Foundation for Sarcoidosis Research

Registration

Sponsor: Foundation for Sarcoidosis Research
Investigator: Leslie K. Serchuck, MD, MA, MBioethics
Site(s): Foundation for Sarcoidosis Research
1820 West Webster Avenue, Suite #304, Chicago, IL 60614
Phone: (312) 341-0500
Website: www.fsr-sarc.org
Study Coordinator: Ginger Spitzer
Project Director: Alicia Gerke, MD, MBA
University of Iowa Hospitals & Clinics
Protocol study number: Pro00008556

Taking part in the FSR-SARC Patient Registry is simple.

What your participation will involve:

• Reviewing the “Understanding Your Participation” Document;
• Checking the boxes on the "Participant Informed Consent" Document in this form (or the "Assent Document" if you are a minor which is a separate form);
• Creating an On-line Account;
• Completing a clinical profile with information about the participant with sarcoidosis including diagnosis, treatment, and medical history;
• Periodically updating the profile at least once a year or as new information becomes available or changes.

By this time you and your parent or guardian have read the “Understanding Your Participation Document”.  You know that you have sarcoidosis and that this is a rare condition that causes lumps of cells called granulomas in different parts of your body. It may cause you to have skin rashes, pain and swelling in your joints (feet, ankles, knees or hands), difficulty breathing or seeing. It can affect any part of your body and can cause problems depending on where the granulomas are.

The "Informed Consent" section below confirms that the FSR-SARC Registry has been explained to you (or your child if they are less than 18 years old). You have had any questions answered and understand any risks or benefits you may get from being a part of this patient registry. You understand that there may be no benefit to you at all however; your information may help scientists find new and better treatments for this disease. By checking the boxes below you (and your child) are agreeing to participate in providing your health information in the survey. You also understand that you have the ability to withdraw your consent at any time without cause.

The "Informed Consent" can be filled out by anyone older than 18 years of age with sarcoidosis if they are able to understand the document, and either a parent or legal guardian of any person who is a minor (less than 18 years old) or an adult dependent diagnosed with sarcoidosis. A separate box is available for the child’s agreement to participate.

If you are the parent or legal guardian of a child between 7 and 18 years of age with sarcoidosis who wishes to take part in this registry, your permission and the agreement of your child to participate will be needed. In that case when “you” appears in this form, it will refer to your child, the person with sarcoidosis. 

Creating your Account:

You can create an account if you are:

• A patient 18 years or older and have been given a diagnosis of sarcoidosis AND are ABLE to understand the consent form explaining the benefits and risks of your participation.
• A parent or legal guardian of a minor or adult dependent with the diagnosis of sarcoidosis (including juvenile sarcoidosis or Blau Syndrome).

Some Definitions that might be helpful:

• You/Your/Participant/I/My: the person diagnosed with sarcoidosis whose health information is entered into the profile.
• The Registry: FSR-SARC Patient Registry.

Participant Informed Consent Document:

I understand that:

• The FSR-SARC Registry is completely voluntary. I do not have to participate.
• Once I register for the FSR-SARC Registry, all of my identifying information will automatically be given a code. The list linking the code to me will be kept on a secure encrypted computer and will only be available to the FSR-SARC Principal Investigator and Coordinator, if necessary. All of my private health information that I provide the Registry will be stored separately in a secure database by this code.
• The Registry will never share my private information with other people (unless required to do so by law).
• The Registry may share the coded de-identified (not identifiable) information with researchers and other databases, but I will not be able to be identified. No personal information, such as my name, phone number, email or other contact information will be provided. Everything possible will be done to protect my privacy at all times. However, because my disease is rare, there is a small risk I may be identified.
• I understand that there is a small risk that some of the questions I am asked may make me feel uncomfortable. I do not have to answer these questions if we choose not to. If I decide not to participate, there will not be any effect on my relationship with the Foundation for Sarcoidosis Research or my doctors.
• I understand that by agreeing to participate, I will be contacted by the registry to update or correct my health information at least once a year.
• I also understand that I can choose to be contacted by FSR if a study becomes available that I may want to know more about. In that case, FSR-SARC will contact me with that information and I will decide whether to contact the investigator on my own.
• By responding “Yes” to the questions below, I do not give away any legal rights or benefits to which I am otherwise entitled.
• Creating an account, answering all questions below and completing a profile means that I am giving my electronically signed consent/authorization to participate in the FSR-SARC Patient Registry for myself as an adult or my minor child or adult dependent.

ALL OF THE FOLLOWING QUESTIONS MUST BE ANSWERED IN ORDER TO PARTICIPATE IN THE REGISTRY.

Please enter the code below