Foundation for Sarcoidosis Research
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: Mindy Buchanan 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:
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:
Some Definitions that might be helpful:
Participant Informed Consent Document:
I understand that:
ALL OF THE FOLLOWING QUESTIONS MUST BE ANSWERED IN ORDER TO PARTICIPATE IN THE REGISTRY.
1. The Registry has been fully explained to me and I have had all of my questions answered. I know how to access the “Understanding Your Participation” and “Patient Informed Consent” documents in the future if I want to review them and I have had the opportunity to ask questions of The Registry Coordinator. All of my questions have been answered to my satisfaction.
2. I understand that my participation in this project is entirely voluntary. Should I change my mind and wish to withdraw my data from The FSR-SARC Registry, I will be free to do so at any time without having to provide an explanation. I will need to write a letter or email to FSR-SARC Registry Coordinator at Foundation for Sarcoidosis Research, 1820 West Webster Avenue, Suite #304, Chicago, IL 60614 ( registry@stopsarcoidosis.org)
3. I understand the potential risks and benefits of participating in the FSR-SARC Patient Registry. I agree to participate in The FSR-SARC Patient Registry.
4. I would like FSR-SARC to contact me in the future about planned new research studies written by researchers using these databases and related to sarcoidosis. This is not a guarantee that I will be eligible to enter the study or that I will have to do so. Any new study will require my additional consent to participate.
If the participant is between the ages of 7 years and 17 years inclusive (or below the age of adulthood according to local law) they need to read the Participation Assent Form and agree to participate in the Registry.
IMPORTANT: If data for an adult is being entered by anyone other than the participant, this should only be done IF the adult participant has given permission OR if the adult participant is a dependent of the person consenting on their behalf.
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