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Sample Parental Consent Form for Non-Therapeutic Research That is Less than Minimal Risk

IRB #061717-4 

Title of the Research StudyAssessing the Impact of Speech Rate and Performance in Dysarthric Speakers 

Summary
The purpose of this study is to examine how changing the speed your child talks affects the function of the soft palate in the roof of the mouth.  You might decide to allow your child to participate in the study because your child might learn to speak more clearly.  You might decide not to allow your child to participate in the study because it will take one hour of your child’s time.

You are invited to permit your child to participate in this research study.  The following information is provided in order to help you to make an informed decision whether or not to allow your child to participate.  If you have any questions, please do not hesitate to ask. 

Your child is eligible to participate in this study because your child has a neurologically based speech disorder called dysarthria.  

The purpose of this study is to investigate how changes in speech rate affect the function of the soft palate during speech.  The soft palate is the back of the roof of the mouth. 

This study will take approximately one hour of your child’s time.  In order to assess soft palate function during speech we will place a small nasal mask over your child’s nose.  Your child will be able to breathe through this mask at all times.  We will also place a small plastic tube at the corner of his/her mouth.  When your child speaks at various rates by repeating word strings such as “Buy Bobby a Puppy,” we will measure air pressure in the mouth and the amount of airflow through the nose.  This information, in turn, will allow us to assess the functioning of the soft palate.  We will also record your child’s speech.  All of these measures are considered routine clinical procedures. 

There are less than minimal risks associated with this research. 

As a result of participation in this research, it is possible that your child may learn to speak more clearly by controlling the rate of his/her speech.  The information obtained from this study may help us to better understand the impact of speech rate on the functioning of the soft palate during speech. 

Any information obtained during this study that could identify your child will be kept strictly confidential.  The information obtained in this study may be published in scientific journals or presented at scientific meetings, but the data will contain no identifying information. 

Your child’s rights as a research subject have been explained to you.  If you have any additional questions concerning your child’s rights, you may contact the University of Nebraska at Kearney Institutional Review Board (IRB), telephone (308) 865-8496. 

You are free to decide not to enroll your child in this study or to withdraw your child at any time without adversely affecting your child’s or your relationship with the investigator or the University of Nebraska.  Your decision will not result in any loss of benefits to which your child is otherwise entitled. 

Documentation of Informed Consent 

You are voluntarily making a decision whether or not to allow your child to participate in this research study.  Your signature certifies that you have agreed to allow your child to participate having read and understood the information presented.  You will be given a copy of this consent form to keep. 

____________________________________         __________________________ 
Signature of Parent                                                       Date 
 

In my judgment the parent/legal guardian is voluntarily and knowingly giving informed consent and possesses the legal capacity to give informed consent to participate in this research study. 

____________________________________           __________________________ 
Signature of Investigator                                                  Date 

Identification of Investigators 

     Primary Investigator 

          Mike M. Robinson, Ph.D.                                       Off:  865-1000  

Approved 07/04/17

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