SMILE App Privacy Policy

Privacy Policy

February 26^th, 2024

This Privacy Statement (“Privacy Statement”) explains how RTI International and the University of North Carolina, Chapel Hill (“UNC”, “RTI,” “us,” “our,” “research team”, and “we”) uses your information and applies to all who participate in the Stress Management Intervention Leveraging Electronic health records (SMILE) study and use the SMILE mobile app (referred to as the “Study”). This study, supported by the National Institute on Minority Health and Health Disparities (NIHMD), is being conducted by researchers at RTI International, a not-for-profit research organization in the Raleigh/ Durham area of North Carolina and the University of North Carolina-Chapel Hill.

Please read this Privacy Statement carefully and review it periodically for the latest information about our privacy practices. By voluntarily consenting to participate in the study, you agree to the terms of this Privacy Statement. If you do not agree with the practices described in this Privacy Statement, please contact the Study coordinator to withdraw from the study. Use of the Study app is restricted to those participants who consent to participate in the Study.

We will routinely update this Privacy Statement to clarify our practices and to reflect new or different privacy practices, such as when we add new services, functionality or features to the Study. If we make any material changes, we will notify you by email (sent to the email address specified in your account) or by means of notice on the Site prior to the change becoming effective. You can determine when this Privacy Statement was last revised by referring to the date it was “Last Updated” above.

1. Types of Information We Collect

The purpose of the study is to determine whether a training program can help you feel calmer and more relaxed during times of stress, worry or concern.  The SMILE mHealth app provides guidance and instructions for research procedures so that the participants can collect and share study related data independent of researcher guidance.

We will not collect Personal Information when you use the SMILE app.

The Study app only collects Non-Identifying Information such as your responses to various questionnaires. In addition, during research activities you will wear a commercially available chest strap heart rate monitor and the Study app will record your heart rate during research activities.

This Privacy Statement does not apply to the collection of information in any way other than by interacting with the Study.

2.Your Choices

Participation in the Study is completely voluntary, and you can withdraw at any time. Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the researcher, your health care provider, or the University of North Carolina-Chapel Hill.

You may choose not to answer specific questions. If you feel uncomfortable while you are using the Study app, you may stop, inform the investigators, and, if you desire, withdraw from the study.

Similarly, although there are no known risks to wearing the heart rate sensor, it is a commercially available “off-the-shelf” product. While it should be worn to fit snuggly, when used in this study protocol, it should not cause any discomfort or irritation. If you feel uncomfortable while you are wearing it, you may remove it, inform the investigators, and, if you desire, withdraw from the study.

3. How We Use the Information

The information obtained from you will be used for app development purposes. Research is designed to benefit society by gaining new knowledge.  You will not benefit personally from being in this research study, as this research is designed to test a protocol to be used in the home-based intervention study.

The aggregated study data will be compiled for statistical analysis and reporting to determine new areas of research and possible recommendations to clinicians working with patients suffering from psychological health problems.

4. When and Why We Disclose Information

The research team will keep the research information for up to five years after the end of the study. At that time, all the information will be destroyed. Participants will not be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety.

Except as described above, we will not share or sell your study data to anyone for any purpose. We will not use your study data for any marketing purposes.

5. How We Collect Information

You will not provide us with your Personal Information.

We collect Non-Identifying Information via your interaction with the Study app.

6. Security

We use commercially reasonable security procedures to protect personally identifiable information that you provide to us. While we consider these procedures to be adequate, no method of transmission over the Internet, or method of storage, is completely secure. Therefore, there is still a risk that your personally identifiable information could be misappropriated and we cannot guarantee its absolute security.

7. Accessing and Correcting Personal Information

No Personal Information will be collected.

8. Privacy Practices of Third Parties

This Privacy Statement only addresses the use and disclosure of information by the research team through your interaction with the Study.

9. Notice to Residents of Countries outside the United States of America

This study is intended to use within the United States. Participants may continue to participate if they leave the country.

10. Children’s Privacy

We do not intend that any portion of the Study will be accessed or used by children under the age of eighteen, and such use is prohibited. The Study is designed and intended for adults. By consenting to participate in the Study, you represent that you are at least eighteen years old.

11. Contact Us

Please contact us if you have any questions or comments about our privacy practices or this Privacy Statement. You can reach us via postal mail at the following address:

SMILE Study Coordinator
University of North Carolina at Chapel Hill
Campus Box 7260

Chapel Hill, NC 27599-7200
Phone: (919) 378-1543
Email: SMILE@unc.edu

12. Glossary of Terms

Non-Identifying Information means information that alone cannot identify you. Non-Identifying Information may be derived from Personal Information. This includes the following types of information:

• Demographic Information (e.g., gender, race, ethnicity)
• Questionnaire Responses

Other Sources means sources of information that legally provide us with your information, and which are outside the scope of this Privacy Statement at the time of collection.

Personal Information means information about you that specifically identifies you or, when combined with other information we have, can be used to identify you. This includes the following types of information:

• Contact Information: email addresses, telephone numbers

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