Comments on Draft NIH Scientific Integrity Policy
Comments on Draft NIH Scientific Integrity Policy
The NIH recently asked for public comments on a draft Scientific Integrity Policy (You can still submit comments here by Nov. 9.)
The Good Science Project submitted comments arguing that the NIH has taken admirable steps, but it should go just one step further so as to proactively look for integrity problems.
Our comments are below.
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Introduction. We are pleased to submit these comments on the Draft Scientific Integrity Policy of the National Institutes of Health (NIH), particularly with regards to topics 1 and 3 (role and responsibilities for the NIH Scientific Integrity Officer and the Scientific Integrity Council).
NIH is to be applauded for its commitment to scientific integrity and reliability, and the Draft Scientific Integrity Policy takes an important step forward in establishing a new Scientific Integrity Official to have primary responsibility across NIH, along with the advice of a Scientific Integrity Council. These new offices will hopefully create more of a mechanism to ensure that scientific integrity is given its proper due.
Ensuring Accountability. The Draft Policy notes that there are already several NIH offices that adjudicate integrity issues “when an allegation or complaint is received,” and that the new Scientific Integrity Official will help coordinate how NIH responds to “allegations to ensure effective oversight.”
We believe that NIH should take one further step as to ensuring accountability: Give the Scientific Integrity Official enough of a budget and staff to proactively look for research integrity issues, rather than merely reacting to allegations and complaints.
The reason for this recommendation is straightforward: Problems with research integrity are much more prevalent than the rate of official allegations and complaints would suggest. In many cases, we will not find research integrity problems unless we look for them more proactively.
Think of the stakes for a trainee who suspects potential data fraud in a published article by a leading scholar in their field. All the incentives weigh strongly against making any such allegation. After all, making an allegation of fraud:
Takes time away from your own research agenda and publications;
Could create damaging controversy for your mentor(s), lab head, etc.;
Could cause the leaders in your field to view you as a potential troublemaker rather than a scientist worth hiring; and,
Could even lead to an expensive lawsuit for defamation.
By contrast, there are enormous incentives for academics to cheat:
NIH hands out some $39 billion in external research funding a year
Academics have jobs, tenure, and up to 100% salary support on the line
Faking data is relatively easy, especially if no one is looking
Just by the balance of incentives here, there are definitely more research integrity issues than will be discovered by waiting for someone to put their own career on the line by filing an official complaint.
It should therefore be no surprise that some of the most dramatic instances of fraud have been found by anonymous Internet commenters, and often by people (such as Elizabeth Bik) who are unemployable in academia.
Consider the recent case of apparently fraudulent research in the Alzheimer’s field.[1] The original 2006 article that has come into question[2] was supported by grants from the NIH to three of the authors, and has been cited more than “all but four other Alzheimer’s basic research reports published since 2006.” Independent investigators who reviewed the lead author’s work (Sylvain Lesné) found reason to “cast doubt on hundreds of images, including more than 70 in Lesné’s papers.”
Notice that these potential integrity issues only came to light more than 15 years after the fact when PubPeer commenters noticed many cases of apparent image duplication. NIH program officers apparently never uncovered any problems via progress reports or any other mechanism for monitoring research output.
Nonetheless, Lesné has apparently received at least $8,762,207 in NIH support since 2008.[3] Even worse, as Science revealed, the very NIH program officer (Austin Yang) for Lesné’s most recent R01 (which was awarded four months after NIH had been notified of research integrity issues) had literally been a co-author with Lesné on the apparently fraudulent 2006 article!
As this incident shows, substantial cases of fraud can contaminate an entire field of research for 15+ years, not only without anyone at NIH noticing, but with NIH continuing to send millions of dollars to the problematic researcher, even with one of his co-authors as the program officer for a major grant!
The NIH should look to the Center for Medicare and Medicaid Services, which devotes substantial resources to a Center for Program Integrity that proactively looks for signs of fraud, improper payments, etc. That is, the NIH Scientific Integrity Official should be given a staff and budget to proactively audit NIH-funded studies for signs of fraud, data manipulation, and other violations of research integrity. One-twentieth of one percent of NIH’s overall budget would be a good starting point.
[1] Charles Piller, “Blots on a Field?,” Science (July 21, 2022), available at https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease.
[2] See Sylvain Lesné et al., “A specific amyloid-β protein assembly in the brain impairs memory,” Nature 440 (2006): 352-357.
[3] See https://reporter.nih.gov/search/W9KkSxMJBU2WJkvp7N8SaA/projects.