Forschungsmissbrauch: ORI veröffentlicht endgültige Regelung mit modernisierten und vereinfachten Vorschriften

On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have not been updated since 2005 and were in need of revision to address the complexities of modern-day research. In the Final Rule, the U.S. Department of Health & Human Services (HHS) and ORI implemented changes which may significantly impact how institutions must address and respond to allegations of research misconduct.

The Final Rule follows the previously issued notice of proposed rulemaking (Proposed Rule). Foley’s recent blog, “ORI Proposes New Rulemaking for Research Misconduct Regulations,” analyzed the Proposed Rule, which generated a host of comments submitted for HHS consideration. Many commenters requested that ORI reconsider proposed regulatory revisions that would have imposed burdens on institutions addressing allegations of research misconduct. In the Final Rule, and in response to such commenter requests, ORI removed many of the suggested revisions to the regulations in order to strike a “balance between ensuring a complete review of misconduct allegations and protecting the rights of respondents[.]”

The Final Rule applies to all institutions that receive Public Health Service (PHS) funding for research activities, including, but not limited to, universities, colleges, academic medical centers, medical schools, hospitals, and health care systems. All institutions that receive PHS funding and engage in research should take care to familiarize themselves with the Final Rule. The effective date of the Final Rule is January 1, 2025; however, ORI has clarified that institutional compliance will be required as of January 1, 2026, giving institutions adequate time to prepare for and effectuate compliance with the Final Rule.

In this article, we summarize certain of the significant changes to the regulations made in the Final Rule and analyze their potential impact on institutions.

Key Terms Defined

ORI adopted definitions for key terms — some as set forth in the Proposed Rule and some with revisions.

A finding of research misconduct requires the misconduct be committed intentionally, knowingly, or recklessly. ORI did not define these terms in the 2005 rulemaking. The Final Rule adopts the following definitions:

• Intentionally means to act with the aim of carrying out the act;
• Knowingly means to act with awareness of the act; and
• Recklessly means to act with indifference to a known risk of fabrication, falsification, or plagiarism. (Note the Proposed Rule’s formulation had been “without proper caution despite a known risk.” ORI explained in the Final Rule that it adopted revisions to the definition to “make it specific to proposing, performing, or reviewing research, or reporting research results, rather than ‘acting’ more generally, and specific to a risk of fabrication, falsification, or plagiarism.”)

We continue to note that this level of knowledge is the same as required for False Claims Act (FCA) knowledge, making it easier for the Department of Justice (DOJ) Civil Division attorneys to evaluate and investigate allegations of fraud with respect to the provision of PHS funds. 

The Final Rule excludes authorship or credit disputes, as well as self-plagiarism, from the definition of plagiarism (which constitutes research misconduct).

The Final Rule adopted a definition for Institutional Record:

• Records the institution compiled or generated during the research misconduct proceeding, except those the institution did not rely upon, including:
  • Documentation of assessment;
  • The inquiry report and any supporting records;
  • The investigation report and any supporting records
  • Decisions by the institutional deciding official; and
  • The complete record of any institutional appeal.

The Institutional Record also includes a record index listing all records, except those the institution did not rely upon, and a general description of records not relied upon.

Research misconduct does not include honest error. While the Proposed Rule sought to define honest error (“a mistake made in good faith”), ORI opted to remove the definition in light of comments suggesting it was unnecessary. Still, the exception for “honest error” remains consistent with the FCA, which is not intended to convert honest mistakes to fraud claims. Additionally, ORI removed proposed language that would prohibit institutions from making a finding regarding honest error at the inquiry stage, agreeing with commentors that such a prohibition would unfairly burden institutions and respondents.

ORI likewise removed definitions of several terms suggested in the Proposed Rule (Appeal, Difference of Opinion, Research Integrity, Suspension, and Debarment) in light of comments that these terms did not help clarify the regulations.

