This checklist can be used as a guide to creating a KUMC consent form. It includes the necessary elements of a consent and the typical requirements for drug studies conducted at KUMC.
Consent forms for full-committee submissions to the KUMC IRB review must be based upon the consent templates below. These templates also may be adapted as applicable for projects eligible for expedited review. Please contact the IRB Office for additional guidance on developing consent forms that are appropriate for your study design.
Q & A Consent Template for Clinical Trials - FDA Studies - Jan 2018. Appropriate for FDA-regulated studies, this template 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 Parental Permission - Revised 5-18-2009
Consent Template Child Assent Examples - Revised 1-26-2009
Consent Template for Surrogate Decision-Makers - Revised 3-12-2014. 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 Emergency Use - 11-11-2014
Consent Template for Pregnant Participant / Partner - Revised 1-29-2015
Consent Template for Optional Sample Storage and Future Use - Revised 10-07-2016
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.