Addressing Foreign Interference and Associated Risks to the Integrity of Biomedical Research, and How You Can Help

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On Tuesday, June 23, Dr. Kelvin Drogemeier, the Director of the Office of Science and Technology Policy (OSTP), gave a presentation to the Federal Demonstration Partnership (FDP) on “Enhancing the Security and Integrity of America’s Research Enterprise.”  Dr. Drogemeier articulated five “key takeaway” messages:

  • The integrity of our research enterprise rests upon core principles and values, including transparency, honesty, accountability, objectivity, respect, freedom of inquiry, reciprocity, and merit-based competition;
  • Principled international collaboration and foreign contributions are critical to our success;
  • Some individuals and foreign governments violate core principles of integrity and pose risks to research security;
  • Hidden diversions of intellectual property weaken our innovation base and threaten our security and economic competitiveness; and
  • The U.S. government is taking deliberate steps to address risks to research integrity and security while maintaining an open and collaborative enterprise.

I’d like to take this opportunity to summarize Dr. Drogemeier’s presentation and how it fits within the context of NIH extramural research.

Dr. Drogemeier reviewed a number of case examples of scientists who engaged in unethical behaviors in the course of their undisclosed work for foreign institutions or governments.  One scientist whose work was funded by NIH signed a full-time employment contract through the  Chinese “Thousand Talents Program.”  He had not informed his American employer, who thought he was working full-time here in the United States and represented that belief on grant documents submitted to the NIH.  The Talents contract stipulated that one of his job objectives was for “the laboratory in the United States [to be] gradually moved back to China.”  In this case an American scientist whose work had been supported by U.S. taxpayers became party to an undisclosed contract with a foreign government.  The foreign institution dictated that the U.S. laboratory be moved to China.  The U.S. institution was unaware of this commitment.

Over the past few years, we have learned much about the “Thousand Talents Program” and other problematic foreign talent recruitment programs.  Reports about these programs have been issued by the U.S. Senate (a bipartisan report of the Permanent Subcommittee on Investigations), by the JASON group (a report commissioned by the National Science Foundation), and by scholars (e.g. a report for the Center for Strategic and International Studies).  These programs’ interactions with American scientists do not reflect typical recruitments – that is a scientist openly leaves one institution to work for a different institution.  Instead, in secret or without proper disclosure, scientists continue to work for American institutions while at the same time working in “shadow laboratories” elsewhere.  Without the knowledge or approval or their American employers, they have signed contracts or engaged in relationships that pose numerous problems:

  • undisclosed foreign employment,
  • undisclosed obligations to generate foreign patents that may be related to NIH-funded work,
  • undisclosed preferential treatment in American laboratories for certain students or visiting scientists,
  • undisclosed research support – often for similar if not identical research being supported by the NIH,
  • undisclosed compensation deposited into secret foreign bank accounts,
  • undisclosed obligations to assign credit to foreign institutions for work done largely in the United States,
  • undisclosed obligations to keep foreign arrangements and scientific work secret,
  • undisclosed obligations to transfer propriety information and technologies to foreign institutions,
  • stringent restrictions on termination of contract,
  • undisclosed significant financial conflicts of interest, and
  • egregious violations of peer review confidentiality rules.

How widespread are these behaviors?  We don’t know.  The absolute number of scientists appears to be small compared to the total universe of scientists supported through NIH funding to their institutions.  Nonetheless, the data suggest widespread and systemic activity across geographic location and scientific disciplines.  The incidents we have seen – so far involving 87 institutions with confirmed violations of NIH rules by over 150 scientists – are not unique to any one background, ethnicity, or nationality.  A few incidents involving NIH funding have become public.  These include resignations or terminations from prominent institutions (e.g. MD Anderson Cancer Center, Moffitt Cancer Center, and the University of California at San Diego); a guilty plea for filing false tax returns; and a false-claims settlement involving failure to disclose foreign grant support.  The National Science Foundation (NSF) Inspector General has reported a 20% increase in case load.  One NSF-supported scientist was convicted of grant fraud after he secured U.S. funding for research that was already supported by the Chinese government.

