News & Analysis as of

Regulatory Oversight National Institute of Health (NIH)

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

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

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

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

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 #1

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In Washington - White House Chief of Staff Mark Meadows on Tuesday said that there has been “real progress” in talks with congressional Democrats and Republicans on coronavirus relief legislation. ...more

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

Top experts, by failing to disclose conflicts of interest, shortchange taxpayers

Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential...more

Hogan Lovells

NIH issues long-awaited guidance on other support, foreign components, and financial conflicts of interest

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On 10 July 2019 the National Institutes of Health (NIH) issued its long-awaited guidance addressing grantee disclosure obligations related to researchers' activities outside the United States. ...more

Bricker Graydon LLP

Keeping up with NIH rules impacting research involving human subjects

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The National Institutes of Health (NIH) made a number of changes to the rules impacting research involving human subjects in recent years, including the launch of several new initiatives that fall into two categories: those...more

Akerman LLP - Health Law Rx

Get your Single IRB lined up for Multi-Site Research

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...more

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