MedicalCollege of Wisconsin & FroedtertHospital
Minor’s Assent for Research
Assent - Version: June 1, 2014
IRB Protocol Number: <Enter Study #>
IRB Approval Period: «ApproveDate» - «ExpireDate»
This assent template is for minor subjects ages 7-13. For ages 14 and up, the consent form should suffice. The language used should be at a 2nd -3rd grade reading level.
Instructions:
To stand out both on your computer screen and in black/white copies, instructions are in bold, italic, and blue type. Instructions are in boxes and should be deleted in final consent.
IRB-required template language is in black type and should not be changed. Rarely, changes to the required language may be necessary. To petition for a change in required language, submit proposed changes with justification on the “ICF Template Change Form” to the IRB office. Sample language, which can be used, modified, or deleted as appropriate for your study, is in blue type. Please maintain the blue color to distinguish your study-specific information from the required template language.
Arrows are used to show alternative choices. In the final consent, arrows can be deleted and the usual margin maintained.
Medical College of Wisconsin and FroedtertHospital
ASSENT TO PARTICIPATE IN RESEARCH
Name of Study Subject: ______
Nature Mentors: a pilot community-based program to shift time use toward outdoor physical activity among children and mentors for cancer prevention
Dr. Kirsten Beyer
Institute for Health and Society
(414) 955-7530
Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee WI 53226
A1. WHAT IS A RESEARCH STUDY?
Research studies help us learn new things. We can test new ideas. First, we ask a question. Then we try to find the answer. This can help us learn about how activities work. We can also learn why people make certain choices.
This paper talks about our research study. We want you to ask us any questions that you have. You can ask questions any time.
There are a few things you should know about the study:
- You get to decide if you want to be in the study.
You can say ‘No’ or you can say ‘Yes’.
- Whatever you decide is OK.
- If you say ‘Yes’, you can always say ‘No’ later.
- No one will be upset if you say ‘No’.
A2. WHY ARE WE DOING THIS RESEARCH STUDY?
You are being asked to take part in this research study because you are age 9-13 and may be interested in playing outside or nature.
In this study we want to find out if playing and learning in nature will make people want to be outside more. And if we teach you about nature activities, if you will do them more in your free time.
B1. WHAT WOULD HAPPEN IF I JOIN THE STUDY?
If you are going to be in the study you willdo outdoor activity at the Urban Ecology Center with a mentor this summer. The first week, you will talk with a researcher about nature, physical activity, and how you spend your time. You will be given an accelerometer. An accelerometer isa little tracker you will wear on a belt. This tracker will tell us when you move, and how you move. If you jump, run, or do other things, the tracker records it. You will wear this every program, and on every Wednesday and Saturday in the summer. You will fill out short surveys every Wednesday and Saturday about your free time. You can tell us how you played, how long you played, and where you played.
The programs will happen on Tuesday nights, five times this summer. Each time is 5:30-8, and starts with a snack. Then, an Urban Ecology Center teacher will show you and your mentor a new activity. You and your mentor will play a game or do a challenge together. Then, you can explore and play how you want. The last program is a celebration. At the celebration, you can do any of the activities you learn this summer.
The last week of summer, you talk with a researcher again. You will talk about nature, physical activity, and your free time again. You will also talk about what you liked and did not like in the program. You will give back the accelerometer. We will give you some things for finishing the program.
C1. COULD BAD THINGS HAPPEN IF I JOIN THE STUDY?
Some of the activities you do may be scary if they are new, like exploring outside or biking. If you are afraid of animals or bugs, you may be scared until you learn more about them. Adults will help you in activities but you may get a little hurt, like sometimes in gym class, sports practice, or playing outside.
The researchers willask you some questions. They may be hard to answer.
C2. IF I JOIN THE STUDY WILL IT HELP ME?
We think being in this study may help you because you will learn about nature and outdoor activities.
We hope to learn something from this study. And someday we hope it will help other kids who want to play more outsidelike you do.
D1. WILL I BE PAID FOR TAKING PART IN THIS STUDY?
No, you will not be paid.
D2.DO I HAVE TO JOIN THIS STUDY?
You do not have to be in this study, and if you are in it you can stop at any time.
E1. WILL INFORMATION BE CONFIDENTIAL?
We don’t plan to share your information or tell anyone if you join this study. But, there are a few reasons we would tell someone:
- If we found out you were in serious danger.
- If we found out someone else was in serious danger.
Here are some examples of when we would tell someone:
- If you told us you were being abused.
- If you told us you were going to hurt yourself or someone else.
We would tell to protect you or someone else from being hurt.
E2. IF I HAVE QUESTIONS, WHO DO I ASK?
You can talk to Kelly or Mike. Ask us any questions you have. You can ask questions any time. Take the time you need to make your choice.
PERMISSIONTO PROCEED
Writing my name on this page means:
- That this document was read (by me/to me) and that I agree to be in this study.
- I know what will happen to me.
- If I decide to quit the study, all I have to do is tell the person in charge.
IMPORTANT:Your parents/guardian will receive a copy of this form. A copy of the signed form will be kept in your medical record.Please keep this form where you can find it easily. It will help you remember what we discussed today.
Date or Date & Time: Time on subject’s line is optional to include; if included in template, must be completed by each subject.
Child/Subject's Name please print / Child/Subject's Signature / Date OR Date/Time* Name of person discussing/ obtaining assentplease print / Signature of person discussing/obtaining assent / Date
* A member of the study team trained and authorized by the Principal Investigator to act on her/his behalf in obtaining assent according to the protocol. In all research study protocols the Principal Investigator is responsible and accountable for the study.
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Version: <Enter Study #>