Consent to Participate in the Lupus Registry using the “MyLupusJourney” App

Your confidence in the privacy of your personal information is of the highest concern to the FORWARD staff. We will never give anyone any information that can identify you by name. We take care to respect your privacy and we comply with all privacy requirements. You will never be asked to pay any fee or purchase anything. Participation in the project is absolutely free and voluntary!

COPY ONLY – CONSENTING CAN ONLY BE COMPLETED IN THE “MyLupusJourney” APP

Informed Consent

Please read this information carefully. Talk to the researchers if you have any questions about the study. You may also want to discuss it with your friends, family, or your doctor.

If you choose to join the study, you will need to read this consent form, and if you agree, your information will be electronically shared with the Study Sponsors and the Investigators to show you chose to join the study (such as name, email address, and date). Before you sign, make sure you understand what the study is about, including any risks and benefits.

You do not have to join the study if you do not want to. You may also leave the study (withdraw your consent) at any time. If you choose to leave early or choose not to join, there will be no penalties, and your future care will not be affected.

Who is doing this research?

Study Sponsor: This study is supported by the Arthritis Research Center Foundation/FORWARD (727 N. Waco, Suite 200, Wichita, Kansas 67203) and Alira Health (1 Grant St, Suite 400, Framingham, Massachusetts 01702)

Investigators:

  • Kaleb Michaud, PhD, FORWARD (associated with the University of Nebraska Medical Center)
  • Patti Katz, PhD, University of California San Francisco
  • Jennifer Lannon, Alira Health

Location of Research:     FORWARD, 727 N. Waco, Suite 200, Wichita, Kansas 67203

What is this research study about and how long will it last? Who will take part?

We invite you to join a study about lupus, including:

  • Systemic lupus erythematosus (SLE): A form of lupus that affects many parts of the body.
  • Cutaneous lupus: A type of lupus that affects the skin.
  • Lupus nephritis: A kidney condition that happens in people with lupus.

The goal is to understand how lupus affects people, find the best treatments, and improve care for those with lupus.

This is a long-term study with no set end date, so there is no fixed number of months or years. You can leave the study at any time without affecting your legal rights or your medical care.

Thousands of people from all over the world will take part in this study.

What happens if you join this study?

If you join, you will be asked to download the MyLupusJourney App and fill out a survey each month. The surveys will ask about your lupus, your treatments, and how it affects your daily life. You will keep getting surveys even if you move or change doctors.

As explained in a separate email, if you shared personal or health information to Heath Storylines or FORWARD, and if you agree to use the new MyLupusJourney App, the information you provided before and in the future may also be analyzed to reach the study goals.

If you join this study, it also means you will update us if your Country, State or ZIP code changes.

This study has no experiments and will not change your medical care. Your choice to join or not will not affect your legal rights or your medical care.

Data about you that we will store includes:

  • ID number from previous platform
  • First name
  • Last name
  • Email address
  • Phone Number
  • Country, State/Province, and ZIP/Post code
  • Alternative Email and Phone
  • Diagnosis
  • Health Questionnaire responses
  • Activity status in the program (Completed/In Progress/To Do)

Data from this study might also be linked with data from the National Center for Health Statistics, the Center for Medicare and Medicaid Services, and other administrative databases. These databases have details about diagnoses, doctor visits, hospital visits, and lab tests. Your name, date of birth, city, and/or state might be used to match your data with theirs.

Your data from this study will be linked with your data in the FORWARD Databank and/or in Health Storylines. Only the FORWARD and Alira Health researchers will have access to your data. This data linkage will allow us to see data about you from the FORWARD Databank and/or Health Storylines, such as:

  •  Medications you have taken and when you took them.
  • Side effects you experienced.
  • Specific health conditions.
  • Responses to health questionnaires.

What are the risks or discomforts from being in this research?

There are no physical risks in this study. You can skip any questions in the App or on the survey if you do not want to answer them.

The main risk is about keeping your information private. Your data will never be shared with others in a way that reveals who you are. If results from this study are published, your identity will remain hidden. Your information may be shared with federal and regulatory agencies if needed. We will do our best to protect your privacy, but there is always a small chance that your information could be accidentally shared.

What are the possible benefits from this research?

