[The information on this page was prepared and contributed by Kate Gardner, Clinical Research Specialist, Division of Hereditary Genomics, Department of Medical and Molecular Genetics, Indiana University School of Medicine.]
About The Database
The Charcot-Marie-Tooth North American Database is a dynamic resource that allows researchers to connect with the individuals they want to study. Whether you are a neurologist studying the onset of symptoms in CMT, an orthotist determining the benefits of a new device to help individual’s with CMT retain walking abilities, or a geneticist investigating CMT’s many sub-forms, the CMTNA database can put the data and participants you need closer than ever before. The database can give CMT researchers access to a large number of people with CMT as well as to the detailed information that has been collected.
The database is an endeavor jointly funded by the Charcot-Marie-Tooth Association (CMTA) and the Muscular Dystrophy Association (MDA). In keeping with the CMTA’s dedication to encouraging and funding new research, the organization has sponsored the registry since its inception in 2001. The database is maintained at Indiana University in the Department of Genetics, which has a long standing history of experience and excellence in maintaining registries and building registry-based research.
Usage of the Database
Two types of research can be conducted using the database:
- Statistical/Demographic Research: This type of query does not involve the use of any identifiable information and can be released to researchers requesting statistical/demographic information.
- Research with Identifiable Information: In this type of query, identifiable information is requested. For example, you may wish for us to identify individuals in the database who meet the criteria for a clinical trial or you may wish for us to invite all database participants to take part in a study.
In this second type of query, no identifiable information would be released to you without the explicit, written permission of the participant.
Information Collected
The database maintains extensive data on a number of areas that CMT touches upon. Data is collected on the following categories:
- Demographics
- Family History, including other known affected individuals in family
- Effect on Work
- Motor Development
- Age of Onset/Age of Diagnosis
- Symptoms
- Testing (including genetic)
- Rapid Progress
- Surgeries
- Abnormal Sensation
- Ambulatory, Writing, and Breathing Difficulties
- Drinking and Smoking
- Medication History
- Physical Exam
How to Request Use
If you are interested in conducting research using either de-identified Statistical/Demographical data or identifiable information you will need to submit a proposal through the following steps:
Step #1: Submit your proposal to Indiana University
Submit a formal proposal for research along with the following documents:
- Study Protocol
- Approval from your institution’s IRB or a commercial IRB
- Informed Consents
- Any advertisements to be used
If your proposal involves multiple study sites, you will need to submit documentation of IRB approval for each of the sites.
Study documents can be sent via mail or email to:
Step #2: Evaluation by the CMT Scientific Advisory Committee
If your proposal involves the use of identifiable information, IU will forward it to the Database Advisory Panel, a committee of CMT researchers and clinicians, for review. The panel will evaluate your proposal in order to determine if it is appropriate and ethical.
If your proposal uses de-identified Statistical/Demographic data, this step will not be necessary and your proposal will immediately go to Step #3.
Step #3: Indiana University IRB Approval
If the proposal is approved by the committee, it is then sent to Indiana University’s IRB for review. This is not a full new study submission, rather a necessary step for the IRB at IU to know how the registry is being utilized.
Step #4: Execution of Approved Requests
Once your proposal has been approved by the Database Advisory Panel and/or IU’s IRB, IU will work with you to fulfill your request.
If you are requesting data that is statistical or demographic in nature and you do not need any identifying information, IU will compile the requested data.
If you are requesting identified information or if your proposal involves identifying individuals in the database that fit your requested criteria, IU will synthesize the appropriate list and send out an informational letter. This letter will explain to those identified individuals what your study is about and how they can request further information or how to join the study. When IU contacts these individuals, they are not obligated to take part in the offered study. Those who are interested will return the signed consent form and at that point, their identifying information can be released to you.
The registry is a communal tool that can only grow stronger through the sharing of information. There is no cost to researchers who use the registry, but it is asked that the registry be cited in any publications, conferences, or other presentations of material or findings that result from registry use.
Learn More about Using the CMTNA Database
If you are interested in finding out more about how the CMT North American Database can connect you with the data and people you need, please contact:
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Kate Gardner
410 West 10th St
HS 4000
Indianapolis, IN 46202
Email: kskirvin@iupui.edu
Phone: (317) 278-7132 |
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