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Consent Templates

Consent Checklist

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 Templates for Full Committee Review Research

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 - 06/2018. Appropriate for FDA-regulated studies, this template is written in a Question and Answer format. 

         Summary of Changes for the Q & A template 01/2018

Consent Form Template  2 - Revised 6/2008. 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 9/2016

Consent Template Parental Permission - Revised 5/2009

Consent Template Child Assent Examples - Revised 1/2009

Consent Template for Surrogate Decision-Makers - Revised  3/2014. 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 - 11/2014

Consent Template for Pregnant Participant / Partner - Revised 1/2015

Consent Template for Optional Sample Storage and Future Use - Revised 10/2016

Consent Template for Humanitarian Use Devices - Revised  7/2009. 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 Templates for Minimal Risk Research

Withdrawing Consent 

Template for Withdrawal or Partial Withdrawal of Consent for Research - 02/2016

Last modified: Jun 18, 2018
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