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Holland & Knight LLP

Another Change to NIH Grant Civil Rights Terms and Conditions

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The National Institutes of Health (NIH) issued a notice on June 12, 2025, rescinding recent civil rights–related changes to the terms and conditions governing federally funded research (the Rescission). Effective immediately,...more

Dorsey & Whitney LLP

The Next Front in the Administration’s Sponsored Research Crackdown: What Recipients of Federal Funding - Particularly Grantees -...

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The Trump Administration’s effort to remake the Federal government’s relationship with Higher Ed and research grantees continues to gather steam, and an unprecedented recent letter to Harvard presages a potentially new front:...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2025

Great thinkers have sought for centuries to convey a crucial truth about humanity’s interconnection. As the poet John Donne wrote: “No man is an island, entire of itself; every man is a piece of the continent, a part of the...more

Holland & Knight LLP

Nationwide Preliminary Injunction Halts NIH Indirect Cost Rate Change Notice

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Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Latham & Watkins LLP

Update: The NIH Funding Cuts: Implications and Status of Lawsuits

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The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more

Dorsey & Whitney LLP

NIH’s New Unilateral Change to Your Institution’s Indirect Rate: An Old-School Breach of Contract?

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On Friday, February 7, the National Institutes of Health (“NIH”) issued Policy Statement Supplemental Guidance affecting budgets both for active grants and for future grants, which was set to take effect on Monday, February...more

Latham & Watkins LLP

The NIH Funding Cuts: Implications and Status of Lawsuits

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The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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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

Wiley Rein LLP

Capping It All Off: NIH Caps Indirect Rates for Grants

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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

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

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