We are asking you to enter information into The Siegel Rare Neuroimmune Association Registry (which we will call SRNA Registry).
It is important that we explain what is involved and what will be done with the information you provide. This section contains answers to questions about the registry and how it might benefit you and our community.
SRNA membership and consent are required to join SRNA Registry. You will be asked to read SRNA Registry consent form. After you read the form, you will be asked a series of questions to confirm that you understand the study. Then you will be asked to sign an electronic consent form. Parents or legal guardians can sign on behalf of their child or on behalf of an adult who does not have the ability to consent for him/herself. Participation is voluntary.
If you have questions that are not answered in this document, please contact SRNA’s Associate Director of Research and Education, GG deFiebre, at [email protected].
What is a registry?
A registry is a place to store detailed information about individuals with a specific disease or disorder. The information does not include names or identifiers. Each participant’s information is stored with a code number. In this case, SRNA Registry is for individuals with rare neuroimmune disorders (acute disseminated encephalomyelitis, MOG antibody disease, neuromyelitis optica spectrum disorder, optic neuritis, or transverse myelitis, including acute flaccid myelitis) and related disorders (multiple sclerosis, spinal stroke, HTLV I and II, anti-NMDA receptor encephalitis etc.).
What are the benefits of collecting information from individuals diagnosed with ADEM, TM (AFM), MOGAD, NMOSD or ON in a registry?
There is no direct medical benefit to the individual from being in SRNA Registry. Although there is no guaranteed benefit to any individual participating, it greatly benefits our community. By collecting information, scientists can:
- Study what symptoms individuals have.
- Study what treatments individuals receive and whether improvement was seen after the treatment.
- Study how to help medical professionals improve how they treat individuals with rare neuroimmune disorders.
- Speed up research by collecting information that scientists can use.
- Let individuals diagnosed with a rare neuroimmune disorder (or their family) know when they may be eligible for clinical research studies or clinical trials.
Whose data are you collecting in SRNA Registry?
SRNA Registry collects data about individuals who have a rare neuroimmune disorder (acute disseminated encephalomyelitis, neuromyelitis optica spectrum disorder, optic neuritis, MOG antibody disease, or transverse myelitis, including acute flaccid myelitis) and related disorders (multiple sclerosis, spinal stroke, HTLV I and II, anti-NMDA receptor encephalitis etc.).
Who can consent?
Individuals diagnosed with a rare neuroimmune disorder over the age of 18 who understand the consent form (and thus do not have a legal custodian) are eligible to join SRNA Registry on their own. Otherwise, the legal guardian, parent, or custodian of the patient must provide consent for the individual diagnosed with a rare neuroimmune disorder to join. When a minor diagnosed with a rare neuroimmune disorder becomes 18 (and if they are able), consent will be obtained directly from the individual diagnosed with a rare neuroimmune disorder for continued participation. When a legal guardian/representative is completing SRNA Registry, an additional signature is required for participant assent, which is required if an individual is 7 years of age or older and is cognitively able to provide assent.
What are the steps to filling out SRNA Registry with information about the individual diagnosed with a rare neuroimmune disorder?
If you are the individual diagnosed with a rare neuroimmune disorder or the representative for the individual diagnosed with a rare neuroimmune disorder, you should finish reading this document, then decide if you want to participate in SRNA Registry.
Step 1: Please read the informed consent form that you can access here.
Step 2: Please fill out this form to have the survey sent to you.
Step 3: You will be asked to complete a brief assessment questionnaire.
Step 4: Sign the electronic consent.
Step 5: Complete the registry survey provided. The registry questionnaire should take no more than 60 minutes to complete.
Where will the data go?
All of the information you provide will be in a password protected online survey database powered by SurveyMonkey. Any information that could identify you and your family members will not be shared without your consent. As this patient registry is designed to identify patients for clinical trials and/or research studies, your de-identified information may be shared with the research community, and The Siegel Rare Neuroimmune Association Board of Directors.
