On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule (Final Rule) adopting changes to federal regulations governing research misconduct involving federally funded research. The regulations have not been updated since 2005 and required revision to address the complexities of modern research. In the Final Rule, the U.S. Department of Health and Human Services (HHS) and ORI implemented changes that could have a significant impact on how institutions address and respond to allegations of research misconduct.
The final rule follows a previously issued Notice of Proposed Rulemaking (proposed rule). Foley’s recent blog, “ORI Proposes New Rulemaking to Regulate Research Misconduct,” analyzed the proposed rule that received numerous comments for HHS consideration. Many commenters urged ORI to reconsider proposed regulatory changes that would impose burdens on institutions that respond to allegations of research misconduct. In the final rule, in response to such commenters’ requests, ORI removed many of the proposed regulatory changes in order to “strike a balance between ensuring a thorough review of allegations of misconduct and protecting the rights of respondents.”
The final rule applies to all institutions that receive funding for research activities from the Public Health Service (PHS), including, but not limited to, universities, colleges, academic medical centers, medical schools, hospitals, and health systems. All institutions that receive PHS funding and engage in research should become familiar with the final rule. Although the effective date of the final rule is January 1, 2025, ORI has clarified that institutions will be required to comply beginning January 1, 2026, to allow institutions time to fully prepare and comply with the final rule.
This article summarizes some of the key regulatory changes made in the final rule and analyzes their potential impact on agencies.
Definitions of Key Terms
ORI has adopted definitions of key terms, some as set forth in the proposed rule and some with modifications.
For research misconduct to be found, the misconduct must be committed knowingly, knowingly, or recklessly. ORI did not define these terms in the 2005 rulemaking. The final rule adopts the following definitions:
Knowingly means acting with the intent to perform an act. Willful means acting with knowledge of the act. Recklessly means acting with indifference to known risks of fabrication, falsification, or plagiarism. (Note that the proposed rule’s formulation was “without due care despite the known risks.” In the final rule, ORI explained that it adopted a revised definition to “specifically address the risks of proposing, conducting, or reviewing research, or reporting the results of research, and of fabrication, falsification, or plagiarism, rather than the more general ‘conduct.'”)
We continue to point out that this level of knowledge is the same as that required for knowledge of the False Claims Act (FCA) and will make it easier for Department of Justice (DOJ) Civil Division attorneys to evaluate and investigate allegations of fraud involving the provision of PHS funds.
The final rule excludes disputes regarding authorship or credit, and self-plagiarism, from the definition of plagiarism (which constitutes research misconduct).
The final rule adopted a definition of agency records.
Records collected or created by the institution during any research misconduct proceeding (other than those on which the institution did not rely), including documentation of the evaluation, the investigation report and supporting records, the investigation report and supporting records, the decision of the institution’s decision maker, and the complete record of the institution’s appeal.
The agency record also contains a record index that lists all records except those on which the agency is not relied, and a general description of the non-relied records.
Research misconduct does not include honest error. Although the proposed rule attempted to define honest error (“errors made in good faith”), ORI elected to remove that definition in light of comments that suggested it was unnecessary. Nevertheless, the “honest error” exception is consistent with the FCA, which does not intend to transform honest error into a fraud allegation. Additionally, ORI removed proposed language that would have prohibited institutions from making honest error determinations at the investigation stage, because it agreed with commenters that such a prohibition would place an undue burden on institutions and respondents.
ORI similarly removed the definitions of several terms proposed in the proposed rule (appeal, disagreement, research integrity, suspension, and disqualification) after considering comments that these terms did not help clarify the rule.
Responsibilities of Subrecipients
In the proposed rule, ORI sought to explicitly place responsibility for subrecipient compliance with ORI regulations on primary recipients of PHS funds. ORI noted that commenters recommended removing this provision because it “failed to clarify agency responsibility for regulatory compliance.” Ultimately, ORI removed the liability proposal. ORI explained that it “did not intend to impose new burdens on primary recipients of funds.” The final rule requires subrecipients to submit their own assurances to ORI.
