Consent Form Templates

Which template should I use?

  • If you have a question about which template is appropriate for your study (A, A-NCI, A-Com,  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 below (Keep checking back for recently updated versions, including the PDF templates!)
  • All continuing studies and amendment applications should continue to use their already-approved consent forms

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
 Consent templates, version 05/01/2014

Note: PDF templates are in the process of being updated and will be available Fall 2014

  • A Template:  DOC
    For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.
     
  • A-NCI Template: DOCX
    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
    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
    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
    For projects which involve only observation, interviews, audio recording, surveys, focus group discussion and/or other non-interventional activities.
  • HUD Consent Template: DOC
    For projects which involve the use of an HDE-cleared device in the course of clinical treatment.  This consent template should only be used if the Sponsor has not provided any documents or information to provide patients. 
 Assent Templates, version 06/01/2014

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 (DOC)
    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 (DOC)
    For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.
     
  • A-Community (Assent/Consent) Template (DOC)
    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 (DOC)
    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 (DOC)
    For projects which involve only observation, interviews, audio recording, surveys, focus group discussion and/or other non-interventional activities.
 Short Form Consent Templates

Use these short forms in the consenting process with non-English or Limited English proficient subjects. For more information, please review IRB SOP: Recruitment and Enrollment of non-English or Limited English Proficient Subjects.

 Consent 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.

 Adobe Template Troubleshooting & Instructions

HRPP Contact Information

Phone: (414) 955-8422

Fax: (414) 955-6575

Email: IRBOffice@mcw.edu

Location:  MFRC 3040
MACC Fund Research Center

Office of Research
8701 Watertown Plank Road
Milwaukee, WI  53226-0509

HRPP Staff Contact Info

HRPP Organizational Chart

Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

View some of the most commonly asked questions regarding the consent process in the IRB FAQ consent section.

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