Fraud in research — How should the punishment be decided?

From the U.S. Department of Health and Human Services’ Office of Research Integrity:

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Robert B. Fogel, M.D., Harvard Medical School and Brigham and Women’s Hospital: Based on information that the Respondent volunteered to his former mentor on November 7, 2006, and detailed in a written admission on September 19, 2007, and ORI’s review of Joint Inquiry and Investigation reports by Harvard Medical School (HMS) and the Brigham and Women’s Hospital (BWH), the U.S. Public Health Service (PHS) found that Dr. Robert B. Fogel, former Assistant Professor of Medicine and Associate Physician at HMS, and former Co-Director of the Fellowship in Sleep Medicine at BWH, engaged in scientific misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), awards P50 HL60292, R01 HL48531, K23 HL04400, and F32 HL10246, and National Center for Research Resources (NCRR), NIH, award M01 RR02635.

Here’s how the story was reported (with useful links) by the Wall Street Journal’s health blog: Researcher Faked Data in Sleep Apnea Study.

PHS found that Fogel engaged in scientific misconduct by falsifying and fabricating data from a study of sleep apnea in severely obese patients, published in Sleep in 2003. The article has since been retracted. Fogel admits wrongdoing but claims that this was the only paper on which he had falsified data. In an investigation of Fogel’s other published work (approximately 30 other papers), Harvard found nothing amiss. The WSJ blog quotes Fogel:

“What I did was obviously horrendously wrong,” Fogel told the Scientist, adding this was the only paper on which he’d done this.

“I moved numbers around to make the data look like there was something there,” he said. “I never really thought through the consequences, and once I did this I got myself into a loop that I found I couldn’t get out of.”

The ORI has placed the following restrictions on Fogel, that will be in place for the next three years. First, he cannot act in any advisory capacity in any kind of projects, research or otherwise, related to the PHS. Second, any research project in which Fogel is named as involved and in which PHS funding is being sought, must also submit a proposal for monitoring his work. Finally, any institution at which Fogel is employed over the next three years, and at which Fogel is involved with PHS-funded research, must submit certification/verification of the legitimacy of Fogel’s data directly to ORI.

I suspect that many, like me, are wondering if these restrictions are too harsh or too permissive. How did the ORI come up with these restrictions? Is a three year restriction enough for one admittedly falsified paper? Would two papers equal six years of restrictions? What is clear, unfortunately, is that some sort of guidelines for assigning restrictions for research misconduct such as fraud, may be necessary. This, in turn, raises more interesting questions. Who should decide what restrictions should be put on researchers guilty of misconduct and how should these restrictions then be enforced? Clearly, this is not the responsibility of an institutional ethics review board. While ethics review boards do monitor ongoing research (not explicitly for researcher misconduct but rather for adherence to ethical standards and for adverse events), it is not their role to set restrictions or punishments for researchers found to be falsifying data or engaged in any other kind of misconduct.

According to federal guidelines, an institutional ethics review board’s responsibilities essentially end when the active part of data collection is over and the project file is, from a board’s perspective, closed. But what about unethical conduct after this, i.e. in data analysis and the reporting of data? Who monitors this phase of research? Arguably, the function of “peer review” in funding bodies decision-making processes and in journals’ selection and publication processes should be, to some degree, to monitor the veracity and legitimacy of researchers’ claims based in collected data. But in this case, it wasn’t the funding body or the journal noting a discrepancy or lack of veracity in the data. Fogel apparently told a former supervisor, two years ago, that he had falsified the data. Basically, if Fogel hadn’t told anyone, no one would have ever known about this as there is no consistent and ongoing monitoring of the conduct of many phases of research activities outside of data collection. And even then, unless you are conducting a clinical trial, in which case the federal bodies carefully monitor data collection, ongoing monitoring of active data collection phases by ethics review boards can be sporadic at best.

It is worrisome that we’re hearing about more cases like this one, it seems, than ever before. Consider this alongside the ever-increasing pressure on academics and scientists to publish original research and it becomes even more concerning. Ethics review board members may be left wondering how and if they should be dealing with these kinds of cases, how to subsequently review other research proposals from investigators found guilty of falsifying data and whether they have a role in helping to prevent such things from happening in the first place.

~ by Nancy Walton on April 12, 2009.

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