Basic Elements of Informed Consent

Basic Elements of Informed Consent

Documentation of informed consent (CFR 46.117 effective January 21, 2019)

Informed Consent Examples

The following examples and guidelines are provided for your use in preparing Informed Consent and Assent documents.  The information contained in each example or guideline is provided in the sequence required in the Common Rule.  On templates, italicized wording should be replaced with your specific information. 

Informed Consent Exempt Signature Waived.  When written consent is waived, the MSU IRB requires the researcher provide subjects or legally authorized representatives with a written or oral statement regarding the research.  When oral statement is provided, please indicate Oral Statement at the top of the page, under Minot State University.

Informed Consent Exempt Signature Required. When written consent is required, the MSU IRB requires the researcher collect signed Informed Consent from each participant prior to collecting data.  Signed Informed Consent should be retained by the researcher for the duration of the study.

Informed Consent Expedited or Full Board (Non-Exempt) Review

Informed Consent Parent/Guardian Expedite or Full Board (Non-Exempt) Review

Youth Assent Template

Child Assent Template