Tuesday, October 18, 2011

This Year in Bioethics: Common Rule Edition

So, fall is (finally) in the air, and 2011 is winding down. It's not too early (is it?) to start thinking about what this year's top bioethics stories were. I think anybody's list has to start with the massive proposed changes to the Common Rule. Proposed changes include 1) beefing up data security standards in order to relieve IRBs from having to review protocols for informational risks; 2) eliminating continuing IRB review requirements for protocols past their active stages, and for all protocols originally subject only to expedited review; 3) expanding the category of exempt studies and reducing oversight of such studies; 4) permitting blanket prospective written consent for research on biospecimens; 5) expanding the category of studies subject only to expedited review, and streamlining of oversight for such studies; and 6) permitting single-IRB approval of protocols for multi-site studies. For a quick overview, look at this Emanuel/Menikoff article in NEJM. Here's the full text of the advance notice of proposed rulemaking. You can submit your own comments here, until October 26!

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