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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.
“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:
Financial conflicts of interest: NIH set forth conflict of interest reporting requirements in regulations updated in 2011. Reporting is a two-stage process: The investigator reports a significant financial interest to the institution, which decides whether it must be managed or eliminated. Then the institution reports the financial interest to NIH if it’s identified as a conflict of interest.
Other support: According to the terms and conditions for NIH grants in the NIH Grants Policy Statement, investigators must disclose everything that supports their research. “It’s a broad concept” and includes lab space, materials and personnel (e.g., visiting, voluntary and adjunct professors), Bonham said.
Foreign components: Also located in the Grants Policy Statement, these requirements are grant specific. NIH must preapprove research activity outside the U.S. if it constitutes a significant part of NIH-funded research. Human subjects research, for example, is clearly in the bucket of “significant,” she said. “What’s less clear is activity that will result in co-authorship, which NIH says ‘may’ represent ‘significant’ parts of a project.”
Scientist Allegedly Caused Harvard to Lie to NIH
Allegations of lying to investigators about funding from China is at the heart of the indictment of Charles Lieber, the chair of Harvard University’s chemistry and chemical biology department, on one count of making a materially false statement in connection with his affiliation with Wuhan University of Technology (WUT) in China. Lieber allegedly caused Harvard to falsely tell NIH that he had “no formal association with WUT” after 2012, DOJ alleged.
According to the criminal complaint, Lieber, the principal investigator of the Lieber Research Group at Harvard, works on “science and technology at the nanoscale” and has received $15 million in funding from NIH and the Department of Defense (DOD) since 2008. An affidavit from FBI Special Agent Robert Plumb said Lieber also “was a ‘strategic scientist’ at WUT and a contractual participant in China’s Thousand Talents Plan for significant periods between at least 2012 and 2017.” China uses its Thousand Talents Program to recruit scientific talent to further the country’s scientific development, prosperity and national security. WUT paid Lieber $50,000 a month for at least three years and about $150,000 in living and personal expenses, as well as $1.5 million to establish a research lab at WUT, the affidavit alleged.
In early 2015, Harvard independently learned of the WUT-Harvard Joint Nano Key Laboratory at WUT and Lieber’s role as director, according to the affidavit. Harvard told Lieber that improperly using the Harvard name and logo violated university policy, and he allegedly “falsely told Harvard officials WUT was using Harvard’s name and logo without his knowledge and consent,” although he admitted doing research there.
DOD investigators asked Lieber in April 2018 whether he had disclosed foreign research collaboration to DOD. “Lieber said he was familiar with China’s Thousand Talents Plan, but that he had never been asked to participate in the program…he also told investigators he ‘wasn’t sure’ how China categorized him. I believe these statements were false because” Lieber signed a three-year Thousand Talents agreement with WUT on July 21, 2012, the FBI affidavit alleged.
Lieber allegedly caused Harvard to tell NIH “that Lieber ‘had no formal association with WUT’ after 2012, but that ‘WUT continued to falsely exaggerate’ Lieber’s involvement with WUT in subsequent years,” the affidavit said. “Lieber also caused Harvard to tell NIH that Lieber ‘is not and has never been a participant in’ China’s Thousand Talents Plan.” None of that was true, the affidavit alleged.. Lieber is on administrative leave from Harvard, according to Bloomberg news. Harvard didn’t respond to RMC’s request for comment.
NIH Warns of Foreign ‘Influence’
This is a fraught environment for foreign support. Institutions could lose their grants or grant eligibility if they don’t comply with reporting requirements, and their reputation takes a blow if their professors or other members of a research team share sensitive data with a foreign power without appropriate approvals.
NIH Director Francis Collins said in a 2018 letter sent to about 10,000 institutions that it’s “aware that some foreign entities have mounted systematic programs to influence NIH researchers and peer reviewers.” He said NIH expects them to “work with your faculty and with your administrative staff to make sure that, in accordance with the NIH Grants Policy Statement, all applications and progress reports include all sources of research support, financial interests, and relevant affiliations.” In July 2019, NIH posted a reminder that the extramural community must “report foreign activities….” Then things got more personal. NIH sent 180 letters to organizations about their researchers’ relationships with foreign governments, “and we have only seen a handful in the news,” said Julie Hamilton, a managing director at Deloitte Advisory. “So there are definitely more to come.”
