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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, version 05/01/2014

 *all PDF templates are in the process of being updated and will be available Fall 2014

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 TemplateDOC   PDF*

For projects which involve only observation, interviews, audio recording, surveys, focus group discussion and/or other non-interventional activities.

 

Assent templates, version 06/01/2014 *NEW*

These templates should be used for studies which will be enrolling subjects who are minors (under the age of 18).   The assent template may be used with subjects ages 7-13.  The Assent/Consent templates may be used for subjects aged 14+

Assent Template

This assent template may be used for all project involving minor subjects ages 7-13. 

The language used should be at a 2nd-3rd grade reading level.

A-Intervention (Assent/Consent) Template

For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.

A-Community (Assent/Consent) Template

For studies involving non-clinical interventions such as education, with community groups or patients NOTE: most community studies will use this form

Banking (Assent/Consent) Template

For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/FH (local banking).

X-Observational (Assent/Consent) Template

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 *Updated 07/01/2014

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

Blood Draw Risks (doc) Use this language for projects which involve blood draws to describe the possible foreseeable risks of this procedure

Certificate of Confidentiality (doc) This language can be inserted into the consent for project which have received a Certificate of Confidentiality from DHHS

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.

Students, Residents or Employees as subjects (doc)  When projects involve the enrollment of students and/or residents.

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

SEWIC CTSI Informational Letter (doc) For projects which are conducting online surveys only and qualify under exempt review criteria.

Education

Informed Consent Frequently Asked Questions
View some of the most commonly asked questions regarding the consent process.
 

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Page Updated 07/02/2014