National Institute of Health Urges Increased Vigilance Against Foreign Attempts to Influence and Steal Biomedical Research and Intellectual Property
February 13, 2019
The National Institute of Health (NIH) recently released a report warning against attempts by foreign governments to improperly influence US-based research, especially at universities conducting biomedical research that is sponsored by NIH. The report describes the threat to research and intellectual property and makes a series of recommendations to improve communication and awareness, enhance research integrity, and identify opportunities for monitoring and remediation.
RisksIn August 2018, NIH appointed an advisory committee comprised of research university leaders to address concerns regarding inappropriate influence on NIH researchers and peer reviewers. The result was this December 2018 report.
The report notes that the American “scientific landscape” has benefited from foreign trainees, investigators (or researchers), and employees, along with interaction between US scientists and counterparts in foreign countries. At the same time, the report finds that foreign entities have “mounted systematic programs to influence NIH researchers and peer reviewers,” including “state-sponsored programs to recruit and sponsor skilled scientists,” including talent recruitment programs in China and information collection efforts in other countries.
NIH advised the biomedical community of “problematic examples” that include:
- similar funding applications made both to NIH and a foreign entity, without disclosure to NIH;
- claims by a foreign government to intellectual property when US governmental support was clearly used for the discovery; and
- the failure of researchers employed by US organizations to disclose foreign support.
Potential ViolationsThe report identifies multiple steps in the NIH grant process where the applicant must disclose foreign support or collaboration, especially any “foreign financial relationships with foreign government or institution of higher education.” This disclosure helps identify financial conflicts of interest. NIH notes that failure to disclose could, in severe cases, result in termination of the non-complying employee.
The report also discusses potential violations of the peer review process, which could result in a violator’s removal from a peer review committee or even suspension and debarment from work with any US government agency. The report notes the possibility of criminal violations for the most severe cases.
There are other criminal consequences beyond peer review violations. Even before the report, the Department of Justice investigated similar conflict of interest violations. In one case, a researcher in the National Oceanic and Atmospheric Administration was convicted of accepting a salary from China based on his dealings with three Chinese talent recruitment programs.
NIH acknowledged that disclosure procedures can be subject to unintended inaccuracies and also noted that this area may not receive the same amount of attention in policy drafting and employee training as do the more commonly discussed issues of scientific misconduct or abuses in conducting, reviewing, or reporting research. It is therefore essential to design and implement effective policies that will facilitate researchers’ understanding of disclosure requirements and consequences of violations.
RecommendationsThe Report identifies a number of recommendations for organizations that receive NIH grants and the need to identify and share best practices:
- To raise communication and awareness, NIH recommends a broad education and awareness campaign, including at universities that receive NIH funding, to encourage evaluation of existing policies and ensure that disclosure forms require explicit statements of any kind of foreign support.
- To reduce risk, NIH proposes updating its disclosure policy for foreign collaborations and affiliations, including those where there is no financial gain.
- NIH also seeks to expand the scope of its policies to cover not just “key personnel,” but technical support staff, postdoctoral fellows, and graduate students working on an NIH-granted award.
- For recipient organizations, NIH recommends increased training and education, particularly for handling outside visits and hosting visiting scholars and students.
- In order to protect the integrity and ownership of intellectual property, NIH recommends that recipient organizations:
- review their controls frameworks for hosting foreign scientists to strengthen protections against exfiltration of data;
- provide loaner computers and electronic equipment for faculty or staff traveling overseas to certain sensitive regions; and
- update their policies for reviewing and adjudicating potential misconduct relating to foreign influences.
- To implement ongoing monitoring, recipient organizations should develop processes with professional organizations (such as the Association of American Universities) in order to identify “flags” that may trigger an audit or investigation, which could include frequent foreign travel, lab resources inconsistent with funding, unexplained assets, and frequent publishing with collaborators outside the US.
ConclusionAs these recommendations are implemented, universities face a broad compliance landscape given the variety of research activities that receive government support and the complexity of addressing this kind of improper foreign support. At the same time, research organizations are trying to collaborate internationally and attract the best scholars from around the world. As the report suggests, organizations may well need to revise disclosure policies and conduct additional training.
Beyond these initial steps, situations will arise—whether because of information learned from whistleblowers or inquiries from law enforcement—that will create the need for an internal investigation. That investigation could be made difficult given that certain evidence may not be within the organization and may be overseas, in a foreign language. The findings from this investigation will result in the need to mitigate risk, which could have implications for the employees at issue and for the organization itself.
This memorandum is a summary for general information and discussion only and may be considered an advertisement for certain purposes. It is not a full analysis of the matters presented, may not be relied upon as legal advice, and does not purport to represent the views of our clients or the Firm. Ronald Cheng, an O'Melveny partner licensed to practice law in California and Hong Kong, Damali A. Taylor, an O'Melveny partner licensed to practice law in California and New York, and Nicole Argentieri, an O'Melveny partner licensed to practice law in New York, contributed to the content of this newsletter. The views expressed in this newsletter are the views of the authors except as otherwise noted.
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