We are grateful to the many experts we have worked with in our efforts to learn more about and to address integrity breaches linked to foreign interference.  In late 2018, a Working Group of the NIH Advisory Committee to the Director (ACD) issued, in short order, a thoughtful report with recommendations that we continue to implement.  Since then, the OSTP, through its Joint Committee on Research Environments (JCORE), has taken a key leadership role in developing a whole-of-government response to problems that clearly are not limited to biomedical science.  Alongside OSTP, our partners include federal government colleagues in the Department of Health and Human Services (DHHS), in the Department of Justice, in the Department of State, in law enforcement agencies, and in other federal funding agencies.  We note the work led by professional societies, including but not limited to efforts by the American Association of Universities (AAU) and the Association of Public and Land-Grant Universities (APLU) to gather and disseminate best practices.  And we are extraordinarily grateful to dozens of institutional leaders (including Presidents, Deans, Vice-Presidents for Research, and Compliance and Integrity Officers) for their work as they have tried to learn about the possible problems occurring within their institutions.

Besides our interactions with individual institutions, our outreach has included Dr. Francis Collins’ 2018 statement and letter; NIH presentations (including updates to the ACD in December 2019 and June 2020); NIH Guide Notice clarifications on conflict of interest, other support, and foreign components; and numerous presentations to and meetings with stakeholders all over the United States.  After Dr. Drogemeier’s FDP presentation, OSTP released a slide deck describing the nature of the problem and the government’s interest to balance openness with security.

We stress that our concerns are with foreign interference that lead to serious noncompliance and ethical breaches.  The serious cases we have seen are not linked to problems with, using Dr. Drogemeier’s words, “principled international collaborations.”  Principled collaborations do not entail secret employment contracts, undisclosed (and sometimes duplicative) foreign grants, undisclosed conflicts of interest or commitment, failure to submit truthful tax returns, secret foreign bank accounts, or peer review breaches.  Those behaviors do not make for collaborations that reflect core values of integrity, transparency, reciprocity, accountability, objectivity, and fair merit-based competition.  But those behaviors often do constitute serious grants non-compliance that require our attention as responsible partners and stewards of limited Federal research funds. 

It is critical to keep in mind that U.S. scientists routinely collaborate productively with investigators in foreign countries.  We must rely on productive research collaborations with foreign entities.  Individuals violating laws and policies represent a small proportion of scientists working in and with U.S. institutions.  We must not reject brilliant minds working honestly and collaboratively to provide hope and healing. 

How can you help?  We encourage you to read and discuss with your colleagues and institutional leaders the thoughtful recommendations and perspectives conveyed in ACD Working Group Report, the bipartisan Senate Report, the JASON Report, and the AAU-APLU Report.  We note the centrality of transparency.  One university web site stated it well:   “While most international collaborations are perfectly acceptable and encouraged, we urge researchers to err on the side of transparency … It protects everyone’s interests – the Federal government, [our university], individual researchers, and their international collaborators – to have international relationships disclosed and vetted to determine if there are any potential conflicts of commitment, duplications of research, and/or diversion of intellectual property in the performance of federally funded research.”

In this spirit, we look forward to continuing to work with you to strengthen values underpinning research integrity and protecting the Nation’s biomedical innovations.

More information can be found on our new webpage, Protecting U.S. Biomedical Intellectual Innovation.

7 Comments

  1. It concerns me that some institutions believe that by having an individual complete a conflict of interest disclosure that these collaborations will be disclosed and/or avoided. I am certain that COIs were completed by these individuals at these prestigious institutions and the situation still occurred. What measures can be taken to ensure that these types of relationships are not happening? Will it take complete background checks including (personal) financial reviews on an ongoing basis?

