You are reading
this consent form because you have decided to undergo Doppler Ultrasound testing
procedures (the “Test”) at the Buffalo Neuroimaging Analysis Center and University
Neurology, Inc./Jacobs Neurological Institute at the University of Buffalo
(collectively “UB”) to determine whether you present with chronic cerebrospinal
venous insufficiency (“CCSVI”), a condition that is characterized by narrowing
of the extracranial veins that restricts the normal outflow of blood from the
brain. The Test is being conducted by UB.
UB wants you to understand the limitations on the information that you
may gain from this Test.
CCSVI may interfere with the
normal venous outflow of the brain, resulting in backpressure within, and
deposits of iron around, cerebral vessels. The venous anomalies can be detected
using either non-invasive or invasive techniques. Non-invasive techniques
include Doppler ultrasound studies of the venous drainage system and magnetic resonance
venography, whereas invasive techniques include injection of dye into vessels
(catheter venography). Recent studies
performed by our group suggest that the non-invasive Doppler ultrasound
approach is preferable for initial diagnosis and follow-up purposes, because it
is safer and yields results similar to those of the invasive venography
At this time, initial research
studies are under way at a number of centers to determine whether there is an
association between CCSVI and multiple sclerosis (MS), and whether treating
CCSVI has an impact on MS. Recent studies suggest that not all patients with MS
have CCSVI, and that CCSVI can be seen in healthy individuals and patients with
other neurological diseases. Consequently, until this process is better
understood, it is not possible to give either definite conclusions regarding
the association of CCSVI and MS or recommendations about the necessity for
You understand that you are
voluntarily agreeing to undergo the Test. Because the research is still in the
initial stage, any information you gain from this Test may have limited value
for a number of reasons, including, without limitation (1) having CCSVI may be
(or may not be) a contributing factor to MS or the development or progression
of MS - it may be just one factor or not a factor at all; (2) UB does not have
evidence as to the safety or efficacy of treating CCSVI, or whether treating
CCSVI effects the development, progression to or treatment of MS; and (3) it is
not determined whether the presence of CCSVI (or not) creates any additional or
new procedure options for your MS.
Understanding all of the above,
you choose to undergo the Test to determine whether you have CCSVI and consent
to the following:
I consent to the
Test and understand that this Test includes those services listed on the Test
that the only benefit I will receive from this Test is the knowledge that I
present (or do not present) CCSVI.
There are little
physical side effects associated with the Test.
that I solely am responsible for paying for the Test, which costs $675.00, and
that UB only accepts payment by credit card or personal check. I understand
that my health insurance does not cover the Test. I further understand that my initial deposit
of $250.00 will be utilized to schedule the Test and, as such, the initial
deposit will not be refundable should I withdraw from the Test at any time. I
also understand that the balance of $425.00 will need to be paid upon my
arrival at your center.
acknowledge and understand that my payment covers only the Test results, and
not any other diagnosis or treatment or prevention of CCSVI or MS.
Limitation on Liability
I expressly understand
and agree that neither UB nor its members, directors, officers, employees,
agent or representatives shall be liable for any direct, indirect, incidental,
special, consequential or exemplary damages, whether in tort, contract or
otherwise, resulting from (a) the information given to me as a result of the
Test; (b) any action or inaction I take based on the information I receive as a
result of the Test; or (c) the costs I incur for the undergoing Test and
traveling to the test site, including, without limitation, any travel, lost
wages and incidental expenses.