Informed Consent

If you wish to participate in the International Dupuytren Data Bank (you don’t need to have Dupuytren disease to participate in the IDDB), or if you have been diagnosed by a physician with Ledderhose disease, Peyronie's disease, rheumatoid arthritis, osteoarthritis, fibromyalgia, lupus or any other rheumatic condition you can enroll in this research project. If you are not sure if you have a rheumatic condition please see our diagnosis list.

Your confidence in the privacy of your personal information is of the highest concern to the NDB staff. We will never give anyone any information that can identify you by name. We take great 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 read the consent form below carefully and click the "I consent to participate" button to proceed.

Click to expand consent form

Consent to Participate in NDB Research

The National Data Bank for Rheumatic Disease Improving Long Term Outcomes in Arthritis is conducting a long-term study of the impact of arthritis and other rheumatic diseases upon the individual. With this study we hope to determine physical and monetary consequences caused by arthritis and other rheumatic diseases and to help guide research into better treatments. We invite your participation.

As a participant you will be asked to complete detailed questionnaires, taking up to one hour, at six month intervals, and to notify us of any change in address. In the future you may be contacted to obtain your permission to contact other doctors or hospitals to collect additional information about your care.  If you agree, you will be asked to sign a form consenting to this collection of information. The questionnaires will ask questions about your arthritis or other rheumatic disease, the treatments you are getting, the effects of the disease on your function, the amount of pain, and the costs which you incur. You may be asked to talk with a telephone interviewer from the study staff from time to time. You will continue to receive questionnaires even if you move or decide to receive your medical care from other doctors. We cannot and do not guarantee or promise that you will receive any benefits from this study, but your participation will help increase knowledge of and interest in arthritis and other rheumatic diseases.

No experimentation is involved in this study, and the study will not alter your care in any way. Your decision whether or not to participate will not prejudice you or your medical care. This is a long-term study, meaning that there is no fixed number of months or years in the study. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without prejudice to you or effect on your medical care. If you chose to withdraw, pleast contact the Principal Investigator in writing at the address below.

There are no risks or costs to you involved in this study, and no payment will be provided to you. The information you give us will not be disclosed to anyone in any way which would reveal your identity. Any data that may be published in scientific journals will not reveal the identity of the subjects. Information may be provided to Federal and regulatory agencies, but your identity will be protected unless required by law.

If you have any questions, we expect you to ask us. If you have additional questions later, call us at 316- 263-2125 or 1-800-323-5871 and we will be happy to answer them.

For further information please call the following who are associated with this research and to whom you may address complaints about this study, as well as questions about research and your right as a research patient:

  • Principal Investigator, Dr. Frederick Wolfe, 1035 N. Emporia, Suite 230, Wichita, KS. 67214 316-263-2125.
  • Chairman, Via Christi Hospitals Wichita, Inc. Institutional Review Board, Via Christi Hospitals Wichita, Inc., 929 N. St. Francis, Wichita, KS. 316-268-5114.

Use and Disclosure of your Medical Information

By clicking on the button below this form, you are authorizing the use and disclosure of your health information collected in connection with your participation in this research study. Your information will only be used in accordance with the provisions of this consent form and applicable law. If you decide to terminate your participation in the study, you may revoke your authorization, except to the extent that the law allows us to continue using your information.

Via Christi Hospitals Wichita, Inc. does not provide free medical treatment or payment for injuries resulting from participation in biomedical or behavioral research.

 

What Information Will Be Used or Disclosed?

Your health information related to this study that you provided to us, including, but not limited to your medical history, symptoms, treatments, side effects, hospitalizations, infections, and work history. 

 

Who May Use and Disclose the Information?

The following parties are authorized to use and disclose your health information in connection with this research study:

  • The Director of the National Data Bank for Rheumatic Diseases (NDB), Frederick Wolfe, MD, and the research and data collection staff of the NDB.
  • A legally constituted review board charged to protect the safety human subjects in medical research, called the Via Christi Hospitals Wichita, Inc. Institutional Review Board (IRB).

Who May Receive / Use the Information?*

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:

  • Qualified medical researchers at other universities
  • The US Food and Drug Administration (FDA)
  • Sponsors of the research study.
  • Your rheumatologist or physicians.
  • A legally constituted review board charged to protect the safety human subjects in medical research, called the Via Christi Hospitals Wichita, Inc. Institutional Review Board (IRB).

*Your information may be redisclosed if the recipients described above are not required by law to protect the privacy of the information.

Your Access to Research Information

You will not be allowed to see or copy information in the NDB research records.

Can I be identified personally?

No, with 2 exceptions:

  1. If requested by the human subjects safety board (IRB);
  2. if ordered by a court.

Otherwise, information that will allow you to be identified personally (e.g., name, address, etc) will be removed from all information used by 1) medical researchers at other universities, 2) FDA, 3) and study sponsors.

Expiration

Your authorization for the use and/or disclosure of your health information will continue indefinitely. However, you may withdraw from the research study at any time by contacting the Principal Investigator in writing at the address above.

Consent

By clicking the button below you indicate that you have read this consent form and agree to participate in the study, and that you accept that personal information will be electronically supplied to the researcher to document their participation (such as name, e-mail name, and date).

To retain a copy of this consent for your records:

  1. Print a copy of this page by clicking File and 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 File and Save. Select a location for the file that you will be able to find again.

I do not consent to participate