Skip to content
Permalink
master
Switch branches/tags
Go to file
 
 
Cannot retrieve contributors at this time

UNIVERSITY OF CALIFORNIA LOS ANGELES STUDY INFORMATION SHEET and TERMS OF USE

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.

You were selected as a possible participant in this study because you are responsible for a child. Your participation in this research study is voluntary. Your use of the app is described below in the Terms of Use.

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 ariana82@ucla.edu (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

Please read the terms and conditions set forth below (“Terms of Use”) fully and carefully before using the ChatterBaby mobile application (the “Application”) or any of its features. These Terms of Use are between you (“you” or “your” or “user”) and The Regents of the University of California, on behalf of its UCLA Health System (“UCLA” or “us” or “we” or “our”). The Terms of Use set forth below, as well as the privacy policy set forth at https://chatterbaby.org/files/view/download_files/Privacy_Policy_IRB.pdf)(“Privacy Policy”), apply to your use of the services, features and content offered by Application. BY ACCESSING, REGISTERING AND/OR USING THE APPLICATION YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREE TO BE BOUND BY THESE TERMS OF USE AND THE PRIVACY POLICY. IF YOU DO NOT AGREE TO THESE TERMS OF USE AND THE PRIVACY POLICY, YOU ARE NOT AUTHORIZED TO USE THE APPLICATION. We reserve the right to modify these Terms of Use and the Privacy Policy at any time and such modification will be effective upon posting to the Application. Your continued use of the Application following the posting of such changes constitutes your acceptance of any such changes.

  1. Age and Eligibility In order to use the Application you must: (1) be at least 13 years of age; and (2) have agreed to the STUDY INFORMATION SHEET- Research Consent Form thereby giving your consent to participate in the voluntary research study described therein. If you are under 13 or you have not agreed to the STUDY INFORMATION SHEET- Research Consent Form, do not attempt to register to use our Application. By accepting these Terms of Use, you represent and warrant that you are at least 13 years of age or older.
    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.

  2. Medical Advice Disclaimer The content, information, data and audio recording analysis results (collectively, the “Information”) provided in or through the Application are for informational purposes only. Using or accessing the Application and/or submitting your/your child’s personal information, including, but not limited to, audio recordings of your child, does not create a physician-patient relationship between you/your child and the UCLA researchers and personnel associated with this research study. Nothing contained in the Application is intended to create a physician-patient relationship.
    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.

  3. Information Provided In or Through the Application UCLA does not warrant the accuracy, reliability, correctness or completeness of the Information provided in or through the Application. You are solely responsible for your use of the Information provided in or through the Application and for all decisions or actions resulting from your use of the Application.

  4. Use of the Application By agreeing to STUDY INFORMATION SHEET- Research Consent Form, you have given your consent to participate in a voluntary research study as further explained therein. Please consult the STUDY INFORMATION SHEET- Research Consent Form for more information regarding the research study and your rights as a study participant. The STUDY INFORMATION SHEET- Research Consent Form can be found at STUDY INFORMATION SHEET- Research Consent Form. By participating in the research study and by using this Application, you will be asked to record and submit audio data of your child crying and to submit [other personal information] regarding your child (as described in STUDY INFORMATION SHEET- Research Consent Form) By submitting audio or video recordings of your child or other personal information through the Application, you grant UCLA the perpetual right to use such recordings and information in connection with the study described in the UCLA IRB Visual of Infant Vocalizations for Deaf Parents IRB#15-000931. For further information regarding the collection, use and confidentiality of your/your child’s personal information, please carefully review our Privacy Policy and STUDY INFORMATION SHEET- Research Consent Form. You agree that you will not submit or transmit any content or recordings that may infringe upon, misappropriate, or violate any rights of any third party. You agree that the following actions shall constitute a material breach of these Terms of Use: • Transmitting material that infringes or violates the intellectual property rights of others or the privacy or publicity rights of others; • Transmitting material that is unlawful, obscene, defamatory, predatory of minors, threatening, harassing, abusive, slanderous, or hateful to any person or entity as determined by UCLA in its sole discretion; or • Intentionally distributing viruses or other harmful computer code. UCLA expressly reserves the right, in its sole discretion, to terminate a your use of the Application at any time and for any reason, including, but not limited to, due to any act delineated above, or any act that would constitute a violation of these Terms of Use. If you have questions regarding use of the Application, please contact the principal investigator Ariana Anderson, at ariana82@ucla.edu

  5. Account Access You are responsible for maintaining the confidentiality of your survey access codes. You shall be responsible for all uses of your login information, whether or not authorized by you. It is your sole responsibility to control the use of your account.

