Foreign Influences and Its Impact on Research Integrity – A Four-Part Series | Part 2: Federal Agencies’ Policies on Foreign Influences

By SRAI News posted 20 days ago

  

Foreign Influences and Its Impact on Research Integrity – A Four-Part Series | Part 2: Federal Agencies’ Policies on Foreign Influences

In this four-part series, we will discuss Part 1: What is Foreign Influence; Part 2: Federal Agencies’ Policies on Foreign Influences; Part 3: How to Conduct an Investigation; and Part 4: Lessons Learned from the NIH Survey.

The NIH Grants Policy Statement defines a foreign component as “any significant scientific element or segment of a project outside of the United States” whether or not NIH grant funds are expended, either by “a research or recipient in a foreign location or by a researcher in a foreign location employed or paid by a foreign organization.”

NIH requires full transparency for all domestic and foreign research activities and does not consider these clarifications to be policy changes. In August 2018, NIH Director Dr. Francis S. Collins issued a foreign influence letter to 65 American colleges and universities stating NIH is currently investigating more than 180 researchers for unlawful participation in foreign programs, such as China’s Thousand Talents Program, which encourages participants to transfer research and other propriety information from the US to China. The NIH, NSF, and DoD require disclosure of membership in these types of programs, but NIH does require disclosure of selection to a foreign “talents” or similar type program. This information must be disclosed regardless of whether it results in monetary support. DoE, on the other hand, expressly prohibits its employees, including contractors and grantees, from participating in foreign talent recruitment programs for specific countries, namely, China, Russia, Iran, and North Korea. Currently, DOE is the only agency to prohibit federal grant recipients from being members of a talent program.

This letter identified concerns about systemic programs of foreign influence in US research. The focus of current concern is China, but the issue is not unique to China. As a condition of receiving NIH funding, scientists and research institutions must comply with NIH policies, including disclosure of financial conflict of interest, research misconduct, and reporting of other research support. NIH awards are issued to the institution and not to the individual researcher, so the responsibility of compliance falls on the institution. In July 2019, NIH issued Guide Notice NOT-OD-19-114, which reminds the extramural community about the need to report foreign activities through documentation of other support, foreign components, and financial conflict of interest to prevent scientific, budgetary, or commitment overlap.

NIH requires notification from recipients when the performance of work by a researcher is being performed in a foreign location or if the performance of work by a researcher in a foreign location is employed or paid for by a foreign organization, regardless if NIH funds are expended. If it is determined that a portion of the work will be conducted outside of the US, the award recipient will have to determine if the activities are considered significant. If either of the above criteria is met, this will constitute a foreign component. If there is an addition of a foreign component to a grant that has already been awarded, NIH requires prior approval before any work can be done at the foreign location.

If the work is being performed within the US, but there is a non-US resource that supports an investigator and/or researcher's research, it must be reported to the NIH as other support. Over the past couple of years, there have been many cases involving allegations that principal investigators on NIH awards have failed to disclose foreign affiliations. If any of the following activities are performed outside of the US, this will constitute a foreign collaboration that must be disclosed as a foreign component:

  • Any research involving human subjects or vertebrate animals
  • Foreign travel for the purpose of collecting data, surveying, sampling, or similar activities (this does not include foreign travel for consulting purposes)
  • Collaborations with investigators which may result in co-authorship
  • Use of facilities or instrumentation
  • Receipt of financial support or resources from a foreign entity

NIH has aggressively enforced the rules that require recipients to report foreign ties and has already had a significant impact on the US. According to a report by Dr. Lauer on June 12, 2020:

  • 54 of 189 (29%) of the researchers investigated have been fired or resigned
  • 173 (93%) received foreign funding from China
  • 133 (70%) received an undisclosed foreign grant, and 102 (54%) received an undisclosed talent award
  • 17 (19%) owned a foreign company, and 7 (4%) held foreign patents
  • 154 (81%) violated NIH research policies, and 70 (37%) violated their own institution’s rules
  • 100 (53%) have been peer-reviewed in the last two years
  • The average demographic of suspects investigated are Asian males 56 years old 

Examples of What to Disclose to NIH about Senior/Key Personnel on Applications and Awards:*

Table 1: Recipients Must Report

Excel File - Table 1 

There are ongoing concerns about inappropriate influence by foreign governments over federally funded research. These concerns are brought about by:

  • Failure to disclose all conflicts of interest, foreign affiliations, conflicts of commitment, and other support in applications for NIH grants
  • Diversion of proprietary or pre-publication information disclosed in grant applications or produced by NIH-supported research to those not authorized to receive it; and
  • Breaches of confidentiality in peer review

NIH has taken steps to address these risks and continues to require full transparency in NIH applications and throughout the life of an NIH grant. In addition, NIH continues to require full disclosure of all research support, foreign components, and financial conflicts of interest as this information is used in making funding decisions to determine if the research being proposed is receiving any other sources of funding that could result in duplication of research, is there enough time being allocated to complete the research and what resources are being used to conduct the research.

Applicants and research institutions need to ensure faculty and other staff include accurate and complete accounts of sources of research support of all senior/key personnel. In addition, they need to ensure that all researchers working on a grant disclose their significant financial interests according to regulations and institutional policy…this includes nonmonetary support.

When in doubt about what to disclose, disclose everything. If there is an omission of foreign ties, especially those with China, there is an increased risk that US funding may be lost, or more severe actions may be taken.

Additional information regarding foreign influence can be found in NIH leadership statements and other references about NIH’s continuing commitment to protecting NIH-supported innovation:

Latest Federal Policy Updates

June 12, 2020: CD Working Group on Foreign Influences on Research Integrity Update

July 8, 2020: NIH Open Mike Blog: Addressing Foreign Interference and Associates Risks to the Integrity of Biomedical Research and How You Can Help

July 11, 2019: NIH Open Mike Blog: Clarifying Long-Standing NIH Policies on Disclosing Other Support

August 23, 2018: NIH Director Statement on Protecting the Integrity of US Biomedical Research

August 20, 2018: Letter from NIH Director to Grantee Community


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Authored by Debbie Pettitt, Senior Grants Management Specialist
National Institutes of Health

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18 days ago

Great Article, Debbie. We are learning more and more about the importance of Foreign Influences and how we all must actively play a role in educating faculty, research staff, and students, protecting our IP and national security.