A recent insights article by Kate Gallin Heffernan published in BNA’s Medical Research Law & Policy Report discusses the Congressional inquiry into the National Football League’s alleged refusal to permit its $30 million previously donated by the League to the
Endpoints
Research law is what Verrill Dana's Academic and Clinical Research Group does, and this blog is where the Group shares its musings and breaking news alerts in the research arena. If your days involve digesting and implementing the complex regulatory framework that governs the conduct of research, and grappling with underlying ethical considerations, this blog will serve as a helpful resource.
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The Common Rule NPRM Blog Series: Part 3 – Posting of Consent Forms
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…
The Common Rule NPRM Blog Series: Part 2 – Single IRB Review
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…
Breaking News – 30 Day Extension to Common Rule NPRM Comment Period!
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…
The Common Rule NPRM Blog Series Part 1 – Biospecimans
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…
Decision Charts to Help You Navigate the Common Rule NPRM’s Proposed Landscape of Covered Research, Exclusions, and Exemptions
In the short time since our first Client Advisory on the recently issued Notice of Proposed Rulemaking (“NPRM”) for the Federal Policy for the Protection of Human Subjects (“Common Rule”) (80 Fed. Reg. 53933 (Sep. 8, 2015)), we have been…
At Long Last, the Notice of Proposed Rulemaking for the Common Rule is Here
For those of us who work in the clinical research field, the last two days have been quite exciting. At long last, the Notice of Proposed Rulemaking for the Common Rule is here, and the field is alive with talk…