commUNITY Study

We are doing this research to measure and collect self-reported mental and physical health across the U.S., along with experiences and perspectives, and a host of factors that may affect the overall impacts of COVID-19.  Through this research, we are collecting individual tracking of changes in heart rate, activity, sleep, and other information available from smartwatches, activity trackers and other personal sensor devices to help determine whether this data can help to provide early indications of COVID-19, along with other illnesses such as the flu or cold.

If you decide to join, we would like you to remain in the study for two years, but the longer the better. Of course, you can stop participating at any time.

You will be asked to download the free app, commUNITY on your iPhone. To participate in this study, you will need to register in the commUNITY app.

HEALTH SURVEYS  

• We will ask you to answer questions about your current health, travel, and medical history at the beginning of the study.  

• If you report that you are feeling sick, we will ask you a few additional questions.  

• You may skip any questions that you do not wish to answer.

SMARTWATCHES, FITNESS TRACKERS, AND OTHER SENSORS  

• Sensors are used to monitor physiological metrics (blood pressure, heart rate) and behavioral metrics (activity, sleep) over time.  

• We will not give you sensors. If you have your own sensors, you can use them. Some examples of sensors are the Apple Watch, Fitbit, or interactions with your smartphone.  

• We will ask for your permission to access HealthKit, Fitbit or other similar fitness trackers in order to collect data from your sensors (such as heart rate, step count and sleep).  

• We will ask for your permission to access location information from your smartphone or any wearable devices. This information will be used to identify geographic hotspots or areas where multiple participants report that they are feeling sick. Your individual location will not be shared externally.  

• If you choose to share the data from your devices, we may have access to historical data, potentially before you joined the study.  

NOTIFICATIONS  

• We may send notifications such as reminders to complete surveys about your health or if we notice that we are not receiving current data from your fitness tracker or sensors.  

• We may send you brief periodic updates such as summaries of information you and others may have shared with researchers and timely reference information from the Centers for Disease Control and Prevention (CDC) or other sources.  

• Please note: This app is not a substitute for medical treatment. If you have symptoms or questions, please call your doctor as you would if you were not participating in this study.

ELECTRONIC HEALTH RECORDS (EHR)  

• Private health information is any information that can potentially be traced back to you.  

• You do not have to share your EHR data to be part of this study.  

• In this study, at any time you so choose, you will have the option of connecting the study app to one of more of your healthcare providers and insurance plans. This connection to your healthcare provider’s or health plan’s patient or member portal will enable you to obtain an electronic copy of your health records and share with the research team.  

• The private health information from your patient portal may include visit history, demographics, test results, procedures, lab results, immunizations, diagnosis, medications, billing-related information and dates of events.  

• In addition to the primary research team, your de-identified data may be made available to other researchers and government agencies such as the CDC.  

• Your information will be used and shared until the research is completed, which we think will be at least 2 years, after the date you sign this form, but no longer than January 1, 2040. 

APP USE  

• We will study how and when you participate in commUNITY Study.  

• This data will be used to improve the study.

The main risk in taking part in the commUNITY Study is to your privacy. The technology is being used to track your personal health information and your data. We take your privacy very seriously. We use advanced technologies to protect it. But we cannot guarantee your privacy. If there is a data breach, someone who is not authorized could get information about you. This chance is very small, but it is not zero.  If you would like to learn more about the technology we use to protect your privacy, you can email us at support@communitystudy.org. 

There may be other risks that are not known at this time. You will be told about any new information that might change your decision to be in this study.

There is no anticipated direct benefit to you. We will make results of this research study available to you, whenever possible. The insights learned from analysis of the study may benefit both COVID-19 and viral illness outbreak tracking and may help people learn that they have a COVID-19 or influenza-like illness more quickly in the future.

Your alternative is to not take part in the research study.

You will not be paid for being in this study.

There is no cost to participate in this Study. There may be an indirect cost to participate in the study because transmitting the data collected for the study to the Research team may use a part of your data plan. We do not expect this usage to be significant.

If you leave the study, no new data will be collected. Data that has already been collected will still be used in the study and cannot be deleted.

This study is not medical treatment. The alternative to joining the study is to not join.

You can email the staff to ask any questions about this study.  
•    You can decide not to be in this study. You can withdraw/quit after starting. 
•    If you have any questions about your rights, you can email or call the VibrentHealth Main Office for the Protection of Research Subjects.  
•    You do not have to be in this study. You still have all your legal rights whether you join the study or not. 
•    You have the right to be told about any new information that might make you change your mind about staying in the study.  

CONFIDENTIALITY/ DATA HANDLING
  
Your contact information and data that directly identifies you will be separated from your study data and replaced with a random code before it is used for research purposes. All information used by this project will be protected so that it can only be accessed by authorized people. No published scientific reports or presentations will identify you directly.  
  
We will do our best to ensure that your data is kept private and secure. Your data will be stored and transmitted using secure systems. The data will be securely stored in the United States. We will NOT access your personal contacts, other applications, text or email message content, or websites visited. We will never sell, rent, or lease your contact information.

Your private information and your medical record will be shared with individuals and organizations that conduct or watch over this research, including:

• The research sponsor
• People who work with the research sponsor
• Government agencies, such as the Food and Drug Administration, and CDC
• The Institutional Review Board (IRB) that reviewed this research 

DATA SHARING
  
We may share the study data with researchers outside of Vibrent Health. Before we do so, we will ensure that nothing in the data can identify you directly.  

As a participant in this study, we may ask you to share your personal health information, as collected by Fitbit, Apple Health, or other connected devices. In each case, you can say yes or no.

You can continue on as a participant, even if you decide to not share any device data.

FUTURE RESEARCH
  
The de-identified information collected about you for this study will stored and used for other future research projects. The future research could include additional analysis on the detection of viral illnesses based on measurements from your fitness tracker and possibly other conditions that are found to affect your usual heart rate, sleep or activity.  

We do not expect anyone to be hurt as part of participating in the commUNITY Study. However, if you are hurt, you should seek medical care.

You or your medical insurance will be responsible for the costs of any treatment given. No money is available to pay you for time off from work. You are not giving up any of your legal rights by being in this study.

If you feel you have been hurt as part of participating in this study, please contact us via email or by calling the Vibrent Health Main Office.  

Vibrent Health is not being paid for the number of people who enroll. Researchers hope the knowledge gained from this study will help to improve the health of everyone in the future.

​Please see our terms of service at https://www.communitystudy.org/en/privacy and privacy policy at https://www.communitystudy.org/en/terms