Informed Consent

If you have been diagnosed with rheumatoid arthritis, osteoarthritis, fibromyalgia, lupus, axial spondyloarthritis, Dupuytren disease, Ledderhose disease, Peyronie’s disease, psoriatic arthritis, Still’s disease, viral arthritis, gout, or any other rheumatic condition you can enroll in this research project.

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!

Please review the two tabs below.

To print these out, you must click each tab separately and print once for each time.

Consent to Participate in Research Study

The National Databank for Rheumatic Disease, Improving Long Term Outcomes in Arthritis 

Informed Consent

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

If you choose to join the study, you’ll need to read this consent form, and you accept that your information will be electronically shared to the researcher 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 don’t have to join the study if you don’t want to.  You may also leave the study 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: Arthritis Research Center Foundation/FORWARD

Investigators:     Kaleb Michaud, PhD, FORWARD (associated with the University of Nebraska)

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 arthritis and similar conditions, called rheumatic diseases.

The goal is to understand how they affect people and to find the best treatments and how safe they are for these diseases.

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 be part of this study.

What happens if you join this study?

If you join, you will be asked to fill out a survey every 6 months by mail, internet, or phone. The surveys will ask about your arthritis or similar conditions, the treatments you’re getting, how the condition affects your daily life, and your medical costs. You will keep getting surveys even if you move or change doctors.

If you join this study, it also means you:

  • Will let your doctor send us lab tests and information about your condition
  • Might talk to an interviewer on the phone
  • Will update us if your address changes
  • Will allow us to contact your doctors or hospitals for more details about your care

This study does not involve any experiments and will not change your medical care. Your choice to join or not will not affect your legal rights or your medical care.

The data from this study might 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, state, and/or social security number might be used to match your data with theirs.

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

There are no physical risks in this study. You can skip any questions on the survey if you don’t 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.

You might get text messages and/or phone call reminders from the research team. Text messages will only be sent if you agree to them when you sign up for the study. Standard rates for calls and texts may apply, and you will not be reimbursed for these costs.

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 arthritis and similar conditions in the future.

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 two random drawings for people who return their surveys by mail, web, or phone. The first drawing is for those who return a longer survey: 5 random people will receive $500 each. The second drawing is for those who return a short survey: 5 random people will receive $100 each. Since we don’t know how many people will return their surveys, we can’t 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 to you to join the study.

How will your privacy and data be protected? 

Your participation in this study will be kept private according to state and federal laws, including the Federal Privacy Act.

To protect your information, we will use methods like coding data, removing personal details, password-protecting computers, using firewalls, and locking drawers and offices.  A firewall is a type of computer security that keeps unauthorized people from seeing your information. 

The researchers will do their best to protect your privacy, but 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 educational purposes, and to help advance medical science.  Your personal identity will not be shared.

TO QUIT THE STUDY:

If you want to stop taking part in this study, you can withdraw your consent at any time. This will not affect your medical care or any benefits you receive. To withdraw, 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 can’t follow the study rules, or if you no longer qualify for the study.

VOLUNTARY PARTICIPATION:

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

CONTACT INFORMATION:

Principal Investigator (PI)

The Principal Investigator or a member of the research staff will be available to answer any questions you have during this study.

Principal Investigator: Kaleb Michaud, PhD, FORWARD

Phone: 316-263-2125

Mailing Address: 727 N. Waco, Suite 200, Wichita, KS 67203

The Institutional Review Board 

The Institutional Review Board (IRB) is an independent group that checks, approves, and watches research studies to make sure they are safe and that your rights are protected.

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 PERSONAL DOCTOR OR LEGAL ADVISOR IF YOU WANT

Consent

By clicking the button below and filling out the survey(s), you are saying that you have read this form, agree to let us use your data for this research, want to take part in the study, and you accept that your information will be electronically shared to the researcher to show you chose to join the study (such as name, email address, and date).

To keep a copy of this consent for your records:

  1. Print a copy of this page by clicking print from your browser menu. You must have a printer attached to your computer.
  2. Or, save a copy of this page to your own computer by clicking Save Page as or print and save as a PDF from your browser menu. Select a location for the file that you will be able to find again.

Authorization (Permission) to Use or Disclose (Release) Protected Health Information (PHI) for Research

Study Title: The National Databank for Rheumatic Diseases, Improving Long Term Outcomes in Arthritis
Principal Investigator: Kaleb Michaud, PhD FORWARD (associated with the University of Nebraska)

What is the purpose of this form?

The Health Insurance Portability and Accountability Act of 1996 (also known as HIPAA) defines privacy rules to keep your health data safe. This law requires the research investigators listed above to get your permission by signing this document before they use or disclose your protected health information for use in the study listed above. This study has been approved by the Solutions Institutional Review Board.

