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Category: Biospecimens

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...
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NIH Updates Policy for Issuing Certificates of Confidentiality

CoC Shield
On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate of Confidentiality (“Certificate”) is issued, see Pub. Law 114-255...
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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...
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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...
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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...
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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...
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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...
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