Title: COVID-19 Screening Through Non-Invasive Vocal Feature Analysis (VFA)
Protocol Number: None WIRB® Protocol #20201268
Sponsor: Soniphi, LLC
Study-Related Phone Number(s): Catherine Kusnick, MD 496 S. Main Street Sebastopol, California 95472 United States

Please review the form below before tapping “I Consent to Participate” if you’re ready to continue.

Consent to Participate in a Research Study
VRI – Voice Research Initiative (the “Study”)

Consent Form Version Date: 06/08/20
Name of Organization: Soniphi
Study Contact Email: research@soniphi.com

GENERAL INFORMATION ABOUT RESEARCH PROJECTS

Research studies aim to obtain new knowledge. This new information may help people in the future. It is important that you understand the information in Part 1 of this document so that you can make an informed choice about participating in this Study in Part 2, below.

You will be e-mailed a copy of this document upon your agreement to Part 2 below. If you have any questions, please e-mail research@soniphi.com at any time.

WHAT IS THE PURPOSE OF THIS STUDY

The purpose of this Study is to collect data that is useful for the screening and diagnosis of patients based on voice analysis. We aim to apply experimental machine learning techniques, digital processing, and artificial intelligence to analyze voice data. At this stage, we are collecting information to advance rapid new techniques for the detection of patterns and markers in voice data.

STUDY PROCEDURES

Participation in this Study involves using Soniphi’s mobile app on your personal device.

Upon providing your consent and agreement to participate in the Study, you will be asked to:

Register an account: Once you provide your consent to participate in the Study, all participants will complete an electronic registration process through the mobile app and create a user account. Registration will include entering your email address and other general information about yourself.

Complete a personal health Questionnaire: You will be provided with a questionnaire about your demographics, health history and diagnoses. Your answers to these questions will help us find patterns in underlying conditions of certain diagnoses. Some of the questions may be personal in nature. You may choose to leave blank any questions you do not wish to answer.

Provide Audio Recordings: You will be provided with reading material and asked to use the mobile app to record and submit audio recordings of you speaking naturally and following the app’s prompts.

Your participation in this Study will take approximately two hours.

After you complete the Study, we may, from time to time, and with your consent, send you notices to your phone or e-mail asking you to complete additional questions or request further voice samples. You may choose to complete any additional questions or provide additional voice samples at your convenience and discretion. You can use the notification settings on your device for the mobile app to control or turn off the notifications.

ARE THERE ANY REASONS YOU SHOULD NOT BE IN THIS STUDY?

You should not be in this Study if you are under 18 years old at the time of participation, or if you have had surgery or cancer or cancer treatments that involve your vocal chords.

WHAT ARE POSSIBLE BENEFITS OF THIS STUDY?

This Study is designed to benefit society by gaining new techniques to screen for and create methods for early detection of potential illnesses. There are no direct medical benefits to you and no incentives will be provided to participants for taking part in this Study.

IS THERE COMPENSATION FROM BEING IN THIS STUDY?

Participants recruited through UserWise, Inc., and select medical sites, may receive compensation.

WHAT IS THE ALTERNATIVE?

This is not a treatment study. Your alternative is not to participate.

WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS INVOLVED FROM BEING IN THIS STUDY?

There are discomforts and inconveniences associated with any research study. These deserve careful consideration. There is the risk of loss of confidentiality of your medical history information.

This Study involves a difficult subject matter, including providing health information, which may cause emotional discomfort. Please keep in mind that you have the chance to skip questions that make you uncomfortable or to stop participating at any point.

HOW WILL MY PERSONAL INFORMATION BE KEPT CONFIDENTIAL?

All information provided by you, including your name, medical history, and other personal information will be kept confidential by Soniphi, unless disclosure is compelled by law. We will be sharing audio samples and health history to third parties, without any personal identifying information. Your name and email address will not be shared with any third party.

