Consent Form Templates

Which template should I use?

  • If you have a question about which template is appropriate for your study (Clinical Intervention, Minimal Risk, NCI- or Banking) or have a special circumstance that does not fit the available templates, please contact IRB Office.
  • 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!)
  • 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 (DOC)
Open AllClose All
  Consent templates, version 02/16/2016
  • Banking Template (DOCX)
    For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/FH (local banking).
  • EFIC Template (DOCX) 
    For projects involving planned emergency research. Consent prior to these interventions is waived because of the condition of the subject and urgency under which procedures need to take place. Template is to be used for obtaining consent for continued participation.
  • Minimal Risk Template (DOCX)
    For projects which involve minimal risk procedures (ex. observation, interviews, audio recording, surveys, focus group discussion) and/or other minimal risk inventions/interactions (ex. blood draws, MRI, community or educational interventions.
  • NCI Template_CIRB Deferred (DOCX) Coming Soon!
    For all NCI cooperative group projects that will be deferred to NCI CIRB for review. This template contains all required MCW language which must be incorporated into the NCI CIRB approved consent.
  • NCI Template_Local Review (DOCX) 
    For all NCI cooperative group projects that will be reviewed by MCW/FH IRB. This template contains all required MCW language which must be incorporated into the NCI consent.
  • Trial Partner Template (DOCX)
    For projects which require the assistance/participation of a caregiver or trial partner in addition to the main study subject.

 

  • HDE 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 12/23/2015

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.
  • Clinical Intervention (Assent/Consent) Template (DOCX)
    For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.
  • Banking (Assent/Consent) Template (DOCX) 
    For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/FH (local banking).
  • Minimal Risk (Assent/Consent) Template (DOCX)
    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

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.

Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
(414) 955-8296
Directions & Maps
© 2016

Page Updated 02/26/2016
Top