The U.S. agency that investigates research misconduct by federally funded biomedical scientists has dropped a controversial proposal that would have allowed it to publicize previously undisclosed misconduct findings by universities.
In announcing the first revision of its research misconduct policy in 20 years, the federal Office of Research Integrity (ORI) said it removed the draft provision in response to complaints from many institutions about “regulatory overreach” and possible “breaches of confidentiality.” ORI also:
- dropped a proposed 30-day deadline for starting an inquiry after an institution first receives an allegation of possible misconduct;
- restored a university’s ability to forgo a full investigation if it decides the conduct was the result of “honest error”; and
- withdrew a requirement that institutions record and transcribe all statements obtained during an initial review of the allegations.
The changes are part of final rules announced Wednesday that reflect responses to more than 170 comments on a draft released last fall. The policy applies to any institution receiving funding from ORI’s parent body, the Department of Health and Human Services, which includes the National Institutes of Health, the nation’s largest biomedical research funder.
“They listened to our concerns,” says Minal Caron, an attorney at Ropes & Gray, which represents several major research institutions. “ORI has been saying for months that it had addressed those problems and that we’d be much happier with the final version. And here’s the evidence.”
But Eugenie Reich, an attorney who represents whistleblowers, sees the reversal as ORI caving to the demands of the community it regulates. “This is further evidence of academic institutions capturing ORI, which I think is shortsighted,” she says.
One veteran university administrator who applauded the earlier draft says she hopes the final rule doesn’t signal a retreat from promoting greater transparency. “I continue to believe we need to be working toward making public final reports to maintain public trust and to improve the quality of institutional investigations,” says C. K. “Tina” Gunsalus of the University of Illinois Urbana-Champaign. “I hope that ORI and other government oversight agencies will start such a process or participate in it if others take the initiative.”
ORI decided it could not release institutional findings itself, because “the institutional investigation report is not a public document and is protected by federal privacy laws,” according to the notice accompanying the final rule. But in a prepared statement, ORI Director Sheila Garrity said the final rule clarifies that institutions can “publish findings if they so choose.”
Caron says the new rules also let ORI be more aggressive in trying to correct the scientific record. “In addition to publicizing the results of its own [subsequent] investigation that relies on what an institution has found,” he notes, ORI will now have the authority “to reach out to a journal and recommend that it retract an article based on those findings.”
The final rule also allows ORI to notify an institution if an employee has been found guilty of research misconduct by a previous employer. That provision is intended to lift the veil of secrecy that has allowed scientists to hide their past transgressions when applying for a new job.
Kristin West of the Council on Governmental Relations, a nonprofit association of several hundred research institutions, applauds ORI for dropping or revising several proposed changes that university administrators saw as misguided or cumbersome. For example, a proposal to require an institution to begin an inquiry 30 days after it has been told of alleged misconduct ignored how long it can take to do an initial assessment, she notes. And adopting a requirement that a stenographer be in the room when someone first comes forward with an allegation of misconduct could have had a serious chilling effect on many whistleblowers.
“Often it’s a graduate student who comes to you in confidence about an incident involving their adviser,” West says. “And they might freak out if there is someone else in the room.”
The new rules go into effect on 1 January 2025, but ORI has given institutions until January 2026 to incorporate them into their procedures and begin to apply them. And they are not the final word, West notes. ORI has promised to issue additional guidance on several unresolved issues, such as what documents need to be part of the investigative record and how far institutions must go in pursuing an allegation of misconduct. Institutions “didn’t get 100% of what we wanted, but it shows that the [regulatory] process works,” West says.
ORI estimates that affected institutions will spend $105 million over 5 years to comply with the new rules, including $11 million in one-time costs. But it predicts those rules will also make the process more efficient and improve the quality of the investigations, thereby justifying the added expense. According to the final notice, institutions carried out 121 investigations of possible research misconduct last year after receiving 230 allegations.
More: https://www.science.org/content/article/final-u-s-misconduct-rule-drops-controversial-changes
