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.
Consent Template for Emergency Use - 11-11/2014