HHS proposal takes heat off research whistle-blowers
HHS proposal takes heat off research whistle-blowers
The Department of Health and Human Services (HHS) released a proposed rule Nov. 27 aimed at protecting from retaliation whistle-blowers who make claims related to public health research projects supported by federal funds. "What I see happening here is that the government is turning up the heat to get the information it needs to move forward with these investigations," asserts Kendra Dimond, an attorney with Arent Fox in Washington, DC.
While all whistle-blowers are afforded protections under the False Claims Act, Dimond says the research community often interacts in a unique fashion. "It is a very tight community," explains Dimond, who used to advise the National Institutes of Health regarding research compliance. She says the fear is that they will not be trusted by
other research organizations after becoming a whistle-blower.
Over the past few years, HHS has encouraged people with research and clinical information to come forward, says Robert Wanerman, Dimond’s colleague at Arent Fox. "There is real recognition that the people who are in the field know what is going on," he says. But in addition to giving whistle-blowers an opportunity to defend themselves in a forum where they can confront those who may retaliate, the proposed rule also would place certain requirements on the institution they work for.
Institutions covered by the proposed rule would have to establish written procedures for whistle- blowers that include specific mechanisms for preventing retaliation. They also would have to establish mechanisms to process whistle-blower complaints and authorize administrative remedies.
To receive federal funds, institutions would have to include in their application an assurance that it has written whistle-blower protection procedures outlined in the proposed rule.
In short, the government is telling institutions they must have these programs in place in order to secure federally funded grant support and keep it in place, says Wanerman. "The government’s only power is the power of the purse, and it is going to exercise it."
Wanerman notes that the proposed rule also includes a provision about reporting by the institution to the Office of Research Integrity (ORI). As soon as a retaliation compliant is filed, the institution must submit a report to ORI along with regular updates.
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