Consent Form Templates
Consent Templates | Troubleshooting & Instructions | Special Case Modules | Education
Which template should I use?
If you have a question about which template is appropriate for your study (A, A-Com, A-NCI, B, or X) or have a special circumstance that does not fit the available templates, please contact Kristin Bastian.
The Consent Builder program was disabled on October 1, 2012; but will continue to function for ongoing studies and studies in pre-submission on October 1, 2012.
New studies may use the Word templates or the Adobe templates below (Keep checking back for recently updated versions!)
All continuing studies and amendment applications should continue to use their already-approved consent forms
Consent templates, Updated 10/01/2012
A Template: DOC PDF
For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.
A-NCI Template: DOC
For all NCI cooperative group projects (either deferred or being reviewed by MCW/FH IRB). This template contains all required MCW template consent language which must be incorporated
A-Community Template: DOC PDF
For studies involving non-clinical interventions such as education, with community groups or patients NOTE: most community studies will use this form
Banking Template: DOC PDF
For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/FH (local banking).
X-Observational Template: DOC PDF
For projects which involve only observation, interviews, audio recording, surveys, focus group discussion and/or other non-interventional activities.
Adobe Template Troubleshooting and Instructions
What if I want to change the required language?
Sample language, which can be used, modified, or deleted as needed for your study is in blue type.
IRB-required template language is in black type and should not be changed without IRB permission
If you propose a change to required language, a petition to the IRB office should be completed:
ICF Template Change Form
Modules for special cases
These modules can be inserted into the appropriate study-specific text boxes in the Word or Adobe consent form templates.
Audio and video recording (doc) When study involves audio or video recording
Device study descriptions (doc) When study involves devices
Distant Banking (doc) When banking health information/ biospecimens only at a location outside of MCW/Froedtert Hospital.
Genetic Research (doc) When study involves genetic analysis
Magnetic Resonance Imaging (doc) MRI Procedures and risks, including for optional gadolinium contrast agent
Risks of fathering a child (doc) When drug is thought to increase the risk of paternity-related birth defects
Request for records of pregnancy (doc) When pregnancy occurs on a clinical study and follow-up records are requested
Informed Consent Frequently Asked Questions
View some of the most commonly asked questions regarding the consent process.