Compliance in research is uncharted territory
Best approach is to stress the basics
Hospitals attempting to gauge the threats emerging from the government’s increased scrutiny in the field of research are facing un-charted territory, warns Stephen Hanlon, who manages Holland & Knight’s Community Services Team in Tallahassee, FL. "I don’t envy those who are charged with compliance in this area," he asserts. "Neither the time, resources, or mechanisms currently exist to get a good idea about what is really occurring on the hospital floor."
Despite lots of talk about whistle-blowers and potential liability, the paramount concern for hospitals should be basic protections for human subjects who are part of clinical research, argues David Hoffman, Assistant U.S. Attorney for the Eastern District of Pennsylvania and one of the federal attorneys spearheading the government’s effort in this area.
Richard Stern, senior counsel at the U.S. Depart-ment of Health and Human Services’ (HHS) Office of Inspector General (OIG), warns hospitals that while his office primarily devotes its attention to Medicare and Medicaid, it also has responsibility for the U.S. Food and Drug Administration (FDA), the National Institutes of Health, and other federal agencies.
"Unlike the FDA, we are not a regulatory agency," Stern explains. "But we certainly respond when allegations come to us regarding the expenditure of federal funds." Under a recent arrangement with HHS, the OIG also will be conducting the initial investigations of research misconduct that had previously been performed by the Office of Research Integrity.
Hoffman says the primary concern in almost all cases is potential harm to individuals as the result of fraudulent conduct. "However, the intent standard is very different for a criminal case and a civil case," he adds.
By and large, grant fraud cases usually are difficult to prosecute, especially if investigators are attacking scientific research itself, Hoffman says. That is because explaining specific scientific research to juries usually is no easy task, he explains. "You are not going to see a lot of those cases brought," he predicts. On the other hand, he says jurors will clearly understand schemes that lie about results in order to gain notoriety or financial benefits.
For example, a clinical researcher who stands to gain significant royalties resulting from a new drug or therapy or has equity or stock options in a clinical trial and then misrepresents the efficacy of such a drug or therapy will not be a sympathetic witness, he argues. "The bottom line is that an individual or institution cannot stick its head in the sand and say, We didn’t know what was going on even though we signed certifications,’" Hoffman warns.
Hoffman also cautioned anybody who signs a certification that he or she is at risk for potential liability. "You are certifying to the government that what you are saying to them is true and correct," he asserts. "So if you have no mechanism by which you check the accuracy of what is being said, then you are putting yourself on the hook."
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