We are inviting you to participate in the FSR-SARC Patient Registry because you or your family member has been diagnosed with sarcoidosis. We would like you to clearly understand what the Registry is and why we feel it is so important and necessary that patients provide their own medical, diagnostic and treatment history and views about how sarcoidosis affects their lives in order to help scientists understand and perhaps one day find a cure for this disease. Here, we will describe the purpose of the Registry, and the risks and possible benefits of participation.
In the sections that follow, the word "We" refers to the Foundation for Sarcoidosis Research (FSR) Registry team and our scientific advisors. The "Participant" refers to the individual with sarcoidosis. "You/Your" is the person entering the information; this may be the participant or a family member or legal guardian of the participant (if they are less than 18 years old or a dependent). If the participant is under 18 years old or unable to complete the registry, a family member may help you. You will be directed to a "Research Subject Assent Information Sheet".
After you have reviewed this section you will be directed to the "Registration" as well as the patient consent form entitled the "Research Subject Consent Information Sheet". There you will create an account and answer a series of questions regarding your participation. If you answer, "yes" to these questions you will have "consented" to participation in the FSR-SARC Patient Registry. Participation in this Registry is completely VOLUNTARY and you do not need to participate in this Registry if you do not wish to.
If you do not understand what is required for your participation in the Registry, information in the Consent Form or any other section please contact the FSR-SARC Registry Coordinator at registry@stopsarcoidosis.org or the Principal Investigator Leslie Serchuck, MD at leslie@stopsarcoidosis.org.
Please read this document carefully; you should print out a copy and keep it in a safe place.
WHAT IS A PATIENT REGISTRY?
A Patient Registry is a place to store basic medical information about individuals with a particular disease or condition. Information such as age, gender, length of illness, treatments received and disease outcomes might be included. Together, all the personal health records make up a Patient Registry of many different individuals with the same disease but likely different histories. Importantly, Rare Disease Patient Registries such as ours aim to collect data from many more patients than would be available to a single Research Center or investigator. The availability of this large and long-term data resource can offer a large enough amount of data to serve to stimulate research into finding the potential cause(s) of sarcoidosis, better ways to make a diagnosis, and at the same time show the available pool of potentially eligible patients for clinical trials.
WHY IS HAVING A SARCOIDOSIS PATIENT REGISTRY IMPORTANT?
Because sarcoidosis is a rare disease (less than 200,000 patients), there has not been sufficient information collected on enough of those with the disease to determine its absolute cause, best method of diagnosis, ideal time to begin treatment or identification of a treatment with the fewest side effects that might lead to a cure. Too much is still unknown.
What We DO KNOW:
- We know sarcoidosis is a complicated inflammatory disease that causes lumps of immune cells called granulomas to clump in organs throughout the body.
- We know that some people never require treatment at all and may not even know they have the disease.
- We also know that there are some people who continue to have active, disease-causing symptoms even with currently available treatments.
- We know that many treated people have an incredibly difficult time tolerating the side effects of currently available treatments.
- We know we need better and gentler treatments.
- We also know that active disease can lead to organ damage, increased symptoms and sometimes death.
What We DON'T KNOW:
- We don't yet know the cause(s) of sarcoidosis.
- We don't know who has to be treated or the ideal time to start treatment.
- We don't know which medications will be best for different organ involvement (such as one or more drugs for affected skin and another for heart or lung involvement).
- We don't know who will need the different types of treatments currently available or the best time to change someone from one to another type of medication.
- We don't know the best way to measure whether a treatment is working.
- We don't know how to cure sarcoidosis.
The Foundation for Sarcoidosis Research is creating this FSR-SARC Patient Registry in order to provide scientists studying sarcoidosis patient-provided information from many patients followed over years with different organ involvement, on different treatments and at different stages of illness. In other diseases, registries have helped to answer some of these questions, find new treatment targets and help scientists determine if there are enough particular patients to conduct specific new studies (e.g. if they wanted to study who should get a pacemaker they might need to know how many participants had cardiac sarcoidosis). While FSR strongly encourages and supports the enrollment of patients into future clinical trials, you do not need to be in a clinical trial to participate in this Registry.
WHAT INFORMATION WILL BE COLLECTED?
If you join the Registry, you will be asked to provide medical information about your sarcoidosis.
We want to know how you were diagnosed and in what organs you have sarcoidosis. We will ask you how long have you had symptoms before you were diagnosed, how many different types of doctors you've seen and what (if any) treatments you've received. This is also your chance to share how sarcoidosis has affected your life, your work, and your family. Once a year you will be reminded by email to update your Registry information. Your Registry account can also be updated whenever there is new organ system involvement, change in medication, or hospitalization.
HOW WILL YOU PROTECT MY INFORMATION?
FSR-SARC is the guardian of the information contained within the Registry. Our goal is to help scientists answer important questions about sarcoidosis that might lead to a cure. In order to do this we must share detailed medical information with scientists and researchers, while firmly protecting your privacy. This means that as soon as you register for an account a computer will automatically assign you a unique code number. Your name and other identifying information will immediately be separated from all the information you are providing. This is called "de-identifying data" and makes the survey anonymous. The link between your code number and your identifying data will be encrypted, stored in a secure place, and protected by a password. Only authorized FSR-SARC Registry personnel (the Coordinator and the Principle Investigator) will be able to access the code and identity of the patient.
