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Loyola University Chicago

Institutional Review Board

General Information

The Process of Informed Consent
Obtaining Informed Consent from human subjects is often thought of as simply getting a signature from participants on the consent form.  Obtaining a signed consent form, however, is only part of an ongoing process of obtaining Informed Consent from participants throughout the entire span of their participation in the research.

Simply providing participants with the Required Elements of Informed Consent and obtaining a signature or verbal affirmation is not enough to satisfy the conditions for informed consent. Investigators have an ethical responsibility to go the distance and assess whether or not the participant understands the information presented, has the ability to give consent, and is free to make a voluntary choice. The process described below is meant to be a useful tool for reminding investigators of their ethical obligations and aiding them in creating an open dialogue between themselves and participants.

The 3 C's

The process of consent might best be conceptualized by the 3 C's: Contact, Conversation, and Confirmation.

According to regulations, "informed consent" refers to the knowledgeable agreement of an individual or her/his representative whereby she or he exercises free choice without any undue inducement or any element of force, fraud, deceit, duress, or other kinds of constraint or coercion. Put simply, there are three key conditions which must be satisfied in order for the participant's verbal or documented consent to be valid:

Required Elements of Informed Consent

In order for participants to be able to give Informed Consent to participate in research, they must be provided with sufficient information about the research in order to make an informed decision about whether or not they wish to participate.  To ensure that participants are provided with sufficient information, the IRB requires that the following information be conveyed to potential participants:

All of these elements must be communicated to all participants, unless the Investigator has an approved Request for Waiver of Informed Consent or Elements of Informed Consent.

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Loyola

Institutional Review Board
Loyola University Chicago · 6439 N. Sheridan Road, Suite 400 · Chicago, IL 60626-5309
Phone: 773.508.2471 · Fax: 773.508.8942 · E-mail: irb@luc.edu

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