Multiple respondents and multiple institutions
The proposed rule introduced an obligation for institutions to consider whether other researchers were involved in suspected misconduct. Specifically, institutions were required to consider principal investigators, co-authors on publications, co-researchers, collaborators, and laboratory members during the evaluation, investigation, and investigation stages.
ORI removed the mandatory language and finalized the regulations to allow institutions to use their own judgment when determining whether to consider whether other researchers are involved. ORI also noted that commenters were concerned that listing the types of potential co-defendants “might confuse the standards and disadvantage those individuals.” ORI agreed and removed the list.
The final rule leaves intact the requirement that, for allegations involving multiple agencies, one agency be designated as the lead agency in the misconduct proceeding and be responsible for obtaining research records and witness testimony from the other agencies. ORI plans to publish guidance on multi-agency investigations, including considerations for designating a lead agency.
Subsequent Use Exception to the Six-Year Statute of Limitations
ORI’s research misconduct rules only apply to misconduct that occurred within six years of the date ORI or an institution received a complaint, unless the tainted research is subsequently used (the subsequent use exception). The subsequent use exception applies when a person uses, republishes, or cites a portion of research records that are allegedly fabricated, falsified, or plagiarized within six years of receipt of the complaint. In practice, the subsequent use exception applies to cases where the tainted research occurred more than six years before the date HHS or an institution learned of the complaint, and thus falls outside the scope of the ORI rules, unless the tainted research is cited by the respondent within six years of receipt of the complaint.
The final rule adopts the language from the proposed rule and clarifies that the subsequent use exception applies to republication or citations in processed data, journal articles, funding proposals or data repositories, submitted or published manuscripts, PHS grant applications, progress reports, posters, presentations, and other research records.
In the proposed rule, ORI proposed a requirement that agencies notify ORI of relevant facts before concluding that the subsequent use exception does not apply. However, commenters expressed concerns about the potential costs and burdens that that requirement would impose on agencies, so ORI removed that language. Instead, ORI finalized a requirement that agencies document (and maintain) how they determine that the subsequent use exception does not apply.
Time for evaluation, investigation, investigation and appeal
In the final rule, ORI agreed with the concerns raised by commenters regarding the proposed time limits for completing the evaluation, investigation, and review stages, as well as agency appeals.
Specifically, commenters rejected the proposed rule’s requirement that an institution must complete an evaluation within 30 days of initiating it, because institutions have historically struggled to comply with this stringent deadline. Commenters noted that evaluations (as opposed to more formal investigations or investigations) can still involve a complex process of evaluating allegations of misconduct, including reviewing research records and interviewing complainants, respondents, and witnesses. ORI responded by removing the 30-day requirement.
ORI also agreed to extend the time frame for completion of the investigative phase from the proposed 60 days to 90 days. If it exceeds the 90 days, the institution must document the reason for exceeding the 90-day period. ORI also extended the deadline for completion of the investigative phase from 120 days to 180 days. If it exceeds the 180-day period, the institution must request an extension from ORI in writing, setting forth the circumstances justifying the extension.
The proposed rule included a requirement that, if an agency’s policy allows for an agency appeal, the appeal be completed within 120 days of initiating it and an extension requested in writing from ORI. In response to comments that an agency appeal is “within the agency’s jurisdiction, not ORI’s,” ORI removed this requirement. However, ORI did finalize a requirement that an agency promptly notify ORI if an appeal is filed after the agency has transmitted agency records to ORI.
In practice, many institutions struggle to complete the steps of research misconduct investigations within the timeframes set forth by ORI, and with ORI agreeing to extend many of these timeframes, it may be possible for institutions to complete each stage without having to document reasons for delays or actively request extensions from ORI (although institutions should still request extensions in case ORI raises an issue).
Documentation of the evaluation steps
The proposed rule required institutions to document the completion of their evaluations of allegations of research misconduct in the form of an evaluation report. ORI has removed this requirement in response to commenters’ concerns that this requirement would impose a significant burden on institutions. Instead, ORI will only require institutions to document the results of their evaluations.
