News & Analysis as of

Research and Development Fraud

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

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On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Health Care Compliance Association (HCCA)

Penn State, GA Tech Cybersecurity Cases Join 10 Others FCA Attorney Has Under Seal

Note to research compliance officials still digesting news of Pennsylvania State’s recent $1.25 million settlement over False Claims Act (FCA) allegations related to cybersecurity and the government’s recent intervention in a...more

Cohen & Gresser LLP

HMRC R&D Fraud Arrests: A New Era for Tax Enforcement?

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On 30 October 2024, the Government published its highly anticipated Autumn Budget 2024 (the “Budget”). Among measures promised to “fix the foundations of the economy” is the Government’s commitment to implement “the most...more

Health Care Compliance Association (HCCA)

Missing COI Program, Fabricated Outreach, Job, Health Records: The Many Types of Falsehoods

Report on Research Compliance 21, no. 9 (September, 2024) - How many types of falsehoods might sully applications for research funds and the studies they support? Unfortunately, the most recent semiannual report to...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Akin Gump Strauss Hauer & Feld LLP

Senate AI Working Group Releases Long-Anticipated Roadmap for AI Policy

On May 15, 2024, the Senate AI Working Group—Senate Majority Leader Chuck Schumer (D-NY) and Sens. Mike Rounds (R-SD), Todd Young (R-IN), and Martin Heinrich (D-NM)—issued their long-anticipated Roadmap for Artificial...more

Health Care Compliance Association (HCCA)

Good investigative practices apply in all settings

As reported in the Report on Research Compliance, the Office of Inspector General (OIG) of the National Science Foundation (NSF) recently held a workshop on the performance of federal research misconduct investigations....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: December 2023

Report on Research Compliance 20, no. 12  (December 2023) Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2023

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

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

HaystackID

[Webcast Transcript] Best Practices for Selecting, Staffing, and Supporting Complex and High-Velocity Legal Document Reviews

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Editor’s Note: In this insightful webcast hosted by HaystackID on April 19, 2023, our expert panel delved into the best practices for selecting, staffing, and supporting complex and high-velocity legal document reviews. The...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. In This Month’s E-News: January 2023

Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more

Morrison & Foerster LLP - Government...

False Claims In Independent Research & Development (IR&D): Federal District Court Adopts ATK THIOKOL As The Knowledge Standard

Many government contractors, like other private enterprises, invest heavily in research and development (R&D) to improve the products and services they offer, in hopes of better meeting their customers’ needs. When those R&D...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 11. In This Month’s E-News: November 2021

Report on Research Compliance 18, no. 11 (November, 2021) - A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - October 2021

The October 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a precedential TTAB decision regarding fraud; the DEA's proposal to increase production quotas for several schedule I controlled substances,...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

Baker Donelson

Thousand Talents Program Exposes New Legal Risks for Universities

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University professors' involvement in the Peoples' Republic of China's Thousand Talents Plan (the Talents Plan) has been in the news quite a bit recently. In recent months, the Department of Justice (DOJ) has made multiple...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Distributed Ledger: Blockchain, Digital Assets and Smart Contracts

This is the inaugural issue of The Distributed Ledger, a periodic publication covering the latest trends and developments in blockchain technology, digital assets and smart contracts. In this edition, we examine a federal...more

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