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Human Subjects Division (HSD)


New Language for Federal Certificates of Confidentiality

Apr 8, 2011 at 9:58am

The Human Subjects Division is working to make the required consent form template language meet the lowest reading level possible.  Our goal is for consent forms to read at an 8th grade level.  This is the reading level suggested for the general population of the Seattle area.

In our efforts to meet this goal we have revised the text researchers must use to explain the protections offered to subjects when a study has a federal Certificate of Confidentiality.  This new text can be found on the HSD website in the following document:

Certificate of Confidentiality Application Instructions

There is no requirement to immediately revise your consent form(s) to this new language if you already are using the previously approved text.  However, we suggest that you revise the text if you are making other consent form changes.  Subjects do not have to be re-consented to the next text.

Please direct any questions about this to your committee administrative team.