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Informed Consent

You are being invited to volunteer for a project whose purpose is to develop a machine-learning screening system that will identify non-linguistic acoustic traits in children’s speech, which research has shown can be associated with autism.  You must read and sign this form before you agree that you can take part in this project.  This form will give you more information about this study.  Please ask as many questions as you need to before you decide if you want you to be in the study.  You should not sign this form if you have any questions that have not been answered.

About the Study



The purpose of the project is to gather audio recording data from autistic and non-autistic children in order to train a machine-learning autism screening system. The system, Evaluative Artificial Speech Intelligence-Autism Screener (EASI-AS), will analyze audio recording data to determine whether a child should be referred for a formal diagnostic evaluation for autism spectrum disorder. The product, EASI-AS, is designed for specific adult end-users: caregivers, educational professionals, and speech-language pathologists. EASI-AS will use mobile devices to collect non-linguistic acoustic data from mobile devices, which the system will analyze to produce a screening result.



The project aims to collect data from 2,000 or more users which will take approximately three to six months total. Participants will record a five-minute audio segment containing a child speaking – who is either autistic or typically developing – and upload it to the EASI-AS site, which should take between 30 to 60 seconds.




Participant Responsibilities


While participating in this research study, you will need to do the following:


  • Be willing and able to follow the project’s directions and procedures

  • Tell the project’s staff about any health concerns

  • Tell the project’s staff about any problems with the technology

  • Ask questions as you think of them

  • Tell the investigator or the study staff if you change your mind about remaining in the project.






Before the study starts, you will be asked to sign this consent form.


Before the study starts, you will be asked whether you belong to any of the following categories:


  • parent

  • licensed speech-language pathologist

  • licensed school psychologist

  • board-certified behavioral analyst

  • credentialed special education teacher


Study Procedures:


We will be collecting anonymized information about the child in the recording through short questionnaires. In order to train the machine-learning screening system, we will need to know the child’s sex, ethnicity, country of origin, and reported positive diagnosis of autism – if applicable. We will not, however, request personal information such as name, address, social security number, or other unique personal information about the child, parent, or caregiver.


We will ask you to try to follow directions when using the EASI-AS website, which will use visual stimuli, speech-recognition, and file transfer interfaces


In order to collect an adequate amount of data, you will need to commit approximately 5 to 6 minutes of your time: part of this will be recording your child; the other part, uploading the data to the website.  You will be asked to complete a questionnaire that will provide some anonymous information about your child, but you will not be asked to share your child’s name, where they live, or any other unique identifying information about them. The data-collection sessions and the data uploading will occur in your home.


On the website, you will be asked to give permission to share the recording to our secure cloud-based storage system.  Your personal information, the data derived from your questionnaire, and the information obtained from the interview will be anonymized: all of your data for this study will be encoded with a numeric value (e.g. 001). The Investigator will keep these recordings in iTherapy’s HIPAA-compliant cloud storage system, and they will only be used by the investigator, sub-Investigator, trained research assistants, and authorized data scientists.




Your child’s participation in this study does not involve any physical or emotional risk beyond that of everyday life.


Because this device/procedure uses familiar desktop and mobile devices, participation poses no more risk than that experienced using your personal computer or mobile phone.


The risks of your participation in this online study are those associated with basic computer tasks, including boredom, fatigue, mild stress, or breach of confidentiality.




You may receive a chance to be in a research study that may help others.  Your contribution may help further technological, diagnostic, and therapeutic interventions for people with autism and other communication delays and disorders. 




Since this project is for technological development only, the only other choice would be not to be in the research activities.




Your records of being in this study will be kept private except when ordered by law.  The following people will have access to your study records:


  • The Investigator

  • Sub-Investigator

  • Trained research staff

  • Authorized data scientists

  • Sponsor company or research institution [including monitor(s) and auditor(s)]

  •  Institutional Review Board

  • Other state or federal regulatory authorities


The Institutional Review Board (IRB) and accrediting agencies may inspect and copy your anonymized data, which will not have your name on them, but will have information about your child such as ethnicity, sex, nationality, and autism diagnostic information.  Therefore, total confidentiality cannot be guaranteed.  If the project results are presented at meetings or printed in publications, your name will not be used.


Throughout the project, identifiers will be removed and your de-identified information may be used for future research without additional informed consent.




The confidentiality of all participants will be maintained throughout the life of the project, and the research team will institute and monitor robust data security protocols. All members of the research team will complete an online course covering research with human subjects and data security before  the study’s commencement. Data will be collected and stored on a secure online server. A code key will be created to assign a unique number to each study participant (i.e. P001). The data collected in this study will in no way be affiliated with the participants’ medical record number or personnel files. All participant data will be stored on a secure, encrypted data storage device and/or a password protected and encrypted internet- or cloud-based storage system, which meets HIPAA privacy standards. The files will also be password encrypted. No data will be accessible from any source that is not password encrypted. The password will only be known to IRB-approved research project members.




This study has no plans to pay for research related injury but will use caution to prevent any type of injury.


Please be aware that some insurance plans may not pay for research-related injuries.  You should contact your insurance company for more information.




You will not lose any of your legal rights by signing this consent form.




If you have questions, concerns, or complaints about this study or to report a study related injury, contact:


Lois Jean Brady

daytime telephone number: 707-651-9915

after hours number: 925-812-0037


If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please go to the nearest emergency room.



If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject, you may contact Argus.  Argus is a group of people that has reviewed this research study.  The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies.  Argus’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:


Mailing Address:            OR            Email Address:

6668 S. Hidden Flower Way

Tucson, AZ 85756-5111


If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:


512-326-3001 or

toll free at 1-877-562-1589

between 8 a.m. and 5 p.m. Central Time





You will be given a free copy of iTherapy’s magazine, Autism Digest, as part of this study. You must complete all the research tasks in order to receive the download.


If you choose to leave or you are withdrawn from the study for any reason before finishing all of the tasks, you will forego the opportunity to receive the app download.




It is your choice if you want to be in the project: no one can force you to participate.  You may leave the study at any time without penalty.

If you leave the project or if you are taken out of the project, you may be asked to return for a final visit to have some end-of-study interviews.  If information generated from this study is published or presented, your identity will not be revealed.  If you leave the project, no more information about you will be collected for this project.  However, all of the information you have given us before you left the study will still be used.


The investigator or IRB may take you out of the study without your permission, at any time, for the following reasons:


  • If you do not follow the investigator’s instructions

  • If we find out you should not be in the project

  • If the project is stopped

  • If it becomes harmful to your health




If there is new information or any significant new findings that could relate to your willingness to continue participation, we will tell you.  You can then decide if you still want to be in the study. 

I Agree
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