Below are several samples that may help investigators draft their study-specific consent forms. Please be aware that these templates may not be appropriate for all settings, particularly for minimal risk research or for community-based research. Please contact the IRB Office for guidance about developing consent forms that are appropriate to your study population.
Q & A Consent Template for Clinical Trials - FDA Studies - Revised August 2014
This consent template, appropriate for FDA-regulated studies, is written in a Question and Answer format.
Consent Form Template 2 - Revised 6-23-2008
This template should be used for internal studies and for other projects where all data released to external parties has been de-identified according to HIPAA standards.
Consent Template for Surrogate Decision-Makers - Revised 7-2-2009
This template is appropriate for persons who are consenting to research on behalf of another adult who does not have decisional capacity.
Approval for a humanitarian use device (HUD) involves special considerations from FDA and the HSC. Please contact the HSC Office for more information when proposing the use of an HUD.