Responsibility of Sub-Recipients

In the Proposed Rule, ORI sought to explicitly place responsibility for sub-recipient compliance with ORI regulations upon the primary PHS-funded recipients. ORI noted that commenters recommended dropping this provision, “because institutional responsibility for regulatory compliance was not clarified.” In the end, ORI removed the responsibility proposal. ORI explained it “did not intend to impose a new burden on prime funding recipients.” The Final Rule requires sub-recipients to have their own assurances filed with ORI.

Multiple Respondents and Multiple Institutions

The Proposed Rule introduced an obligation for institutions to consider whether additional researchers are involved in the alleged misconduct. Specifically, institutions would have needed to consider principal investigators, co-authors on publications, co-investigators, collaborators, and laboratory members during the assessment, inquiry, and investigation stages.

ORI removed the obligatory language, and finalized the regulation to allow institutions to exercise their own judgement in deciding to consider whether other researchers are implicated. ORI also noted that commenters had been concerned listing the types of potential co-respondents “created a confusing standard and could be detrimental to those individuals.” ORI agreed and removed the list.

The Final Rule leaves intact the requirement that for allegations involving multiple institutions, one institution must be designated the lead in misconduct proceedings and will be responsible for obtaining research records and witness testimonies from the other institutions. ORI intends to publish guidance on multi-institution investigations, including considerations for designating a lead institution.

Subsequent Use Exception to the Six-Year Statute of Limitations

ORI’s research misconduct rules only apply to misconduct occurring within six years prior to the date ORI or the institution received an allegation, except in the case of subsequent use of the tainted research (the Subsequent Use Exception). The Subsequent Use Exception applies when a respondent uses, republishes, or cites to a portion of the research record that allegedly has been fabricated, falsified, or plagiarized within six years of receipt of the allegation. In practice, the Subsequent Use Exception applies to instances in which tainted research occurs more than six years prior to the date HHS or the institution learned of the allegations and, as such, would not be within the scope of the ORI regulations, except the tainted research was cited to by the respondent within six years prior to receipt of the allegation.

The Final Rule adopts language in the Proposed Rule clarifying that the Subsequent Use Exception applies to re-publication, or citation 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 institutions inform ORI of the relevant facts before concluding the Subsequent Use Exception does not apply. However, commenters expressed concern about the potential cost and burdens imposed upon institutions by that requirement, and ORI removed that language. In its place, ORI finalized a requirement that institutions document (and retain) how they determined the Subsequent Use Exception did not apply.

Assessment, Inquiry, Investigation, and Appeal Time

In the Final Rule, ORI agreed with concerns raised by commenters related to proposed time limits to complete the assessment, inquiry, and investigation stages, along with any institutional appeal.

Specifically, commenters rejected the Proposed Rule’s requirement for institutions to complete an assessment within 30 days of its initiation, since research institutions have historically struggled to comply with this aggressive timeline. The commenters noted that even an assessment (as opposed to the more formal inquiry or investigation) can require an involved process of evaluating allegations of misconduct, which may include reviewing the research record and interviewing the complainant, respondent, and witnesses. ORI responded by removing the 30-day requirement.

ORI also agreed to lengthen the time to complete the inquiry stage from the proposed 60 days to 90 days. If 90 days will be exceeded, institutions must document the reason for exceeding the 90-day period. ORI also extended the time limit to complete an investigation stage from 120 days to 180 days. If the 180-day time period will be exceeded, institutions must ask ORI for an extension in writing that sets forth the circumstances warranting extension.

The Proposed Rule contained a requirement that institutions, whose policies permit an institutional appeal, complete any such appeal within 120 days of initiation, and request an extension from ORI in writing. ORI removed this requirement in light of comments that the institutional appeal is “within the institution’s purview, not ORI’s.” However, ORI finalized a requirement that institutions promptly notify ORI if an appeal is filed after the institution has transmitted the institutional record to ORI. 

