New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks and Research Data with the US Prime Awardee

The U.S. Department of Education recently issued final regulations governing Title IX, the federal civil rights law prohibiting sex-based discrimination in education programs or activities—such as public or private schools, universities, local or state educational agencies, and museums—that receive federal financial assistance. These new regulations, issued on April 19, 2024, and slated to go into effect on August 1, 2024, make significant changes to the prior Title IX regulations issued in 2020. Whereas the 2020 regulations included a narrower definition of sexual harassment and focused on due process concerns, the 2024 regulations—more akin to the regulations under the Obama administration—broaden the focus of Title IX to sex-based harassment more generally.

The National Institutes of Health (NIH) recently moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation that support research outcomes described in a progress report to the prime award recipient. The new policy is in direct response to recent audits conducted by the Department of Health and Human Services, Office of Inspector General (DHHS OIG) and the Government Accountability Office (GAO), each of which raised concerns about NIH’s oversight of funds provided to, among other institutions, the Wuhan Institute of Virology. More generally, the new NIH policy is among the latest salvos in the government’s ongoing efforts to impose stricter security requirements on U.S. taxpayer-funded research.

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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.

Following the Supreme Court’s June 30, 2023 ruling determining that the Biden-Harris administration did not have authority to carry out its student debt forgiveness plan, the administration released a fact sheet detailing new actions to provide debt relief and support for student loan borrowers.

On June 29, 2023, the U.S. Supreme Court released its highly anticipated decision that overturned 45 years of protection for colleges and universities considering the race of applicants in their admissions process. The Court found that the use of race-conscious admissions by the University of North Carolina and Harvard University is not constitutional.

On June 30, in Biden v. Nebraska, the Supreme Court ruled against the Biden administration’s student loan relief plan in a 6-3 decision. The plan, which was estimated to impact more than $430 billion of student loan principal, would have canceled student loan debt for more than 40 million borrowers.

H.R. 5, the Parental Bill of Rights Act, passed in the House of Representatives on Friday, March 24, 2023 by a vote of 213 – 208. Only Republicans supported the bill and five Republicans – Reps. Andy Biggs, Ken Buck, Matt Gaetz, Mike Lawler, and Matt Rosendale – joined all House Democrats in voting against the bill.