Research Assent Form

Marshfield Clinic Research Foundation

A Division of Marshfield Clinic

1000 N. Oak Avenue, Marshfield WI 54449

Therapeutic Research

Minor Subjects Ages 12 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.]

What is the purpose of this research study?

[Explain in basic language, the research question as it relates to the child’s illness or condition.]

What will be different about my treatment if I join this research study?

[Explain what will be done for research purposes that would not be done for standard care. This could include a bulleted list of tests, medications, procedures, questionnaires, etc.]

What does it mean to give my assent?

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

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. Explain that all treatment for their illness or condition involves some risk and or discomfort. Explain those general to the treatment of their illness/condition and then specify which risks are different for the research interventions. If something will be done more frequently or especially for research and might cause pain or discomfort, you must state this.]

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. You may also include possible future benefits to others.]

Suggested Statement…“Joining this research study and receiving research treatment may help you, but we cannot be sure. The new information we learn from this research might help other children in the future.”

Do I have other choices?

[Describe any specific alternative treatments that are available to the child other than this research study. Do not simply state that they may receive treatment off study.]

Do I have to be in this research study?

Suggested Statement…“You do not have to join this research study. However, it is important that you think about the information your doctor has given you. It is also important to talk with your parents and make this decision with them. You will have to decide what you think will be the best choice of treatment for your condition/illness. If you decide not to take part in research, no one at Marshfield Clinic will be upset with you or treat you differently.”

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. However, it is important to work together with your doctor and parents to make any changes to your treatment in a safe way. You should never just stop taking medicine without talking to your doctor first, because that could be harmful.”

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

Suggested statement…“You can ask your 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

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Signature of Person Obtaining Assent	Date

Assent Document – Therapeutic Research Minor Subjects Ages 12 and Above	Page 2 of 3

Version 1/1/12

Assent Document

jarosl

2012-01-24

Dux, Barbara J

Marshfield Clinic