On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more
The National Institutes of Health (NIH) on April 21, 2025, published a notice (the NIH Notice) updating the civil rights provisions of the NIH Grants Policy Statement and creating new requirements that federally funded...more
Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more
The federal government awards billions of dollars each year in sponsored research funding to institutions of higher education, academic research institutions, non-profit organizations, and companies—making federal grants an...more
In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more
The recent settlement of a False Claims Act case afforded SDNY Judge Ronnie Abrams the opportunity to address the standard for redacting a qui tam Relator’s FCA complaint. Judge Abrams decided that Relator Devin English had...more
Report on Research Compliance Volume 20, Number 3. February 23, 2023 - To those who say whistleblowers are only interested in the money a settlement can bring, meet Devin English. An assistant professor in the Department of...more
Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a research compliance work plan? - How to better shift your program’s research focus in...more
Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
Key Points - Notice reflects NIH’s continued concerns regarding foreign influence and imposes significant new compliance obligations on both grantees and individual researchers. - Obligates grantees to provide NIH...more
Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence Last month the Department of Education (“DOE” or “Department”) released an...more
Report on Research Compliance 17, no. 10 (September 24, 2020) What the federal government—and a whistleblower—allege were False Claims Act (FCA) violations actually resulted from an “accounting discrepancy,” according to the...more
Engineering Firm Settles $37 Million False Claims Act Allegations - As part of a settlement agreement with the Department of Justice, QuantaDyn Corporation has agreed to pay $37,757,713.91 in restitution to resolve...more
COVID-19- Bipartisan Group of Attorneys General Seeks to Expand Production of Antiviral Drug- A bipartisan group of 34 AGs, led by California AG Xavier Becerra and Louisiana AG Jeff Landry, sent a letter urging the U.S....more
Report on Research Compliance 17, no. 8 (August 2020) - Higher education groups and others are hailing a decision by the administration to rescind planned rules that would have required students in the United States on...more
Report on Research Compliance 17, no. 6 (June 2020) - A former assistant veterinary medicine professor at the University of Maryland will retract or correct seven papers published from 2013 to 2016 that contained reused or...more
The Department of Justice (DOJ) recently announced that it reached a $5,500,000 settlement with a biomedical research institute that received NIH grant funding–the Van Andel Research Institute (VARI)–to resolve allegations...more
Report on Research Compliance 17, no. 3 (February 20, 2020) - Despite its earlier agreement to repay just $5,442 in costs questioned by the National Science Foundation (NSF) Office of Inspector General, the University of...more
Report on Research Compliance 17, no. 2 (January 23, 2020) - Acting with “deliberate ignorance” and “reckless disregard” are not words that any institution wants to hear associated with its name. But these are at the heart...more