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Changes to the Common Rule
Templates, Forms and Samples
Main Content
Templates, Forms and Samples
Templates
Child assent
(ages 9-12) (Word)
Consent template
(Word)
Checklist
Lay terminology
Specimen storage and use
(pdf)
Specimen storage and use
(Word)
HUD
(Word)
Cover letter or informational letter
(html) - typically accompanies a questionnaire
Cover letter or informational letter
(Word)
Protocol template
(Word)
Forms
Drug/device management plan
Device - Claim of exemption
Drug - Claim of exemption
Human research self-certification form
Samples
How to write a consent document at the 8th-grade level?
Example: Informed consent document -
"Before"
Example:
"After"
Questionnaire to check participant comprehension