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  • Date:

    Association of American Universities v. Department of Energy (D. Mass. Apr. 16, 2025)

    Order Granting Plaintiffs’ Motion for a Temporary Restraining Order. Plaintiffs, the Association of American Universities, American Council on Education, Association of Public and Land-Grant Universities, Brown University, California Institute of Technology, Cornell University, Board of Trustees of the University of Illinois, Massachusetts Institute of Technology, Regents of the University of Michigan, Board of Trustees of Michigan State University, Trustees of Princeton University, and University of Rochester challenged the Department of Energy (DOE) and its Secretary Chris Wright for the Department’s cut on indirect cost rates for government-funded research. Plaintiffs sought a Temporary Restraining Order (TRO) to prevent immediate and irreparable injury following defendants’ announcement that the DOE will no longer use negotiated indirect cost rates and will instead default to a 15% indirect cost rate for all grant awards to postsecondary institutions. Plaintiffs alleged that the DOE policy violates the Administrative Procedure Act (APA) by way of deviating from the Congressionally approved negotiated cost rates, terminates existing grants, defies cost recovery regulations, and violates authorizing statutes. The Court found that plaintiffs made a sufficient showing that absent issuance of a TRO, they would sustain immediate and irreparable injury. It enjoined defendants and their officers, employees, servants, agents, appointees, and successors from implementing, instituting, maintaining, or giving effect to the DOE Policy Flash: Adjusting Department of Energy Grant Policy for Institutions of Higher Education (the “Rate Cap Policy”) in any form; from otherwise modifying negotiated indirect cost rates except as permitted by statute and by the regulations of the Office of Management and Budget; and from terminating any grants pursuant to the Rate Cap Policy or based on a grantee’s refusal to accept an indirect cost rate less than their negotiated rate. The Court also ordered defendants to provide written notice of the Order to all funding recipients affected by the Rate Cap Policy and to file a biweekly status report to confirm regular disbursement and obligation of federal financial assistance funds until the TRO expires. A hearing is set for April 28, 2025. 

    Topics:

    Contracts | Grants, Contracts, & Sponsored Research | Research

  • Date:

    Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security – The White House (Feb. 10, 2025)

    Executive Order: Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security. This Executive Order requires the Attorney General to review guidelines and policies governing investigations and enforcement actions under the Foreign Corrupt Practices Act (FCPA); cease initiation of any new FCPA investigations or enforcement actions; review in detail all existing FCPA investigations or enforcement actions and take appropriate action; and issue updated guidelines or policies to adequately promote the President’s Article II authority to conduct foreign affairs and prioritize American interests. 

    Topics:

    Foreign Corrupt Practices Act (FCPA) | International Activities | International Ventures | Research

  • Date:

    ACE Letter Offering Comments on the 2025 National Defense Authorization Act (NDAA) (Oct. 8, 2024)

    The American Council on Education (ACE) sent a letter to Chairman Rogers, Ranking Member Smith, Chairman Reed, and Ranking Member Wicker of the Armed Services Committee expressing concerns regarding the House draft of the NDAA, which includes provisions that could restrict academic collaborations with institutions in other countries and further impose career restrictions on researchers who engage in U.S. Department of Defense (DOD) projects. The letter expressed additional concerns with Section 220 of the Senate draft of the bill as it would allow the DOD to withhold funding from institutions that violate Title VI, a measure that would both duplicate and complicate existing enforcement by the U.S. Department of Education.  

    Topics:

    Accreditation, Authorizations, & Higher Education Act | Export Controls | Higher Education Act (HEA) | International Ventures | Research

  • Date:

    Public Health Service Policies on Research Misconduct (Sep. 17, 2024)

    The U.S. Department of Health and Human Services Office of Research Integrity (ORI) published a Final Rule revising the regulations governing Public Health Service Policies on Research Misconduct. The purpose of the Rule is to implement policy changes and respond to technological changes that occurred over the past several years applicable to research misconduct. The Rule establishes requirements for addressing research misconduct in Public Health Services (PHS) funded research, further clarifies ORI’s regulatory oversight responsibility, and outlines the role of PHS-funded organizations in establishing research integrity. The Rule goes into effect January 1, 2025, and all regulatory requirements are applicable beginning on or after January 1, 2026.  

