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Holland & Knight LLP

HHS Announces Updates to Policies on Research Misconduct

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The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

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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

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology,...

The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 6. In This Month's E-News: June 2022

Report on Research Compliance 19 no. 6 (June, 2022) - Auditors for the National Science Foundation (NSF) Office of Inspector General (OIG) questioned $35,316 of costs claimed by the University of Idaho (UI) among $42.7...more

Health Care Compliance Association (HCCA)

NSF Award Mismanagement, Publication Ban Among Costly Actions by Researchers

Report on Research Compliance 19, no. 1 (January, 2022) - During the second half of fiscal year 2021, which ended Sept. 30, the National Science Foundation (NSF) collected more than $2.5 million from six universities and...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)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 5. In This Month’s E-News: May 2021

Report on Research Compliance 18, no. 5 (May 2021) - Rep. Kathy Castor, D-Florida, has relaunched the bipartisan Congressional Academic Medicine Caucus with new co-chair Rep. David McKinley, R-West Virginia, who replaced...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 11. In This Month's E-News: November 2020

Report on Research Compliance 17, no. 11 (November 2020) - In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more

Baker Donelson

New Health Care Provider Opportunities in Fourth COVID-19 Bill and HHS Plans to Distribute Additional Funds

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On April 23, 2020, the House of Representatives passed the Paycheck Protection Program and Health Care Enhancement Act, which previously passed the Senate on April 21, 2020, and is expected to be signed into law by the...more

White & Case LLP

Launch of the Future Fund: Funding for the UK's fast-growth companies

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On 20 April 2020, the Chancellor of the Exchequer announced a scheme aimed at providing support to the UK's most innovative and fastest-growing companies. Below we provide an overview of the scheme and highlight some key...more

Bass, Berry & Sims PLC

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

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The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

Faegre Drinker Biddle & Reath LLP

FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory...

The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more

Baker Donelson

Third Coronavirus Stimulus Package Includes Considerable Funding for Health Care Providers and Other Health Care Provisions

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Both the U.S. Senate and House of Representatives have now passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and the President is expected to sign the bill into law shortly. The CARES Act appropriates...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 3. In This Month's E-News: March 2020

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

Health Care Compliance Association (HCCA)

NSF OIG Deploys 'Redesigned' Audit Approach: Assess the 'Environment,' Then Target Inquiries

Report on Research Compliance 17, no. 3 (February 20, 2020) - Institutions with federal research dollars, particularly from the National Science Foundation (NSF), know they may be subject to an audit by the funding...more

Holland & Knight LLP

Legitimate Academic Pursuits or Illegal Espionage?

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A prominent professor at Harvard University, Charles Lieber, chair of the Harvard Chemistry Department, was arrested on Jan. 28, 2020, and charged with the federal crime of making a false statement to the government arising...more

Health Care Compliance Association (HCCA)

After $5.5M FCA Settlement, Institutions Face Bigger Risks for Mishandling Foreign Support

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

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Troutman Pepper

When Research Misconduct Violates the False Claims Act: Lessons from Duke's $112.5M Settlement

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On March 25, the U.S. Department of Justice (DOJ) announced that Duke University agreed to settle a False Claims Act qui tam action alleging widespread misconduct in federally funded research. ...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

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Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Hogan Lovells

Department of Defense FY18 research funding for the Congressionally Directed Medical Research Program

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The Congressionally Directed Medical Research Program within the U.S. Army Medical Research and Material Command that is a partnership formed by Congress, the military and the manages billions of dollars in Congressional...more

Polsinelli

2017 Omnibus Agreement: Key Health Provisions

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Congress has completed action on H.R. 244, the “Consolidated Appropriations Act for FY 2017” [P. L. 115-31]. This bipartisan legislation, which funds the Federal government for the balance of the fiscal year, passed the House...more

Sheppard Mullin Richter & Hampton LLP

Health-Related Programs Face Deep Cuts In President Trump’s “Budget Blueprint to Make America Great Again”

On March 16, 2017, President Trump Administration released his first budget outline for the 2018 fiscal year (FY 2018). In an effort to “shrink the role of government,” the $1.1 trillion budget proposal calls for a $54...more

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