THE BURKE REHABILITATION HOSPITAL

Consent Form for Clinical Investigation

(If necessary, translate into language of subject)
Project Title:
Subject: ______________________________ Research Project #: ________________
a.

You are invited to participate in a study to determine the health of the nerves in your limbs.
Physicians of The Burke Rehabilitation Hospital hope to learn if the nerve function in the limbs
is compromised in stroke patients. You were selected as a possible participant in this study
because you are a patient on the stroke service at the Burke Rehabilitation hospital.

b.

If you decide to participate, we will study the nerve function in your legs and one of your arms.
The procedure is called Electromyography and nerve conduction studies. It is a procedure
commonly done in the clinical setting to evaluate nerve function. The test involves stimulation
to your nerves by a small electric stimulus during which we measure the size and the speed of
the response. It also may involve the study of the muscles by insertion of a small pin into the
muscle to be studied, during which time we evaluate the electrical activity in the muscle. You
will have one, two or three sessions of testing during your stay at Burke, scheduled so as not to
interfere with your therapy sessions. The actual testing of each limb takes approximately 15-30
minutes.

c.

Your participation in the project involves the following risks: there may be some brief local
irritation at the muscle sites if you allow this part of the study. If only nerve stimulation studies
are performed there is no risk involved.

d.

If a nerve problem is found in your limbs, your treating physicians may investigate this further.
Your treatment plan may or may not be altered.

e.

No standard diagnostic procedure or treatment is being withheld. If you choose to participate in

this study this will furnish more information about your nerves and muscles which may or may
not change management.

f.

Any information obtained during this study and identified with you will remain confidential and
will be disclosed only with your permission. If the information in this study is presented to the
academic medical community, there will be no patient identifiers.

g.

No financial compensation will be provided as part of the study.

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h.

Your decision whether or not to participate will not prejudice your future relations with The
Burke Rehabilitation Hospital Medical Research Institute. If you decide to participate, you are
free to discontinue participation at any time.

Consent Form for Clinical Investigation

(contd.)

i.

In accordance with Federal regulation, we are obligated to inform you about our policy in the
event injury occurs. If, as a result of your participation, you
experience injury from known or unknown risks of the research procedures as described,
emergency medical care and treatment will be provided on our premises to the extent possible.
We will assist you in obtaining additional medical care, as needed, but you will be responsible
for the costs of such further medical treatment, either directly or through your medical
insurance and/or other forms of medical coverage. No further monetary compensation will be
available. Further information can be obtained from from Karen M Pechman, M. D. (914)-5972367.

j.

No protected health information will be disclosed.

k.

The description of each purpose the requested use or disclosure of protected health information
is as follows: the information will be used to study the prevalence of neuropathy in stroke
patients admitted to an inpatient rehabilitation facility.

l.

I understand that I have the right to revoke this authorization in writing at any time.

m.

If you have any questions now or in the future, please call Pasquale Fonzetti MD, Chairman of
the IRB at (914) 597-2502 or Tom Grandville PharmD, Secretary at (914) 597-2349 and they
will be happy to answer them.

n.

You will be offered a copy of this form to keep.

o.

A description of this clinical trial will be available on http://www.Clinical Trials.gov as required

by U.S. Law This Web site will not include information that can identify you. At most, the Web
site will include a summary of the results. You can research this Web site at any time.

You are making a decision as to whether or not to participate. Your signature indicates that the above
information has been reviewed with you and that you have decided to participate. You may withdraw
at any time without prejudice after signing this form should you choose to discontinue participation in
this study.

_____________________________

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__________ AM / PM

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Signature

Date

Time

_____________________________
Signature of Parent/Legal Guardian

______________
Date

__________ AM / PM
Time

________________________________
Signature of Witness

_______________________________
Signature of Investigator

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