CONSENT TO TAKE PART IN RESEARCH
Research to Detect Depression through Digital Behavior on a Smartphone.
You are being asked to take part in a research study. Taking part in this research is voluntary.
Who are we?
This research study is being carried out by Behavidenc Inc (www.behavidence.com), a commercial company that builds mental health navigation tools to help monitor mental health conditions such as Depression, Anxiety and ADHD using the technology of digital phenotyping. (Digital phenotyping refers to the science of leveraging behavioral data from smartphones to characterize individual human traits.) Before you decide to join the research, it is important that you understand why this research is being done and what activities will be involved. Please take time to read and understand the following information sheet carefully. Please email us at email@example.com if you have any questions. This research study is not meant to diagnose or treat medical problems.
What is the purpose of this study?
The purpose of this study is to learn if passive behavioral data, not content, collected through smartphone applications (apps) may be helpful in understanding more about Depression. This will enable us to create accurate digital behavioral models for Depression based on this data. This study involves downloading the Behavidence app to your smartphone and answering a short questionnaire. (<2mins)
Will you benefit from taking part in this study?
The app will help you in monitoring your depression through the help of our Mental Health Similarity Scores. Your participation may help others in the future as a result of knowledge gained from the research. You will not be compensated for participating in this research. You will receive your daily MHSS scores after the questionnaire has been completed. These will be free of charge.
What does this study involve?
The following steps are a core part of the study:
Sign up is anonymous. This means we will not be able to restore your data should you delete the app and reinstall it again.
Alternatively it can be done securely using your preferred email address and password. This app will be password protected using a password of your choice, so no one else will be able to access the app.
We will ask you to input a research code and complete a Depression questionnaire to get a baseline assessment . This will take 2-5 mins.
The app will collect passive data. No personal or content data will be tracked or collected. All of the data collected is immediately encrypted on the phone as soon as it is collected.
Once you have completed the questionnaire you will be routed to the Mental Health Similarity Score page where your scores will be available after an hour.
This research study collects two types of data:
The app will passively collect behavioral data from your phone once you have downloaded the app, but will not collect ANY content or any personal information. The data will be automatically collected unless you delete the app from your phone. Passive data means information about when your phone is turned on or off and when your phone is being used or not used.
Active Data Collection
The app will offer you the questionnaire to answer only once.
What are the options if you do not want to take part in this study?
Participation is voluntary; hence you can withdraw from the study at any time. Please do not sign the consent form if you do not want to take part in the study. Once enrolled in the study, you can withdraw from the study anytime by contacting us.
What are the risks involved with being enrolled in this study?
As a result of your participation in this study, you are at risk for side effects listed in this section. This may or may not happen.
It is also possible that although the app has many features to keep your data secure, there is a remote chance that your data or phone could be stolen. Although, all your data other than the one you see on screen is encrypted. If this were to happen, someone would know all the information the app has been collecting about you including your journal entries.
Other important items you should know:
Number of people in this study: We expect 500 people to enroll in this study.
How will your privacy be protected?
The app is HIPPA (Health Insurance Portability and Accountability Act) compliant, which ensures absolute confidentiality for our users. There is also an option to login anonymously where the user has to enter no personal information. Some of the steps that we take to ensure confidentiality are as follows:
All the data that we hold for our users is encrypted. We create random ID’s when you log in, which can in no way be tracked to your real name/email if you choose to enter it.
If we give any third parties access to our data, we add another level of encryption.
There is an option to sign in anonymously- if you choose to do so, we will not collect any identifiables.
We have an efficient alert based system for any external threat to our servers, i.e we are in complete control to protect our information if there is an external interference.
All Data Collected
You are free to stop the app collecting data at any time by deleting the app from your phone. Any data that has been collected before you delete the app will be used for research purposes, but no further or new data will be collected.
Will you be paid to take part in this study?
No. There is no monetary compensation for the study. You are able to use the app free of charge and receive your daily MHSS ( Mental Health Similarity Scores) for ADHD, Depression and Anxiety.
Whom should you call with questions about this study?
If you have questions about this study or concerns about a research related injury, you can email us at firstname.lastname@example.org
By clicking next I have read the above information about Participation in: Research to Detect Depression through Digital Behavior on a Smartphone and I agree to take part in the study.