News & Analysis as of

Scientific Research Federal Funding

Health Care Compliance Association (HCCA)

New NIH Head: Indirect Payments ‘Tips’; Republican Senator Calls Them ‘Grift’

Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more

Hinckley Allen

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

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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

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

Dorsey & Whitney LLP

Federal Assistance in Jeopardy? What to Know about OMB Guidance About Hundreds of Billions in Federal Research and Loans to...

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On January 27, the Acting Director of the Office of Management & Budget issued a new Memorandum (M-25-13) that presages significant disruption—if not outright cancellation—of many federal assistance awards. ...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

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Weighs in on Temporal Rigidity of the Bayh-Dole Act’s Licensing Provisions

In University of South Florida Board of Trustees v. United States, the Federal Circuit rejected a strict temporal limitation on when the Government’s license rights in patents stemming from federally funded research is...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

Dorsey & Whitney LLP

Fundamental Research & National Security: Recent Developments & New Issues

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According to the National Center for Science and Engineering Statistics (“NCSES”), a key driver in the scientific and technological accomplishments of U.S. research universities is the volume of federal support for research...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

Goodwin

FDA Announces Biosimilar Funding Opportunity

Goodwin on

On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates...more

Jones Day

White House Guidance on Implementing NSPM-33: Standardization of Disclosure and Security Measures for Federal Research Funding

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On January 4, 2022, the White House Office of Science and Technology ("OSTP") released guidance for federal agencies to implement National Security Presidential Memorandum 33 ("NSPM-33"). Issued in the final days of the Trump...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)

First Jail Term for Undisclosed Foreign Support Appealed; NIH’s Lauer Laments ‘Tragic’ OSU Case

Report on Research Compliance 18, no. 9 (September, 2021) - To his supporters and colleagues, Song Guo Zheng, MD, PhD, was the most productive worker they’ve seen in 50 years, publishing nearly 300 papers, a man who lived...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

Lathrop GPM

Don’t Forget the Bayh-Dole Act If Your Research Is Federally Funded

Lathrop GPM on

The Bayh–Dole Act, signed into law in 1980, is U.S. legislation directed to inventions arising from research funded by the Federal government. (See 35 U.S.C. § 200–212, and 37 C.F.R. §§ 401 and 404.) The Act encourages...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

King & Spalding

The Climate Change Debate--A New Direction

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The contentious and partisan debate in Washington over climate change policy may be shifting in a new direction—one that is driven not by partisanship but by a group of bipartisan members of Congress and the engagement and...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

Troutman Pepper Locke

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

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Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

Robinson & Cole LLP

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

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The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

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