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.
- 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).
Below are the informed consent templates for studies that include the procedures listed. Please use as necessary.
- Assent Form Template
- Complex Biomedical
- Debriefing Form Template - Deception
- Debriefing Form Template -General; also see Guidance on Debriefing
- Focus Groups
- International Affective Picture System (IAPS); also see Guidance on Research involving IAPS
- Magnetic Resonance Imaging (MRI)
- Muscle Biopsy
- Online Survey
- Sensitive Topics Template (Research on); also see Guidance on Research with Sensitive Topics
- Paper Survey Consent Paragraph
- Video Use
- VO2 Max