Q & A Consent Template for Clinical Trials (New) - Revised 6-23-2008
This consent template, appropriate for FDA-regulated studies, is written in a Question and Answer format.
Consent Form Template 1 - Revised 6-23-2008
This template is appropriate for studies involving FDA-regulated products. It is also recommended for any other study in which external parties (such as sponsors or collaborators) will receive study data that has not been fully de-identified according to HIPAA standards.
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.
Consent Template for Humanitarian Use Devices - Revised 7-2-2009
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.