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Participating In The Repository
Participating As A Study Subject
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Current study subject
If you are a current study subject (you've already gone to a site and
had your blood drawn and information collected) and you have a
question or concern about your involvement in the repository, please
contact the study coordinator at
the site where you enrolled. You may also find contact
information in the copy of the informed consent form that you signed
prior to participating.
We invite you to stay informed about our progress by signing up for our free
quarterly print newsletter or email mailing lists.
Becoming a study subject
We are currently enrolling subjects at
sites across the United States. We are
seeking individuals with Multiple Sclerosis (MS), Clinically Isolated
Syndromes (CIS), Transverse Myelitis (TM), Neuromyelitis Optica (NMO)
or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic
Neuritis (ON). If you or someone you know has one of these
diseases, please read the following sections to learn about participating in the study.
Benefit of enrolling as a study subject
By enrolling as a subject in the repository, you are participating in
the creation of a critical resource for scientists who are seeking
the causes of and ultimately a cure for MS and other demyelinating
diseases. The repository will enable large-scale studies by providing
access to samples from thousands of people. In addition, because
the population of samples will be relevant to a variety of
research disciplines, "virtual" multi-factorial research can be
accomplished by analyzing the results of multiple experiments on the
same set of samples. Read more about why the
repository is needed.
Study subject enrollment criteria
Individuals with MS, CIS, TM, NMO, ADEM or ON who meet the inclusion/exclusion criteria are eligible to
participate. In addition, we ask enrolled subjects to refer their
affected and unaffected blood relatives and certain unaffected
non-relatives to the study.
How to enroll as a study subject in the repository
If you live near or plan to visit the region of one of the enrolling sites, contact the study
coordinator directly. If you are not located near a current
site, contact our repository director
to be put on the list for
notification of new sites.
Study subject participation process
Upon contacting the enrolling site, you will be screened by the site
staff against the inclusion and exclusion criteria to ensure that you are
eligible to participate. If you are eligible, the site will schedule an appointment for you to visit the clinic. Prior to your study appointment you will be given a
checklist of items to bring to the
appointment. This is particularly important if you are not a patient at the
site where you are enrolling. You will also be given a paper copy of the
case report form in advance of your study
appointment so that you may review and prepare the information required during
the interview.
At your appointment, before providing any samples or data, you will be
given an informed consent form
which describes the study procedures in detail. The study coordinator
or physician at the enrolling site will also describe the study
processes to you and will answer any questions that you may have regarding
your participation in the study. You should feel as though you fully
understand your participation in the study before signing the informed
consent form.
Once you have agreed to participate and you have signed the informed
consent, the following steps will be taken, but may happen in
different orders at different sites:
The study coordinator will document your confidential contact information and assign you a
unique 5 digit barcode. All of your data and samples will be marked
only with this barcode in order to protect your anonymity. Only
Accelerated Cure Project will know the link between your identity and
the barcode and this information is kept in a private and secure
location.
Up to 110 milliliters (about 7 tablespoons) of blood will be drawn from you. These
blood samples will be marked with your barcode, processed at the site and sent
to the central laboratory for further
processing, quality control, and storage.
The study coordinator will conduct an interview with you based on the
case report form. During this interview you will answer questions on several topics including your environmental, geographical, and medical
history and your current medical status. The data that you provide will be stored
electronically at our data management vendor, DSG,
referenced only by your unique barcode.
If you have one of the covered demyelinating diseases, the neurologist will see you to evaluate your current medical status and will also document details concerning how you were diagnosed with your disease.
You may be asked to refer others to the study. In particular, we are
interested in enrolling any blood relatives who are diagnosed with a
demyelinating disease, any identical siblings (affected or unaffected)
and one or two unaffected blood relatives. If you have no relatives
available to participate in the study, you may be asked to refer an
unrelated matched control. This part of the study is optional, but
enhances the value of the samples collected. Read more about control
referrals here.
You will be reimbursed a nominal amount for time, travel, transportation, etc. You will also be given an opportunity to sign up for a free Accelerated Cure
Project t-shirt and our free
quarterly newsletter. The newsletter provides updates on the
repository, fundraising events, and other items related to our operations.
