Study Guide

On July 28, 2023, the Biden administration issued “Executive Order on Federal Research and Development in Support of Domestic Manufacturing and United States Jobs” (the “Executive Order”). How federal agencies implement certain of the Executive Order’s provisions may have a meaningful impact on the existing university, academic medical center, and independent research institution technology transfer processes. Moreover, when viewed in conjunction with other recent actions, the Executive Order is further indicia of the administration’s ongoing assessment and evaluation of the Bayh-Dole Act's technology transfer model. Universities and other research institutions should therefore continue to closely monitor technology transfer-related developments and weigh in when offered an opportunity to participate in rule-making or other legislative or regulatory processes.

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Congressional Republicans are increasingly focused on ensuring that U.S. colleges and universities are properly disclosing gifts and contracts from foreign sources under Section 117 of the Higher Education Act of 1965, 20 U.S.C. §1011f (“Section 117”). The Higher Education and Workforce Development Subcommittee of the House Committee on Education and the Workforce (the “Committee”) held a hearing on July 18, 2023 titled Exposing the Dangers of the Influence of Foreign Adversaries on College Campuses, which discussed the enforcement, and even potential expansion, of Section 117.

In July 2022, the DOJ released a Comprehensive Cyber Review report (the “Review”) summarizing its assessment of its own cyber-related activities and including recommendations focused on its cyber-centric “offensive” (i.e., cyber threat investigations and enforcement) and “defensive” (i.e., approaches to risk mitigation) activities. A key finding declared that “many of the cybersecurity provisions and standards set forth for federal contractors were found to be insufficiently rigorous.” The Review went on to note that where contractual cybersecurity standards were not met, the Department’s Civil Cyber-Fraud Initiative (CCFI), first announced in October 2021, would continue to utilize the False Claims Act (FCA) to pursue cybersecurity-related cases against government contractors and grant recipients. The Review comes on the heels of a recent FCA settlement with Aerojet Rocketdyne Inc. Many colleges, universities and independent research institutions are now in the midst of planning for enhanced research security obligations arising out of the January 2022 National Security Presidential Memorandum 33 Implementation Guidance (the “NSPM-33 Guidance”).

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On July 9, 2024, the White House Office of Science and Technology Policy (OSTP) released the long-awaited “Guidelines for Research Security Programs at Covered Institutions” (the Guidelines). The Guidelines are intended to assist federal agencies in their efforts to implement certification requirements for “Covered Institutions” intended to ensure that such institutions have “established and operate” Research Security Programs (RSPs) addressing four specific areas, each of which is discussed below.

The Assistant Secretary for Export Enforcement Matthew S. Axelrod announced last week at the National Association of College and University Attorneys (NACUA) 2022 Annual Conference a new “Academic Outreach Initiative” by the Bureau of Industry and Security (BIS) at the Commerce Department. The Initiative is aimed at assisting universities, particularly those engaged in proprietary research, in developing and implementing an Export Management Compliance Program (EMCP) to ensure compliance with the Export Administration Regulations (EAR).

The global response to Russia’s invasion of Ukraine has triggered wide-reaching sanctions and new export control restrictions that are changing on a daily basis. While it remains to be seen how these new restrictions will ultimately affect U.S. academic research and higher education institutions, these measures already have serious implications not only for joint academic and research collaborations in Russia, Ukraine, and Belarus, but also for those programs and students in the United States with a link to one of these countries. 

Over the past three plus years, the issue of foreign influence over U.S. government-sponsored research has been front and center for the research community. There have been numerous high-profile prosecutions of professors, and civil enforcement actions against research institutions. Presidential Memorandum 33 (NSPM-33) set forth the goal of “strengthen[ing] protections of United States Government-supported R&D against foreign government interference and exploitation" while "maintaining an open environment to foster research discoveries and innovation that benefit our nation and the world.” In August 2021, the Office of Science and Technology Policy (OSTP) tasked the National Science and Technology Council with promulgating “clear and effective” NSPM implementation guidance. NSTC issued its guidance document on January 3, 2022, which includes a five-part platform to enhance research security.  

As we near the end of the first year of the Biden administration, we wanted to highlight a Department of Justice (DOJ or “the Department”) action that may become increasingly relevant in the federal research space in 2022. Through the so-called “Garland Memo,” DOJ rescinded two Trump-era Memoranda—the Sessions Memo and the Brand Memo—that had restricted DOJ attorneys from using noncompliance with agency sub-regulatory guidance as a basis for False Claims Act (FCA) cases and other enforcement actions. The Garland Memo indicated that the previous memoranda had “hampered Department attorneys when litigating cases where there is relevant agency guidance,” and instructed Department attorneys in all pending and future actions to rely on guidance documents in “appropriate circumstances,” including when they may be entitled to deferential or persuasive weight. Finally, it incorporated these changes into the Justice Manual and the Code of Federal Regulations.