In the past year Congress, federal science agencies, and the media have highlighted concerns about the impact of undue foreign influence on federally funded research in the U.S. For institutions, this means an increased focus on research security and the need to update internal policies and processes, while maintaining a focus on the value of a global workforce and international scientific collaborations. This page provides background information, the latest updates on relevant federal government policies and activities, and considerations and resources for institutional leadership, administrators, and researchers as they address this issue on their campus.
Latest Federal Policy Updates
Updates on NIH Activity and Policies for the Grantee Community
The NIH has been actively involved in the issue of foreign influence since an August 2018 letter sent out to grantee institutions on agency concerns. As of September 2019, the NIH "has investigated at least 180 scientists at more than 65 institutions for violating policies requiring grantees to report their foreign ties" and has identified over 100 cases of researchers “withholding information about funding sources and conflicts of interests and violating the confidentiality of peer review.” The latest updates on agency policy and activities are below.
December 2019: During an update at the December 13 meeting of the NIH Advisory Committee to the Director (ACD), NIH Deputy Director for Extramural Research Mike Lauer, MD, listed several updates the agency had taken to carry out recommendations from the ACD report (see December 2018, below), including clarifying other support, working with NSF, and implementing peer review training and systems controls.
- The NIH Grants Policy Statement (NIHGPS) requires grant applicants to disclose Other Support to ensure no scientific, budgetary or commitment overlap, including “all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors.” (Section 2.5.1)
- The NIHGPS also requires recipients to determine whether activities it supports include a foreign component, which may or may not involve the direct use of NIH grant funds (e.g. performance of work by a researcher or recipient in a foreign location or a collaborator outside of the U.S. who performs experiments in support of an NIH-funded project or with an expected co-authorship).
- Federal conflict of interest regulations (42 CFR Part 50, Subpart F) include a requirement for researchers to disclose to their intuitions significant financial interests (SFIs) in addition to any reporting required by NIH policy (learn more on the AAMC's Conflicts of Interest and Transparency Initiatives page).
- NIH clarified in 2018 that while these regulations do not require disclosure of certain SFIs from “an Institution of higher education,” this is only for U.S. institutions, and remuneration from foreign institutions is a disclosable SFI.
A related FAQ updated July 11, 2019 confirms that these policies and regulations are already in place and that the guide notice serves as a reminder to the community, not an expansion of the Other Support policy.
A blog post from the NIH OER, provides additional context for the timing of the guide notice and states that “depending on the severity and duration of the noncompliance… (it) may contact the affected institutions, impose specific award conditions, disallow costs, withhold future awards for the project or program, suspend the award activities, make a referral for investigator suspension or debarment, or terminate the award.”
December 2018: An NIH Advisory Committee to the Director released a report on foreign influences and research integrity, containing recommendations for recipient organizations related to:
- Communicating with investigators (education campaigns on disclosure requirements and guidelines for visitors);
- Mitigating risk (assessment of internal controls, proactively notifying NIH about breaches), and;
- Ongoing monitoring (developing ‘flags’ for audit, considering post-travel questionnaires for select countries, and working with federal security agencies on best practices).
- Diversion of intellectual property to other entities, including other countries;
- Sharing of confidential information on grant applications by NIH peer reviewers with others, and;
- Failure by researchers working at NIH-funded institutions to disclose substantial resources from other organizations.
The letter also noted that the NIH Office of Extramural Research (OER) would reach out to specific institutions “regarding grant administration or oversight questions or requests about specific applications, progress reports, policies, or personnel.”
Department of Health and Human Services
The Department of Health and Human Services Office of Inspector General (OIG) in September 2019 released three reports related to financial conflicts of interest (FCOI), foreign influence, and the steps the NIH is taking to protect the research integrity.
- NIH Has Made Strides in Reviewing FCOIs in Extramural Research, But Could Do More - This report focuses on whether the NIH has addressed the gaps in the Agency’s oversight of investigator FCOI, previously identified in its 2008 report, NIH COI in Extramural Research. The OIG recommends that the NIH perform quality assurance reviews of FCOI information in its online system and use the information about foreign affiliations obtained during the pre-award reporting process to make determinations about whether to revise its financial conflict review process.
- The NIH Has Limited Policies, Procedures, and Controls in Place for Helping to Ensure That Institutions Report All Sources of Research Support, Financial Interests, and Affiliations - This report discusses whether the NIH has policies and processes in place to ensure the reporting of all sources of research support, including financial interests and affiliations. The OIG recommended that NIH ensure that the 1,013 institutions identified as not having FCOI policies posted on their website, post those policies as required. Other recommendations included, enhancing the NIH FCOI monitoring program, review grantee websites to ensure FCOI policies are publicly accessible, and implement procedures to ensure institutions have FCOI policies.
