Guest post: Why I commented on the proposed changes to U.S. federal research-misconduct policies – and why you should, too

Retraction Watch readers may know that the U.S. Office of Research Integrity, which has oversight of misconduct investigations of work funded by the National Institutes of Health, has proposed changes to its regulations. It’s the first such proposal since 2005, and has generated discussion in various quarters. We’re pleased to present this guest post by James Kennedy, a longtime observer of these issues.

One of the most controversial points about the federal policies for research misconduct is the extent to which a laboratory director, principal investigator, or lead author is held responsible for misconduct by others on their research team. 

It is surprisingly common in cases of extensive research fraud that the person who committed the offense cannot be identified. Data management in such cases is usually uncontrolled, with no tracking of changes to the data or preservation of the original data. The principal investigator is often at the center of the pattern of misconduct, but should they also be held accountable for it when the only provable fact is that they allowed a work environment that was vulnerable to bad behavior?

The regulations for handling misconduct in research funded by the U.S. Public Health Service are currently being modified, and the Office of Research Integrity (ORI), which implements the rules, is asking for public comment. This opportunity to influence the handling of misconduct is all the more important given that the regulations are often used as a model for misconduct policies at universities and research institutions. The comment period was recently extended until Jan. 4, 2024.  

Are you responsible for misconduct by others?

As a scientist who once helped expose fraud and has experience developing regulations, I have already submitted detailed comments on the proposed regulatory changes. My perspective is that the current legal precedent regarding the responsibility of PIs in misconduct cases is problematic. This precedent, which was established in 2018 in a case involving the ORI, holds that principal investigators and lead authors on papers will be held accountable for any fraudulent results they report. Their accountability extends to data provided by collaborators that were not under the management of the principal investigator or lead author. 

The judge apparently expects researchers to delve deeply into the possibility of fraud at all collaborating laboratories, without realizing that such an effort can take months and would make scientific collaboration impractical.

This assignment of responsibility for principal investigators and lead authors is established precedent for ORI but is not addressed in the proposed regulations. I believe it should be, and the new rules should be more realistic than the current precedent. In my view, laboratory directors and principal investigators are responsible for ensuring persons they directly manage follow good research practices, but not for collaborators who are not under their direct management. My comments to the regulator include a more complete description of my proposal (see point 2).

Another controversial topic is whether the final report of a university investigation of research misconduct should be made public for open discussion and evaluation like any other evidence and claims in science. The fact that allegations of misconduct have been made does not turn off the principles of open, transparent science. The justification and rationale for this point are described in point 4 of my comments.

Those who support, oppose, or would qualify the ideas discussed here should also consider submitting comments to ORI. 

Making regulatory comments effective

Submitting comments about proposed regulations will be more effective if the following practices are followed:

  • Multiple comments making the same point bring more attention to the point. The number of positive and negative comments will be considered. It is useful to be redundant even though a similar point has been made by others. 
  • Provide information about your credentials and experience. It is fine for a person with no direct experience in research to express an opinion. That lets an agency such as ORI know the public perception. Opinions by those who have direct experience in research are also needed. The agency needs to be able to distinguish between these two cases.
  • Providing evidence to support your view is valuable. A personal experience that pertains to the need for or effect of a regulation can significantly influence a regulatory decision. References to relevant research findings are also useful. 
  • The comments can be short and focused, or more extensive. My comments are more extensive because I have experience developing regulations and want to address the full thought process of the agency. This includes describing a problem, proposing a solution, and providing a legal rationale. Most comments focus on describing a problem, and may or may not suggest a possible solution. Presenting a legal rationale is not needed for most comments.

When regulations are proposed or adopted, they are posted in the Federal Register. In general, the preamble to the regulations in the Federal Register must be read to obtain a good understanding of the intended meaning and rationale for the regulations.

Read the proposed rules for misconduct here, see instructions for submitting comments here, and read comments posted so far here

James E. Kennedy is an honorary fellow in the psychology department of the University of Edinburgh, Scotland. He previously worked in the pharmaceutical industry and as an environmental scientist.

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3 thoughts on “Guest post: Why I commented on the proposed changes to U.S. federal research-misconduct policies – and why you should, too”

  1. My vote: Yes, supervisors definitely should be held accountable for fraud done by their students or subordinates.

    What is worse than a fraudulent scientist? A stupid or negligent or relaxed supervisor.

    Supervisors (and institutes) should definitely be punished severely, even more severely than the fraudster himself/herself. The principal investigators were there to check their student’s or subordinate’s integrity of work. They were there to help and encourage their students do their job better. They failed. They should be fired or severely punished.

    I know many such stupid, negligible professors, letting fraudulent research slip into theses, journals, and science. They are a disgrace, and they are many. Much more than I first thought.

  2. The regulations process in the US is not a voting process. In fact agencies are allowed to ignore comments if they can determine that they are part of a comment generating scheme. Therefore, it doesn’t help to have more comments for a position if they are all the exact same words, it’s much better to have one well thought out comment for a position than multiple identical ones…

    1. The comment period for the ORI regulations is over, so this is for future reference. In practice the number of comments making a point usually matters. At least that was my experience developing regulations for a state government in the U.S. The hypothetical case of many people making one poorly thought-out comment versus one person making a well thought-out comment has limited applicability.

      For example, there appeared to be an orchestrated campaign by universities for the comments about the proposed ORI regulations. Dozens of universities made comments expressing the same language. This makes it clear to the agency that universities overwhelmingly foresee adverse consequences for certain proposed provisions. The agency will inevitably give more careful consideration to those points than if only one university made the points out of dozens of comments by universities. Similarly, I was the only person to comment on some provisions. The agency will likely interpret the lack of comments as widespread acceptance of their proposals and be less inclined to carefully consider my comments. The agency would be likely to pay more attention if others would have made similar comments.

      For the ORI regulations, most of the comments were by organizations and were well thought out to represent the organizations’ self-interests. Unfortunately, the interests of the public affected by research misconduct and the need for scientific transparency were not well represented in the comments.

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