Study Informed Consent Form 

RESEARCH CONSENT SUMMARY

You are being asked for your permission (consent) to take part in a research study. This section provides a summary. It describes key information to help you decide if you want to take part. Later sections of this document will provide other important details you need to know.

What should I know about this research?

Your participation is voluntary (optional). You can decide to take part now and drop out later and it will not be held against you. If you sign this form, you are giving your permission (or consent) to participate in this study.  You can also agree to participate in this study and withdraw any time if you change your mind later.  If you do NOT want to participate in the study or decide to withdraw from the study later, this will not be held against you (you will not experience any penalty or loss of benefits to which you are otherwise entitled).

Why is this research being done?

The purpose of this study is to gather feedback on a potential program that collects and shares real-world information to help create products and services to support people who have substance use disorders.

What will I be asked to do if I agree to take part in this research?

If you decide to take part in this research study you will be asked to:

• Complete a screening and eligibility questionnaire
• Complete an online interview with a study researcher (this will be recorded)
• Agree to share data you have already contributed through your Evidation account

Could taking part in this research hurt me? 

This study involves questions about substance use which may cause emotional stress or discomfort. Another potential risk is that your study information could be subject to unauthorized access and your data could be linked to you.

Will taking part in this research benefit me?

It is not expected that you will personally benefit from this research. 

What else should I know about this research?

This study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). To protect your privacy, it has a Certificate of Confidentiality (CoC), which legally prevents us from sharing any identifying information unless you give written consent.

What other choices do I have besides taking part in this research?

This is not a treatment study. Your alternative is to not take part in this research study.

DETAILED RESEARCH CONSENT

Thank you for your interest in the  RESHAPE study sponsored by Evidation. We are interested in your feedback about the design of a program to collect and share real-world data with organizations seeking to develop products and services to support individuals with social challenges and substance use disorder.

The RESHAPE study is divided into two parts, an interview phase and a survey phase. We’re inviting you to take part in the interview phase because you’ve told us you’ve used substances or medications with mood-altering effects like cannabis, tobacco, illegal drugs, or prescription medications for nonmedical reasons.

Approximately 8 to 10 individuals will participate in this portion of the study.

Who is funding this study?

This study is being funded by the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH). 

What do I have to do to participate? 

• Complete a short eligibility screening questionnaire 
• Complete an approximately 60-minute online interview with an Evidation-designated academic researcher

The interviews will be recorded and conducted via Google Meet. You can choose to turn your video camera on or off during the interview. You may also ask interviewers to skip any questions that you do not wish to answer and you may end your interview participation at any point.

• Agree to share data you have already contributed as outlined in “What data will be collected from me as part of this study?” below

What data will be collected about me as part of this study?

• If you choose to participate, we may collect and analyze the following information (“study data”):
  • Information from your survey responses to the RESHAPE study screening questionnaire and information from your responses to interview questions about your attitudes and feedback on the design of a program that collects and shares real-world data with organizations and on potential program features and content to improve well-being; the questions may address the following topics: 
    • Your feedback about the design of a program to collect and share real-world information about experiences related to substance use and health-related social needs
  • Name and contact information, for example: 
    • Name
    • Postal (mailing) address
    • Email and phone number
  • Identifiers and device information, for example:
    • Internet Protocol (IP) address
    • Device identifiers, operating system, browser type 
    • Other system settings, such as language, time zone, and configuration 
    • Information from “cookies” and similar technologies, which we use solely for drop-off analysis (keeping track of when you exit out of a survey, questionnaire, or other window without finishing the task, so we can improve future surveys and tasks by making them more engaging)
    • Usage data for the Evidation platform, such as pages you viewed and how long you spent on a page
  • Audio and video recordings of the interview, though you may choose to turn your video camera on or off during the interview
• We’ll also link your RESHAPE data to the following data you’ve already contributed, and continue to contribute, as you use the Evidation platform. This includes the following data (when available): 
  • Self-reported demographic information: 
    • Age
    • Height
    • Weight
    • Birth sex
    • Gender
    • Race/ethnicity
    • Education status
    • Employment status
    • Caregiver status
    • Household size
    • Relationship status
    • Household income
    • Health insurance type
    • Zip code
  • Information from your responses to previous surveys you have completed about social determinants of health and substance use
  • Up to 1 year (for example, April 1, 2024 through April 1, 2025) of your previously collected activity data (for example, steps, sleep, and heart rate) from connected devices you have linked to your Evidation account with the 1-year lookback period starting on the day you agree to participate 

How long will this study last?

