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National Institute of Health (NIH) Pharmaceutical Industry Universities

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Bass, Berry & Sims PLC

Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years' Worth of Back Data Owed

The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Health Care Compliance Association (HCCA)

From Remote Oversight to Wind-Downs: Research Struggles in the Time of COVID-19

Report on Research Compliance 17, no. 4 (April 2020) - “In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment for...more

Troutman Pepper

When Research Misconduct Violates the False Claims Act: Lessons from Duke's $112.5M Settlement

Troutman Pepper on

On March 25, the U.S. Department of Justice (DOJ) announced that Duke University agreed to settle a False Claims Act qui tam action alleging widespread misconduct in federally funded research. ...more

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