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Research and Development › Regulatory Requirements › National Institute of Health (NIH)

Venable LLP

Another Change, Did You See NIH's Near-Immediate Change to Your Indirect Cost Rate?

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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

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

Health Care Compliance Association (HCCA)

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

Health Care Compliance Association (HCCA) on

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

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

Health Care Compliance Association (HCCA) on

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

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

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

Morgan Lewis on

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

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