As part of the government’s broader efforts to combat foreign threats to U.S.-funded scientific research, the National Institutes of Health (NIH) and White House Office of Science and Technology Policy (OSTP) have announced new requirements and recommendations relating to disclosure and oversight of sources of foreign support. Compliance with the NIH requirements is required by May 25, 2021.
In this alert, we provide the following:
- Summary of government action on foreign influence in U.S. scientific research.
- Overview of the modifications to NIH reporting requirements.
- Analysis of the OSTP recommendations for research organizations.
- Best practices and recommendations going forward.
Undue Foreign Influence in U.S. Scientific Research
Since 2018, Congress, the Department of Justice, Federal Bureau of Investigation, Department of Education (DOE), National Science Foundation (NSF), and NIH have been working to address suspected misappropriation of U.S. intellectual property, technology, and basic and applied research by foreign governments, a practice sometimes referred to as “undue foreign influence.” In August 2018, NIH issued a letter to roughly 10,000 institutional awardees describing threats to American research and areas of concern, including the diversion of intellectual property, sharing of confidential information in grant applications, and the failure of researchers to disclose substantial resources from other organizations and foreign governments. The Director of NSF issued a similar “Dear Colleague” letter in July 2019. On June 18, 2020, 14 Senate co-sponsors introduced the bipartisan Safeguarding American Innovation Act following an investigation and report by the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations.
The government has aggressively targeted alleged violations of existing regulations, such as the NIH rules on “significant financial interests,” “other support,” and “foreign components,” through enforcement actions including arrests and criminal prosecutions. The U.S. government contends that by violating these rules, researchers who are effectively controlled by foreign governments are obtaining taxpayer funds for research for the benefit of foreign governments that they would not have otherwise obtained if all the required information had been disclosed.
Modification of the NIH Reporting Requirements
In March of this year, NIH announced new disclosure requirements for U.S. scientists applying for NIH grants. These requirements, effective May 25, 2021, impose the following obligations on researchers:
- Researchers must submit English-language copies of all “other support” received, which includes contracts, grants, and any other agreements specific to foreign appointments and/or employment with a foreign institution, regardless of whether or not they have a monetary value.
- The Biographical Sketch (Biosketch) submission has been modified to include scientific appointments in the section requiring disclosure of Positions and Honors.
- Researchers may now include in their Biosketch details of ongoing and completed research projects from the past three years to which they would like to draw attention.
- A signature block requiring researchers to attest to the accuracy of their submissions, under penalty of law, has been added to the disclosure forms.
Universities, academic medical centers, hospitals, and other NIH grant recipients should plan for these new changes now by educating scientists about the new requirements, reminding them of the potentially severe penalties that can be (and have been) inflicted for submitting incomplete or misleading information in grant applications, and ensuring translation resources are in place to process any foreign-language “other support” materials.
New Guidance from OSTP
In January of this year, the Trump Administration’s OSTP published recommendations for research institutions to maintain compliance with federal rules on undue foreign influence. Since the inauguration, the Biden administration has expressed no intention to modify these guidelines. The OSTP guidance focuses on undue influence from foreign governments and government-sponsored talent recruitment programs, which may use contractual provisions in agreements relating to things such as academic appointments to require recipients to share research with the funding foreign entity in violation of U.S. export controls. OSTP’s guidance for American research organizations falls under the following five broad goals:
- Demonstrate organizational leadership and oversight.
- Establish an expectation of openness and transparency.
- Provide and share training, support, and information.
- Ensure effective mechanisms for compliance with organizational policies.
- Manage potential risks associated with collaborations and data.
Some of OSTP’s recommendations are steps that research institutions should be doing already – including the maintenance of conflicts of interest systems – but others would represent substantial expansions of existing compliance efforts at many institutions. For example, OSTP encourages all organizations to create research integrity working groups and task forces, as well as to establish and operate a comprehensive research security program that includes elements of cybersecurity, foreign travel security, insider threat awareness and education, and export control training.
Best Practices and Recommendations
While institutions that have NIH- and NSF-supported investigators must be familiar with the various NIH, NSF, and DOE rules falling under the foreign influence umbrella and revise their pre-award processes in light of the changes to the NIH Biosketch and “other support” submissions, we do not view the OSTP’s recommendations as a checklist of requirements that the government expects all research institutions to follow. Nevertheless, institutions with substantial federal funding should review the OSTP recommendations and consider whether it is sensible to implement any features they are not currently implementing. There is every indication that the Biden Administration plans to continue the Trump Administration’s campaign against foreign interference in the American research enterprise.
If you have any questions on these changes or how to develop effective compliance mechanisms for your organization, please contact one of the authors.