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Research and Development › Final Rules

Ropes & Gray LLP

With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

Ropes & Gray LLP on

On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more

Troutman Pepper Locke

Navigating the Uncertain Waters of Marijuana Research in the US

Troutman Pepper Locke on

In recent years, federal and state governments have taken action to make marijuana research easier. These actions are a step in the right direction, and researchers operating in the marijuana space must be aware of the...more

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

K&L Gates LLP on

On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...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)

ORI’s Garrity: Final Rule ‘Walks Delicate Line’

Health Care Compliance Association (HCCA) on

Sheila Garrity, director of the HHS Office of Research Integrity (ORI), recently spoke to RRC about the agency‘s new rule revising research misconduct regulations, which has a compliance date of Jan. 1, 2026 (see related...more

Hinckley Allen

ORI Issues Final Revisions to 2005 PHS Research Misconduct Regulations

Hinckley Allen on

On September 12, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Office of Research Integrity (“ORI”) issued its Final Rule, the long-anticipated update to the 2005 Public Health Service Policies...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Health Care Compliance Association (HCCA) on

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Fenwick & West LLP

New Controls on Biotech Software May Restrict Exports, Trigger CFIUS Filings

Fenwick & West LLP on

On October 5, 2021, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published a final rule amending the Export Administration Regulations (EAR) to include new controls on genetic editing software and...more

King & Spalding

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

King & Spalding on

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

McDermott Will & Emery

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

McDermott Will & Emery on

In Depth - On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more

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