In the past several years 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 March 2022, NIH staff have contacted institutions regarding 232 foreign interference compliance reviews, with over 80 percent of cases revealing at least one serious compliance violation. The majority of cases fall under undisclosed affiliations, grant support, or talent awards.
The NIH posts the latest updates on how the agency is handling this issue on the following page: “Protecting U.S. Biomedical Intellectual Innovation.” Details about these agency policies and activities are below.
September 2022: NIH issued a notice to remind the extramural community about existing policies and regulations around financial conflicts of interest and other support.
June 2022: NIH updated a table which extensively details the required pre- and post-award disclosures relating to the Biographical Sketch and Other Support.
December 2021: NIH issued a guide notice on “Maintaining Security and Confidentiality in NIH Peer Review: Rules, Responsibilities and Possible Consequences,” to remind all participants and stakeholders in the NIH peer review process of federal statutes, regulations, and NIH policies regarding peer review security and confidentiality; their responsibilities for abiding by those rules; and possible actions that the NIH (in coordination with other offices) may take and consequences that may ensue from a violation of those rules.
July 2021: NIH published a summary of findings on foreign research interference from 2016 to 2021, highlighting the major issue areas and sharing four scenarios based on real cases, outlining the situation and the consequences/corrective actions taken.
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 Office of Inspector General
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 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.
March 2023: The OSTP just released a request for information containing a draft NSPM 33 research security programs standard requirement, with a response deadline of June 5, 2023. This requirement is described in the NSPM-33 implementation guidance released last year, which expands on the provision that “research institutions receiving Federal science and engineering support in excess of 50 million dollars per year certify to the funding agency that the institution has established and operates a research security program. Institutional research security programs should include elements of cyber security, foreign travel security, insider threat awareness and identification, and, as appropriate, export control training.” This draft was prepared by the Interagency Working Group on Research Security Programs, part of the NSTC Subcommittee on Research Security, with a goal of uniformity across Federal research agencies in implementing the requirement. AAMC will be engaging with constituents in the coming months to develop a response to this inquiry.
October 2022: The AAMC submitted comments to the National Science Foundation (NSF) requesting feedback on behalf of the NSTC subcommittee on proposed common disclosure forms for the Biographical Sketch and Current and Pending (Other) Support sections of a research application, intended to clarify what is expected of senior personnel applying for research funding from federal agencies. The association additionally submitted a joint letter with partner higher education organizations, highlighting the importance of clarifying definitions, ensuring a transparent and uniform process for updating the common forms, and limiting agency variation in required disclosure data elements and instructions.
January 2022: The NSTC JCORE research security subcommittee released a report containing guidance for federal departments and agencies regarding their implementation of NSPM-33. The five key areas covered in the document are: disclosure requirements and standardization, digital persistent identifiers, consequences for violation of disclosure requirements, information sharing, and research security programs.
September 2021: The AAMC sent a joint letter on Sept. 30 in response to a request for feedback from the White House OSTP on implementing the research security guidelines in National Security Presidential Memorandum 33 (NSPM-33). The comments emphasized: building on existing policies created by institutions to address research security; recognizing that the vast majority of university research is open and unrestricted and should not be subject to research standards from the commercial sector; and incorporating the use of pilot programs and continued community engagement as any new policies are implemented.
January 2021: The White House issued National Security Memorandum-33 (NSPM-33), which “directs action to strengthen protections of United States Government-supported Research and Development (R&D) against foreign government interference and exploitation.”
At the same time, the NSTC JCORE subcommittee on research security released recommended practices for research organizations to strengthen the security and integrity of the research enterprise.
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, PhD, 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.”
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 an 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 Reports and Institutional Resources on Research Security
- 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)
- Threats to the U.S. Research Enterprise: China’s Talent Recruitment Plans from the U.S. Senate, Permanent Subcommittee on Investigations, Committee on Homeland Security and Governmental Affairs
- NIH Should Take Further Action to Address Foreign Influence by the U.S. Government Accountability Office
- A New Institutional Approach to Research Security in the United States from Georgetown’s Center for Security and Emerging Technology
- Research Security and Compliance Committee from Cornell University
- Research and Foreign Engagement from New York University
- International Relationships and Activities from Penn State University
- Academic Integrity and Undue Foreign Interference from Stanford University
- Research Security Program from Stony Brook University
- Research Security Office from the Texas A&M University System
- Research Security Governance Board from the Ohio State University
- Ethics, Compliance and Audit Services from the University of California
- Research Security Program from the University of Illinois Chicago
- Research Security and Compliance from the University of Missouri System
- Guidance on Science and Security from the University of North Carolina at Chapel Hill
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
Chinese medical student accused of trying to smuggle cancer research material out of Boston
Boston Globe, 12/30/2019
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