Millikin University Irb Consent Form Instructions


Millikin University IRB Consent Form Instructions
The purpose of obtaining informed consent is to provide participants with information they
can easily understand to allow them to accurately weigh the risks and benefits of
participating in a research study. Whenever possible, documentation of participant consent
is strongly recommended though not required for research that meets the “Exempt from
Review” criteria. For “Expedited and Full IRB Review” categories, written or oral (using a
verbatim written script, detached signature page, and witness) consent is required, unless
the researcher can provide a compelling argument explaining how foregoing the consent
process reduces participant risk or harm.
Types of Consent
1. Written Consent: Except as described below, informed consent must be documented on
a written consent form submitted with the Review Request for Research form and
approved by the IRB. A copy of the consent form must be provided to the participants.
2. Oral Consent: A researcher may present an oral summary (script) to the participants
including all the required information about the research. Participants sign only a short
form written consent document stating that the elements of informed consent were
presented orally to the subject or the subject's legally authorized representative and
including the information required by Millikin University. When this method is used,
there must be a witness to the oral presentation who will sign both the shortened
consent form and a summary of the script. Participants will be given a copy of the oral
summary as well as a copy of the shortened consent form. The IRB must approve the
oral script submitted with the Review Request for Research form.
3. Waiver of Consent: The IRB may waive the requirement for written informed consent
under the following conditions:
a. The only record linking the subject and the research would be the consent document,
and the principal risk would be potential harm resulting from a breach of confidentiality.
Each subject will be asked whether the subject wants documentation linking the subject
with the research, and the subject's wishes will govern; or
b. The research presents no more than minimal risk of harm to subjects, and involves
no procedures for which written consent is normally required outside of the research
Assent: Assent is a participant’s voluntarily agreement to participate in research. The IRB
will approve research that presents no more than minimal risk to children or persons with
diminished autonomy provided that parent/legal guardian consent and the assent of the
participant is also obtained.
 Children under age 8 may assent either orally or passively, depending on their level
of maturity (e.g. an infant may not be able to assent).
 Children 8-17 years old should sign a written assent form unless the Millikin IRB
approves of a different process.
IRB Consent Form Guidelines


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