In practice, many institutions struggle to complete the steps of a research misconduct investigations in ORI’s prescribed time frame. ORI’s agreement to extend many of these time frames may make it more likely institutions can complete each stage without the need to either document reasons for the delay or affirmatively request an extension from ORI (though institutions still should do so in case ORI raises issues).

Documentation of the Assessment Stage

In the Proposed Rule, institutions would have been required to document the completion of an assessment of a research misconduct allegation in the form of an assessment report. ORI removed this requirement in response to commentors’ concern that this requirement caused significant burden on institutions. In its place, ORI will merely require institutions document the outcome of the assessment.

Changes Related to Confidentiality of Impacted Individuals and Institutions

The Proposed Rule sought to require ORI, where an investigation results in a settlement or research misconduct finding, to provide notification to the respondent, relevant institution, and HHS officials. However, the Final Rule adopted language that ORI may provide such information to those individuals in light of commentors’ concerns regarding confidentiality and regulatory overreach.

The Proposed Rule also identified potential “need to know” institutions, but ORI removed that list in recognition that it “overcomplicated institutional confidentiality obligations.”

The Final Rule does not include a Proposed Rule provision that would have required an institution to inform respondents, complainants, and witnesses before they are interviewed about how their information may be disclosed.

Additionally, where a final HHS action does not contain a settlement or finding of research misconduct, the Proposed Rule had suggested permitting ORI to publish notice of the outcome “if doing so is within the best interests of HHS to protect the health and safety of the public, to promote the integrity of the PHS supported research and research process, or to conserve public funds.” This language was not adopted in the Final Rule, which only allows ORI to provide written notice to the respondent, the institution, the complainant, and HHS officials.

Streamlined Appeals Process

The Final Rule features a streamlined process for disputing ORI’s findings and administrative actions. The 2005 regulations required a Departmental Appeals Board Administrative Law Judge (ALJ) to undertake a de novo review of ORI’s findings based on evidence presented at a hearing before an ALJ. Under the Final Rule, an ALJ will instead review the administrative record, including information provided by the respondent to ORI, and determine whether ORI’s findings and HHS’s administrative actions are (or are not) based on a material error of law or fact.

ORI suggested in the Proposed Rule that ALJs be permitted to hold a limited hearing should the ALJ determine there is a genuine dispute over a material fact. However, ORI has removed the proposal in light of comments suggesting that the “research misconduct process allows for sufficient procedures to make such limited hearings unnecessary.”

Transkription

The Proposed Rule sought to require institutions to prepare transcripts of all interviews conducted during research misconduct proceedings. ORI noted that commenters objected to the broad requirement out of concern for institutional burdens and discouragement of reporting of misconduct allegations. The Final Rule retains the interview transcription requirement during the investigation phase but no longer calls for transcription during the assessment and inquiry phases.

Schlussfolgerung

The Final Rule introduces clarifications to regulations governing research misconduct in PHS-funded research. These clarifications reflect consideration of the changing research landscape and attempt to reduce certain of the burdens to research institutions. In particular, the Final Rule reflects ORI’s appreciation that many institutions struggle with the time-intensive and costly process of investigating allegations of research misconduct. Additionally, ORI further recognized the complexity of research misconduct investigations and indicated that guidance is forthcoming on topics such as: practices for pursuing leads, general policies for compliance, research integrity assurances, institutional committee or consortium, multi-institution investigations, and the institutional record.

Whether the revised regulations are better suited to govern investigations involving innovative research across institutions and disciplines, and spanning many years, remains to be seen. Research institutions of all sizes should take care to review the Final Rule and consider how the revisions to the research misconduct regulations affect current and future institutional practices. Foley has an expert team of attorneys with deep experience advising institutions, including universities, academic medical centers and health care systems, navigate internal and ORI-initiated research misconduct proceedings.

We will continue to monitor the implementation of these new regulations, as well as any guidance affecting research institutions.

Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, our Health Care Practice Group or to our Government Enforcement Defense & Investigations Practice Group with any questions.