Endpoints

A blog from the attorneys of Verrill

Search Blog

Category: NPRM

A Wrinkle in Common Rule Time

Stopwatch
In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“ IFR ”) delaying the effective date and the general compliance...
Go

The 2018 Common Rule: Implementation Checklist

Chemicals
As many of you know, most of the provisions of the Final Rule updating the Common Rule ( “2018 Common Rule” ) will go into effect, and compliance is required, on January 19, 2018 . Notwithstanding some uncertainty with respect to the current Administration’s regulatory plans, as of now...
Go

Early Adoption Not an Option for Research Rule Changes

Kate Heffernan
Portions of Kate Gallin Heffernan’s presentation at the American Health Lawyers Association conference on legal issues affecting academic medical centers and teaching institutions were quoted in a March 15, 2017 Bloomberg Law: Medical Research Law & Policy Report article entitled “Early Adoption Not an Option For Research Rule Changes.&rdquo...
Go

Just Under the Wire: The Final Common Rule is Here

Medical Research
As many of you know, the long-awaited final rule updating the Common Rule (“Final Rule”) was issued officially January 19 (after an unofficial release to the public yesterday). Like many of you, we are in the process of digesting and analyzing the new regulations and how they alter the...
Go

The Common Rule NPRM Blog Series: Part 3 – Posting of Consent Forms

Informed Consent
The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent...
Go

The Common Rule NPRM Blog Series: Part 2 – Single IRB Review

Number One
To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), this would generally no longer be a question...
Go

Breaking News – 30 Day Extension to Common Rule NPRM Comment Period!

Happy Thanksgiving
Earlier this morning, Health and Human Services and the fifteen other federal departments and agencies with which it is collaborating on the Common Rule Notice of Proposed Rulemaking (“NPRM”) announced that the NPRM comment period, which was scheduled to end on December 7th, will be extended for 30 days...
Go

The Common Rule NPRM Blog Series Part 1 – Biospecimans

Medical Research
As we previously announced , sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”). The Common Rule NPRM is the latest development...
Go