Informed Consent Form
INFORMED CONSENT FORM
Chesapeake IRB Approved Version 7 Jun 2016
Email Address: firstname.lastname@example.org
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 pre-chronic and chronic disease with human coaching. To improve the quality of lifestyle interventions provided and inform research questions regarding weight loss 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 listed below according to your program:
- Weight Loss research study
- Diabetes prevention research study
- Hypertension (high blood pressure) prevention research study
- Hypertension management research study
- Diabetes management research study
- Comorbidities (diabetes and hypertension) management research 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.
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 record your food intake, physical activity and weight through 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 weight loss and behavior that may help in the future improvement of the app, the programs offered through the app, and pre-chronic and chronic disease management.
There are no foreseeable risks involved with using the Noom app. You may feel some discomfort as you adapt to your new lifestyle with changes in exercise and eating habits.
You may or may not experience weight loss, and improvement in blood sugar levels or blood pressure, according to your in app program. Additionally, you might contribute to our knowledge of pre-chronic and chronic disease management programs, which could potentially help others lose weight and manage their pre-chronic and chronic conditions in the future.
You will not be compensated for participation in Noom’s research studies. There is no cost to you for taking part in this study.
The study doctor and principal investigator, has a proprietary interest in this research study (for example, patent, trademark, copyright, or licensing agreement). Contact email@example.com if you have additional questions.
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 Chesapeake IRB may have access to the study data.
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 fill out this form.
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 submit your request here.
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.
If you have any questions about your participation in the study, suggestions or concerns, please contact firstname.lastname@example.org.
Getting answers to your questions or concerns about the study
You can ask questions about this consent form or the study (before you decide to start the study, at any time during the study, or after completion of the study). Questions may include:
– Payment or compensation for being in the study, if any;
– Your responsibilities as a study subject;
– Eligibility to participate in the research;
– The investigator’s or study site’s decision to exclude you from participation;
– Other questions, concerns, or complaints.
Contact the investigator or study staff listed on the first page of this form with any questions, concerns or complaints.
Getting answers to your questions about your rights as a research subject
This study has been reviewed by an Institutional Review Board (IRB). This Committee reviewed this study to help ensure that your rights and welfare are protected and that this study is carried out in an ethical manner.
For questions about your rights as a research subject, contact:
Study Subject Adviser
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
or call toll free: 877-992-4724
or by email: email@example.com
Please reference the following number when contacting the Study Subject Adviser: Pro00017565.
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.