Basic Elements of Informed Consent

Basic Elements of Informed Consent

Documentation of Informed Consent (CFR 46.117 effective January 21, 2019)

Informed Consent Templates and Instructions 
The following informed consent templates are provided to ensure compliance with Federal regulations and the Common Rule. Templates include the required information in the correct sequence. You are strongly encouraged to use the templates. On templates, italicized wording should be replaced with your specific information, and then italics should be removed.

Informed Consent Exempt Signature Waived.  When written consent is waived, the MSU IRB requires the researcher to provide subjects or legally authorized representatives with a written or oral statement regarding the research. When the 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 to 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 Expedited or Full Board (Non-Exempt) Review

Information Regarding Child and Youth Assent Forms

Youth Assent Template

Child Assent Template