NIH’s warnings led Moffitt Cancer Center in Florida to review employees’ collaborations with research institutions in China, and in December 2019, Moffitt announced the resignation of its then-CEO, Dr. Alan List, and then-center director, Thomas Sellers, “for violations of conflict of interest rules through their work in China,” according to its website. “Moffitt found several compliance violations that also prompted separation of four additional researchers.” Preliminary findings of its review, which focused on employees’ participation in China’s Thousand Talents Program, have been shared with the federal government, Moffitt said, adding, “There is no indication Moffitt research was compromised or patient care affected.”
Institutions with NIH grants “need to be taking any NIH communications, including their letter, very seriously,” said Denise Hall-Gaulin, a principal with PYA. Research compliance has become increasingly risky, and it “takes a lot more legwork to ensure compliance with all regulatory requirements. This is such a new increase in focus by the government, trying to get your arms around how to put best practice controls in place is not very well established.”
Policies, Education May Need a Refresher
There are several moves for compliance officers to make to help protect their organizations in this area. They should check their policies to ensure “they are current with guidance about the meaning of the three reporting duties,” Bonham said. For example, NIH clarified its definition of “other support” in July 2019, and the Joint Committee on the Research Environment (JCORE) “is expected to come out with recommendations for federal science funders” soon.
They also may want to look at their disclosure forms. “Compliance officers need to review the annual conflict of interest survey to ensure there’s an explicit question that asks if there’s foreign support,” said Kaitlin McCarthy, a senior manager at Deloitte Advisory. Everyone should be queried, including executives, Hamilton added. “Researchers have always had expectations they report ‘other support,’ but I think NIH is saying they have to be more explicit in what they are looking for from the academic community,” she noted.
When there’s a question about the information provided by investigators, Bonham recommends taking extra steps to validate it. “If a faculty member says, ‘I don’t have an affiliation with Institution X,’ but the publication history indicates they do, that should give us reason to question it.” Institutions may also want to have a preapproval process for researchers and other employees who travel internationally for work, Hamilton added.
At Tampa General Hospital, which has a separate research compliance office, investigators are asked about their financial interests when they submit a new protocol and on annual renewal, Smith said. “From a research perspective, we ask whether they have an interest in the sponsor of research,” she explained. The institutional review board asks the same question. She tracks the answers on a spreadsheet so she can verify them against the CMS Open Payments database, but obviously that stops at the border. “We have to do surveillance in different ways because the traditional ways to respond are not sufficient,” Smith said.
Even if the question is on your disclosure form, it’s a good time to review the reporting and management process, Hamilton and McCarthy said. It needs to be robust, with input from researchers and scientists. Whether a certain kind of foreign support creates a conflict can be complicated and requires careful analysis, they said.
If conflict of interest programs are not monitoring potential research faculty conflicts, there could be gaps in reporting, said Kristen Lilly-Davidson, with PYA. She also thinks compliance officers should be included in critical strategic decisions that impact the compliance of research programs. “It’s important for research leadership to understand potential compliance risks that may be wrapped around the research initiatives, whether it’s grant funding, export controls or strategic partnerships,” she said.
Compliance officers also should get the word out about reporting foreign affiliations and support. Education is a centerpiece because “you are always dependent on investigators to disclose,” said Tracy Popp, senior director of clinical research at Tampa General Hospital. The message would be: “Conflicts are not necessarily bad. They can be managed. But if you are going to commit time to [another] institution, it better be OK with the institution that employs you. And if you are going to be paid for research by a foreign country, it better be OK with NIH,” Smith said. She will also caution investigators and physicians that they may be targeted by foreign governments.
Contact Bonham at firstname.lastname@example.org, Hamilton at email@example.com, Popp at firstname.lastname@example.org, Smith at email@example.com, Denise Hall-Gaulin at firstname.lastname@example.org, Lilly-Davidson at email@example.com and McCarthy at firstname.lastname@example.org.