    Topics:

    Contracts | Grants, Contracts, & Sponsored Research | Research | Research Misconduct

  • Date:

    People for the Ethical Treatment of Animals v. Tabak (D.C. Cir. July 30, 2024)

    Opinion reversing and directing entry of judgment in favor of the appellants. Plaintiff-appellants, People for the Ethical Treatment of Animals (PETA) and two animal rights activists who “frequently commented on the official Facebook and Instagram pages of appellee National Institutions of Health (NIH), criticizing NIH’s funding of research conducted on animals,” brought First Amendment claims against NIH challenging its use of keyword filters “to filter out comments containing words that frequently appeared in posts that it considered ‘off-topic,’ such as the terms ‘animal,’ ‘testing,’ and ‘cruel.’” The district court granted summary judgment in favor of NIH, “holding that NIH’s keyword filters were viewpoint-neutral and reasonable restrictions in a limited public forum.” In reversing and directing summary judgment in favor of the appellants, the D.C. Circuit held that “NIH’s off-topic restriction, as currently presented, is unreasonable under the First Amendment,” finding that (1) NIH’s assertion of its present list of off-topic keywords “defies common sense” in that a substantial number of the posts affected “either directly depict animals or discuss research conducted on animals;” (2) NIH provided no definition of “off-topic” to guide either its moderators or the public and no line at which repetitive off-topic posts become unacceptable; (3) its protocol was inflexible and unresponsive to the context by providing “little, if any, ability to ask NIH to restore” filtered comments; and (4) its position was “further compromised by the fact that NIH chose to moderate its comment threads in a way that skews sharply against the appellants’ viewpoint.”  

    Topics:

    Constitutional Issues | First Amendment & Free Speech | Research | Social Media

  • Date:

    Yoon v. Garg (5th Cir. June 6, 2024)

    Opinion affirming denial of preliminary injunction. Plaintiff, a research scientist at the University of Texas Medical Branch whose research was supported by NIH grants, brought due process claims against multiple University officials after he was disciplined but not terminated for intentionally falsifying and fabricating images in a published journal article. After the U.S. Department of Health and Human Services (HHS) Office of Research Integrity found that the University’s initial report of research misconduct findings did not fully comply with Public Health Service (PHS) Policies on Research Misconduct, the University created a new committee to restart the investigation that ultimately reached the conclusion that was the basis for the University’s disciplinary actions. The district court denied plaintiff’s motion for preliminary injunction, finding he failed to explain how the officials’ actions interfered with a property interest in the PHS Policies or the University’s policies and procedures. In affirming denial of preliminary injunction, the Fifth Circuit found his complaint that departures from PHS and University procedures resulted in a prolonged investigation was insufficient to identify a protected property interest, particularly as he is still employed by the University in the same lab. It further held that even with the alleged procedural flaws, because he had received notice and responded to the allegations at every step, the University had afforded him constitutionally sufficient process.   

    Topics:

    Research | Research Misconduct

  • Date:

    Croce v. Ohio State Univ. Bd. of Trs. (Ohio App. June 4, 2024)

    Opinion affirming-in-part and reversing-in-part Judgment on the Pleadings.  Plaintiff, a biomedical researcher at The Ohio State University, brought contract claims against the University after an investigation, allegedly sparked by a defamatory newspaper article, cleared him of research misconduct allegations.  The Dean of the College of Medicine nevertheless took non-disciplinary actions against him, including removing him from an endowed chair.  Plaintiff alleged that the University departed from (1) federal standards for addressing research misconduct, (2) its own internal policy to rehabilitate the reputation of researchers who are cleared of research misconduct allegations, and (3) its faculty rules.  The court below granted judgment on the pleadings, finding that (1) the claims based on federal standards were preempted and (2) the remaining claims failed because the University policies leave rehabilitation measures to the discretion of the Vice President of Research and the remaining measures to the discretion of the Dean.  The Court of Appeals of Ohio affirmed that plaintiff’s claims based on federal standards were preempted.  It reversed on the remaining contract claims, noting that the rehabilitation policy stated that the University will “work with” the respondent on such measures and finding that the trial court erred in holding that no set of facts would entitle plaintiff to relief.   