If you are a resident of European Economic Area (EEA), you have certain data protection rights. FSR-SARC aims to take reasonable steps to allow you to correct, amend, delete or limit the use of your Personal Data. Your Data Protection rights are outlined in FSR's Privacy Policy, which can be found on this website's privacy policy page. [hyperlink: https://www.stopsarcoidosis.org/privacy/]
WHO WILL HAVE ACCESS TO THE DE-IDENTIFIED DATA?
No researcher will have access to the identity of Registry participants and they will not be able to contact any participant directly. They will be able to view with appropriate permission the coded data (anonymous) from all participants but will not be able to identify individuals. No identifiable information will be shared with anyone outside the FSR-SARC Registry (unless you give your permission to share it upon specific request) or unless required by law (such as a subpoena.)
Through FSR's SARConnect Program [hyperlink: https://www.stopsarcoidosis.org/sarconnect/], Researchers with active Internal Review Board (IRB) approved research protocols may request FSR-SARC alert Registry Participants of their potential eligibility. If you are one of the Registry participants who have elected to receive information regarding potential new trials AND FSRSARC believes, based on your coded data, you may meet study eligibility criteria, FSR-SARC Registry coordinator will contact you with specific information related to that trial. Only participants who have given their permission to be contacted by the Registry will be contacted and only by FSR. Those participants will receive an email or phone call from the Registry with information about the protocol and the Principal Investigator or Study Coordinator contact information. Each Registry participant will be responsible for contacting the new investigator on his or her own if they wish to learn more about the study or have further questions. FSR-SARC Registry will not be responsible for the conduct of the new study. No participant is either guaranteed enrollment into a new study or required to enroll in a new study in order to join or to continue in the Registry.
Your "de-identified" coded information may also be shared with other existing sarcoidosis databases or yet to be developed databases for the purposes of biomedical research. We will ask you if you are already participating in any other Registries or Databases so that your data will not be repeated.
WHAT ARE THE BENEFITS OF PARTICIPATING IN THE REGISTRY?
Providing your information to the Registry and participating in this Registry is completely voluntary. Participation may not benefit you personally, medically, or financially but we hope that your participation may help others with sarcoidosis by increasing our understanding of this disorder, its causes and best treatments. Researchers may learn whether and how treatments work and which patients they are the best for. You may benefit by opting to receive information about opportunities to participate in research, clinical trials, medical advances and other news from the Registry. In addition, you will be able to learn how your disease and treatments compares with other members of the Registry whenever you go online and submit information. This will be done in summary form - you won't be able to see results of individuals in the Registry.
You will not be paid for participating in the Registry.
WHAT ARE THE RISKS OF PARTICIPATING IN THE REGISTRY?
There is minimal risk in taking part in the Registry. The Registry includes questions that may be sensitive and you may feel uncomfortable answering them. You do not have to answer any question you do not wish to. Another unlikely risk is the potential breach in the computer security system. In the event there is a breach in the Registry's computer system all participants will be notified as soon as we are aware of it.
There is no cost to you other than your time for participating in the registry.
I WANT TO BE INVOLVED IN A CLINICAL TRIAL. IF I REGISTER, IS THIS GUARANTEED?
There is no guarantee that you will be eligible for a trial written with the use of the Registry's data. Please note that even if the coordinators of a clinical trial believe that you might be eligible for the trial, based on the de-identified coded data about you stored in the Registry, it is possible that you don't meet the trial requirement criteria. In order to participate in any trial, you will need to discuss with the research staff about the trial and fill out a separate informed consent form.
I DON'T WANT TO BE IN A CLINICAL TRIAL. SHOULD I STILL ENROLL IN THE REGISTRY?
Absolutely, we hope that you will still be willing to register and provide data in this Registry, even if you don't want to take part in a trial. Your information will be useful to researchers who are trying to learn more about sarcoidosis and its effects.
WHAT ARE MY OPTIONS IF I DO NOT WANT TO BE IN THE REGISTRY?
You do not have to join this Registry. Participation is voluntary. You do not need to participate in this Registry to receive healthcare from your doctors. You may choose to join a clinical trial without participating in this Registry.
HOW DO I WITHDRAW FROM THE PATIENT REGISTRY?
You may choose to stop your participation in the FSR-SARC Patient Registry at any time by contacting FSR at registry@stopsarcoidosis.org. However, if your de-identified coded data has been shared with an approved study prior to your request for removal, that data cannot be retrieved from researchers that have already accessed it. However, as noted before, no information identifying you will be shared. Your participation in the Registry may stop (for example, if the Registry closes). You will be notified of this or other new relevant information if it becomes available.
WHO SHOULD I CONTACT IF I HAVE ANY QUESTIONS?
If you have any questions about the registration process or about participation in the Registry, please contact the Registry Coordinator at registry@stopsarcoidosis.org. Additional information can be found at the Terms and Conditions and Privacy Policy sections of this website. [hyperlink:www.stopsarcoidosis.org/privacy/]
The Chesapeake Research Review Institutional Review Board has approved the contents of the FSR-SARC Registry. If you have questions about your rights as a participant in the Registry, you may also contact:
By mail:
Study Subject Adviser
Chesapeake IRB
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
or call toll free:
877-992-4724
or by email:
adviser@chesapeakeirb.com
Please reference the following number when contacting the Study Subject Adviser: Pro00008556