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 institutions should be taking stock of what needs to be done to bring IRBs and human research protection programs into timely compliance with the revised regulations. (more…)
Posts Tagged: 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…)