  2. I completely agree with NIH policies with respect to prevention of foreign interference in US science. However, it is not apparent whether NIH has a policy regarding what I call as indirect contributions to NIH funded researchers from foreign countries in the form of research fellowships (for eg, there are huge numbers of foreign PhD students at multiple universities supported exclusively by research fellowships mainly from China working in the labs of NIH funded PIs). In general, there are 4-5 such foreign students in a single lab, that works out to more than 200,000-250,000 US dollars / year of funding by foreign country that is funneled into the PI’s research indirectly. These contributions will immensely contribute towards generating preliminary data as well as research publications, interestingly without any disclosure. Most of these NIH funded PIs who can accrue this indirect and currently permitted funding strategy, in general, are well established. As current NIH peer review system does not even consider this aspect of having huge indirect funding and personnel advantage for these established PIs during peer review process, this automatically will put younger PIs to compete for the same NIH grant money in this inherently disadvantaged but seems to be legal system!!
    NIH should make a real effort to know how many foreign supported student fellows are currently working or worked in the past decade in the labs of PIs who are supported by NIH grants and list this information in NIH reporter along with the grant information. In this stringent funding environment, this apparent foreign funding lacuna will entice more and more researchers look for this sort of indirect funding currently allowed by NIH. This might have catastrophic impact on the trained personnel pool in STEM fields within the US and also has possibilities of exposing other unpublished studies within the university as well as universities across US under current Zoom environment. NIH should have steps to reduce the direct costs and NIH total grant funding accordingly for PIs that have a lot of temporary research students that are supported by foreign fellowships. Until this loophole is fixed, any other efforts to restrict foreign influence in NIH funded research might be meaningless.

  3. I completely agree with “support ethical science” on the loopholes involving foreign-funded fellowships – it amounts to an unfair playing field, with huge advantages for those PIs. However, it not only disadvantages new investigators! Mid-level investigators, who face the most difficult stage in their careers (i.e. renewing a first R01), have been confronting this for the past decade of tightening budgets, and it’s fair to say that a generation of scientists has been lost to unfair practices that are widespread and have been for a long time. Wake up, NIH!

  4. While some of those involved clearly broke laws, the entire program is a concerning US march to authoritarianism and control of science by individuals and institutions that do not really know what science is. The FBI and Trump administration only see it as a way to make money in companies, while science is underfunded more and more each year. Unlike the cases where foreign companies buy a large US holdings and all of the profits go off-shore, a substantial portion of these new foreign funds pay students and scientists working on US soil, spending money in the US economy that supports jobs in the community much more than foreign businesses. The US reaction essentially takes out twice the amount of research funding in the examples cited because the NIH money is gone back into a federal budget that gives money to the ultra-rich and the foreign money is gone from the US economy.
    The illegal activity has to be redressed, but in the face of such blatant illegal activity by those running our government with almost no consequences and similar treatment for large corporations, the hypocrisy of FBI investigations and jailing perpetrators is seems pretty extreme. Given the extent that this program is being used as political tool, it’s pretty hard to take this article at face value. NIH should take its money back and ban funding for a length of time, as was done in some previous cases of grant fraud by US researchers. The involvement in ICE-like tactics of the FBI under an increasingly authortarian government should be giving us all pause. We are put in a position to choose between the lesser of two evils, and it is pretty hard to say which is worse. When law-enforcement acts like a domestic military police beyond banning research funding, I cannot say what the right course of action is for this level of fraud. The fraud puts me at a disadvantage and I don’t like, but the reaction is part of something much bigger, much worse and which I dislike much more.

    1. I agree that several of the past administrations have been diminishing funding for science, and that we are definitely not making American Science great again. However, the unfair practices referred to have been going on for more than a decade, including having many foreign funded students and fellows, and the NIH has done nothing about it – it’s only now that they have started to acknowledge and combat some of these practices. I welcome the initiative, and more should be done.

  5. I don’t really understand the “unfair advantage” argument. If a laboratory can find trainees who want to come and learn and contribute, and if the lab is lucky enough to have those trainees funded, even in part, by their own country, it would seem a win-win to me. We are, after all, in the knowledge-generation business. Many NIH-funded PI’s have had numerous foreign trainees over the years, and it has been a great privilege to become educated about other cultures while sharing scientific expertise that allows them to go back and contribute to science and medicine in their own country. Science, medicine,and disease is country-independent. The more brains, the better!

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