There are no direct benefits to you from taking part. However, the information from this study could help others with lupus and similar conditions in the future. You may also be contacted about other research opportunities for which you may be eligible.

What are the other options if you don’t join this study?

You can choose to not join the study.

Is there a payment for taking part in this study?

Every 6 months, there will be a random drawing for people who complete their surveys in the app: 5 random people will receive $100 each. Since we do not know how many people will return their surveys, we cannot say your exact chances of winning. Payments will be made with a gift card sent via email or mail, or a check sent by mail. We send out payments twice a year after the 6-month survey period ends.

Are there costs for joining the study?

No, there are no costs for you to join the study. You will, however, be responsible for the cost of your device and internet required to use the app. We will not reimburse you for these costs.

How will your privacy and data be protected?

Your participation in this study will be private. State and federal laws, like the Federal Privacy Act, help protect your information.

Here is how we will keep your information safe:

  • We will code the data and remove your personal details.
  • Computers will be protected with passwords and firewalls. A firewall is a kind of computer security that stops unauthorized people from accessing your information.
  • We will lock drawers and offices where your data is stored.

Researchers at FORWARD and Alira Health will do their best to protect your privacy. However, there is a small chance that your information could be lost or shared by mistake.

By agreeing to this form, you allow us to use information from this study in medical journals, for education, and to improve medical science. Your name or identity will not be shared.

How will my personal health data be used and transferred?

If you agree to participate, the MyLupusJourney App will require your consent to use your Protected Health Information, like your answers to Lupus-related questions. You will also be asked to allow us to share this information with the FORWARD team. They might contact you to help with the questionnaire or to ask for more details.

Both Alira Health and FORWARD will have access to your personal information to manage the study, following the rules described in the MyLupusJourney Application Privacy notice.

We will not look at your medical records (the information that your healthcare providers have about you) unless you sign another consent form.

Can my personal information be used for something else?
If you agree to an optional consent form, your personal data could be used in the future to offer you opportunities like:

  • Finding out if you qualify for a new clinical trial, interview, patient advisory board, survey, or other research activity.
  • Contact you to participate in one of these activities.

If you qualify, you will get a notification or email. If you are interested, you can ask for more details and will be
provided with more information.

You can change your mind at any time and opt out of having your data used or receiving related emails and
notifications. To do this, contact Customer Support through the Support section of the app.

TO QUIT THE STUDY:

You can stop being part of this study anytime by withdrawing your consent. This will not affect your medical care or any benefits you get.

To quit:

  • Go to the Support section of the App and ask Customer support to withdraw from the study.
  • Or write to Rebecca Schumacher at 727 N. Waco, Suite 200, Wichita, KS 67203.

The principal investigator can also end your participation if they think it is best for you, if you cannot follow the

VOLUNTARY PARTICIPATION:

Joining this study is your choice. If we find any information during the study that might change your decision, we will let you know.

CONTACT INFORMATION:

Principal Investigator (PI)

The Principal Investigator or someone on the research team will be available to answer your questions during this study.

  • Principal Investigator: Kaleb Michaud, PhD, FORWARD
  • Phone: 316-263-2125
  • Mailing Address: 727 N. Waco, Suite 200, Wichita, KS 67203
  • Email: [email protected]

The Institutional Review Board  (IRB)

The IRB is an independent group that checks, approves, and watches research studies to make sure they are safe and protects your rights.

If you have any questions about your rights as a research subject, or if you have concerns or complaints about the study, you can contact:

If you don’t understand any part of this consent, ask the investigator to explain it before you agree. You can also talk to your doctor or a legal advisor if you want.

Consent

By checking the box below and filling out the survey(s), you agree that:

  • You have read this form and understand it.
  • You give permission for your data to be used in this research.
  • You want to take part in the study.
  • You accept that your information (like your name, email address, and the date) will be shared electronically with the researchers to confirm you chose to join the study.

You can always review this consent form in the Mobile app:

  1. From the Mobile app homepage click on the Menu icon (≡) on the upper right side of your screen.
  2. Click on the support Tab.
  3. From the Support screen you can review this Informed consent.

Optional Consent for Data Reuse and Recontact
By selecting “I Agree” below, you allow us to reuse your data to see if you qualify for future research opportunities. You also agree to let us contact you to invite you to participate in these opportunities.