Below are a brief list of frequently asked questions and general comments about the procedures of the National Registry.
- Q. How can I be assured that my confidentiality will be maintained?
- The staff at the Registry takes the issue of confidentiality seriously. The Registry was created under the U.S. Government Privacy Act 42 United States Code 241. Additionally, the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) detailed important new guidelines for maintaining patient privacy and the security of health information. The Research Subjects Review Board at the University of Rochester approved the Registry's process for collecting, using and storing confidential patient information. They regularly review our procedures to ensure that your information is handled appropriately.
- No identifiable information about Registry members will be provided to anyone. If a Registry member is eligible to participate in a study, the Registry will contact the member and give them contact information for the researcher. The member is responsible for contacting the researcher directly if they are interested in the study.
- Q. How can I get information about the Registry?
- Call, email or write to the Registry staff using the information provided on this Web site. If you are requesting an application, you will need to provide your mailing address, diagnosis (whether you are affected with DM or FSHD or whether you are an unaffected blood relative) and the age of any minors for whom you might be requesting information. We will be glad to send you a packet. For your convenience, you can download the appropriate packet from this website (See the application packet links under "Join the Registry").
- Q. How long does it take to get the information?
- We strive to mail application packets out within a few days of the request. Occasionally, it may take a bit longer. Your membership is important to us, and we are interested in getting you registered! We will send you the information as soon as we can!
- Q. Why does the Registry need my medical records?
- In order to confirm your diagnosis, we need to see information from your medical records such as muscle biopsy reports, EMG results and DNA testing results. We also need them to determine if you are eligible for a particular study. Some studies require that the individual not have certain other diseases or be taking particular medications. The goal of the Registry is to be as accurate as possible, including only those individuals who have been properly diagnosed, or who have a family member that has been properly diagnosed.
- Q. How old do children have to be to join the Registry?
- We accept applications for affected children and unaffected children from birth to 18 years of age.
- Q. Do I have to have DNA testing to join the Registry?
- No. You are not required to have DNA testing done in order to join the Registry; however, a researcher may ask that we contact only people who have DNA confirmation of their disease. The Registry staff will work with you to make your application as strong as possible so that you are eligible for as many studies as possible. We may recommend that you get DNA testing if it would help confirm your diagnosis, however, you are not required to do so.
- Q. What kinds of studies are being conducted that I might be eligible for?
- The Registry assists with two primary types of studies, those needing anonymous (deidentified) data based on the information contained in the data base or by assisting with subject recruitment for a particular study.
- An example of anonymous data that may be requested is the approximate length of time it takes from the time a person begins to show symptoms of one of these diseases to the time they received a diagnosis. For this type of question, members would not be contacted directly. The Registry staff would prepare a report for the investigator providing this information without revealing the names, birthdays, locations, etc., of the people who are in the data base. All of the information identifying specific members has been removed, or "de-identified."
- The Registry can also help investigators with their subject recruitment effort. Once enrolled, members will be contacted by mail with announcements regarding new studies that are using the Registry for assistance. Examples of this type of study include protocols that want to test a new drug or who need subjects with these diseases to complete a survey, etc.
- Approved Research Protocols
- Q. Is there a charge to join the Registry?
- No, there is no charge to join the Registry. Additionally, there is no charge for investigators who use the Registry.
Jim Hilbert and Liz Luebbe
Toll free: (888) 925-4302
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