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  4. A “key information” mention suffices for informed consent contents

A “key information” mention suffices for informed consent contents

Remember that new Revised Common Rule requirement to start informed consent with a “concise and focused” summary of “key information” to help subjects decide whether or not to participate in a study? We all know we haven’t gotten too much direct guidance about what that “key information” should address. For some studies, that “key information” section will be enough to serve as an entire written consent information sheet. Other studies will require a full-blown consent after that summary. Note that there is no requirement to repeat information in the summary in the main consent. Nor does the summary have to cover everything about the study; you can always summarize, say, possible risks and then add something like, “see the full consent form for more information about risks.”

Posted by Edith Paal on March 14, 2019

Filed Under: Institutional Review Board Members

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