News & Analysis as of

Department of Health and Human Services (HHS) Compliance Clinical Trials

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

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The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

Foley & Lardner LLP

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

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On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

Health Care Compliance Association (HCCA)

News Briefs: January 8, 2024

H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...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

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology,...

The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 10. In This Month’s E-News: October 2021

Report on Research Compliance 18, no. 10 (October, 2021) - An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

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

King & Spalding

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

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Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...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

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

BakerHostetler

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

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The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

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