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What to Do When Your University, FBI, or DOJ Knocks on Your Door: Responding to University, Criminal, and Civil Investigations
Chien-Shiung Wu - The First Lady of Physics (Women's History Month)
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more
The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more
SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...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
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...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
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
In early May 2024, the New Civil Liberties Alliance (NCLA) notified the U.S. Consumer Product Safety Commission (CPSC) that it intended to file suit against CPSC and CPSC Commissioner Richard Trumka for allegedly violating...more
New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...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 Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more
Report on Research Compliance Volume 20, Number 5. April 27, 2023 - - NIH should conduct “site visits to foreign facilities that perform NIH-funded animal research” or require third-party verification to offer “reasonable...more
Report on Research Compliance Volume 20, Number 2. (January 2023) -Hired under the Intergovernmental Personnel Act (IPA), staff referred to as IPAs assist the National Science Foundation (NSF) as temporary directors,...more
The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more
NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more
On 25 August 2022, the Office of Science and Technology Policy (OSTP) released a guidance memorandum instructing federal agencies with research and development expenditures to update their public access policies. Notably,...more
Report on Research Compliance Volume 19, Number 9 (September, 2022) - According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more
Report on Research Compliance 19, no.8 (August, 2022) - An audit of San Francisco State University (SFSU) by the National Science Foundation (NSF) Office of Inspector General (OIG) that tested more than $1.9 million of...more
Report on Research Compliance 19, no. 7 (July, 2022) - Given the already “heavy …burden” faced by small institutions and the National Science Foundation's (NSF) low award rate, the Council on Governmental Relations (COGR)...more
Report on Research Compliance 19, no. 4 (April, 2022) - Terry Magnuson, the long-time research vice chancellor at the University of North Carolina (UNC) at Chapel Hill, described his three instances of plagiarism inserted...more