Millikin University Irb Consent Form Instructions (Page 3 of 7) in pdf

f. Inform participants that participation is completely voluntary and that they have

the right to end their participation at any time without penalty. Millikin University

requires some version of this statement to be a part of all consent / assent

: “I understand that my participation is voluntary and that I am free to end

forms

my participation at any time, or refuse to answer any question, without penalty.

I understand that none of my legal rights regarding negligence and the liability

of Millikin University or its agents have been waived.”

4. A written copy of the consent form, verbatim written consent script, or consent

disclosure (e.g., survey research) must be provided to the IRB with the Review

Request for Research and approved before the research begins.

5. Signed consent forms or group consent signature sheets (oral consent) must have

the participant’s or parent/ legal guardian’s printed name, signature, date, and the

signature and title of the research staff member obtaining the consent (e.g., Jane

Smith, PI) on the signed form. For oral consent, the witness must also sign the

consent form and script.

6. Participants should receive a copy of the consent form or consent information sheet

that provides contact information as required by the IRB. For online surveys, the

participant should be able to record the researcher and IRB contact information.

7. If research is being conducted at another site and uses a consent form specific to

that site, the researcher must ensure that some version of all the Millikin required

information is included in the consent form used in the study.

A. Additional Consent and Assent Form Elements (when applicable)

The researcher must inform the participant if more than minimal risk is probable, if

confidentiality may be limited, if participants will receive rewards or incur costs, and if

medical, biological or other invasive procedures are to be used as a part of the study’s

procedures.

1. An explanation that the participant may be removed from the study based on the

researcher’s judgment, despite the participant’s consent to continue participating.

2. For biomedical research, if there are available treatment alternatives to those being

offered in the study, participants must be made aware of these options.

3. An estimate of the number of participants being recruited to provide a context for

the ability of the researcher to detect real differences and or generalize the data.

4. Indication of whether or not participants will be debriefed or provided with an

opportunity to ask questions at the conclusion of their participation.

IRB Consent Form Guidelines

2/13/2015

Millikin University Irb Consent Form Instructions Page 3