HHS updates rules for probing research misconduct
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The Biden administration has finished the first update in 20 years of rules for investigating fraud in federally funded research but backed away from some aggressive changes after getting blowback from universities.
Why it matters: Research misconduct hit an all-time high last year, with the number of journal article retractions hitting more than 10,000, Nature reported.
- High-profile cases involving flawed research by university presidents and Nobel Prize winners have thrust the issue into the spotlight.
Driving the news: The Health and Human Services Department last week finished updating rules for investigating fabricated or falsified results and plagiarism in medical projects that receive federal funding.
- They clarify how to keep misconduct investigations confidential, as well as how to deal with allegations involving multiple researchers or multiple institutions, and rules for documenting reviews of allegations, along with other changes.
- The regulations go into effect January 1, but HHS won't enforce the new requirements until 2026.
Zoom in: HHS walked back some of the biggest changes it proposed back in October after universities and research institutions said some proposals amounted to overreach and could make researchers more distrustful of their institutions.
- Regulators originally wanted misconduct allegations to automatically receive full investigations if an institution failed to complete an initial review of alleged research misconduct within 30 days.
- The final rule doesn't specify a time frame and instead requires institutions to document their initial assessments so HHS can review the case.
- "We thought that was perfectly fine balancing of our needs and the needs of the institution," HHS Office of Research Integrity Director Sheila Garrity told Axios.
The bottom line: The finalized regulations aren't a "seismic shift," and they'll make the process for investigating research fraud more efficient, said Minal Caron, a lawyer at Ropes & Gray who advises institutions on research issues.
What's next: Charges of research misconduct likely will continue to climb, Caron said.
- In addition to the new federal investigation standards, institutions and the federal government need to better educate researchers on scientific integrity, ORI's Garrity said.