Your permission is needed to use and disclose your protected health information (PHI) for this study. Protected health information is defined as any health data that can be used to identify you.

You must sign this form and the Consent Form if you choose to give us your permission to take part in this study.

What personal identifiers and/or protected health information (PHI) may be used and disclosed?

In addition to information related to your medical history, surgical history, and laboratory results, the information and/or PHI that will be collected, used, or disclosed may include:

  • Names
  • Addresses
  • Dates directly related to you such as birth date
  • Age
  • Phone numbers
  • Email addresses
  • Sex
  • Other unique identifying numbers, characteristics, or codes

How will your protected health information be used or disclosed in this study?

Your health information you provide to us, including, but not limited to your medical history, symptoms, treatments, side effects, hospitalizations, infections, and work history. In addition, hospital or doctor records are used to confirm the information you provided.

The use and disclosure of your protected health information is needed to do the research described. Records of you being in this study may only be disclosed as allowed or needed by law.

By accepting this form, you agree to let us use information gained in this study for research. This means we can publish de-identified data in medical journals, use it for educational reasons, and use it to improve medical science.  You will not be personally identified. Your data will only be shown as anonymous data.

Who will disclose and/or receive my Personal Health Information?

The following parties may use and disclose your health information in connection with this study:

  • The Director of FORWARD, Kaleb Michaud, PhD, and the research and data collection staff of FORWARD
  • University of Nebraska
  • A legally constituted review board charged to protect the safety of human subjects in medical research, called the Solutions Institutional Review Board (IRB)

How will my Personal Health Information be shared for research?

If you agree to be in this study, the research team may need to share your information. If we share your information, it can only be for use in this study. These are the persons or groups we can share with:

  1. Qualified medical researchers at other universities
  2. Government official, when required by law
  3. Shared with business partners of the sponsor
  4. Your doctor

Other researchers interested in using the data may apply for access through FORWARD. Before access is given, small groups of approved scientists and patients will review these applications. The data that is given to researchers will have no personal information.

Your personal health information will be removed from all data used by:

  1. Medical researchers at other universities
  2. Government officials, when required by law
  3. Study sponsors.

Those listed above who follow HIPAA agree to keep your protected health information safe. They can only use and disclose it if you sign this Authorization or as directed by law.

You need to be aware that some parties getting your protected health information may not have the same requirements to safeguard your protected health information and may re-disclose your protected health information to other people or groups not named above.  If this happens, your information may no longer be protected by privacy laws.

You do not have to sign this document.  If you choose not to sign:

  • It will not affect your treatment, payment or enrollment in any health plans
  • It will not affect your eligibility for benefits.
  • You will not be able to take part in the study

This HIPAA Authorization does not have an end date.

After signing this Authorization document, you can change your mind and not allow us to obtain and use your PHI. You can cancel your Authorization by:

  • Sending a written letter to Rebecca Schumacher, 727 N Waco Suite 200, Wichita, KS 67203
  • If you cancel, your information that was already collected and disclosed can still be used for limited purposes. If the law requires it, the sponsor and government agencies may use your medical records to review the quality or safety of the study.
  • Choosing to cancel your will not affect your care or legal rights.
  • Note that if you cancel your permission, you will no longer be in the research study.

If you have any questions or concerns about your privacy rights, you should contact Solutions IRB at (855)226-4472.

If I sign this form, will I be entered into the research study? 

No, you will not be entered into any research study without further discussion and signing a separate consent. After discussion, you may choose to take part in this study and sign a specific research consent form.

What are my rights to access my personal health information? 

You have the right not to sign this permission form. You have the right to look at and/or copy your protected health information kept by the FORWARD Databank. You do not have the right to look at and/or copy records kept by other groups or researchers connected to the research study.

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Signatures

I agree that my protected health information may be used for the research purposes described in this form.

Patient Signature:   Date:

or Legal Representative:  Date:

Printed Name of Legal Representative (if any):

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To keep a copy of this consent for your records:

  1. Print a copy of this page by clicking print from your browser menu. You must have a printer attached to your computer.
  2. Or, save a copy of this page to your own computer by clicking Save Page as or print and save as a PDF from your browser menu. Select a location for the file that you will be able to find again.

I confirm that I have read the General Consent and the HIPAA consent above.

By clicking the button below, you agree that:

  1. You have read the General Consent form, which agrees to let us use your data for this research, want to take part in the study, and you accept that your information will be electronically shared to the researcher to show you chose to join the study (such as name, email address, and date).
  2. Your protected health information may be used for the research purposes described in the HIPAA Authorization form.
I Consent to Participate