New HHS Research Misconduct Rules Bring Seismic Changes
By: Paul S. Thaler, Anam Abid, Sydney Smith Forquer and Paul E. Simon
On Sept. 17, the U.S. Department of Health and Human Services formally published a new set of regulations to guide research misconduct investigations. This marks the first changes to the regulations since 2005.
Although the new regulations have an effective date of Jan. 1, 2025, the Office of Research Integrity and HHS have announced that the new requirements will not be required until Jan. 1, 2026.
Institutions will have a little more than a year to develop new policies and procedures consistent with the final rule, which contain many changes from the 2005 regulations. Herein, we explore some of the most significant changes to the regulations, and the potential impact to all stakeholders.
Confidentiality, or a Lack Thereof
Perhaps the most drastic changes introduced in the final rule are the revisions to the confidentiality requirements, which could potentially eviscerate any semblance of traditional confidentiality.
While HHS ultimately retained the requirement that disclosure of respondents’ identities “is limited … to those who need to know[,]” the determination of who needs to know now rests solely with the institution conducting the research misconduct process.
Furthermore, “those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions.”
This nonexhaustive list, coupled with the discretion granted to institutions, makes it clear that respondents’ identities may become public early in the research misconduct process.
Such disclosures would almost certainly result in undue harm to respondents, even those who are later found to be not responsible for research misconduct.
This risk can and should be mitigated by institutions. Under the final rule, although an institution has discretion to determine who has a need to know the identity of respondents, that determination must still be made “consistent with a thorough, competent, objective, and fair research misconduct proceeding.”
The onus, then, should be on the institution to ensure that any third party — particularly any entity over whom the institution has no control — agrees not to engage in any further disclosure resulting in the respondent’s identity becoming public.
To do otherwise would harm both respondents, some of whom are wrongfully accused, and the public interest, by casting a specter of doubt and mistrust over research that may ultimately be proven reliable.
Additionally concerning, confidentiality “no longer applies once an institution has made a final determination of research misconduct findings.”In its commentary, the ORI notes that it “changed the final rule to provide latitude for institutions to decide confidentiality requirements for themselves, “in instances where there is “a legitimate need to inform persons outside the institution,” such as journals, about “potentially inaccurate data in a timely manner.”
The ORI further explained that the removal of confidentiality following a final determination is meant “to prevent some institutions from keeping research-related information confidential longer than necessary.”
In short, although the confidentiality provisions may no longer apply after there are research misconduct findings, institutions should not read this as an invitation to disclose more than necessary to third parties or the broader public — particularly during the pendency of the process.
When allegations have been improperly or prematurely made public, resulting reputational damage has frequently been enormous, sometimes ruining researchers’ careers.
Though the final rule permits earlier disclosure of respondents’ identities, we urge institutions managing research misconduct processes to use appropriate restraint in making decisions that might have such damaging, and long-term, effects on science, careers and reputations.
The ORI Recommits to Remedial Purpose
As in the 2005 iteration of the ORI’s regulations, the final rule reflects that the research misconduct regulations’ purpose is “remedial;” that is, the goal is to protect public health and safety, to promote research integrity, and to safeguard science, while allowing for the rehabilitation of those scientists who might have engaged in research misconduct.
The final rule expressly excludes previous sanctions of suspension or debarment from the potential administrative actions imposed as a direct result of research misconduct findings.
Instead, the final rule permits the ORI to refer a research misconduct matter to the HHS suspension and debarment official for consideration under the suspension and debarment regulations in appropriate circumstances.
This implicitly recognizes that the research misconduct process itself is not meant to be a death knell to a respondent’s career, particularly in the absence of factors not present in the vast majority of research misconduct matters.
Similarly, the final rule retains the ORI’s discretion to refer an institution to the HHS suspension and debarment official to consider whether suspension or debarment is warranted against the institution if institutions fail to comply with regulatory requirements. Accordingly, institutions are warned to be cautious in exercising their discretion.
The ORI Retains Discretion in Publication Decisions
Research scientists winding their way through the research misconduct process are constantly worried about the possibility that their plight might become public and damage their careers and reputations.
Although these regulations have always aimed to be remedial, not punitive, they instead evolved into a threat that scientists accused of research misconduct could, at some point, have their cases published in the Federal Register.
