Informed Consent 

 

Participation in: Research to Detect Mental Health Conditions through Digital Behavior on a Smartphone.  

 

Introduction:  

You are being invited to take part in research. This research is being carried out by Behavidence Inc. Behavidence (www.behavidence.com) is a commercial company that builds mental health navigation tools to help monitor mental health conditions such as Depression, Anxiety and ADHD (Attention Deficit Hyperactivity Disorder) 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 research@behavidence.com if you have any questions. Please note that this research study is not meant to diagnose or treat medical problems.

 

Why am I being invited to take part in a research study?  

We invite you to take part in this study because you have agreed to help research in developing a digital similarity score for mental health conditions. . There will be a total of 100 persons with a mental health condition in this study in addition to 100 control participants. All participants will be recruited online.

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Why is this research being done?  

The purpose of this investigational study is to learn if passive behavioral data, not content, collected through smartphone applications (apps) may be helpful in understanding more about affective mental health conditions. This will enable us to create accurate digital behavioral models for these conditions  based on this data.  This study involves downloading the Behavidence app to your smartphone and answering a short questionnaire (less than 2 mins).

 

How long will the research last and what will I need to do?  

You will need to download the app and use it as per your convenience for a period of 30 days. You will also answer the questionnaire only once i.e. when you sign up for the app.  

 

This research study collects two types of data: 

 

1. Passive 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.

The forms of passive data that we collect are App open and close, digital screen time, digital sleep time and gyroscope. 

   2. Active Data Collection  

The app will offer you the questionnaire to answer only once, while onboarding, during the 30 day duration, which you are encouraged to answer. 

 

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. 

 

Research Procedures

If you qualify to take part in this research study, you will undergo these research procedures:

• At the time you decide to respond to the advertisement, you will be asked to sign up and provide basic demographic details. We will ask you to complete a standardised  questionnaire to get a baseline assessment. 

• Sign up can be done securely using your preferred email address and password

• This will take 2-5 mins. This app will be password protected using a password of your choice, so no one else will be able to access the app.  You have the choice to log in anonymously. This means we will not be able to restore your data should you delete the app and reinstall it again. 

• The app will collect passive data but no personal content data will be tracked or collected. All of the data collected is immediately encrypted on the phone as soon as it is collected. .

• You are free to use the app according to your convenience, 

 

I am not very technologically inclined; how will I be able to use the app? 

The app is very simple to use. It will give you a daily Mental Health Similarity Score to ADHD, Depression and Anxiety. There is also a journal option. You can simply use the app to monitor your mental health, journal and also to manage your digital use just by opening the app. 

 

Is there any way being in this study could be harmful to me?

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.There may be other unforeseeable risks.

 

1. Data loss 

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, 22although all your data other than the one you see on screen is encrypted. If this were to happen, someone would know  your MHSS scores and your journal entries. 

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Steps to ensure confidentiality:

The app is HIPAA (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-

1. All the data that we hold for our users is encrypted. We create random IDs when you log in, which can in no way be tracked to your real name/email if you choose to enter. 

2. If we give any third parties access to our data, we add another level of encryption. 

3. There is an option to sign in anonymously. If you choose to do so, we will not collect any identifiables. 

4. 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. 

5. As noted above, all data the apps collect are not monitored in real time and no one will be able to respond to that data in real time. If at any time, and for any reason you need help you can email the research coordinator at research@behavidence.com

 

AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES 

 

What information may be used and given to others?

The physician and the research team associated with the study  will have access to your completely de-identified data, and your daily mental health similarity scores. The study doctor has no access to your name, or any other personal identifiable information. 

 

Who may use and give out information about you?

As you are completely de-identified, your data will be shared as part of an anonymous bucket of information to build machine learning algorithms. 

 

Who might get this information?

• The sponsor of this research.  “Sponsor” means any persons or companies that are:

• working for or with the sponsor, or 

• owned by the sponsor.

In this case, the sponsor is Behavidence.

 

Your information may be given to the following groups. Absolute confidentiality is guaranteed as your data is completely de-identified. 

 

• The U.S. Food and Drug Administration (FDA),

• Department of Health and Human Services (DHHS) agencies,

• Governmental agencies in other countries,

• Governmental agencies to whom certain diseases (reportable diseases) must be reported, and

• WCG IRB. 