Your participation will end when you complete the approximately 60-minute online interview. Continued participation is completely voluntary (optional). You can decline to participate by exiting this consent form or asking to stop the interview at any time.

The Investigator can stop your participation at any time without your consent for the following reasons:

• If you fail to follow directions for participating in the study;
• If it is discovered that you do not meet the study requirements;
• If suspicious activity or abuse is identified;
• If the study is canceled; or 
• For administrative reasons, for example, enough people have already signed up for the study, or the sign-up period ended.

This study will also end if you withdraw. Details about how to withdraw are described in the “What if I want to stop taking part in this study?” section below. 

Will I be compensated for participating?

If you agree to participate you will earn:

• 100 Evidation points for completing the one-time screening questionnaire. 
• 25 Evidation points for completing the steps to schedule the online interview.
• $75 for successfully completing a one-time approximately 60-minute online interview as part of the RESHAPE study.  The compensation earned from this interview will be sent to you electronically via Tremendous, our online payment partner, at the end of participation in the research study. 

 

All point earnings are subject to Evidation’s terms of use and rules, available here. There are no costs to participate in this study.  

 

10,000 points can be redeemed for $10 through your Evidation account

 

How will study data be used? Who will have access to study data?

Evidation and external academic research partners will use study data to understand your feedback about the design of a program to collect and share real-world data and support individuals with social challenges and substance use disorder.  In general, before disclosing study data to persons not affiliated with Evidation, we will remove directly identifying information (such as your name and email address). We then replace that data with a randomly generated sequence of numbers and letters (for example, 18903fhsi564afs), so it becomes “coded study data.” We will only use coded study data for analysis in this study. 

 

We may make uncoded study data and coded study data available to specific third parties. Uncoded study data will only be accessible by a limited number of authorized Evidation personnel and select Evidation vendors in the list below. 

1. External research partners (e.g., University of Southern California)
   1. Type of uncoded study data: Your name, email, responses to interview questions about your attitudes and feedback on the design of a program for people who use substances, and any other information you provide during the interview
   2. Purpose: To conduct your interview.

2. Google Meet
   1. Type of uncoded study data: Your name, email, audio and video recordings
   2. Purpose: To schedule and record your interview (if applicable). Their privacy statement can be viewed by visiting https://support.google.com/meet/answer/9852160.
3. Tremendous, Inc.
   1. Type of uncoded study data: Your name, address, telephone number, email
   2. Purpose: To send you payment for your participation in this study. Their privacy statement can be viewed by visiting https://www.tremendous.com/privacy.

The following persons may have access to coded study data or a summary of coded study data:  

• Evidation personnel, who help administer this study.  
• External research partners, who advise on and help administer this study and prepare the results of this research for presentation and/or publication.
• Scientific publications, who verify the quality of the research and help prepare the results for publication. 
• External Evidation vendors, who assist with executed study-related activities. For example, we use the Google Meet service to help facilitate your interview.

We will only publicly share results from this study using a summary of coded study data. We will never include directly identifying information, such as your name, in public results from this study.  We may also use quotations from study data, including your answers to the survey and/or interview (if applicable), in publications and presentations, but we will not attribute the quotations to you. Evidation may also use study data to identify future research or other opportunities for which you may qualify. Taking part in such future research is voluntary and may require you to sign a new consent form. Coded study data may also be used for the following purposes: 

• Research related to this study, and
• To design future studies.

Identifiers might be removed from your identifiable private information collected during this study and could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.

What are the potential benefits and risks of this study?

This is a greater than minimal risk study that involves questions about substance use which may cause emotional stress or discomfort. If you’re uncomfortable with any part of the screening survey, you can exit or choose to stop the survey at any time by tapping “Done” in the top right corner of the survey screen in your Evidation app. 

If you’re uncomfortable with any part of the interview, you can ask the interviewer to take a break or skip any questions that you do not wish to answer or you may end your interview participation at any point. 