Anonymized information (no personal names or email addresses) collected during this Study may be transferred to third parties for related research purposes. Anonymized information collected during this Study may also be used in analyses and may be published and presented to the scientific community at meetings and in journals. If the results of this Study are published, your identity will remain confidential. Anonymized information may also be used as part of a submission to regulatory authorities around the world including the U.S. Food and Drug Administration (FDA) and the IRB to support the approval of Soniphi’s voice analysis tool as a screening method for various illnesses.

Even though the likelihood that someone may identify you from the Study data is very small, it can never be completely eliminated.

Any information and voice samples sent outside across borders may increase the risk of disclosure of information because the laws dealing with protection of information may not be as strict in the other countries. However, all information and voice samples that are transferred across borders will be coded (this means it will not contain your personal identifying information such as your name, address, or contact information). By signing this consent form, you are consenting to the disclosure of your coded information to organizations located in other countries, as applicable.

Note that, data collected on the device you use to download Soniphi’s mobile app may reside on the device manufacturers’ servers and Soniphi does not make any representations or assurances with respect to such manufacturers’ confidentiality policies.

Communication via e-mail is not absolutely secure. We do not recommend that you communicate sensitive personal information via e-mail.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

VOLUNTARY PARTICIPATION

Your participation in this Study is completely voluntary. You may decide not to be in this Study. You may refuse to answer questions you do not want to answer. Agreeing to participate does not waive your legal rights.

WITHDRAWAL

You can choose to end your participation in this Study at any time without having to provide a reason. Your decision not to participate in or withdraw from the Study will not affect your relationship with Soniphi, or any other organization associated with this project. If you choose not to participate or to stop participating, there is no penalty or loss of benefits to which you are otherwise entitled. Upon your withdrawal, all associated data collected will be immediately destroyed wherever possible.

If you no longer want your information, including your voice samples, to be used in the Study after you have submitted it to Soniphi, you should notify us at research@soniphi.com to destroy the information you provided. If your information has already been anonymized at the time of notification, it may not be possible to withdraw it because we will not be able to identify which data set is yours.

WHAT IF YOU HAVE QUESTIONS ABOUT THIS STUDY?

You have the right to ask, and have answered, any questions you may have about this Study. If you have questions about the Study, complaints, feedback, concerns, or research problems you should contact us at research@soniphi.com.

This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. You may talk to them at (800) 562-4789, help@wirb.com if:

• You have questions, concerns, or complaints that are not being answered by the research team.
• You cannot reach the research team.
• You want to talk to someone else about the research.
• You have questions about your rights as a research subject.

Any person who is requested to consent to participate as a subject in a research study involving a medical experiment, or who is requested to consent on behalf of another has the right to:

(a) Be informed of the nature and purpose of the experiment.

(b) Be given an explanation of the procedures to be followed in the medical experiment and any drug or device to be used.

(c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment, if applicable.

(d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment if applicable.


(e) Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.

(f) Be informed of the avenues of medical treatment, if any, available to the subject after the experiment or if complications should arise.

(g) Be given an opportunity to ask any questions concerning the experiment or other procedures involved.

(h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and the subject may discontinue in the medical experiment without prejudice.

(i) Be given a copy of a signed and dated written informed consent form when one is required.

(j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.

PARTICIPANT'S AGREEMENT

By tapping the "Agree" button, you agree with all of the following statements:

1. I have read the foregoing information (or it has been read to me). All my questions about the Study have been answered to my satisfaction and I understand that I can ask further questions about the Study at any time.

2. I consent voluntarily to be a participant in this Study and understand that I can refuse to answer questions and that I can withdraw from the Study without reason at any time.

3. I understand that taking part in this Study involves providing answers about my medical history and previous diagnoses, if applicable, and audio recordings of my voice.

4. I understand that the information I provide will be used to help develop a new screening method using voice samples for early detection of illness.

5. I understand that my personal identifying information will be held in confidence, to the extent permitted by law, and my identity will not be disclosed in any publication or presentation. I further understand that Soniphi cannot guarantee complete confidentiality of the information I share in this Study.

6. I understand that there is no compensation for my participation in this Study and this Study will not benefit me specifically.

I give permission to Soniphi to store the information I provide during this Study, including my audio recordings, so it can be used for future voice analysis research by Soniphi.