HHS Proposes New Research Integrity Guidelines

This week, the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that addresses how the HHS’s Office of Research Integrity (ORI) will handle cases of research misconduct in the future.

The National Institutes of Health (NIH) is part of the HHS and is responsible for awarding grants for various research projects. According to an NIH report, the organization awarded some $33.3 billion in grants in 2022 across some 58,368 different awards.

However, part of that process of awarding grants is dealing with allegations of research misconduct, which is what the ORI is tasked with.

Unfortunately for the ORI, they have been incredibly busy. According to a March report, in 2013 there were only 104 allegations of research misconduct during the calendar year. However, by 2022, that number had grown to 564.

Despite the sharp increase in allegations and the changing landscape of research integrity, the last time the ORI updated its policy was in 2005, which is why it’s proposing the changes today.

Those changes are currently in a public comment period, which will last until December 5. They then hope to finalize the new standards in the summer of 2024 and have them take effect on January 1, 2025. These changes would apply to all institutions and subrecipients receiving Public Health Services funding from the US government

But while many of the changes are mundane and more for clarification purposes than to shift policy, there are a few larger changes that are worth noting, including the removal of self-plagiarism as an ORI offense.

What’s Changing

The changes are sweeping through the entity policy, touching on all five major subsections of the policy. That said, many of the changes are more for clarification, such as adding new definitions, grouping the definitions into a single section, and clarifying confusing rules or statements.

However, there are several changes that will have potentially significant impacts on how the ORI handles allegations of research integrity.

  1. Streamlined Appeals: Under the current rules, when an appeal is filed, the Departmental Appeals Board Administrative Law Judge performs a de novo review of the ORI findings. This means that the process basically repeats itself.  Under the new rules, in cases not involving suspension or disbarment, the appeals process would be basically a review of existing evidence and testimony, not a de novo review. This would greatly shorten those cases, something the ORI says is “advantageous to all parties”.
  2. Increased Transparency: The ORI is also wanting the ability to make the findings of institutions part of the public record. Previously, such findings were held in confidence by the federal government, though they would be used in ORI reviews. It is unclear exactly when this would happen, but it would likely be in cases where the ORI had a different opinion than the institution.
  3. Subrecipients Must Comply: The new rule also clarifies that subrecipients, meaning those who receive federal funding via a middle institution that won the grant, also have to follow the same rules and policies. 
  4. Clarification on Self-Plagiarism and Authorship Disputes: Finally, the proposed rule changes updates the definition of plagiarism to clarify that both self-plagiarism and authorship disputes do not meet the definition of research misconduct and are not part of the ORI’s jurisdiction. Traditional plagiarism, however, remains under ORI purview. It also differentiates unattributed text copied from “the limited use of identical or nearly-identical phrases which describe a commonly-used methodology” from other kinds of text.

Of those changes, it’s the last that’s most likely to turn heads among those not directly receiving federal funds. On the surface, it seems as if the ORI is greatly reducing the scope of plagiarism cases it will address, limiting it solely to traditional cases of plagiarism that do not involve “commonly-used” methodologies.

However, the rule change seems to represent more of a clarification, not a change. The ORI says that these are all issues that are best handled on the institutional level, which is supposed to be the first line of defense on all research integrity issues.

That said, it’s still an interesting change and one worth making note of.

My Thoughts 

As I said above, most of the changes are purely for clarification and to help make the ORI process more easily understood. Those changes are long overdue and are very welcome to see.

I also support any increased transparency, especially when it comes to awards made using public funds. Though I do find the clause that would make full transcripts of witness interviews available to the subject of the case, even in situations where it might put a witness at risk, somewhat worrisome, the intentions seem to be good.

Even the streamlining of the appeals process makes sense as many of the decisions by the ORI result in relatively light action being taken, and a de novo appeal does not make sense. A full review is still available in cases involving suspension or disbarment, ensuring that those protections are available in more serious cases.

The plagiarism policy change, however, does raise serious questions.

On one hand, I agree with the ORI. The ORI isn’t particularly interested in authorship. Their goal is to ensure the funding of quality research that advances scientific understanding.

Authorship issues are certainly ethical issues, but they always pertain to whether the research meets the criteria above. Just because an author commits self plagiarism or an author is left off the final paper, doesn’t necessarily mean that the research itself is compromised.

However, there are times in which these issues can highlight significant problems with the research. For example, cases where a researcher commits self plagiarism to secure multiple grants for the same work or multiple publications for the same research.

That is a fine line unto itself. Researchers often perform a series of studies with very similar methodologies, and it can be difficult to tell when a study extremely similar to earlier research to expand on that earlier work, or it’s just a carbon copy with no significant changes. 

By completely removing self-plagiarism and authorship as areas of ORI jurisdiction, they are also removing their ability to address those cases, even if they are rare.

While I understand the logic of the ORI and I agree that institutions are better equipped to handle these disputes, it seems like there should be at least some kind of carve out for cases where self plagiarism and authorship issues do have a real impact on the research being performed.

Bottom Line

The proposed changes are up for public comment until December 5, 2023. If you want to comment, you can do so at Regulations.gov, referring to Regulatory Information Number 0937–AA12. 

For the most part, the regulation changes are just clarifications and small tweaks. Clearly, the ORI is attempting to take the lessons that it learned from the past 18 years of work to clarify and streamline the process. Likely, they are further motivated by the sharp increase in cases.

Still, I think that the ORI, in a bid to clarify its non-role in authorship disputes, may be limiting itself from hearing at least some cases that do raise research misconduct issues. 

While it’s smart of the ORI to focus its energies on the kinds of misconduct that are most harmful to the HHS’ goals, ignoring these issues outright could leave it on the outside looking in on some unfortunate situations.

That criticism aside, I overall think that the new rules are well-intentioned and provide much needed clarity in this space. Given the public comment period, there is still plenty of time for the ORI to make tweaks and changes to the policies, addressing the potential issues that do exist.

Header Image: Sarah Stierch, CC BY 4.0, via Wikimedia Commons

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