This checklist can be used as a guide to creating a KUMC consent form. It includes the necessary elements of a consent form and the typical requirements for drug studies conducted at KUMC.
These samples may help investigators draft their study-specific consent forms. Please be aware that these templates may not be appropriate for all settings. (See *below for minimal risk 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 January 2018
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 Registries - Revised 9-8-2016
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.
Consent Template Parental Permission - Revised 5-18-2009
Consent Template Child Assent Examples - Revised 1-26-2009
Consent Template for Pregnant Participant/Partner - Revised 1-29-2015
Consent Template for Optional Sample Storage and Future Use - Revised 1-29-2015
Focus Group consent template - Revised 1-20-2017
Survey consent form template - anonymous, no HIPPA - Revised 1-28-2015
Survey consent form template - not anonymous, no HIPPA - Revised 1-28-2015