The applicable section stated the ORI may publish the result. It can be argued that because the word “may” is permissive, not mandatory, the ORI had the discretion not to publish a result when appropriate. In practice, the ORI disagreed and required all findings of research misconduct, and any settlements, to be published.
The final rule now clearly acknowledges the discretion given to the ORI. In comments to the final rule, the ORI notes that it considered changing the word “may” to “shall,” effectively codifying its practice to publish all determinations and settlements, but decided to stick with the permissive “may.”
The ORI specifically commented that the final rule “restored the 2005 regulatory language of ‘may’ to retain flexibility” in the publication choice.
Appeals
The final rule makes notable changes to the processes governing appeals of research misconduct findings, both at the institutional and federal levels.
Institutional Appeals
Many institutions provide respondents the opportunity to appeal research misconduct findings, which may be reversed, modified or upheld. Under the 2005 regulations, institutions that permitted appeals frequently transmitted the final investigation report to the ORI for its oversight review before the appeal process had begun, let alone concluded.
These institutions rarely informed the ORI that an appeal was being considered, leading the ORI to make conclusions based on an incomplete institutional record. The final rule requires institutions to “promptly notify [the] ORI” if a respondent appeals and refrain from transmitting the institutional record to the ORI if transmittal has not occurred before the appeal.
If transmittal has occurred, institutions must provide the ORI with the complete appellate record once the appeal has concluded.
This suggests that the ORI will refrain from reviewing an institution’s investigative conclusions until the institutional appeals process has concluded and the complete institutional record — including the record of the appeal — has been transmitted to the ORI.
This ensures the ORI conducts a holistic review of institutional findings and the evidentiary record before making its own determinations, which, under the 2005 regulations, were at times premature.
Administrative Appeals
Respondents have always had the right to appeal the ORI’s findings of research misconductand proposed HHS administrative actions. Though the final rule continues to protect respondents’ right to appeal the ORI’s findings and proposed HHS administrative actions, the rule also significantly restricts the procedural and evidentiary processes governing these appeals.
Under the 2005 regulations, the administrative appeal process included a hearing. Respondents and the ORI both had the right to conduct discovery, present evidence relevant to the issues at the hearing, present and cross-examine witnesses, and present oral arguments.
The administrative law judges assigned to these appeals would consider both the administrative record and all the evidence presented throughout the appeal in reaching a decision.
In contrast, the final rule provides that the ALJ may only consider the administrative record and any related briefs when making determinations as to the propriety of the ORI’s findings and proposed HHS administrative actions.
Although ALJs retain some authority to hold conferences in lieu of a hearing, the ORI and respondents will no longer be permitted to conduct discovery, present relevant evidence not included in the administrative record, present and cross-examine witnesses, present oral arguments, or otherwise supplement the administrative record during the administrative appeal process.
This dramatically reduces the scope of evidence ALJs may consider when deciding an administrative appeal. Though we have yet to see how these evidentiary restrictions will affect administrative appeals, it is possible that these changes will not be unfavorable for respondents.
The new regulations both bolster the requirements for the institutional record and incorporate the institutional record into the very administrative record ALJs consider when determining the appropriateness of the ORI’s findings and proposed HHS administrative actions.
Investigation Reports, Now With More Reporting
The prior regulations resulted in vastly different investigation reports prepared by institutions — differences in form, amount of information and analysis.
While slimmer reports relying on summarization and generality may have passed under the previous regulations, the ORI has prescribed greater specificity and documentation for reports pursuant to the final rule.
Previously, investigation committees were only required to “identify and summarize” the evidence reviewed and merely identify evidence that was not relied upon. Respondents have long been frustrated by investigation reports that seem to make findings without being thorough.
The final rule should remove most of this frustration by requiring institutions to demonstrate a far more robust investigation with a more specific, detailed report. Among other required details, this includes a description of committee members’ subject matter expertise; interview transcripts specifically identifying any exhibits utilized; and an inventory of all sequestered records and evidence considered by the investigation committee. Institutions must also include in the institutional record a general description of any materials “that were sequestered but not considered or relied on.”
Additionally, investigation committees must address their recommendations with respect to each individual allegation in detail. In recommending a finding, investigation committees must identify the specific publications or other research records where the alleged falsified, fabricated or plagiarized material exists, and indicate the person responsible for the research misconduct, the type of research misconduct and the level of intent.
