Sneak Preview: ORI Overhauls Research Misconduct Rule

(The following was excerpted from a recent Thompson Grants Compliance Expert article). The Department of Health and Human Services (HHS) Office of Research Integrity (ORI) recently released the 2024 final rule on Public Health Service (PHS) Policies on Research Misconduct at 42 CFR Part 93. According to ORI, the updated policy addresses the responsible conduct of research across PHS-funded agencies and organizations, while balancing the “needs of the research community and ORI’s oversight responsibilities.”

The current PHS policies on research misconduct have not been revised since they were first published in 2005. According to ORI, the purpose of the research misconduct policy 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 funded institutions and authorize administrative actions, when necessary (see §744 in the Federal Grants Management Module).

“The research landscape has changed over the past 20 years, thanks to new technology, scientific advances, and the globalization of research,” said HHS Secretary Xavier Becerra. “To preserve the integrity of the research that we help to fund, it is necessary to update the regulations around how that research is conducted, and that is what we are doing today.”

The updated regulation clarifies both ORI’s regulatory oversight responsibilities and the role of PHS-funded organizations in institutionalizing research integrity in addition to refining requirements for addressing research misconduct in PHS-funded research. The final rule was drafted after ORI considered the public comments on the notice of proposed rulemaking (NPRM) issued last fall and internal review (see “HHS Seeks Input on Revised Misconduct Policy”).

ORI emphasizes that the 2024 final rule highlights several major revisions to the 2005 regulation:

• Streamlining institutional responsibilities in the general conduct of misconduct proceedings by (1) clarifying institutional confidentiality obligations and identifying areas of institutional discretion, such as notifying journals to correct the research record due to a finding of research misconduct; and (2) providing a clearer description of research misconduct investigation requirements, among which includes addressing situations involving multiple respondents.
• Recognizing institutional best practices and timelines by (1) acknowledging institutional discretion to make determinations of honest error, and the application of subsequent use exception when evidence of misconduct occurred; (2) describing the institutional assessment as “a pre-investigation phase” within the purview of institutional best practices and realistic timelines, while clarifying institutional documentation requirements for ORI oversight; (3) extending the timeline of institutional inquiries from 60 days to 90 days; and (4) highlighting that institutional findings are separate from ORI findings and clarifying institutional discretion to publish findings.
• Providing a clear appeal process and administrative remedies for respondents.
• Adding commonly used definitions to clearly highlight how these concepts are applied by ORI when conducting oversight of research misconduct proceedings.

(The full version of this story has now been made available to all for a limited time here.)

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