Colleges will have more discretion in how they handle research-misconduct cases under a revised federal rule released Thursday. The final rule, from the U.S. Office of Research Integrity, marks the first change since 2005 to its policy, which covers research funded by the Public Health Service.
The final version vastly differs from last year’s proposal, which was criticized for giving the government too much oversight.
“This final rule has really pared back,” said Kate Heffernan, a lawyer who represents colleges and focuses on academic research. “They were very responsive to the feedback that the regulated community gave.”
Sheila Garrity, director of the Office of Research Integrity, said that as soon as the rule was released, she was flooded with emails and texts from people happy that it looked so different from the proposal. Garrity assumed her role last March after spending much of her career as a research-integrity officer at the Johns Hopkins University School of Medicine and George Washington University.
“We balanced the needs of our position — we are a regulatory-oversight agency — with the needs of the institutions, giving them the discretion to handle certain things,” Garrity said.
The office received more than 200 comments last year on its proposed policy. Many comments described the proposed changes as being too “formalized” and “burdensome.”
“A lot of the things that were in the initial review copy that everyone responded to would have burdened institutions tremendously, both large and small, private and public,” said James Mohler, the associate vice president for scientific integrity and research compliance at Purdue University.
The government agency modified or abandoned many aspects of the proposal, giving institutions greater flexibility in how they run misconduct proceedings. Some logistical provisions published in the final rule erred on the side of relaxing the administrative burden on research-integrity officers.
For example, the proposal originally required that primary recipients of federal funds be responsible for the compliance of their grant partners. In the final version, partners are required to file their own assurances.
One major change that pleased many research-integrity officers is that a finding of “honest error” can now be made at any stage in a misconduct proceeding — not just at the investigation stage, as previously required. Mohler said this provision will save research-integrity officers time and resources because they won’t have to escalate an honest-error allegation all the way to the time-intensive investigation phase.
“They take that responsibility very seriously,” Mohler said. “Most of the [research-integrity officers] involved in this are not in it for the money. They’re not in it for the glory. They’re in it because they believe in protecting the research record.”
Lowering Barriers
Two changes are designed to lessen the burden on research-integrity officers and lower the barriers for whistleblowers. First, the final rule does not include the proposal that all interviews during the inquiry and assessment phases be transcribed. Lauran Qualkenbush, the senior director of research integrity at Northwestern University and the president of the Association of Research Integrity Officers, said that transcribing interviews can have a “chilling effect.”
"[Research-integrity officers] felt that that would really make it more difficult for people to feel comfortable coming forward,” she said. “At Northwestern, it’s important that I foster an environment where people know they have a safe place to report. Otherwise, people won’t report.”
The rule also removes a provision in the 2005 policy that many institutions interpreted as requiring respondents to be in the room during witness interviews. Mohler said that created an “adversarial courtroom-type situation.”
The timelines of each phase were also relaxed. Institutions now have 90 days to complete an inquiry and 180 days to complete an investigation.
Several revisions concern language, adding new definitions or amending existing ones. Words that guided whether and how research officers investigated cases lacked clear definitions in the 2005 policy. For example, errors were considered misconduct if they were made “intentionally, knowingly, and recklessly,” and now those adverbs are defined.
“Allegations” are defined as complaints “brought directly to the attention of an institutional or [Health and Human Services] official” in the new rule. Because allegations by armchair sleuths are now frequently posted on social media and sites like PubPeer, Heffernan says the definition will relieve research-integrity officers who felt like they had to scour those sites themselves to ensure they caught everything.
The final rule also made clarifications about confidentiality requirements. In the 2005 rule, institutions could disclose the identity of the complainant or respondent only to “those who need to know,” a category that was not clearly defined but was interpreted by some to mean only those directly involved in research-misconduct proceedings. Now, institutions are permitted to alert other stakeholders, such as journal editors and publishers.
Holden Thorp, editor in chief of the Science family of journals, sees that as a step in the right direction — but one that doesn’t go far enough. To insure the most accurate scientific record, federal regulators should require institutions to notify journals, he said.
“The bureaucratic detritus that has stuck itself to this process is very difficult to cut through,” Thorp said. “I would love to see even more direction for the institutions to tell us what’s going on.”
The final rule will take effect January 1, 2025, and all regulatory requirements will apply beginning on January 1, 2026.