Who will have access to the Registry records?
The Siegel Rare Neuroimmune Association is the guardian of the information contained within SRNA Registry. The goal of SRNA Registry is to share medical and other information with scientists and other researchers, while still protecting your privacy. This is done by removing your name, address, and other “identifying” information. We call this “de-identified” data (information from which all personal identification has been removed). The registry can share this de-identified data with approved scientists, researchers, clinicians and bio-tech companies. SRNA Registry has to follow rules to protect information about you. Federal and state laws also protect your privacy.
Will I be expected to provide SRNA Registry with additional information in the future?
Yes. SRNA Registry is most valuable for scientific research when it is kept up-to-date. Therefore, you will be asked to update your profile and information semi-annually or annually. We will send out notifications to remind you. Please contact GG deFiebre at [email protected] if there is a change in your contact information.
I want to be involved in a clinical trial. If I register, is this guaranteed?
Although one of the main goals of SRNA Registry is to make it easier to participate in research, there is no guarantee that that you or your family member will be eligible for a trial. Please note that even if the coordinators of a clinical trial believe that you might be eligible for the trial, based on the data about you stored in SRNA Registry, it is still possible you do not meet the trial inclusion criteria after all. Please also be aware that if we inform you about the existence of a trial, this does not imply that we endorse it. In order to participate in any trial, you will need to fill out a separate informed consent form directly with the researchers conducting the trial. Please remember that joining SRNA Registry does not obligate you to participate in any clinical trial or study.
I don’t want to be involved in a clinical trial. Should I still register?
Absolutely. We hope that you will still be willing to register, even if you don’t want to take part in a trial. Your information may still be useful to researchers who are trying to learn more about patients with rare neuroimmune disorders. Your information will give us a better understanding of our community as a whole.
Can I withdraw if I change my mind?
Your participation in this project is entirely voluntary. Should you change your mind and wish to withdraw your data from SRNA Registry, you will be free to do so without having to provide any explanation. Simply contact GG deFiebre at [email protected] and all of your data will be removed from the database. De-identified data accessed prior to your request for removal cannot be retrieved from researchers that have already accessed it.
If I have given data or information to doctors, researchers, clinics or hospitals in the past, is it okay to give my data to SRNA Registry now?
Yes. This registry is the first of its kind for rare neuroimmune disorders, so even if you have given data in the past, we are likely asking questions other than the ones you have answered previously.
Will it cost me anything?
No. There is no cost to join SRNA Registry.
Who should I contact if I have any questions?
If there are questions concerning SRNA Registry, your participation, or to report any problems that result from your participation in SRNA Registry, please contact GG deFiebre at [email protected] or you may call us at 866-380-3330 and speak to an Officer of SRNA.
How can I participate?
The consent form and additional information about the registry is available here. Please read the consent form and contact us if you have any questions. After reading the consent form, please click here to fill out a brief form with your contact information. You will then be sent a link to the registry survey which includes a brief assessment questionnaire. You will then sign the consent form electronically. Once you have signed the consent form, you will be directed to the registry survey.
What is the optional data sharing with UTSW?
Dr. Benjamin Greenberg at UTSW is partnering with SRNA to share data about registry participants with TM who want their information shared. Dr. Greenberg is the Director of UTSW’s Transverse Myelitis and Neuromyelitis Optica Program. Dr. Greenberg’s study, entitled Comprehensive Outcomes Registry Exploring Transverse Myelitis Study (CORE TM Study), will create a registry focused on short and long-term outcomes, and further inform the development of an outcomes measure for use in clinical trials. The CORE TM Study will collect similar information as SRNA Registry, but will also include review of medical records. The CORE TM study is only enrolling individuals with TM. If you would like SRNA to share your information and responses with UTSW, please indicate this when you consent to the study. Dr. Greenberg’s team will contact you and may ask for additional information and medical records. If you do not want your information shared, please indicate this when you consent to the study.