Institutional Review Board Consent Form Checklist

The IRB Consent Form Checklist should be filled out and submitted for all protocols that have direct contact with subjects and utilize consent/assent forms for your subjects to sign.  This form will help to ensure that your documents meet our requirements.

 

Please take special care to ensure that your consent/assent forms are written to the reading level of your subject population.  For research involving the general public, the preferred range is 6th-8th grade.  Please also make sure that the form is short enough to be easily read and understood in a single sitting.  A separate information sheet may be provided to keep the consent to a reasonable length.  The subjects MUST be able to read and comprehend the consent/assent document for it to be considered "informed" consent.