News & Analysis as of

Scientific Research NPRM

Health Care Compliance Association (HCCA)

Penn Calls for Withdrawal of ORI’s Misconduct Proposed Reg; Many Commenters Also Critical

The HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Bricker Graydon LLP

Clinical research compliance alert: Common Rule update - Additional proposed delay

Bricker Graydon LLP on

The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an...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

McDermott Will & Emery

HHS Finalizes Toned-Down Version of Common Rule Overhaul

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

BakerHostetler

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

BakerHostetler on

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more

Sheppard Mullin Richter & Hampton LLP

HHS Recognizes Changing Environment of Research: Still Time to Comment

Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

King & Spalding

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

King & Spalding on

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

McDermott Will & Emery

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Mintz - Health Care Viewpoints

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

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