News & Analysis as of

Research and Development False Claims Act (FCA)

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Hinckley Allen

Impact of the Trump Administration’s Executive Orders and Actions for Academic Institutions & Federal Funded Research Community

Hinckley Allen on

The Trump Administration’s first two months have been marked by a flurry of actions impacting federal grant recipients, federal contractors, and academic and scientific researchers. These unprecedented measures, including...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

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

Health Care Compliance Association (HCCA)

NIH Disavows China Initiative, Offers ‘Trusted Asians’ Support But Cases, Questions Linger

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

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

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

Holland & Knight LLP on

The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more

Akin Gump Strauss Hauer & Feld LLP

Research Security Program Guidelines Have (Finally) Arrived

On July 9, 2024, the White House Office of Science and Technology Policy (OSTP) released the long-awaited “Guidelines for Research Security Programs at Covered Institutions” (the Guidelines). The Guidelines are intended to...more

Husch Blackwell LLP

False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct

Husch Blackwell LLP on

Host Jonathan Porter welcomes Husch Blackwell attorney Karen Courtheoux to the show to discuss the False Claims Act in the context of government-funded research programs that are often carried out under the auspices of...more

Dorsey & Whitney LLP

Some Serious Strings Attached: Sponsored Research Funding, Adequate Accounting Systems, and False Claims Act Exposure

Dorsey & Whitney LLP on

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

Health Care Compliance Association (HCCA)

Moffitt Center’s FCA Settlement is First of 2024; Questions Surround Nature of Billing Errors

Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

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

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

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

Health Care Compliance Association (HCCA)

MITRE: Risk Approach May Thwart Foreign Threats, Better Federal Info, Support Essential

Report on Research Compliance 18, no. 2 (February 2021) - “I don’t want to be on the front page of the paper with my best researcher being dragged off in handcuffs. It doesn’t look good for our university,” a senior...more

Morgan Lewis

Higher Education Community Faces Federal Scrutiny of Financial Ties to China

Morgan Lewis on

Both individuals and higher education institutions could face criminal and civil liability if they are not in compliance with federal law in the administration of federal grants and expenditure of federal research dollars, as...more

Foley & Lardner LLP

That ‘Hot’ Research Project May Land Your Lab in Hot Water

Foley & Lardner LLP on

Most busy scientific research laboratories have a spectrum of projects underway at any given time. Some projects are producing exciting results, and others seem to be heading nowhere. Why not shift personnel from the losers...more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act Suit Dismissed Based on Granston Memo Considerations

• DOJ is implementing the Granston memo policy in seeking dismissal of FCA qui tam actions when it is in the government’s interest, particularly when protecting its resources, discretion and litigation priorities. • DOJ...more

Holland & Knight LLP

Granston Memo in Action: DOJ Successfully Exercises Authority to Dismiss Meritless Qui Tam

Holland & Knight LLP on

A recent dismissal of a qui tam action demonstrates there exists an affirmative approach for disposing of wasteful and meritless non-intervened qui tam claims without the time and expense of protracted litigation with...more

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