Part IV of a series on proposed changes to the common rule: standardizing informed consent

Mar 31, 2012 | Labs Blog

This post serves as fourth in a series addressing the Advanced Notice of Proposed Rulemaking for proposed changes to the Common Rule.  I had the opportunity to interview John Stillman, Director of the University of Utah Institutional Review Board.

There is language in the ANPRM about standardizing informed consent; that the real purpose of informed consent is to educate research participants and not to protect research entities.  The ANPRM seems to be critical of some research entities in general for creating written consent forms that are long or difficult to understand.  I asked John whether he agreed with this criticism and what he thought of the proposal to simply the written consent process.

John said that he agrees with the criticism and thinks it would be wonderful if significant steps could be made in this direction.  He said it sounds like a great idea, but wonders what such a simplification process might actually look like.  One possible place for change is the “liability statement” – a highly criticized component of many informed consent forms.  Liability statements are usually written at a fairly high reading level and are generally very complex.  So one possibility would be to limit what could be included in future liability statements to simply telling people whether medical care is available if they are harmed and whether that medical care will be paid for.  Perhaps using some kind of template written at a low reading level that could be modified for disease specific conditions.

This is obviously a much needed change, but one that a variety of stakeholders have struggled with for some time.  What changes would you like to see in informed consent forms involving human subjects research? Tell us in the comments below, or provide a comment to the ANPRM.  The comment period closes on October 26, 2011.

– Kim Child