- Vetting Peer Reviewers at NIH's Center for Scientific Review: Strengths and Limitations - In this report, the OIG recommends that the NIH take steps to address concerns related to vetting peer reviewer nominees, recommending that the NIH update its guidance on vetting peer reviewers to identify potential foreign affiliations that may impact research integrity. The OIG also recommended that the NIH coordinate with HHS’ Office of National Security to develop an approach for identifying peer reviewer nominees that require additional vetting.
White House OSTP and Government-Wide Coordination
The National Science and Technology Council (NSTC), overseen by the White House Office of Science and Technology Policy (OSTP), launched the Joint Committee on Research Environments (JCORE) in May 2019. A subcommittee focused on research security, comprised of 17 agencies from across the government, is working on coordinating federal outreach to research institutions, developing guidance and best practices, and standardizing conflict of interest and commitment disclosure requirements and enforcement.
January 2020: AAMC sent a letter to OSTP in response to a request for information on actions that Federal agencies can take, working in partnership with private industry, academic institutions, and non-profit/philanthropic organizations, to maximize the quality and effectiveness of the research environment, including protecting the security and integrity of the research enterprise.
November 2019: the AAMC participated in the JCORE summit to discuss research security and other issues, a summary of which is available online.
September 2019: White House OSTP Director Kelvin Droegemeier September 16 sent an open letter to the research community, reaffirming the importance of using a risk-based framework to evaluate research security concerns, and highlighting the progress of OSTP in coordinating federal efforts.
The AAMC previously joined over 60 organizations on a September 4 letter to OSTP and federal research funding agencies (NIH, NSF, DOD, and DOE) stressing the importance of balancing “an openly collaborative scientific environment and protecting our economic and national security.”
December 2019: The President signed the National Defense Authorization Act (NDAA) for Fiscal Year 2020, including text of the Securing American Science and Technology Act (SASTA, see May 2019 below) as Sec. 1746. The NDAA also included Sec. 5713, Oversight of Foreign Influence in Academia, requires the Director of National Intelligence to submit a report to Congress related to foreign influence in research and its impact on national security. Find details in Washington Highlights.
November 2019: The Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations November 19 held a hearing titled, “Securing the U.S. Research Enterprise from China’s Talent Recruitment Plans.” Witnesses included representatives from five federal research and security agencies, and was held in conjunction with release of a bipartisan subcommittee staff report Threats to the US Research Enterprise: China’s Talent Recruitment Plans. Full details at Washington Highlights.
July 2019: The Secure American Research Act (S. 2133), a bill aimed at protecting research from foreign interference, was introduced in the Senate.
May 2019: Several members of the House of Representatives introduced H.R. 3038, the Securing American Science and Technology Act (SASTA), to standardize and evaluate existing mechanisms of control for federally-funded research. SASTA has been endorsed by AAMC and several other higher education organizations, in a letter which cited the legislation as “a proactive and sensible approach to safeguarding federally funded research and development from growing threats of foreign interference, cyberattacks, theft, and espionage.” Find details in Washington Highlights.
AAMC Professional Development Affinity Groups
- The AAMC works with leadership at medical schools through the Council of Deans and Group on Research Advancement and Development (GRAND) to provide education and tools for addressing this issue at their institutions.
- The AAMC Forum on Conflict of Interest is a active community which works on how conflict of interest reporting overlaps with concerns about foreign influence.
- The AAMC Compliance Officers Forum, and particularly its Research subgroup, regularly holds discussions on audit practices and other compliance measures having to do with research security.
Selected Institutional and Community Resources on Research Security
Ethics, Compliance and Audit Services from the University of California Office of the President
International Relationships and Activities from Penn State University’s Senior Vice President for Research
Academic Integrity and Undue Foreign Interference from Stanford University
Effective Practices for Responding to Undue Foreign Influence and Security Concerns on Campus from the Association of American Universities and the Association of Public Land-Grant Universities
Framework for Review of Individual Global Engagements in Academic Research from the Council on Government Relations
Fundamental Research Security from the National Science Foundation and JASON
People’s Republic of China (PRC) Targeting of COVID-19 Research Organizations from the Federal Bureau of Investigation (FBI) and Cybersecurity and Infrastructure Security Agency (CISA)
AAMC in the News
US Cancer Centers Embroiled in Chinese Research Thefts
Chinese Scientist Is Accused of Smuggling Lab Samples, Amid Crackdown on Research Theft
The New York Times, 12/31/2019
As China Anxiety Rises in U.S., Fears of New Red Scare Emerge
Bloomberg News, 12/31/2019
Keep US research open amid threat from China, says elite JASON group
Mistrust and the Hunt for Spies Among Chinese Americans
Bloomberg Businessweek, 12/10/2019
180 cases of Chinese intellectual property theft under investigation at academic medical centers
Becker's Hospital Review, 11/04/2019
Scientists With Links to China May Be Stealing Biomedical Research, U.S. Says
The New York Times, 11/04/2019
Holes Found in NIH Oversight of Conflicts, Foreign Influence
Bloomberg Law, 09/27/2019
Foreign data theft: What academic institutions can do to protect themselves
AAMC News, 05/28/2019