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Research and Development › Regulatory Requirements › Department of Health and Human Services (HHS)

Cozen O'Connor

Democratic AGs Block NIH Grant Cuts

Cozen O'Connor on

A coalition of 22 Democratic AGs obtained a preliminary injunction blocking the implementation of the Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would have...more

Venable LLP

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

Venable LLP on

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)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Health Care Compliance Association (HCCA) on

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...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)

After GAO Report, OHRP Asks SACHRP to Tackle Elusive Goal: Define, Measure IRB Effectiveness

Health Care Compliance Association (HCCA) on

After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

Morgan Lewis on

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

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