On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more
This is part two of a series on health care budget cuts. The President’s Budget Requests Dramatically Reduce Biomedical Research - The president’s budget request was a major disappointment to those interested in...more
The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more
When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more
The National Institutes of Health (NIH) on April 21, 2025, published a notice (the NIH Notice) updating the civil rights provisions of the NIH Grants Policy Statement and creating new requirements that federally funded...more
On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for...more
On March 5, 2025, Judge Angel Kelley, a federal district court judge sitting in Massachusetts, granted a nationwide preliminary injunction which serves to temporarily block the Trump Administration’s attempt to cap the...more
If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more
On Feb. 13, moments after Robert F. Kennedy Jr. was confirmed as secretary of health and human services, President Donald Trump issued his first health care Executive Order (EO) under new leadership, laying the groundwork to...more
On January 27th, the Trump administration issued an order (the January 27th order) freezing all federal grants and loans, which would have cut billions of dollars of federal funding, largely to research universities....more
Over the past few weeks, the Trump administration has introduced sweeping changes across the federal government that have impacted the federal grantee and contractor community. Adding to these changes, the National Institutes...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
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
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more
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
On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
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
New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more
A group of four bipartisan senators known as the Bipartisan Senate Artificial Intelligence (AI) Working Group (Working Group) on May 15, 2024, released "Driving U.S. Innovation in Artificial Intelligence: A Roadmap for...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
This is the fifth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more
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
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more