Informed Consent (Parents)

What is the purpose of this project?

Your child is invited to participate in a research study about the impact of sports-related concussions on the human voice. This study is being conducted by Professors Christian Poellabauer and Patrick Flynn from the University of Notre Dame and Contect Inc. The goal of this study is to collect voice samples from youth athletes between 8 and 18 years of age playing a variety of sports and therefore your child is invited to participate in this study. Participation in this study is voluntary and non-participation will not affect any benefits, services, etc. received now or in the future.

If you agree to allow your child to participate in this study, your child will be asked to:
- Perform a simple reading test at the beginning of the study. In this test, your child will be given a tablet device and your child will be asked to read 15 words appearing on the screen of the tablet into the tablet’s microphone.
- Perform the same reading test again periodically (e.g., once per week) or occasionally as determined by the coaches and medical staff at your child’s school.
A doctor, trainer, or teacher from your institution will supervise this activity and these tests will take place at your school’s sport facilities.

In addition, you the parent/guardian will be asked to answer brief surveys at the beginning and the end of the study. These surveys will ask for your child’s age, gender, and pre-existing medical conditions such as concussions that may have been experienced in the past.
Note: the voice samples collected will only be used to study certain aspects of the speech of children and will not be used to detect or diagnose concussions or other medical conditions!


Are there any risks in this research?

We don’t believe this study will involve any risks for you and your child. If you find some health questions upsetting, please tell us. You can choose to skip any question. You are free to stop the assessment at any time. There may be unknown risks.


What are the benefits of being in this study?

Participation will not lead to any direct benefit to your child. You and your child may, as a result of participation, gain increased awareness of the potential long-term effects of undetected concussions.


How will we protect your privacy?

The surveys will ask for certain details of the medical history of your child. We will protect your privacy to the extent allowed by law in several ways. First, all collected data will be identified only by a code number. Only your child's doctor, trainer, or teacher will have your names and contact information, and the list that links your name to your code number. Audio recordings will be saved electronically using state-of-the art security measures. When we report the results of this study, you and your child will never be named or identified in any way.

We are required by law to make reports to prevent serious harm to you, your child, or others. If we see evidence of child abuse or neglect, we have to report it.


If you agree to participate, can you change your mind later?

Yes. You are free to join the study or decline. If you join and later change your mind, you can withdraw from the study at any point, without any penalty, and audio recordings from your participation will be destroyed immediately. Choosing not to join the study will not affect any services you may receive from the University of Notre Dame or your school.
If you have any questions about this study, please contact Dr. Christian Poellabauer (574-631-9131, cpoellab@nd.edu) or Dr. Patrick Flynn (574-631-8803, flynn@nd.edu). If you have questions about your rights as a research participant, please contact Dr. Tracey Poston, Director of Research Compliance, (tposton@nd.edu), phone (574-631-1461).

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