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Methodist Healthcare System IRB - Comment

Document ID: FDA-2009-N-0592-0006
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: January 06 2010, at 12:00 AM Eastern Standard Time
Date Posted: January 7 2010, at 12:00 AM Eastern Standard Time
Comment Start Date: December 29 2009, at 12:00 AM Eastern Standard Time
Comment Due Date: March 1 2010, at 11:59 PM Eastern Standard Time
Tracking Number: 80a76cb3
View Document:  View as format xml

This is comment on Proposed Rule

Informed Consent Elements

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The draft language that will be required to be added to consent forms tests at a 12.2 reading level. The information should be provided in language that can be understood by the average lay person who participates in clinical trials. I recommend re-writing the section to a reading level of 8.5 or lower.

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Methodist Healthcare System IRB - Comment
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