2025.

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