Duke University’s ground-breaking $112 million settlement of a False Claims Act lawsuit underscores the high stakes of research integrity and raises important questions for research institutions.
This much is clear: We must work together to foster and preserve a culture that places an emphasis on research integrity. Merriam-Webster defines integrity as a “firm adherence to a code of especially moral or artistic values: incorruptibility.” This is essential to any institution whose primary purpose is to educate and generate knowledge.
The issue of responsible conduct poses serious challenges as both research enterprises and regulatory requirements grow. To assess these challenges and create a roadmap for responsible research culture, The Committee on Science, Engineering, and Public Policy (COSEPUP) of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine released a comprehensive report, Fostering Integrity in Research, that is a worthwhile read.
The Duke case
The Duke settlement far exceeds other recent federal cases. In 2015, the University of Florida settled for $19.8 million, for example, and at the time, that was high. Cornell University had resolved a 2009 case for $2.6 million, by comparison, and Northeastern University in 2013 for $2.9 million. Those two cases involved misappropriated federal funds, breaches that could be traced back to the failure of internal controls or insufficient staff training and expertise in grant management. These errors could be remedied with improvements to administrative systems.
In the Duke case, however, the falsification of data was much more difficult to detect by administrative systems. The primary tools available to universities are preventative in nature and primarily fall into the categories of training and education. Responsibility for actually monitoring data collection generally falls to the academic or laboratory personnel local to where the research occurs.
The recent settlement was the second high-profile case of data falsification at Duke’s medical school in a decade, which may have influenced the magnitude of the penalty levied against the university. You can read more about the Duke case here.
Among initiatives outlined in a corrective action plan with the National Institutes of Health, Duke is creating an Office of Scientific Integrity, establishing an Associate Vice Provost for Scientific Integrity, and forming an Executive Oversight Committee. Duke also formed an Advisory Panel on Research Integrity and Excellence to provide additional recommendations to the university this summer.
At Clemson, the Office of Research Compliance manages a robust Responsible Conduct of Research program with training opportunities, answers to frequently asked questions, numerous forms and other resources, and a confidential third-party Ethics/Safety hotline to report concerns.
Additionally, our Office of Sponsored Programs provides materials on the False Claims Act as part of the Training in Research Administration at Clemson (TRAC) program delivered to both grant support staff and associate deans for research.
Please visit the webpages hyperlinked above and familiarize yourself with these matters and contact these offices for guidance.
Promoting research integrity requires high-level support and also collegiality, communication and cooperation with research teams, academic departments and administrative units. The high visibility of the Duke case will undoubtedly stir conversations on best practices among research universities. Perhaps most importantly, this presents an opportunity to open campus-wide dialogue on expectations and ethical and regulatory responsibilities.
I would like to close with this: At universities, our primary role is to educate and to create new knowledge to share with the world. Everything we do is rooted by facts, by scientific evidence, by experimental failures and successes, by the endlessly hard work of searching for answers, by truth. This is our responsibility and our opportunity. Integrity, then, is at the heart of the university mission. It is more important than dollars awarded or manuscripts published.
As always, I welcome your input. Email email@example.com.
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