Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.”[1] The article is the latest in a sequence of alarms that some clinical researchers might not be as squeaky clean as we would hope them to be. Senior DOJ officials have in turn emphasized in public remarks that investigating clinical research shortcomings is now a Justice Department priority, with the whistleblower bar following suit.Continue Reading DOJ Continues to Eye Clinical Researchers (and the Universities and Hospitals Employing Them)

COVID-19 is not the sole focus of the Department of Health and Human Services (“HHS”) these days. On May 15th, the Office of Inspector General (“OIG”) announced that it added to its Work Plan a “Review of Institutions of Higher Education Grantees Receiving National Institutes of Health Awards” to address areas of potential risk at institutions of higher education (“IHE”).
Continue Reading OIG Tags Higher Education Grantees Receiving NIH Awards

Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are critical when structuring research studies that involve pediatric patients.
Continue Reading Don’t let research on ‘little’ subjects get you in big trouble