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
- 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,
- 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.