You may terminate your ChatterBaby account at any time. To terminate your ChatterBaby account, please uninstall the Application from your mobile device.

  1. Privacy Your privacy is important to us. Please review our Privacy Policy (https://chatterbaby.org/files/view/download_files/Privacy_Policy_IRB.pdf) for a description of what personal information is collected by this Application, how that information is protected and the manner in which that information is used and shared.

  2. Warranty Disclaimer THE APPLICATION, ITS CONTENT, AND ANY INFORMATION MADE AVAILABLE BY OR THROUGH THE APPLICATION, INCLUDING, BUT NOT LIMITED TO, AUDIO RECORDING ANALYSIS, ARE PROVIDED “AS IS,” “AS AVAILABLE” WITH ALL FAULTS, AND WITH NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. YOU ASSUME TOTAL RESPONSIBILITY AND RISK FOR YOUR USE OF THE APPLICATION, ITS CONTENT, INFORMATION MADE AVALIABLE BY OR THROUGH THE APPLICATION, AND THIRD PARTY WEBSITES ACCESSED THROUGH THE APPLICATION. UCLA DOES NOT WARRANT THE APPLICATION IS FREE OF VIRUSES, BUGS, ERRORS OR OMISSIONS. ANY REFERENCES TO SPECIFIC PRODUCTS OR SERVICES ON THE APPLICATION DO NOT CONSTITUTE OR IMPLY A RECOMMENDATION OR ENDORSEMENT BY UCLA UNLESS SPECIFICALLY STATED OTHERWISE. UCLA DOES NOT MAKE ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, AS TO THE OPERATION OR AVAILABILITY OF THE APPLICATION. YOU AGREE AND UNDERSTAND THAT UCLA TAKES NO RESPONSIBILITY FOR AND DISCLAIMS ANY AND ALL LIABILITY ARISING FROM ANY INACCURACIES OR DEFECTS IN SOFTWARE, COMMUNICATION LINES, THE INTERNET, COMPUTER HARDWARE OR SOFTWARE, OR ANY OTHER SERVICE OR DEVICE THAT YOU USE TO ACCESS THE APPLICATION. YOU UNDERSTAND AND AGREE THAT THE APPLICATION, ITS CONTENT, SERVICES AND FEATURES MAY NOT BE AVAILABLE TO YOU AT ALL TIMES DUE TO SYSTEM FAILURES, BACK-UP PROCEDURES, MAINTENANCE, OR OTHER CAUSES. ACCESS IS PROVIDED ON AN “AS-IS,” “AS-AVAILABLE” BASIS AND UCLA DOES NOT GUARANTEE THAT YOU WILL BE ABLE TO ACCESS THE APPLICATION AT ANY PARTICULAR TIME OR THAT THE APPLICATION WILL OPERATE IN AN UNINTERRUPTED OR ERROR-FREE MANNER.

  3. Limitation of Liability IN NO EVENT WILL UCLA OR ITS EMPLOYEES, OFFICERS, DIRECTORS, AFFILIATES, SUPPLIERS, OR AGENTS BE RESPONSIBLE OR LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE, ECONOMIC OR OTHER DAMAGES (INCLUDING, WITHOUT LIMITATION, THOSE RESULTING FROM LOST PROFITS, LOST DATA, OR BUSINESS INTERRUPTION) ARISING OUT OF OR RELATING IN ANY WAY TO YOUR USE OF OR INABILITY TO USE THE APPLICATION, WHETHER BASED ON WARRANTY, CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR ANY OTHER LEGAL THEORY AND WHETHER OR NOT ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. WHEN USING THE APPLICATION, INFORMATION WILL BE TRANSMITTED OVER A MEDIUM THAT MAY BE BEYOND THE CONTROL OF UCLA. ACCORDINGLY, UCLA ASSUMES NO LIABILITY FOR OR RELATING TO THE UNAUTHORIZED DISCLOSURE OR INTENTIONAL INTRUSION, OR OF ANY DELAY, FAILURE, INTERRUPTION OR CORRUTION OF ANY DATA OR OTHER INFORMATION DURING TRANSMISSION BY YOU TO US.
    YOUR SOLE AND EXCLUSIVE REMEDY FOR DISSATISFACTION WITH THE APPLICATION, ITS CONTENT, AND ANY INFORMATION MADE AVALIABLE BY OR THROUGH THE APPLICATION IS TO STOP USING THE APPLICATION. YOU ACKNOWLEDGE, BY YOUR USE OF THE APPLICATION, THAT YOUR USE OF THE APPLICATION IS AT YOUR SOLE RISK. APPLICABLE LAW MAY NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.

