News & Analysis as of

Reporting Requirements National Institute of Health (NIH)

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

Holland & Knight LLP

Holland & Knight Health Dose: October 3, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Akin Gump Strauss Hauer & Feld LLP

Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime...

On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

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Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

Hogan Lovells

OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies

Hogan Lovells on

A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required to submit results to...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

Mintz - Health Care Viewpoints

FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area...more

Bass, Berry & Sims PLC

NIH Begins Implementation of OSTP Foreign Influence Recommendations for Research Institutions

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As part of the government’s broader efforts to combat foreign threats to U.S.-funded scientific research, the National Institutes of Health (NIH) and White House Office of Science and Technology Policy (OSTP) have announced...more

Jackson Lewis P.C.

COVID-19 Vaccination: Setting Up On-Site Programs

Jackson Lewis P.C. on

The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more

King & Spalding

Heightened Focus on Foreign Influence in Academia

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Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence Last month the Department of Education (“DOE” or “Department”) released an...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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Federally Funded Inventions and Compliance with the Bayh-Dole Act

Organizations that receive federal funds or that license technology from third parties that receive Federal funds need to be aware of Federal funding obligations under the Bayh-Dole Act. Any invention conceived or reduced to...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 4. In This Month's E-News: April 2020

Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Troutman Pepper

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

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Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

Epstein Becker & Green

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

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On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

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