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Consent Form Templates

Consent Templates  |  Troubleshooting  |  Special Case Modules  |  Education

Which template should I use?

Upcoming training for
Adobe consent forms

Wednesday, Dec. 2nd
9:00am-10:00am - MFRC 3075
 
  • If you have a question about which template is appropriate for your study (A, A-Com, B, or X) or have a special circumstance that does not fit the available templates, please contact Kristin Bastian or Patricia Witt.
  • The Consent Builder program was disabled on October 1, but will continue to function for ongoing studies and studies in pre-submission on October 1.
  • 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
  • Cancer Cooperative Group consent forms may be used with minor modifications per previous agreements

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, Updated 10/9/09

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

( DOC )    ( PDF )

A-Community Template:
For studies involving non-clinical interventions such as education, with community groups or patients.

( DOC )    ( PDF )

A-Community Template without HIPAA:
For studies involving non-clinical interventions such as education, with community groups or patients in which no Protected Health Information is collected or used.

( PDF )

Banking Template:
For banking of clinical records or biospecimens at MCW/FH (local banking).

( DOC )    ( PDF )

X-Observational Template:
For observational studies, surveys, and other non-interventional or behavioral studies.

NOTE: most community studies will use this form

( DOC )    ( PDF )

X-Observational Template without HIPAA:
For observational studies, surveys, and other non-interventional or behavioral studies in which no Protected Health Information is collected or used.

( PDF )

Adobe Template troubleshooting and additional options

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

Humanitarian Use Device (doc)
When HUD is to be used either for treatment or research

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

Education

Eliciting Truly Informed Consent
View suggestions and guidance on eliciting truly informed consent geared specifically to research professionals.

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

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Page Updated 11/18/2009