Visualization of Infant Vocalizations for Deaf Parents
Dr. Ariana Anderson from Department of Psychiatry and Biobehavioral Sciences at the University of California, Los Angeles (UCLA) is conducting a research study.
Why is this study being done?
The purpose of the study is to create a baby monitor smart-phone app for Deaf parents, which will allow infant vocalizations to be transmitted and “translated” into both a visualization modality and labeled states on the smart-phone of Deaf parents. The study may help us understand how infant vocalizations change over time and with different needs, and how to visually “translate” this information so that a Deaf parent may interpret a child’s vocal cues.
The secondary purpose of this study is to collect infant vocalizations to identify vocal patterns associated with autism and other neurodevelopmental disorders. Your uploaded audio samples will be stored in a secure HIPAA compliant private cloud along with your Infant History Questionnaire. You may also be given annual followup survey(s) when your baby is older regarding infant behavior and whether your infant has been diagnosed with a neurodevelopmental disorder.
We will send annual follow-up surveys when your children are between the ages of 1-6 years, so that we can identify which children received any diagnosis of a neurodevelopment delay. Some of the screeners we are using are standard screening instruments which assess autism risk (Q-CHAT and CAST). We will provide you with your child’s autism risk score, so that you can followup with your physician if your child is at elevated risk for autism or a related disorder.
What will happen if I take part in this research study?
If you volunteer to participate in this study, the researcher will ask you to do the following:
• Take audio recordings of your child • Record your perception of your child’s mood state • Fill out questionnaires regarding your infant’s developmental history and family background.
How long will I be in the research study?
Participation will take a total of about 30 minutes, including the introductory survey. You may record your child’s vocalizations in smaller time periods, and on your own time. Follow-up surveys will take between about 15 minutes.
Are there any potential risks or discomforts that I can expect from this study?
All research contains some risks. While there is no physical danger from this study, there is always the potential for a breach in confidentiality. We have sought to minimize this risk as much as possible. The study and accompanying Chatter Baby software are specifically designed to protect your privacy, using the same HIPAA compliant security features that are used to store medical data. Although we have thoroughly tested the software, it is, however, possible that a yet unseen bug in the code might accidentally lead to identification.
Are there any potential benefits if I participate?
There are no direct benefits to you or your child for participating in this research study.
Will information about me and my participation be kept confidential?
Any information that is obtained in connection with this study and that can identify you will remain confidential. It will be disclosed only with your permission or as required by law. Confidentiality will be maintained by means of transmitted data in an encrypted manner, and stored the data on a physically secure private cloud that has been scanned for vulnerabilities.
Certificates of Confidentiality
Your specimens and information about you are protected by a federal Certificate of Confidentiality. This means that we can’t be forced to release your specimens or information about you for any legal proceeding, even if a court of law asks.
The Certificate allows us to use your specimens and information about you for purposes of this research, or to disclose it for other research when allowed by law. The Certificate requires other researchers to also protect [specimens and] information we share with them.
There are limits to this protection. The Certificate does not protect your information when: • You or your family voluntarily release information about yourselves. • You consent to release of information (for example, the uses described in this form, or if you sign release forms for employment, insurance or medical care). • A federal agency audits or evaluates research that it funds. • Researchers are required to report possible intent to harm yourself or others, child abuse, elder abuse, or infectious disease cases. • The Food & Drug Administration requires information as part of overseeing drugs, devices or other products.
What are my rights if I take part in this study?
• You can choose whether or not you want to be in this study, and you may withdraw your consent and discontinue participation at any time.
• Whatever decision you make, there will be no penalty to you, and no loss of benefits to which you were otherwise entitled.
• You may refuse to answer any questions that you do not want to answer and still remain in the study.
Who can I contact if I have questions about this study?
• The research team:
If you have any questions, comments or concerns about the research, you can talk to the one of the researchers. Please contact:
Ariana Anderson, Ph.D. University of California, Los Angeles Department of Psychiatry and Biobehavioral Sciences 760 Westwood Plaza, Ste 28-224, Los Angeles, CA 90095-1406 email@example.com (213) 973-7465
• UCLA Office of the Human Research Protection Program (OHRPP): If you have questions about your rights while taking part in this study, or you have concerns or suggestions and you want to talk to someone other than the researchers about the study, please call the OHRPP at (310) 825-7122 or write to:
UCLA Office of the Human Research Protection Program 11000 Kinross Avenue, Suite 211, Box 951694 Los Angeles, CA 90095-1694
ChatterBaby Mobile Application Terms & Conditions
Further, you represent and warrant that you are the parent or legal guardian of the child that you submit audio recordings of or that you are otherwise authorized by the parent or legal guardian to record and submit such information to this Application.
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The Information provided in or through the Application is not a substitute for the medical judgement of a physician or other qualified healthcare professional. Always seek the advice of a physician or other qualified healthcare professional with any questions you may have regarding any medical symptoms or medical conditions of your child. Never disregard professional medical advice or delay in seeking it because of Information provided in or through the Application. If you think your child may have a medical emergency, call your child’s physician or 911 immediately. You hereby agree that you will not make any health or medical related decision pertaining to your child based in whole or in part on any Information provided in or through the Application.
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By clicking ‘ok’ you are providing your digital signature, indicating your informed consent to participate in this research study.