Undergraduates, graduate students, post-doctoral fellows, and faculty members engaged in federally funded research at colleges and universities across the country should be aware of proposed changes—the first since 2005—to the Public Health Service (PHS) Policies on Research Misconduct proposed by Department of Health and Human Services Office of Research Integrity (ORI). The Proposed Rule would clarify the guidelines and significantly alter how institutions respond to allegations of research misconduct. While those who work in academic research have welcomed many aspects of the proposed changes, some have raised concerns about some aspects. For example, institutions may no longer dismiss a complaint during the initial phases of the investigation even if the issue is found to be the result of an “honest error”—a full investigation would still be required.

The comment period for the proposed changes closed on December 5, 2023; ORI will review the comments and determine whether to proceed with the process to implement the new rules or issue a modified proposal.

Opportunities to participate in a research project are available at many universities, even for undergraduates at schools like MIT and the University of Michigan. It can be overwhelming to be caught up in an investigation of research misconduct at such a young age, and there may be significant concerns about the effects on a student's academic future. Contact the Lento Law Firm Education Law Team online or by phone at 888.535.3686 to learn how we can help navigate the process if you or your child is implicated in an investigation of research misconduct.

Highlights of the Proposed Changes to Research Misconduct Guidelines

Here are some of the areas touched upon in the Proposed Rule:

Key Term Definitions – Newly provided definitions for the words describing the intent in acts of research misconduct are consistent with those used to evaluate allegations of grant fraud by the Department of Justice:

• Intentionally – to act with the aim of carrying out the act
• Knowingly – to act with an awareness of the act
• Recklessly – to act without proper caution despite the known risk of harm

Responsibility of Primary Recipients – Responsibility for compliance by sub-recipients lies with the primary recipient of federal funding.

Obligation to Identify All Possible Respondents – Institutions accused of research misconduct must consider whether additional researchers, e.g., principal investigators, co-authors, or laboratory members, are involved.

Designation of Lead Institution – When allegations involve multiple institutions, one of them must be designated as the lead for the research misconduct investigation.

“Subsequent Use” Exception Clarification – The Proposed Rule would include specific examples of instances of use or citation of research tainted by misconduct, such as journal articles, funding proposals, and presentations.

Timeline Adjustments – New regulations would require that institutional assessments be completed within thirty days and would extend the investigation phase from 120 days to 180 days. In addition, the appeals process would be streamlined.

Confidentiality Rules Changes – Several changes include the option for ORI to publish notice of institutional findings in an investigation (without identifying the respondents' information) and a requirement that interviewees in an investigation be informed about how their information may be disclosed.

The Lento Law Firm Education Law Team Can Help if You Face Allegations of Research Misconduct

Institutions of higher learning are infamous for their complicated bureaucracies, and if passed, the Proposed Rule for changes to the guidelines on research misconduct will add new layers to the process each institution follows when investigating allegations. The Lento Law Firm Education Law Team can provide the skilled, knowledgeable guidance you need when facing allegations of research misconduct. Call now at 888.535.3686 or leave us a message online to arrange a consultation.