Archives: January 2016

Bloomberg BNA Medical Research Law & Policy Report – The NFL-NIH Research Partnership: Why Congress is Worried

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 Foundation for the NIH to support research at Boston University into chronic traumatic encephalopathy (CTE).

Reproduced with permission from Medical Research Law & Policy Report, 15 MRLR 61 (Jan. 20, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>:

The NFL-NIH Research Partnership: Why Congress is Worried?

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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 a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.

In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities.

Thanks to a 30-day extension of the public comment period for the NPRM, HHS extended the comment period to January 6, 2016 – and that has come! The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.

ACRG Rapid Rundown: Three Things You Need to Know (more…)

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