Each finding must also be supported by a summary of the facts and analysis underlying the conclusion, including consideration of the merits of “any explanation by the respondent.”
If an investigation committee does not recommend a research misconduct finding, it must still “provide a detailed rationale” demonstrating a thorough analysis that satisfies the institutional burden required regardless of the recommended outcome.
Hopefully, these explicit guidelines for investigation reports will be instructive to those institutions whose reports have previously made findings without the requisite specificity and evidentiary support for respondents to understand and refute institutional findings of research misconduct.
Defining and Specifying Intent
A cornerstone of the research misconduct process is the analysis and determination of a level of intent required to support a research misconduct finding.
The previous regulations did not prescribe definitions for the three levels of intent sufficient to conclude there was research misconduct: intentionally, knowingly and recklessly. Under the 2005 regulations, the ORI allowed institutions, and at times itself, to make findings that a respondent committed research misconduct “intentionally, knowingly, and/or recklessly,” failing to specify a level of intent supported by evidence.
This practice substitutes any actual analysis with mere recitation of the requisite levels of intent necessary to support findings.
The ORI seems to have considered the negative impacts of this approach, as the final rule requires that investigation committees select, and defend, one specific level of intent supported by the evidence when making findings of research misconduct.
While an investigation report must “indicate whether the research misconduct was falsification, fabrication, and/or plagiarism[,]” it must “indicate whether the research misconduct was committed intentionally, knowingly, or recklessly.”
This recognizes that while an allegation may have resulted from multiple types of research misconduct, a finding of intent must be specific. Requiring specificity forces investigation committees to conduct a full analysis, relying on actual, specific evidence to determine a respondent’s level of culpability.
Specific findings are better for the investigatory record, where revisiting nondetailed findings may lead to inaccurate assumptions. Furthermore, respondents would no longer beleft wondering what specifically the investigation committee concluded and why they did so.
To aid both institutions and respondents in evaluating and defending against findings of intent, the ORI included for the first time in the final rule definitions for “intentionally,” “knowingly,” and “recklessly.”
Standardization of the definitions used across institutions will help all stakeholders apply the regulations more accurately and predictably.
Lastly, the final rule specifies that institutions may determine that honest error exists as early as the inquiry stage, thus potentially saving both institutions and respondents time and resources.
High Burden for Missing Data Responsibility
Many respondents face potential findings of research misconduct when data are unavailable. Previously, to utilize the absence of data as evidence of research misconduct, institutions were required only to determine that a respondent had the opportunity to produce or maintain the records, but failed to do so in accordance with accepted practices.
Findings under this previous standard did not take into account the myriad of unique circumstances that may account for data unavailability and often were prejudicial to respondents who had been otherwise cooperative. We have seen requests for data decades old, data ruined in a flood in the laboratory, and data stolen from a car. All cases resulted in the institution blaming the scientist for not producing the data.
Under the final rule, it is only the destruction of data after being informed of research misconduct allegations that can be utilized as evidence of research misconduct.
More specifically, an institution, or HHS, must determine that a respondent destroyed research records either intentionally or knowingly — a significantly higher bar that makes findings based on actions, rather than potential organizational difficulties or the routine practice of discarding old data.
Such a finding requires that the destruction occurred after the respondent was informed of the research misconduct allegations. This new standard is a much-needed change that will ensure institutions are still able to make findings against bad actors, while preventing findings against respondents who may have simply misplaced a record or been the victim of laboratory damage or theft.
Conclusion
The final rule represents significant changes to the research misconduct processes utilized both at the institutional and federal level. While some changes will likely benefit respondents and signal a recommitment to the remedial purpose of the process, other changes may result in institutions causing additional harm to scientists accused of research misconduct.
The stakes in research misconduct cases are high, as even mere allegations can cause serious damage to a respondent’s reputation, resulting in limitations placed on the use of or the complete loss of research funds, or even adverse employment actions.
Considering the discretion afforded to institutions in the final rule, institutions must ensure that they do not weaponize the research misconduct process and must maintain its remedial purpose.
To do otherwise has the potential to irreparably destroy respondents’ careers, thereby depriving us all from benefiting from the important work they do.
