The Rule states that research misconduct will be found where conduct is a “significant departure” from accepted practices in the relevant research community, intentionally, knowingly or recklessly committed, and proven by a preponderance of the evidence.
The Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI) recently issued a final rule on research misconduct policies for Division of Public Health Services (PHS) funding recipients, updating a regulatory regime that has existed since 2005.
ORI’s updates are a response to public concerns about research integrity and questions about the misconduct review process. The Final Rule will apply to institutions that applied for or received PHS support for behavioral, biomedical or intramural research.
Firstly, research misconduct is defined under the rule as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” The definition explicitly excludes honest error or differences of opinion.
The Rule states that research misconduct will be found where conduct is a “significant departure” from accepted practices in the relevant research community, intentionally, knowingly or recklessly committed, and proven by a preponderance of the evidence. The Rule includes definitions of “intentionally,” “knowingly” and “recklessly” for institution reference. Notably, ORI revised its proposed definition of recklessly to make clear that the definition is in reference to reckless research proposal, performance, review or reporting results, in particular.
The research misconduct process begins with an institutional assessment of whether an allegation warrants an inquiry. An inquiry is a more formal fact-finding process, including written notice to a respondent and followed by an investigation to determine whether to find research misconduct. Following an institution’s final misconduct determination, the respondent or individual accused of research misconduct may initiate an appeal.
The regulatory regime traditionally has included a six-year limitation on reporting to HHS viable research misconduct allegations from the time of its occurrence. ORI clarifies in its Final Rule that the subsequent use exception to the six-year limitation applies when the respondent “continues or renews any incident” of the alleged misconduct that predates the six-year limitation by republishing or citing to “portions of the research record” (e.g. journal articles, funding proposals) that is alleged to be falsified, plagiarized, fabricated or is used for the respondent’s benefit. The Rule requires institutions to document where a case seems to fit into the subsequent use exception, yet the institution finds that it does not. The institution must then retain that documentation.
The Final Rule requires institutions to promptly initiate an assessment process upon receipt of an allegation. This process should determine whether an allegation warrants beginning a formal inquiry, including whether the allegation is “sufficiently credible and specific.” If a research integrity officer or designated official finds that the allegation warrants an inquiry, the individual must document the assessment and sequester research records. If the allegation does not warrant an inquiry, the institution must retain detailed documentation of the assessment process. ORI notes that it may further address this topic through policymaking. The Rule clarifies that the designated official who makes a final determination regarding research misconduct or institution action must remain separate from the research integrity officer who manages the institution’s compliance and structures policies to respond to research misconduct.
The Rule extends the inquiry or pre-investigation timeline from 60 days to 90 days, with any ongoing inquiry activities after 90 days requiring documentation in the inquiry report. Prior to the investigation phase, ORI directs that within 30 days of determining that an investigation is proper, the institution must provide ORI with an inquiry report. This inquiry report should include interview transcripts. This is significant because a copy of the inquiry report must be given to the respondent as a part of the Rule’s notice requirements. While interviewee privacy was a notable concern for those responding to the proposed rule, the Final Rule’s policy is that institutions should retain discretion over redacting these interviews.
The Final Rule further discusses confidentiality in regard to party identities. ORI clarifies that while conducting the research misconduct process, institutions may only disclose witness, respondent or complainant identities to those who “need to know” about potentially inaccurate data, including journals, editors and institutional review boards. The Final Rule added a provision to limit the identity confidentiality timeline to when an institution has made a final determination of research misconduct findings. ORI believes that this will prevent institutions from holding confidential information for an excessive period of time. The confidentiality provision also does not prohibit institutions from managing or acknowledging published data that may be unreliable.
ORI extended the investigation period, which follows the inquiry period, from 120 to 180 days. ORI noted that this extension balances the needs of institutions and respondents. ORI also clarified in its Rule that institutions retain the ability to request extensions should they require more time to investigate.
The Rule includes certain recordkeeping provisions. For example, the Final Rule includes a definition of institutional record that excludes documents that an institution compiled or generated during a research misconduct proceeding but did not rely on or consider. However, the record for an institutional appeal should include a description of records sequestered but not relied on or considered. This definition is significant because institutions must transmit the institutional record to ORI after making a final determination of research misconduct findings and will not have to include such documents in that transfer. ORI notes that it will issue guidance on the topic.
Given respondents may appeal to the institution and ORI may initiate its own review, ORI clarified that to ensure institutional appeals do not overlap with any ORI oversight review, institutions should not transmit the institutional record until institutional appeals end. The timing is important because ORI could issue a misconduct finding contrary to the institution’s finding. The Final Rule also clarifies that if an institution transmits the institutional record before a respondent files an appeal, the institution must promptly notify ORI.
According to HHS, PHS-funded institutions can expect ORI to release sample policies and guidance to build off the final rule. The Final Rule is effective January 1, 2025―however, the requirements will not be applicable until January 1, 2026.
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