Your Study Data will be treated as private and confidential, as explained in this consent agreement. Evidation, along with our partners and vendors, take measures to ensure the confidentiality of your Study Data. There is, however, the potential risk of loss of privacy associated with participating in the study, and absolute confidentiality cannot be guaranteed. If confidentiality were breached, information about substance use could lead to stigma or legal concerns. There are technical and organizational procedures in place to minimize this risk. As described in the “How will study data be used? Who will have access to study data?” section, we use coded study data to help us minimize the overall amount of information that we share with others while still achieving the purpose of this study.  Study data and coded study data will be stored securely at all times on limited access, encrypted servers by Evidation Health and external research partners. Only limited, authorized Evidation staff can view study data, and all analysis will be done using coded study data. This means directly identifying information, like your name and contact information, will be removed. It’s also possible that another person near you may see your survey responses on your phone or computer screen or may hear your interview responses. You may have audio and video recording of you so there is the risk that someone may recognize you. There may be other risks that are unknown. 

As part of this research, you may be required to use your personal device to access Evidation’s mobile application or web app/site. The confidentiality of information kept on a personal device is always at risk for being compromised in several ways, such as when the device is shared with others, lost or stolen, or hacked. Please refer to Evidation’s Privacy Notice and Terms of Use if you have any questions. 

While the Terms of Use or Privacy Policy may include statements limiting your rights if you are harmed as a result of your use of the Evidation’s mobile application or web app/site in this study, you do not release the investigator, sponsor, institution, or agents for responsibilities from mistakes. You also do not waive any of your rights as a research subject.

To protect your privacy, this research study has been granted a Certificate of Confidentiality by the National Institutes of Health (NIH). This means that we are legally prohibited from disclosing any information that could identify you in any legal proceeding, unless you provide written consent to do so. 

There are some important limitations that you need to know.  The Certificate DOES NOT stop reporting that federal, state or local laws require, such as laws that require reporting of threats to harm yourself or others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.

This study is for research purposes only. There is no direct benefit to you from your participation in the study. Information learned from the study may help other people in the future.

 

What if I want to stop taking part in the study?

Continued participation is completely voluntary (optional). You may ask to end the interview at any time. You may also withdraw from the study by navigating to your Evidation profile, choosing “programs”, selecting this study (RESHAPE), and choosing “unenroll” or when viewing your signed informed consent form choosing the “Withdraw consent” option. 

You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care. If you choose to stop taking part in the study, ongoing collection of study data will end when  you withdraw, and any study data already collected will continue to still be used as described in the “How will study data be used? Who will have access to study data?” section.

If you choose to delete your Evidation account during your participation in this study, we will treat your account deletion as a request to remove yourself from the study, which will include deletion of your study data except interview data. This includes, but is not limited to the following data: App/Platform interactions, surveys, wearable activity trackers, and profile data. However, interview data and any study data that has been archived as part of the study dataset will not be subject to data deletion requests, and any previous data shared with the research partners (e.g., Medical University of South Carolina, University of Southern California) before receiving the data deletion request cannot be reversed.

This research study is for research purposes only. The only alternative is to not participate in this study.

What happens if there are changes to the study?

If there are any changes to this study that may impact your decision to participate, we will promptly notify you as required by law. When we notify you of changes, you’ll be given the opportunity to stop participating in this 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 such as:

• Whom to contact in the case of a research-related injury or illness;
• Payment or compensation for being in the study, if any;
• Your responsibilities as a research subject;
• Eligibility to participate in the study;
• The Investigator’s or study site’s decision to withdraw you from participation; 
• Results of tests and/or procedures;

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, 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: Pro00085294.

 

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

 

Responses to this survey are subject to our Privacy Notice and Terms of Use.

I have read all of these study materials. I understand the consent form. I fully understand the contents of this research study as it relates to my participation.

By completing the fields on the next screen, I give my consent to take part in this research study. I also consent to receiving standard email communication, texts, and phone calls, from the research team. Standard text message rates apply.

[checkbox] I give my consent to take part in this research study and allow my personal information to be collected and used as described above.

[checkbox] I certify that I am completing this consent on my own behalf and that my electronic signature, as documented by completing the fields below, is a true and binding legal equivalent of my handwritten signature on this consent form. 

Electronic Signature (please type name below)

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First Name:

Last Name:

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