IRB APPLICATION HELP:
Informed Consent/Assent

Go to: Sample Documents

The purpose of an informed consent is to help investigators protect subjects by informing them about the research and their rights as human subjects. In compliance with federal regulations, the IRB carefully reviews informed consent forms. Consent forms vary in the way they are written and formatted. The IRB does not have a “model” consent form because it believes that subjects’ rights will be better protected if investigators determine the appropriate language, format, and tone of the consent based on what they feel will best convey study information that is accurate and understandable to their subjects. However, regulations require that certain basic elements be included in an informed consent. As a general rule, the following points should be considered when writing an informed consent:

		Include the basic required consent elements specified by the federal regulations.
		Use simple language. Many IRBs suggest that a consent form be written at no more than an 8th grade reading level.
		Avoid technical and legal terms.

Below are links to some sample consent forms. These samples include the basic language and elements we commonly see in consent forms at John Carroll University. These samples should be used as a guideline and tailored accordingly for each study. Under certain circumstances the IRB can waive some or all consent elements or the need for a principle investigator to document a subject’s written signature on a consent form. Please contact the IRB to learn more about waivers or if you feel a waiver may apply to your study.

Sample Documents

Document Title		MS Word
	Adult Consent Form
	Parental Consent Form
	Child/Minor Assent Form (under age 18) (See also: assent information)
	Oral Child Assent Script
	Consent for JCU Student Participants in a Classroom Setting

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