Compliance and IT at Tampa General Hospital are teaming up to try to identify emails that its researchers receive from foreign domains. The emails may be innocuous—international data sharing and collaboration are a mainstay of the research community—but the teaching hospital won’t know unless it reviews them, and the stakes are higher now because the government has put foreign research support under a microscope, said Lynn Smith, research compliance officer. The email review would supplement its conflict-of-interest questions on foreign funding, but there will be more to come as monitoring evolves.
“We have to rethink how we manage this area going forward,” she said.
All eyes are on foreign support in the wake of recent developments from the National Institutes of Health (NIH) and the Department of Justice (DOJ). In a recent notice, NIH reminded the “extramural community”—medical centers, hospitals and research institutions—they’re required to report foreign “activities,” including conflicts of interest. NIH also has instructed some of them to review specific researchers, which has led to a handful of resignations and terminations. Allegations of lying about foreign money can have serious consequences; DOJ said Jan. 28 it charged a Harvard University professor with making a false statement about his financial support from China.[1]
“Faculty are under increased scrutiny and so are their institutions,” said attorney Valerie Bonham, with Ropes & Gray in Washington, D.C., who isn’t commenting on any specific cases. “There are concerns that economic and national security will be compromised and taxpayer investment in research will be compromised by unauthorized foreign government access to intellectual capital.” For example, if investigators fail to disclose foreign funding and other support for research, NIH worries “it’s making a distorted funding decision because it doesn’t have all the information it needs to make a decision about giving a grant to person A or person B,” she said.
In this environment, compliance officers have a “valuable opportunity” to work with investigators to educate them and improve compliance, Bonham said. It’s a delicate balance, however. “University compliance officers are not set up as law enforcement shops,” she said. But they can use their compliance chops—reviewing and updating policies when new guidance is released, as expected soon, and validating information from principal investigators, among other things.
With NIH grants, Bonham said there are three “reporting pathways the government is concerned about” in terms of foreign influence in research:
