INFORMED CONSENT FORM AND AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION
| Sponsor / Study Title: | Noom, Inc. / “Noom Stress and Anxiety Management Observational Protocol” |
|---|---|
| Principal Investigator: | E. Siobhan Mitchell, Ph.D., (Study Doctor) |
| Telephone: | 347-687-8522 (24 Hours) |
| Address: | Noom, Inc. 450 West 33rd Street New York, NY 10001 |
You are being asked to be a volunteer in a research study.
Please read this form carefully. If you have any questions, ask the study staff.
Introduction and Purpose
Noom delivers structured programs to manage stress and anxiety with human coaching. To improve the quality of interventions provided and to inform research questions regarding wellbeing and behavior, Noom will collect in app user data over a period of 10 years. You will receive a notice indicating when a new study begins and ends. By using the app, you consent to and authorize Noom to use your information for research purposes. This information is always de-identified (coded) and does not include protected health information. You might be enlisted in one of the research studies related to your use of our stress and anxiety management program.
About 3,000 subjects are expected to volunteer for this study.
What is a research study?
A research study is when scientists try to answer a question about something that we don’t know enough about. Participating may not help you or others. People volunteer to be in a research study. The decision about whether or not to take part is totally up to you. You can also agree to take part now and later change your mind. Whatever you decide is okay. There will be no penalty or loss of benefits to you. It will not affect your ability to use Noom’s applications (apps). Any new information that develops during this research study which might make you change your mind about participating will be given to you promptly.
Study description
You will download the Noom mobile application to your Android or Apple phone. You will be assigned a lifestyle coach who will guide you through your program and daily participation in the Noom app. You will be asked to read articles and complete activities within the app. Your coach from Noom, Inc. will contact you on the app periodically to offer advice and encouragement.
De-identified in-app data you log (including but not limited to age and gender) will be used to answer research questions related to wellbeing and behavior that may help in the future improvement of the app, the programs offered through the app, and stress and anxiety management.
Risks
There are no foreseeable risks involved with using the Noom app. You may feel some discomfort while reflecting on difficult experiences or emotions. There may be other risks that are unknown. You may stop using the Noom app at any time.
Benefits
You may or may not experience improved psychological wellbeing related to your in-app activities. Additionally, you might contribute to our knowledge of stress and anxiety management programs, which could potentially help others improve their wellbeing in the future.
Compensation and Cost
You will not be compensated for participation in Noom’s research studies, unless you complete additional, optional surveys sent to you by the Academic Research team. If you are invited to complete these surveys, you will receive a separate consent form where you can indicate if you agree to participate and which will notify you of potential compensation, including being entered into a raffle for up to $200 and/or compensation of $20 per survey packet. There is no cost to you for taking part in this study.
Financial Disclosure
The principal investigator and study staff have a proprietary interest in this research study (for example, patent, trademark, copyright, or licensing agreement). Contact research@noom.com if you have additional questions.
Confidentiality
The information that we collect from you for this research project will be kept confidential. Only authorized personnel will have access to your identifying information. A participant ID will be issued to you and used within our research database.A code will be used instead of your name. All of your study data will be kept in a secure location.The Department of Health and Human Services and Advarra IRB may have access to the study data.
Options
You may decide not to take part in this research study without any penalty. The choice is totally up to you. If you decide not to participate, please contact research@noom.com.
Ending Participation in a Research Study
You may stop taking part in this research study at any time without any penalty. This will not affect your ability to continue using the Noom app.
If you decide to stop being in the research study, please contact the Research Department at research@noom.com.
Your part in the research may stop at any time for any reason, such as, the sponsor or the investigator decides to stop the study.
Whom to contact about this study
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study, please contact the Investigator at the telephone number listed on the first page of this consent document. If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, contact:
By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
or call toll free: 877-992-4724
or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser: Pro00055306.
By using your UPID (unique program identification) or logging into the app, it means that you have read the information given in this consent form, you would like to be a volunteer in one of our studies, and you authorize Noom to use your information for research purposes.
