Verisense Smart Watch Demonstration Informed Consent Agreement

Sponsor / Study Title: Verisense Health, Inc. / “Verisense Smart Watch Demo”

 

Principal Investigator: Geoffrey Gill

 

Telephone: (617) 945-2628

 

Address: Verisense Health, Inc.

810 Memorial Dr, Ste 109

Cambridge, MA 02139

 

Please read this consent agreement carefully before you decide to participate in the study.

Purpose of the research study: The purpose of this project is to demonstrate the technologies and refine the procedures that are being used to create a large Digital Health Panel to help accelerate progress in Digital Health. The data collected may also be combined with data from other participants in this and other studies to help establish population norms.

What you will do in the study: You will be asked to wear a wearable sensor on your wrist for at least 20 hours each day, including when you sleep, for a minimum of seven days. Additional data may be collected post-study if the participant chooses to continue wearing the device after the study has ended.

Time required: The study will require about 20 minutes of your time in total. You will be asked to:

  • Unpack the sensor, read the participant instructions, and power up and pair the sensor to your smart phone. (10 minutes)

  • Wear the wrist-based sensor for a minimum of 20 hours per day for a minimum of seven days. Wearing the sensor should not interfere with any of your normal activities. (0 minutes)

  • Answer a survey asking about your experience with the device and the study.

Risks: The risks of participating in this study are minimal. The sensor is plastic and made of materials that are commonly used in wrist watches, but in rare cases people have developed minor skin irritation when wearing the sensor. If you develop such an irritation, you will be free to stop wearing the sensor. There are no other anticipated risks.

As part of this research, you will be required to use your Android or iPhone smartphone and wear the Verisense Smart Watch. Because the primary purpose of the study is to demonstrate the Verisense Smart Watch and our procedures, we will not be collecting personal health information, but we will collect device data and certain demographic information (e.g., gender). Although these data will be stored in a secure fashion, there is a risk of data breach or accidental disclosure.

There may be other risks that are unknown.

Alternatives: This research study is for research purposes only. The only alternative is to not participate in this study.

New Findings: Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.

Benefits: This study is for research purposes only. There is no direct benefit to you from your participation in the study, other than the use of the Verisense Smart Watch. Information learned from the study may help other people in the future.  Digital Health Technologies have the potential to change medicine from reactive treatment of disease to proactive management of health and preventing illness. This study is a demonstration of the Digital Health Panel technology.

Participant will be able to keep the Verisense Smartwatch following completion of the study. There will be no other direct benefits to the participant.

Confidentiality: The information that you give in the study will be anonymous. Your name and other information that could be used to identify you will not be linked to the data.

Records of your participation in this study will be held confidential except when sharing the information is required by law or as described in this informed consent. The investigator, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) will be able to inspect and copy confidential study-related records which identify you by name. This means that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at meetings, you will not be identified.

Voluntary participation: Your participation in the study is completely voluntary. You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled.

The investigator or the sponsor can stop your participation at any time without your consent for the following reasons:

  • If it appears to be medically harmful to you;

  • If you fail to follow directions for participating in the study;

  • If it is discovered that you do not meet the study requirements;

  • If the study is canceled; or

  • For administrative reasons.

Right to withdraw from the study: You have the right to withdraw from the study at any time without penalty. 

How to withdraw from the study: If you want to withdraw from the study, please just stop wearing the watch and uninstall the app. 

Payment: In consideration of the time you dedicate to the study, we will offer you a Verisense Smartwatch to keep and own after the study ends, on the condition that the data gathered through the watch can still be utilized for anonymous research purposes.

Using data beyond this study: The data you provide in this study will be retained in a secure manner by the researcher. In addition, your data may be used by qualified researchers to investigate connections between the sensor data that is generated and from any other source that you may have consented to. You will not have access to the sensor data that is generated from your participation in the study. At no time will any researcher have access to any information that could reveal your identity. 

Whom to contact about this study: During the study, if you have questions, concerns or complaints about the study such as:

  • Payment or compensation for being in the study, if any;

  • Your responsibilities as a research participant;

  • Eligibility to participate in the study;

  • The investigator’s decision to withdraw you from participation;

 

Please contact the investigator at the telephone number listed on the first page of this consent document.

AUTHORIZATION TO USE AND DISCLOSE PERSONAL IDENTIFIABLE INFORMATION (PII) DEVICE DATA

If you decide to be in this study, the investigator and study staff will use and share your PII and Device Data to conduct the study. The data may include:

  • Your name

  • Email address

  • Zip Code

  • Phone number

  • Gender

  • Date of birth

Your PII will be used to contact you to conduct the study and may be used to generate pseudonymized tokens to facilitate sharing your data in the future. The Device Data may include:

  • Acceleration data

  • PPG data

  • Temperature data

  • ECG data

  • Device logs and other operational data

The Device Data and PII will be stored separately and securely. Your permission to use and share these data about you will end in 50 years unless you revoke it (take it back) sooner.

You may revoke (take back) your permission to use and share these data about you at any time by writing to the investigator at the address listed on the first page of this form. If you do this, you will not be able to stay in this study. No new data about you will be gathered after your written request is received. However, data about you that has already been gathered may still be used and given to others as described in this form.

If you decide not to consent to these terms, you will not be able to take part in the study.