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Final Rules The Common Rule

Foley & Lardner LLP

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

Foley & Lardner LLP on

In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Nelson Mullins Riley & Scarborough LLP

A Framework for Readying Your Institution for Complying With the Revised Common Rule

Earlier this year, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the ‘‘Common Rule,’’ was published in the Federal Register (the ‘‘Final Rule’’). 82 Fed. Reg. 7149 (Jan. 19,...more

Shumaker, Loop & Kendrick, LLP

Client Alert: U.S. Department of Health and Human Services ("HHS") Delays Effective and Compliance Date for the Revised Common...

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” was originally published in 1991 and has been adopted and codified in separate regulations by HHS and 15 other federal departments and agencies. ...more

Arnall Golden Gregory LLP

HHS Issues Final Revisions to the Common Rule – New Protections for Human Research Subjects

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies issued a final rule to update “Federal Policy for the Protection of Human Subjects,” also known as...more

Hogan Lovells

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

Hogan Lovells on

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...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

BakerHostetler

Welcome to the Future: HHS Releases Final Rule to Modernize Protections for Clinical Trial Participants

BakerHostetler on

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” governs the ethical conduct of research involving human subjects and is funded through various federal agencies. On January 19, the U.S....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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