On October 5, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) issued a Notice of Proposed Rulemaking (NPRM) proposing revisions to the 2005 Public Health Service (PHS) Policies on Research Misconduct (42 C.F.R. Part 93).

The proposed regulation establishes requirements for addressing allegations of research misconduct in PHS-funded research. Its purpose is to “promote integrity in research, establish the definitions and processes to assess and investigate allegations of research misconduct, ensure the appropriate handling of research misconduct by PHS-funded institutions, and authorize administrative actions, when necessary.”[1]

For convenience, we have created a redline showing the proposed changes.

Prior to the NPRM’s release, ORI published a Request for Information (RFI) to solicit views on the 2005 regulations from the public, including key stakeholders and collaborative groups.

The proposed rule includes the following key revisions:

  • Public Posting of Standard Operating Procedures (SOPs): To maintain “active research integrity assurance,” institutions must make their policies and procedures for addressing research misconduct publicly available.
  • Burden of Proof: Respondents no longer have an explicit burden of proof regarding affirmative defenses.
  • Statute of Limitations: Any institutional conclusion that the subsequent use exception to the six-year statute of limitation does not apply (i.e., the statute of limitation applies) must be previewed with and approved by ORI based on the relevant facts of the case.
  • Notable New Definitions:
    • Reckless” is defined to mean “to act without proper caution despite a known risk for harm.”
    • Honest Error” is defined to mean “a mistake made in good faith.”
    • Difference of Opinion” is defined to mean “an alternative view held by a researcher who is substantively engaged in the scientific subject area. It generally contrasts with a prevailing opinion included in a published research record or generally accepted by the relevant scientific community. The differing opinion must concern scientific data, methodology, analysis, interpretations, or conclusions, not policy opinions or decisions unrelated to data practices.”
    • Assessment” is defined to mean “a consideration of whether an allegation of research misconduct appears” to meet the regulatory standards for moving to an inquiry.
  • Notable Revised Definitions:
    • Plagiarism” is defined to mean “the appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit. (a) Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work, which materially mislead the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases which describe a commonly-used methodology. (b) Plagiarism does not include self-plagiarism or authorship or credit disputes including disputes among former collaborators who participated jointly in the development or conduct of a research project. Self-plagiarism and authorship disputes do not meet the definition of research misconduct.”
  • Assessments: Assessments must be conducted in accordance with new proposed requirements, including within a 30-day timeframe.
    • To the extent an Assessment cannot be conducted within 30 days, the allegation must move to an inquiry without the availability of an extension.
    • To the extent interviews are pursued as part of the Assessment phase, they must meet the same requirements for interviews conducted at later stages of the proceedings.
    • If an Assessment determines that an inquiry is warranted, the Assessment must be documented in accordance with the proposed regulations.
  • Inquiries: If an inquiry will take longer than the permitted 60 days, an extension from ORI is required (as opposed to the current practice of documenting the reasons for the longer timeframe in the record).
  • Investigations: If new allegations against the same respondent or pertaining to the research record under investigation arise, those can be pursued as part of the investigation and do not require a separate inquiry.
  • Witness Interviews: New conditions for the conduct of witness interviews must be met, regardless of the phase of the proceeding, including:
    • Interviews must be transcribed, and exhibits shown to the interviewee must be numbered and referred to by that number in the interview.
    • Transcripts must be made available to the relevant interviewee for correction.
    • Transcripts with any corrections and numbered exhibits must be included in the record of the investigation.
    • The respondent must not be present during the witnesses’ interviews but must be provided a transcribed copy of the interview.
  • Scope of Proceedings: New conditions relating to the existing requirement to pursue all leads are proposed at both the inquiry and investigation stage, including “the examination of additional research records (g., published papers, grant applications) of the respondent(s) that contain similar data elements as that of the initial allegation(s).”
  • Honest Error/Difference of Opinion: The regulations codify guidance that previously appears in the preamble to the current regulation, instructing that a determination of no misconduct based on honest error or difference of opinion may not occur until the investigation stage.
  • Confidentiality: Provides confirmation that notifying those with a “need to know,” including journals and other impacted institutions, is consistent with the regulations’ confidentiality requirements under certain circumstances.

Notably, the proposed rule acknowledges the lack of a regulatory requirement to perform certain actions that are common practice in the regulated community but then presents conditions to such non-required actions if pursued, for example:

  • Respondents or complainants must be provided the opportunity to object to the person/committee/consortium members chosen to conduct, support, or participate in the research misconduct proceedings.
  • Interviews conducted during the Assessment or inquiry phase must meet the same requirements as Investigation phase interviews.

ORI is seeking comments from individuals, organizations, institutions, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of the regulations. Comments regarding the proposed revisions should be submitted on or before December 5, 2023, electronically to this website and should refer to the Regulatory Information Number (RIN) [0937–AA12].

We continue to digest and analyze the significance of the proposed rule and will share further detailed analysis in the near future.

* * *

This Insight was authored by Kate Gallin Heffernan, Marylana Saadeh Helou, and Olivia Plinio. For additional information about the issues discussed in this Insight, or if you have any other questions or concerns regarding the proposed rule, please contact one of the authors or the Epstein Becker Green Health Care and Life Sciences attorney who regularly handles your legal matters.

[1] See https://www.hhs.gov/about/news/2023/10/05/hhs-releases-notice-proposed-rulemaking-update-2005-public-health-service-policies-research-misconduct.html.

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