Consent Templates

Informed Consent Templates

To assist investigators in creating consent forms, the IRB has prepared a template that addresses the elements of informed consent required by federal regulations

The template is divided up into distinct sections. Each section contains information about what is required for that section, as well as suggested and/or required wording.  Instructions are italicized.  Instructions should be deleted after they have been read and followed. 

Information presented in the informed consent form must be in a language understandable to the subject.  The standard reading level is about eighth grade level.  Medical terminology and academic jargon should be avoided or explained parenthetically.

Formatting Instructions:

  • Leave a 1.5 inch space on the bottom of each page to accommodate the IRB approval stamp.
  • The font size used for the consent form should be at least 12 point.  For some populations (e.g. elderly or individuals with visual deficits) it may be appropriate to user a larger font size.
  • Include a footer with page numbers (“Page # of #”).
  • Footers for longer or complex Informed Consents should also include space for subjects to initial (see template).

 

Basic Template for the Informed Consent

 

Additional Templates

Below are the informed consent templates for studies that include the procedures listed. Please use as necessary.