This study is longitudinal, meaning that the principal investigator or
study staff at the enrolling site may contact you every year or two
for a follow-up visit which may include additional blood sample collection, additional
interview questions, and the updating of medical status. These
additional visits are optional, but greatly enhance the usefulness of
your samples. You may withdraw from the study at any time as described
in the informed consent form.
What if I have questions?
If you are a current participant, contact the study coordinator at the site where you
enrolled.
If you are not a current participant, please contact
the repository director at Accelerated Cure Project.
Participating As A Collection Site
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Additional collection sites
Additional sites will be brought online as funding allows. Funding a
site costs $250,000 - $500,000 annually. If you work for a clinic that sees patients with one or more of the demyelinating diseases covered by our repository, we invite you to read further about participating in this project.
Opening a new collection site
We evalute potential collection sites based on interest in
performing the study as described in the
study protocol document, ability
to meet the collection requirements as described in the
site requirements document, geographic
location, the population of patients served, and the availability
of site staff to conduct the study.
If a potential site meets these requirements, we work together to negotiate a
letter of agreement and
site budget.
In parallel, the site customizes the study protocol,
informed consent form, and
any materials given to the
subject for submission to its Institutional Review Board
(IRB). Note that our study documents have been
approved by a central IRB if the site has the option of using one in lieu of
a local IRB. The site submits the materials to their IRB for approval.
Once a budget is agreed upon and IRB approval has been received, we work together to negotiate a contract.
After the contract is signed, the principal investigator and study staff receive training on the
protocol and the electronic data capture system, and
the staff who will be collecting samples are additionally trained
on laboratory and shipping procedures.
Enrolling sites participate in biweekly site monitoring calls conducted by
Omnicare Clinical Research.
At this point the site can begin enrolling subjects.
Read additional details on how the repository works
.
Contact information for collection sites
If you are a current site and you have a question or concern about the
study, please contact the repository director at
Accelerated Cure Project. You may also contact the storage vendor for questions related to sample
collection and storage, electronic data capture
vendor for questions related to the electronic data capture system
and/or the contract research organization for site
management questions.
If you are not currently a collection site but are interested in participating, please contact the repository director at Accelerated Cure Project.
Participating As A Researcher
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Our repository is a collection of samples and data from
people with MS, CIS, or related demyelinating diseases (TM, ADEM, NMO, ON),
their affected and unaffected relatives, and unrelated unaffected
controls. The repository is a shared resource available to the
research community investigating the causes of these diseases.
The repository is being created to accelerate research into the
causes, sub-types, and biomarkers of MS and related demyelinating
diseases. The research proposed by
researchers requesting samples must conform to the
informed consent.
Scientists conducting research meeting the goals of the repository
may be granted access to samples and data. In return, recipients
agree to provide the per-sample data resulting from use of these
samples back to us for inclusion in the
database. This data then becomes available for others receiving the
samples and data from the repository. We allow a grace period for publication and
the registration of intellectual property rights.
Sample availability and pricing
You can find more information about the types of samples collected here. Please
contact the repository director for additional
details of specific samples available.
Sample & data pricing is outlined
here.
Applying for samples
If you are interested in requesting samples and/or data from the repository, we ask that you submit a written proposal, describing
the type and amount of samples needed, the planned research,
details regarding the data which will be returned to the repository,
status of IRB approval and funding, etc.
This proposal will be reviewed by Accelerated Cure Project
staff for completeness, alignment with the purpose of the
repository, and our ability to fulfill the request. You will be
notified of any problems and given the opportunity to submit changes.
After preliminary review, the proposal will be further reviewed by our repository oversight committee who will make a
recommendation on whether or not to grant your request. Factors which
are weighed during this evaluation process include, for example:
- Potential benefit to people with MS and/or related demyelinating
diseases
- Scientific merit of the proposal
- Adequacy of the plans for contributing data back to the repository
Oversight committee reviews occur on a bimonthly schedule; proposals are
sent to committee members on the first business day of January, March,
May, July, September, and November. We recommend that you send your
proposal to Accelerated Cure Project two weeks or more before the next
distribution date in order to be included in that review cycle.
Acclerated Cure Project will make a final decision on providing the
samples and data to you. If we are unable to meet your needs, we will
attempt to identify an alternate resource for you.
You can find additional details of the application process here.
Contacts for researchers
Please contact our repository director with
questions related to sample availability or data transfer.
Please contact our VP of scientific operations
with questions related to the request review process.
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