    Topics:

    Contracts | Research | Research Misconduct

  • Date:

    Monge v. Univ. of Pa. (E.D. Pa. May 14, 2024)

    Memorandum denying Defendants’ Motion to Dismiss. Plaintiff, a former anthropology professor and museum curator at the University of Pennsylvania, brought defamation, false light, defamation by implication, and civil aiding and abetting claims against, among others, the University and its former president and provost in the wake of a public controversy surrounding her work with human remains from the 1985 police bombing of the MOVE house in Philadelphia. Plaintiff alleged that a former student, whom she had accused of “unlawful and disturbing” conduct, tried to “cancel” her by falsely reporting to University officials and the media that she had mishandled the remains. After media and professional associations condemned her, the University demoted her and issued a statement describing her actions as “insensitive, unprofessional, and unacceptable.” In permitting her defamation and false light claims to proceed, the court held, first, that plaintiff was a limited purpose public figure, noting her use of the remains in a Coursera course. It then found she had sufficiently pled actual malice, noting her assertions that defendants (1) had previously not acted when she reported the student’s conduct and (2) published the statement without an investigation by the Institutional Review Board. In permitting her defamation by implication claim to proceed, the court found it plausible that the defendants would have known that their statements would hurt her professional reputation. In permitting her civil aiding and abetting claim to proceed, it found her assertions sufficient to allege that the University defendants had acted in concert with the former student.  

    Topics:

    Litigation, Mediation & Arbitration | Research | Research Misconduct | Tort Litigation

  • Date:

    United States ex rel. Ruggeri v. Magee-Women’s Research Inst. & Found. (W.D. Pa. Apr. 24, 2024)

    Opinion granting-in-part and denying-in-part Defendants’ Motions to Dismiss. Plaintiff, a former Director of Grants and Contracts at the Magee-Women’s Research Institute and Foundation (Foundation), brought this qui tam action against the Foundation, the University of Pittsburgh, the University of Pittsburgh Medical Center (UPMC), and the UPMC Magee-Women’s Hospital, alleging accounting practices that were falsely certified as compliant with National Institutes of Health grants requirements. She further alleged that her termination was in retaliation for her negative assessment of the grants compliance. The court dismissed the claims against UPMC and the Hospital, finding that although they leased employees and provided space and administrative services to the Foundation, plaintiff failed to allege with specificity any action beyond association taken in the alleged false claim scheme. In permitting her fraud claims to proceed, the court found plaintiff had alleged with sufficient particularity (1) that the Foundation knew that its accounting systems were inadequate to meet NIH requirements and (2) that Foundation and University officials, including Principal Investigators from the University, improperly transferred other costs to the grants in order to spend them down. The court further found that plaintiff’s assertion that NIH investigated her allegations and altered how it interacted with the Foundation sufficient to allege materiality. In permitting her retaliation claim to proceed, the court noted the close temporal proximity of her termination to her delivery of her compliance assessment to a member of the Foundation’s Board. 

    Topics:

    Discrimination, Accommodation, & Diversity | False Claims Act (FCA) | Research | Retaliation

  • Date:

    McCarter v. The Univ. of N.C. at Chapel Hill (M.D. N.C. Mar. 15, 2024)

    Memorandum Opinion and Order granting-in-part and denying-in-part Defendants’ Motion for Summary Judgment. Plaintiff, a graduate of the Ph.D. program in Bioinformatics and Computational Biology and former post-doctoral fellow at the University of North Carolina at Chapel Hill who is African American, brought discrimination, retaliation, and equal protection claims against the University and several former advisors, alleging that they delayed his progress and subsequently plagiarized his work. Of note, though the court granted summary judgment to the University on most of his claims, plaintiff also alleged (1) that his advisors imposed “last minute” requirements on a manuscript he was completing toward fulfillment of the curricular requirement, which they later waived, of submitting work for professional publication and (2) that after he resigned his fellowship, they falsely attributed work contained in his unpublished manuscript to another graduate student. The court granted summary judgment to the defendants regarding the alleged new requirements, citing insufficient evidence that the additional requirements were the result of race-based discrimination. It permitted him to proceed regarding the plagiarism allegation, however, finding that (1) plaintiff’s side-by-side comparison of his manuscript with another student’s dissertation was sufficient to raise a question of plagiarism and (2) evidence of previous allegations against the professors of publishing the work of another student of color without attribution was sufficient to raise a question of pretext.   

    Topics:

    Discrimination, Accommodation, & Diversity | Race and National Origin Discrimination | Research | Research Misconduct