  4. Copyrights, License and Restrictions Except as otherwise indicated, all content provided in or through the Application (that is not the user’s or their child’s personal information), including text, graphics, logos, button icons, photos, images, forms, audio, video, data analysis, questionnaires, and software (collectively, the “Content”), is the exclusive property of UCLA or its licensors and is protected by United States and international copyright laws. Unless specifically authorized in writing by UCLA, any use of the Content, or of any materials contributed to the Application by entities other than UCLA, on any other website for any purpose is prohibited. UCLA grants a limited, non-exclusive, non-sublicensable, non-transferable license to each user to make personal non-commercial use only of the Application solely for the purpose of serving as a study participant in accordance with these Terms of Use. You may not sell, transfer, assign, license, sublicense, or modify the Application or Content or reproduce, display, publicly perform, reverse engineer, make a derivative version of, distribute, or otherwise use the Application or Content in any way for any commercial purpose. You have no rights in or to the Content, and you may not use the Content except as permitted under these Terms of Use. Any rights not expressly granted by these Terms of Use are reserved by UCLA. Content and features are subject to change or termination without notice in the discretion of UCLA.

  5. Trademarks and Service Marks Use of the UCLA or the University of California name without authorization is prohibited by California law. Other proprietary marks of UCLA or third parties may be designated as such from time to time on the Application through use of the TM, SM, or ® symbols. Users of the Application are not authorized to make any use of the University name, UCLA marks or the proprietary marks of third parties, including but not limited to, as metatags or in any other fashion that may create a false or misleading impression of affiliation or sponsorship with or by UCLA or the applicable third party. Nothing in the Application should be construed as granting any license or right to use any trademark, service mark, or logo displayed in the Application without the express written permission of UCLA or the third party that may own the trademark, service mark or logo.

  6. Indemnification You agree to defend, indemnify and hold harmless UCLA, its affiliates, officers, agents, faculty and employees and their respective assigns and successors-in-interest from and against any and all liability for claims, damages, awards, and expenses, including but not limited to reasonable attorneys’ fees and court costs for bodily injury, including death, personal injury, damage to property and violation of patent or copyright law (herein referred to as Claims) relating to or arising from your use or accessing of the Application, any violation of these Terms of Use by you, or your violation of any rights of another.

  7. Third Party Websites The Application may provide links or references to websites operated by third parties. UCLA makes no representations whatsoever about any third party website that you may access through the Application. When you access a third party website, please be advised that it is independent from UCLA, and that UCLA has no control over the content on that website. UCLA does not endorse or accept any responsibility for the content or use of any other linked website. If you decide to access any third party websites linked to this Application, you do so entirely at your own risk. We suggest that you read the terms of use and privacy policies on those third party websites. You agree that UCLA has no liability for any damage or loss of any type that is a result of your use of a third party website.

  8. General These Terms of Use are governed by California law without regard to its principles of conflicts of law. All disputes arising from or relating to these Terms of Use will be within the exclusive jurisdiction of the federal or state courts located in Los Angeles, California. Both parties irrevocably consent to jurisdiction and venue in Los Angeles, California. If any provision of the Terms of Use is found invalid or unenforceable, the remaining portions will remain in full force and effect, and the invalid provision will be partially enforced to the maximum extent permitted by law to effectuate the purpose of these Terms of Use. UCLA’s failure to exercise or enforce any right or provision of the Terms of Use will not constitute a waiver of such right or provision. These Terms of Use constitute the entire agreement between you and UCLA with respect to the subject matter herein and supersede all prior arrangements and understandings between the parties, whether oral or written, with respect to the subject matter herein. You may not assign or otherwise transfer this agreement to anyone.

By clicking ‘ok’ you are providing your digital signature, indicating your informed consent to participate in this research study.