Frequently Asked Questions
Why is this research being done?
The purpose of this study is to create a research database of COVID-19 related data. It is helpful for researchers to share and link information to advance science. Researchers do this by creating a scientific database (called a research registry or repository) that stores information on individuals.
How long will I be in the study?
You will be in the study for 6 months. You are free to withdraw at any time.
What will happen to me during the study?
During the study you will answer survey questions on the study web portal. You will be asked to repeat some of the surveys approximately every 2-4 weeks.
Throughout the study you will be asked questions on the following areas:
- Basic information: We will ask some basic information about you before you start the survey, like your name, date of birth, phone number, and email address.
- Survey information: An initial set of surveys will ask information about your health, home, family, and work. It will also ask about your health behaviors, what you know about COVID-19, and the community where you live. It will take about 30 minutes to complete the initial set of surveys. You may skip any question(s) that you do not want to answer.
- COVID-19 specific information: Based on your response to specific questions (occupation, exposure, residence) you will be prompted if you would like to share this information on your testing status, testing experience, signs/symptoms, and access to appropriate care.
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 study 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.
What are the risks of participating?
Risks of participation are minimal. It is possible that you will be upset by answering some of the questions in our survey. You may skip any question that you do not wish to answer. The other biggest known risk is if the privacy and confidentiality of your information is compromised. The study will use Amazon Web Services (AWS), a secure cloud-based service, to store your information in a secure way. Any information that could directly identify you (name, date of birth, email address, and telephone number) will be removed from your study records and will be encrypted separately on the AWS server, accessible only by authorized members of the study team.
What are the benefits of participating?
This research will not diagnose or treat medical problems. You will not get direct medical benefit from taking part in this study. However, you may indirectly benefit. For example, at your request we will provide ways for you to get access to all the data you share with us and all other participants in this study. You will also have the option to learn about additional study opportunities that may have a more direct benefit for your health.
Will I be paid?
If you choose to participate you will be eligible for gift card drawings based on the surveys you complete. Drawings will be held monthly for one of twenty $50 gift cards. Additionally, upon completion of the study, you will be eligible to win one of four total $500 gift cards.
Will it cost anything to be in the study?
There is no cost to participate in this Study.
What if I want to stop participating?
This study is not medical treatment. The alternative to joining the study is to not join.
What treatments could I take instead of joining this study?
This study is not medical treatment. The alternative to joining the study is to not join.
What are my rights?
Taking part of this study is your choice. If you decide not take part, your choice will not affect any medical benefit to which you are entitled. You may choose to leave the study at any time. The investigator may decide to take you off this study if you revoke your authorization or if your consent expires. We may tell you about new information that may affect your health, welfare or willingness to stay in this study. Information learned from this research may be used in reports, presentations and publications. None of these will personally identify you.
In conducting this research study, it may be necessary for the research team to send information about you and your health to persons in other organizations. The purpose of this study is to create a research database of COVID-19 related data. It is helpful for researchers to share and link information to advance science. Researchers do this by creating a scientific database (called a research registry or repository) that stores information on individuals. Access to the registry will be controlled. Researchers will need to apply and get approval to use any information from the registry. With approval, researchers may link information from different studies or data sources to learn more about COVID-19 in multiple ways.
During the study you will provide information such as your name, phone, and email so they can contact you. This information may include what we call “protected health information (PHI),” which includes personal information about you. All of your information will be encrypted and stored securely on a cloud-based server. Information that could directly identify you, like name, date of birth, email address, and telephone number, will be removed from your study records and will be encrypted separately on the AWS server, accessible only by authorized members of the study team. Except when required by law or for your care and safety, you will not be identified. Information that will be shared with others only as described below:
Description of Your PHI to be disclosed: Contact information (name, telephone, email), medical history, gender, race, zip code, history of clinical tests, and use of health care services.
- Organization and person disclosing your PHI: Dr. Sunita Dodani, Healthcare Analytics and Delivery Science, EVMS. 855 W. Brambleton Ave., Norfolk, VA 23510.
- Organization and person receiving you PHI: Research Study Team, Health Care Providers at Sentara Healthcare, Government/Health Agencies.
- Purpose of disclosure: This information will allow the study team to discover patterns related to COVID-19 signs/symptoms, exposure, treatment, and outcomes.
If you refuse to give your approval for your personal information to be shared as described in this consent form, you will not be able to be in this study. However, your choice will not affect any medical benefits to which you are entitled.
You have the right to cancel your approval for the sharing of PHI. If you cancel your approval, you will have to leave the study. All information collected about you before the date you cancelled will continue to be used as part of the report. To cancel your approval, you must notify Dr. Marilyn Bartholmae in writing at EVMS, Williams Hall, 855 W. Brambleton Ave, Norfolk, VA 23510.
Your approval for the sharing of personal information about you for this study expires at the end of the study.
You also have the right to review your research records, or someone you designate may review your research records on your behalf, once the study has ended unless prohibited by law.
Any research information in your medical record will become a permanent part of that document.
Your study records may be reviewed and/or copied in order toto meet state and/or federal regulations. Reviewers may include, for example, an Eastern Virginia Medical School Institutional Review Board, staff and team members of this research project.
Information learned from this research may be used in reports, presentations and publications. None of these will personally identify you.
Right now, there are no plans to use your survey responses for another research study. However, the identifiers might be removed and, after such removal, your survey responses could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you or your legally authorized representative.
What if I get injured while in the study?
Study partners will not provide free medical care for any sickness or injury resulting from being in this study. Financial compensation for a research-related injury or illness, lost wages, disability, or discomfort is not available. However, you do not waive any legal rights by signing this consent form.
Will Vibrent Health or co-sponsors benefit from this study?
Vibrent Health or co- sponsors including EVMS and GMU will not be 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.
Can’t find the answer to your question? Contact us.
If you have any questions about the study, feel free to contact our research team by email at support@COVIDsmartstudy.org.