 

Why will this information be used and/or given to others?

• to do the research, 

• to study the results, and 

• to make sure that the research was done right.  

 

If the results of this study are made public, information that identifies you cannot be used, as you are completely de-identified. 

 

What if I decide not to give permission to use and give out my health information?

Then you will not be able to be in this research study.

 

May I review or copy my information?

 

Yes, but only after the research is over, and if you sign up with an email address. Should you sign up anonymously, we are unable to find your data. 

 

You have the right to review any mental health information collected about you and shared with others.  

 

May I withdraw or revoke (cancel) my permission?

 

Yes, but this permission will not stop automatically. 

 

This permission will be good until December 31, 2070. [pre-board: check to see if there is a definite time in the submitted section]

 

You may withdraw or take away your permission to use and disclose your health information at any time.  You do this by sending a written notice to the study doctor.  If you withdraw your permission, you will not be able to stay in this study.

 

When you withdraw your permission, no new health information identifying you will be gathered after that date.  Information that has already been gathered may still be used and given to others.  

 

Is my health information protected after it has been given to others?

There is NO risk that your information will be given to others without your permission.

 

However, as a result of your participation in this study, you are at risk for less than minimal side effects listed in this section. 

 

Will being in this research help me in any way?  

There are no personal benefits to you from taking part in this research. This application is experimental and should not be used to diagnose or monitor mental health conditions. Your participation may help others in the future as a result of knowledge gained from the research.

 

What happens if I do not want to be in this research? 

Participation in research is completely voluntary. Your alternative is not to be in this study. You can decide to participate or not to participate. If you choose not to take part, or if you leave the study, your decision will not result in any penalty or loss of benefits to which you are otherwise entitled. This research study is not meant to diagnose or treat medical problems.  Participation in this research study does not take the place of routine physical examinations or visits to your regular doctor. In addition, you are free to leave this study at any time even if you have already consented to be in the study. Withdrawing from the study or leaving early will have no negative consequences.

 

Do I have to pay anything from my side for my participation in this study? 

You will not be charged for your participation in this research study. 

 

You will not be paid for being in this study.

 

Can I use the application even after the study is over?

Yes, you are welcome to use the app for however long you want to. It will always be available to you free of cost.

 

What happens at the end of the study? 

Your data will be used as unidentified data to help build more accurate models. You are free to continue using the app or uninstall the app. 

 

Undertaking by the investigator 

 

Your consent to participate in the above study is sought as a user. You have the right to refuse consent or withdraw the same during any part of the study without giving any reason. In such an event, you will not be forced to continue in the study.

 

Behavidence Inc., undertakes to maintain complete confidentiality about the information that you provide us as part of this study. The information / data obtained from you will be stored with coded identification to ensure anonymity and utmost confidentiality and will be used for research only. Data obtained in this research study may be used in other of our research studies in deidentified format. The results of this study may be presented at meetings or in publications; however, your identity will not be disclosed in those presentations or publications. 

 

If you have any questions, complaints or concerns regarding this study, or if any problems arise during your participation in the study, you may contact us at research@behavidence.com  or +1 252 486 4519

 

This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if: 

• You have questions, concerns, or complaints that are not being answered by the research team.

• You are not getting answers from the research team.

• You cannot reach the research team.

• You want to talk to someone else about the research.

• You have questions about your rights as a research subject.

 

Consent for participating in the research:

I have read this consent form and have been informed about the procedures involved in Research to Detect Mental Health Conditions through Digital Behaviour on a Smartphone.

 

I understand that for this study I will use the Behavidence application on the smartphone that I have downloaded. The study duration is 30 days and requires a questionnaire to be filled at one time point. I have understood the types of active and passive data that are being collected through these devices. I understand that the data collected will be processed and summary measures of the anonymized data will be used for data analysis, interpretation and scientific publications where no personal information will be revealed.

 

I understand that I have the right to refuse my consent or withdraw it at any time during the study. I am able to save this consent form on my smartphone and print it should I wish. Furthermore, for participating in this study, I may not stand to benefit directly through my participation in this research project.

 

By consenting to this, I hereby give my consent for participation in this research project and my consent for storage & sharing of my de-identified data as described above.