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The federal Office of Research Integrity (ORI) is proposing changes that would give the government more oversight of investigations of research misconduct at colleges and universities.
But scores of university and research hospital leaders and the organizations representing them are opposed and say the proposed rules would be burdensome to institutions and could potentially deter people from reporting alleged research misconduct, among other perceived negative consequences.
“The proposed regulations inappropriately fail to recognize that ORI and institutions conduct separate research misconduct review processes that are necessarily subject to different Standards,” reads a letter the Council on Governmental Relations (COGR), which represents research institutions, wrote to ORI, which is under the U.S. Department of Health and Human Services.
The ORI oversees misconduct investigations involving Public Health Service–funded research, the majority of which is related to medical research.
“Yet rather than give institutions appropriate discretion in the conduct of their research misconduct review processes, the proposed regulations appear to reflect ORI’s expectation that an institution conduct a review for ORI that meets the standards that only apply to ORI’s review,” COGR wrote. “This approach streamlines ORI’s review, at institutions’ expense.”
The council’s letter is among nearly 200 public comments submitted to ORI after the agency published the proposal in October. Other organizations that expressed concerns about the proposal include the Mayo Clinic, the Association of American Universities (AAU) and the Association of Public Land Grant Universities (APLU).
“The proposed regulations’ more mandated and highly structured approach will lead to some meritless inquiries that risk harming the respondent’s reputation and the reputations of their collaborators,” a letter from the APLU said. “It will also dramatically increase the cost to the research enterprise to conduct a meritless inquiry.”
The proposed changes include creating a more stringent timeline for opening institutional inquiries, recording and transcribing witness interviews and requiring institutions to turn over all documents related to their investigations. It would also authorize ORI to publish a notice of “institutional research misconduct findings and implemented institutional actions.”
Some opponents believe those changes could have unintended consequences.
The recording requirement, for instance, may create a “chilling effect” on reporting suspicions of research misconduct, said Lauran Qualkenbush, senior director of research integrity and training at Northwestern University and president of the Association of Research Integrity Officers, which also sent the ORI a public comment letter detailing concerns about the proposed changes.
“We have to worry about protecting anonymity where we can. Think about a grad student who’s raising concerns about their faculty adviser,” Qualkenbush said. “We have to have flexibility at the institution to manage these situations at a really fundamental level. We have to use discretion. We need the regulations to provide a strong framework for us, but if it gets too prescriptive that becomes very problematic for how we can manage cases on a daily basis.”
The ORI last updated its rules on research misconduct, which includes publishing falsified or fabricated data, in 2005. Since then, “ORI has gained extensive experience handling all aspects of the HHS research integrity program,” Joya Patel, a department spokesperson, said in an email.
“Any changes aim to be responsive to the concerns raised by institutions over the years in interpreting the current regulation, in addition to considering feedback received by stakeholders during the RFI [Request for Information] comment period and addressing other changes not foreseen in the 2005 regulations due to changes in the dynamic field of research.”
Over the past two decades, numerous high-profile instances of alleged research misconduct have made headlines, including recent examples at Harvard and Stanford Universities.
There are one or fewer confirmed research misconduct cases per every 10,000 researchers, according to the ORI. The real number, however, is likely higher because researchers don’t always report suspicious conduct. A 2022 paper published in Springer Nature said, “Deceiving scientific research, misconduct events are possibly a more common practice than foreseen.”
The 2021 Dutch National Survey on Research Integrity, the largest study of its kind and widely considered a landmark study on the subject, found that half of 6,800 Dutch researchers who completed the survey employed murky research practices; One in 12 said they’d fabricated or falsified research results.
The implications of falsification, fabrication and plagiarism, or FFP, the three categories that fall within the federal definition of research misconduct are far-reaching and “may harm the public’s health and safety, waste public funds, compromise the integrity of the research process, and distort the research record,” according to the ORI. “Even when journals publish retractions that correct the scientific record, the impact of FFP is sometimes extensive and difficult to undo.”
Holden Thorp, editor-in-chief of the Science family of journals, said increasing the transparency of research misconduct investigations would better support academic publications grappling with the aftermath of publishing a faulty paper.
“The journals are at the front-line of all of this,” Thorp said. “I’m the person that has to go out and defend the retractions and corrections, not the universities. They get to keep sending out vague press statements, meanwhile I’m the one who has to deal with the reporters and sleuths asking me why I haven’t retracted a paper. The universities aren’t giving me any way to give an answer.”
It’s also a decidedly different world than it was when ORI wrote its first rules more than 30 years ago.
“When we all started, everybody started from the perspective that this was private, confidential and institutions would do this themselves,” said C.K. Gunsalus, director of the National Center for Principled Leadership and Research Ethics and a former academic integrity officer. “We no longer have the trust in institutions as a society that we used to have.”
After years of working in research misconduct, Gunsalus said her views have evolved to support increased transparency in the investigation process.
“There are fundamental conflicts of interest in an institution investigating its own institutional member,” she said. “Given that institutions have a strong interest in the outcome, one of the things that making the outcome of these reports public does is provide discipline and accountability for institutions to do a good job.”
But with such strong opposition to the proposal, Gunsalus said it’s unlikely to gain approval in the near future.
“The sentiment appears to be too far against it right now,” she said. “And I think that’s to our detriment.”
