Consent Templates | Troubleshooting | Special Case Modules | Education
Wednesday, Dec. 2nd 9:00am-10:00am - MFRC 3075
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.
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).
X-Observational Template: For observational studies, surveys, and other non-interventional or behavioral studies.
NOTE: most community studies will use this form
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.
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
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.