Consent to Participate in Research

HRP-1721 / v11262019
Research Study Consent for Participants
Study Title:

Feasibility of a Mobile Educational Tool for Chronic Pain

Principal Investigators:

A. Vania Apkarian and Melissa A. Farmer

Support:

This research is supported by Aivo Health.

Protocol Pre-Registration:

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.

Conflict of Interest Disclosure:

The following disclosure is made to give you an opportunity to decide if this relationship will affect your
willingness to participate in this research study: this study is funded by Aivo Health.

Why am I being asked to take part in this research study?

You have expressed willingness to provide feedback about Aivo Health’s new mobile educational tool.
You are either an individual over age 18, a person living with any type of chronic pain, or a health care
professional who treats people with chronic pain. We expect up to 25 people in this research study.

What should I know about participating in a research study?

The following is a short study summary to help you decide whether to be a part of this study.
 The purpose of this study is to evaluate use and engagement with a new mobile educational
tool designed for people with chronic low back pain.
 You will be screened for eligibility with an online questionnaire (10 min) and a video interview
(1 hr). If you are eligibile, you are shown how to download the app and are allowed to use it for
2-4 weeks. We conduct follow-up interviews 2 days after you begin using the app (1 hr), a
small focus group interview after 2 weeks of app use (1-2 hr), and for individuals who choose
to continue using the app, an additional interview after 4 weeks of app use (1-2 hr). All
research is done remotely, with no in-person visits. You will interact with one or more Aivo
Health Coaches and interact with other research participants via the Peer Group chat function
on the app.
 We expect that you will be in this research study for up to 4 weeks, with no in-person visits.
A member of Aivo Health will explain the study to you and answer any questions you have. You can
ask all the questions you want before you decide. Whether or not you take part is up to you. You can
agree to take part and later change your mind. Your decision will not be held against you. You do not
have to answer any question you do not want to answer.

Will being in this study help me in any way?

We cannot promise any benefits to you or others from your taking part in this research. The main
benefit of being in this study is that your feedback will help streamline an educational tool that can
help many people living with chronic pain. There is no payment for participating in this study.
Is there any way being in this study could be bad for me?

Is there any way being in this study could be bad for me?

The primary potential risk of participation is distress related to chronic pain (if you have chronic pain),
given that the app promotes reflection about pain. We will do everything we can to minimize this risk.

How will the researchers protect my information?

Your data will be encrypted and identifiable information is stored separately from the rest of the
research data. We keep de-identified transcripts of interviews/focus groups. Please respect the
privacy and confidentiality of other focus group participants and keep discussions confidential.
However, we cannot guarantee confidentiality. Please keep this in mind when choosing what to share
in the group setting. We comply with the EU’s General Data Protection Regulation (GDPR).

Who will have access to the information collected during this research study?

We limit the use and disclosure of your personal information to people who have a need to review this
information. Researchers may release information about you when you say it is okay. Aivo Health
researchers cannot release or use information that may identify you in any action or suit unless you
say it is okay. They cannot provide them as evidence unless you have agreed. You can obtain a copy
of your data by submitting a formal request.
Identifiable information that could still be disclosed beyond the research team: reporting required by
federal, state or local laws. Disclosures may be required by the federal Food and Drug Administration
(FDA). Your information may be used for other research if allowed by federal regulations.
Information about you may be used or seen by other people beyond the Aivo research team during or
after this study. Examples include:
 Government officials may need access to study information to make sure the study is done in
a safe and appropriate manner.
 The Aivo Health research team may give information to authorities for reasons of health and
safety. If you indicate that you plan to harm yourself or others, you tell us about child abuse or
neglect or sexual misconduct, we may be required by law to report to authorities.

How might the information collected in this study be shared in the future?

We will keep this study data for recordkeeping and for potential future research. The researchers may
contact you again for future research studies. We cannot guarantee anonymity of your personal data.

HIPAA Authorization -- Permission to Use Personal Health Information For Research

We are committed to respect your privacy and to keep your personal information confidential. You
are giving us the permission to use your personal health information that includes information that can
identify you. Personal health information may include your name, email, and phone number.
We may collect and use the following data types: daily symptom reporting, medical history, certain
health information indicating or relating to chronic pain, questionnaires related to personality and
behavior, medication history, and mental and physical health information (e.g., previous diagnoses).
We request your permission to record the video interview for internal use only. You may choose to opt
out of video recording, but the video interview is required for participation.
This consent expires on December 31, 2040. After this date, Aivo Health may not gather new
information about you unless we obtain permission from you. Illinois State Law permits use and
disclosure of your mental and physical health information only to the extent specified in this document.
We may share some of this health information with the US Office of Research Integrity; the US Office
for Human Research Protections; and the US FDA. Research information shared with outside entities
will not contain your personal identifiers unless it is necessary for review or is required by law or
company policy.

The following entities may receive your health information:
 Authorized members of the Aivo Health (clinic and data science teams).
 Study monitors and the company’s contractors and partners who make sure that the study
is being done properly;
 Government agencies and public health authorities, such as the FDA and the Department
of Health and Human Services (DHHS).

The people who get your health information may not be required by Federal privacy laws (such as the
Privacy Rule) to protect it and may be able to share your information without your separate
permission. Federal law/42 CFR Part 2 prohibits unauthorized disclosure of these records.
This consent expires December 31, 2040. You do not have to authorize the use or disclosure of your
health information; however, you will not be allowed to take part in this research study. Although you
may revoke consent to participation in this research at any time and in any format, you must revoke
authorization for use or disclosure of your health information in writing.
If you have questions, concerns, complaints, or to revoke your authorization, contact Dr. Melissa A.
Farmer at melissa@smtg.co. This research is for internal use within Aivo Health and has not been
reviewed by an Institutional Review Board.

Confirming Consent

If you want a copy of this consent for your records, you can print it from the screen. If you wish to
participate, please click the “I Agree” button and you will be taken to the survey. If you do not wish to
participate in this study, do not select the “I Agree” button in the corner of your browser.