Research Assent Form

Marshfield Clinic Research Foundation

A Division of Marshfield Clinic

1000 N. Oak Avenue, Marshfield WI 54449

Non-Therapeutic Research

Minor Subjects Ages 7 and Above

SP Code:	PI:

[Complete this form in 14 point type. Delete all instructions and suggested statements. Please do not cut and paste from one assent form to another, as each assent document should be written with the specific study in mind. Please do not cut and paste from the protocol as the technical language is not appropriate. Please ensure your language is understandable to young people.]

What is the name of this research study?

[Provide the name of the protocol.]

Why are you meeting with me?

Suggested Statement…“We want to tell you about this research study. A research study is a way that we learn new information about something. We are trying to learn more about [insert purpose of the study in simple language]. You are being asked to join this study because [insert reason for inclusion].”

What does it mean to give my assent?

Suggested Statement…“You can only join this research project if you agree to. If you agree to join, that is called giving your “assent.”

What will happen if I join this research study?

[List in bullet points and simple language the procedures that the child will undergo for research. This would include blood work, questionnaires, exams, etc.] Suggested Statement…“During each visit you will:

Answer questions about…

Have blood taken from your arm by a needle

Have your temperature taken with a thermometer

Get weighed on a scale”

How long will I be in this research study if I join?

Suggested statement…“You will come back to the Clinic six times. You will have one appointment every month for six months. You will be here for half an hour each time.”

[Be sure to include the number of visits, how often they will occur and how long each visit might take in language understandable to a child].

Could anything bad happen to me because of this research study?

Suggested Statement…“Sometimes things happen to people in research studies that may hurt or make them feel bad. These are called risks. The risks of this study are…”

[Explain any possible discomforts to the child. Consider physical and emotional risk. If something might be painful you must state this.]

Suggested Statement…“You may get a sore spot from the needle. It might feel bad when we swab the inside your nose.”

Could anything good happen to me because of this research study?

[Be very clear as to whether or not the child can expect direct benefit. If there are no know benefits you must say so. You may include possible future benefits to others.]

Suggested Statement…“Joining this research study will not necessarily help you. But, the new information we learn from this research might help other children in the future.”

Do I have other choices?

[Describe any alternative procedures that might be available to the child other than this research study. Delete this section if not applicable to a particular study.]

Do I have to be in this research study?

Suggested statement…“You do not have to join this research study. If you say no, no one at Marshfield Clinic will be mad or upset with you.”

If I say yes and join the research study, can I change my mind and stop later?

Suggested statement…“You can change your mind later and stop the study. You can tell us that you want to stop. You can also tell your parents. No one at Marshfield Clinic will be mad or upset with you if you change your mind.”

If I think of questions about the research study, who can I ask?

Suggested statement…“You can ask you parents questions about the research. You can also ask (insert name of Principal Investigator and research coordinator or nurse) the next time you come to the Clinic. You may also phone them at (insert telephone number).”

Research Subject Assent

I am signing this paper because I agree that I want to join this research study.

__________________________________________________________________

Signature of Subject	Date

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Printed Name of Subject	Age

__________________________________________________________________

Signature of Person Obtaining Assent	Date

Assent Document – Non-Therapeutic Research 7 and Above	Page 2 of 3

Version 1/1/12

Assent Document

jarosl

2012-01-24

Dux, Barbara J

Marshfield Clinic