Human Research Protection Program

New & Revised Draft Consent Form Templates 

The draft consent form templates have been revised as of May 7, 2008, according to suggestions from our MCW/FH research community. We continue to welcome review or pilot testing, before the templates become final in July. Templates are designed for four different types of studies:

• A – Interventional studies (such as drugs, devices, surgery, psychotherapy, but not neoplastics)
• B – Banking clinical records or biospecimens
• X – Non-interventional studies (such as observational studies, surveys, and non-interventional behavioral studies. NOTE: most social and community studies will use this form)
• A-Com – Interventional studies where the interventions impact communities rather than individuals.

Other specialized consent forms are planned (surveys, genetics, record review, biospecimen-taking, neoplastics …)

PILOT THE NEW FORMS

• Use of these templates is accepted on a pilot basis, with prior approval by Patricia Witt, pwitt@mcw.edu or 456-4585. 
• If starting a new consent, please use the new version.
  

REVIEW AND COMMENT

• The IRB welcomes comment (please send to Patricia Witt, pwitt@mcw.edu).

Link to A – Intervention consent template

Link to B – Banking consent template

Link to X – Non-intervention consent template

          Link to A-Com – Community intervention consent template

WHY NEW CONSENT FORMS?

• MCW/Froedtert investigators have asked for better consent forms
• Surveys show that the longer the consent form, the lower the comprehension by subjects
• In line with current initiatives by the American Association of Medical Colleges, the National Cancer Institute, and other IRBs

MAJOR CHANGES

• Focus on purpose of study and regulatory requirements
• Simpler sentence structure and language throughout
• Simplified HIPAA section with study-specific options

WHAT REMAINS THE SAME

• Neoplastics investigators will work with IRB to develop a Neoplastics version
• Cancer Cooperative Group consent forms will continue as agreed, without changes

FUTURE PLANS

• On July 1, after 4 months of review and pilot testing, the final templates will replace the present forms in Consent Builder (for all departments but Neoplastics).