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Health Care Compliance Association (HCCA)

Their Terms Ended by Trump, SACHRP Members Form New Committee, Vow to Continue ‘Mission’

Health Care Compliance Association (HCCA) on

Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more

Holland & Knight LLP

HHS Cuts Impacting Human Subject Research – No More SACHRP?

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In a remarkable federal human subject research policy development, it appears that the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) has been...more

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

Health Care Compliance Association (HCCA) on

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

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

Health Care Compliance Association (HCCA) on

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2023

Health Care Compliance Association (HCCA) on

Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 12. In This Month’s E-News: December 2021

Health Care Compliance Association (HCCA) on

Report on Research Compliance 18, no. 12 (December, 2021) - A month after rumors circulated that President Biden planned to tap former Food and Drug Administration (FDA) Commissioner Robert Califf to serve again, the...more

K&L Gates LLP

Research Community Alert – NIH Finalizes Updated Data Sharing Policy

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On 29 October 2020, the National Institutes of Health (NIH) issued its final NIH Policy for Data Management and Sharing (the DMS Policy), which updates and replaces the 2003 NIH Data Sharing Policy. Although the DMS Policy...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 8: In This Month's E-News: August 2020

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Report on Research Compliance 17, no. 8 (August 2020) - Higher education groups and others are hailing a decision by the administration to rescind planned rules that would have required students in the United States on...more

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