On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct (the Proposed Rule), which set forth the requirements for addressing research misconduct in PHS-funded research. Many types of institutions receive PHS funding for research endeavors, including universities, colleges, academic medical centers, medical schools, hospitals, and health care systems.
The Proposed Rule contemplates a much needed clarification to the research misconduct regulations, which have not been updated since 2005. However, the Proposed Rule also includes some changes that, if implemented, would significantly impact how research institutions must respond to allegations of research misconduct. Institutions undertaking PHS-funded research should take note of these proposed changes and prepare to submit comments to HHS by December 5, 2023.
In this article, we summarize the most significant changes proposed and analyze their potential impact on research institutions if finalized in their current form.
1. Key Terms Defined
A finding of research misconduct requires the misconduct be committed intentionally, knowingly, or recklessly. ORI did not define these terms in the 2005 rulemaking, but proposes the following definitions in the Proposed Rule:
- Intentionally means to act with the aim of carrying out the act;
- Knowingly means to act with an awareness of the act; and
- Recklessly means to act without proper caution despite known risk for harm.
We note this level of knowledge is the same as required for False Claims Act (FCA) knowledge, making it easier for the DOJ civil division attorneys to evaluate and investigate claims of grant fraud.
Research misconduct does not include “honest error,” which ORI proposes to define as “a mistake made in good faith.” This, too, is consistent with the FCA, which is not intended to convert honest mistakes to fraud claims. Likewise, ORI proposes to exclude from the definition of “plagiarism” (which constitutes research misconduct) self-plagiarism, or authorship or credit disputes.
The Proposed Rule includes a new defined term: institutional record.ORI requires institutions to maintain and transmit the institutional record to ORI upon completion of an investigation. If finalized, the institutional record would be defined to include:
- The assessment report;
- 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.
2. Responsibility of Sub-Recipients
The Proposed Rule would explicitly place responsibility for sub-recipient compliance with ORI regulations upon the primary PHS-funded recipients. With an increasing amount of research occurring across institutions, the primary awardee of PHS funds should be aware of its responsibility for sub-recipients.
3. Multiple Respondents and Multiple Institutions
The Proposed Rule introduces an obligation for institutions to consider whether additional researchers are involved in the alleged misconduct. Specifically, institutions would need to consider principal investigators, co-authors on publications, co-investigators, collaborators and laboratory members during the assessment, inquiry, and investigation stages.
Likewise, for allegations involving multiple institutions, one institution must be designated the lead for the purpose of the research misconduct proceedings and would be responsible for obtaining research records and witness testimonies from the other institutions.
4. Subsequent Use Exception to the Six-Year Statute of Limitations
ORI’s research misconduct rules only apply to misconduct occurring within six years of the date HHS or the institution received an allegation. However, the six-year statute of limitation does not apply when a respondent subsequently uses 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 when HHS or the institution received the allegation. ORI proposes implementing clarifying language by providing specific examples of subsequent use that fall under the exception, including use, re-publication, or citation in:
- Processed data
- Journal articles
- Funding proposals or data repositories
- Submitted or published manuscripts
- PHS grant applications
- Progress reports
- Other research records
5. Shortened Assessment Time and Lengthened the Investigation Time
ORI proposes a new section of the regulations regarding the institutional assessment process. ORI would require institutions to complete an “assessment” within 30-days of initiation. Assessment means:
consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct; appears to involve PHS supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training . . . ; and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
The new section included in the Proposed Rule sets forth the required steps in assessing allegations of research misconduct and when an inquiry is warranted based on the assessment. Research institutions may struggle to comply with this aggressive timeline given the involved process of assessing allegations of misconduct, which may include reviewing the research record and interviewing the complainant, respondent, and witnesses.
In contrast, ORI proposes extending the time limit to complete an investigation stage from 120 days to 180 days. Institutions must ask ORI for an extension in writing that sets forth the circumstances warranting extension if they will exceed this time limit. In practice, many institutions have struggled to complete investigations within 120 days and routinely request extensions from ORI. Institutions may be more likely to complete their investigation within 180 days and, under the Proposed Rule, would then obviate the need to seek an extension.
6. Changes Related to Confidentiality of Impacted Individuals and Institutions
ORI proposes several changes affecting the confidentiality of research misconduct proceedings and the individuals involved. First, the Proposed Rule would allow ORI to publish notice of the institutional findings and implemented actions, not including identifying information of the respondent(s), if doing so is within the best interest of HHS to “protect the health and safety of the public . . . promote the integrity of PHS supported research and research process, or . . . conserve public funds.” Institutions may oppose this proposal since institutional proceedings and findings (as opposed to ORI’s findings) traditionally have been kept out of the public record as a matter of course.
Under the ORI rules, disclosure of information is limited to those who have a need to carry out the research misconduct proceeding. ORI proposes to clarify that those with a “need to know” may include public and private entities, journals, editors, publishers. Additionally, other institutions may have a need to know if they possess records relevant to the allegations, they employ a respondent alleged to have committed misconduct, or they fund research being conducted by a respondent. This clarification is helpful, as many institutions have grappled with when it is appropriate to disclose information, especially after a respondent has moved to a new institution.
The Proposed Rule also incorporates provisions that would require institution to inform respondents, complainants, and witnesses about how their information may be disclosed before they are interviewed. Practically, lawyers leading interviews of respondents, complainants, and witnesses should be certain to make this disclosure in addition to the traditional Upjohn warning.
7. Streamlined Appeals Process
Finally, in the preamble, ORI described stakeholders’ requests for a simpler appeals process – which historically has taken years. Given this, ORI proposes a more streamlined process for disputing ORI’s findings and administrative actions. The 2005 regulations require a Departmental Appeals Board Administrative Law Judge (ALJ) to undertake a de novo review of ORI’s findings based on evidence presented by ORI and the respondent. Under the Proposed Rule, an ALJ would review the administrative record including information provided by the respondent to ORI and determine whether ORI’s findings and HHS’s administrative actions (other than suspension or debarment) are not based on a material error of law or fact.
Make Your Voice Heard
HHS urges the research community to provide comments in response to the Proposed Rule. Anyone may submit comments – anonymously or otherwise – on or before December 5, 2023 via electronic submission at: https://www.regulations.gov/ (search RIN 0937–AA12).
If implemented, the Proposed Rule would introduce clarifications to the regulations governing research misconduct in PHS-funded research, which have been in place in their current form for nearly two decades. These clarifications reflect consideration of the changing research landscape, including unique challenges with multi-institutional research. ORI also proposes significant changes that would materially impact institutions and individuals involved in research misconduct proceedings.
While a number of the proposed changes simply codify existing informal practice, others – such as the definition of “need to know,” and the implementation of short deadlines to assess and investigate allegations – could have profound consequences for institutions with other research obligations. At the same time, it is not at all clear that the proposed changes to the research misconduct regime adequately address the concerns among many stakeholders that the investigatory process is too cumbersome, time-consuming, and costly to both institutions and respondents.
Foley has an expert team of attorneys with deep experience advising institutions, including universities and health care systems, navigating internal and ORI-initiated research misconduct proceedings.
We will continue to monitor the Proposed Rule and 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.