Millikin University Irb Consent Form Instructions (Page 2 of 7) in pdf

Consent and Assent Form Elements

All consent and assent forms must adhere to the requirements stipulated in the Common

Rule (45 CFR 46.116). Required elements are listed below, followed by samples.

Required Consent and Assent Form Elements

1. Use language that is age/reading level appropriate for someone without research

training or scientific expertise.

2. Provide a general description of the research that clearly enables participants to

know that they are participating in a research study. The researcher need not

provide hypothesis or design details that would compromise the validity of the

research design, but should provide enough information to give participants a

general idea of the study’s purpose (e.g., You will be asked to answer an online

survey about your attitudes on gender by selecting your response from a list of

alternatives provided with each question).

3. Provide participants with any relevant study details that may affect their decision

whether or not to participate:

a. Explain what data will be collected and how confidentiality of the data will be

maintained. Millikin University requires some version of the following statement

“I understand that the responses I give will be

in all consent and assent forms:

considered confidential, reported only as group data, and that every possible

effort will be made to preserve my confidentiality regarding these data.”

b. Describe any risks or discomfort the participant may experience as a

consequence of participation. Also, provide the potential benefits that could

result from participation, if applicable.

c. Provide information on any inducements participants will receive for participation

(e.g., gift card, # of course points).

d. Provide a statement detailing the responsibility for and coverage of treatment

costs should an injury or health condition arise due to participation in the study.

e. Provide the name, title, phone number, and email address for the Principal

Investigator, the faculty or staff Project Supervisor, and the IRB Chair so that

participants may contact those responsible for providing participant safeguards

and answering study questions. Millikin University requires that this statement

“I understand that if I have any

be included in all consent / assent forms:

questions regarding the study, I can contact… [Researcher contacts]. If I have

any questions about my rights as a participant, I can contact… [IRB contacts].”

IRB Consent Form Guidelines

2/13/2015

Millikin University Irb Consent Form Instructions Page 2