1. Meridian Health IRB
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CONSENT TO ACT AS A HUMAN RESEARCH SUBJECT
TITLE OF RESEARCH: INTERCOSTAL NERVE TRANSFER TO RESTORE PROTECTIVE
SENSIBILITY IN SCI PATIENTS
PRI NCIPAL
INVESTIGATOR: Andrew Elkwood, MD
535 Sycamore Ave
Shrewsbury, NJ 07702
732-741-0970
____________________________________________________
Printed Name only of Subject’s Study Doctor (if not the PI)
(The person conducting the consent process may print name)
SPONSOR: N/A
Introduction
You are being asked to participate in a research study conducted by Andrew Elkwood, MD, from the Institute for
Advanced Reconstruction and Jersey Shore University Medical Center. You are being asked to take part in this
study because you have a recurring pressure sore resulting from a spinal cord injury.
Participation in this study is completely voluntary.
Please read the information below, and ask questions about anything you do not understand, before
deciding whether or not to participate.
Purpose of the Study
The management of pressure sores in patients with spinal cord injuries is a complex problem, which to
date, has no good solution. The wounds are often chronic and debilitating (disabling), requiring extended
hospitalizations and resulting in a decreased quality of life. Although numerous methods for wound
closure are available, the lack of sensibility (sensation) contributes to a high recurrence rate. The purpose
of this study is improvement of the quality of life of severely debilitated (disabled) patients, reduce the
morbidity (recurrence) and mortality (death) rates associated with chronically progressive open wounds,
and reduce the health care cost burden of chronic wound care and recurrent hospitalizations. Nerve
transfer, with or without nerve grafting, is a technique that has been successfully applied to treat brachial

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plexus (upper arm) injuries and can be used to restore protective sensation to the areas commonly
affected by pressure sores.
Duration
For each participating subject, the study will take at least one year including follow-ups and treatment. After
surgery, an overnight stay in the hospital will be necessary, after which arrangements will be made to for the
patients return home, or to a rehab facility. If you qualify for this study you would participate in the study from
the time you are first seen by a doctor until you complete the therapy that is required after surgery.
Explanation of Procedures
The procedure is intended to restore protective sensation to the region of the pressure sore. The surgery will take
up approximately 3 hours. The wound is excised and skin from an adjacent area is rotated into the wound to
close it. A nerve will be harvested from your leg and a small incision will be made in your lower back to allow
access to the donor nerve. A nerve graft will be performed on the patient from an intercostal nerve above the
level of the injury to a nerve in the area of the pressure sore. After surgery, an overnight stay in the hospital will
be necessary after which arrangements will be made to you to return home, or to a rehab facility.
Potential Risks and Discomforts
The risks of the procedure include, but are not limited to:
1. Any risks that may be associated with medicine to make you go to sleep during surgery.
2. Bleeding- excessive bleeding and/or hematoma (a collection of blood under the skin) could occur that
may require re-operation and/or a blood transfusion
3. Infection- requiring antibiotics and/or incision and drainage
4. Scarring- the surgical cuts will result in scars
5. Nerve injury- surgery of nerves may result in temporary or permanent injury to the nerves
6. Lack of improvement or recurrence - surgery may not result in any improvement
7. Worsening of function
8. Pain
9. Muscle weakness
All side effects can be different from person to person. It is important that you tell the study staff right away if
you have any side effects or any other problems with your health, even if you do not think they are related to the
study.
The risks or discomforts described may happen more often or be more severe than has been seen before. Your
health and safety will always be the first concern of your study doctor. If you notice anything unusual, you
should inform your study doctor or the nurse immediately. In the event of any serious unexpected events, all
necessary medical action will be taken.

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Anticipated Benefits
The benefit is to improve the quality of life for paraplegic patients with recurring pressure sores by
closing the wounds and restoring protective sensation to those areas. This procedure may improve your
quality of life, allow increased independence with activities of daily living, and decrease the cost of the
assistance required for these tasks.
Alternatives
You do not have to take part in this study to receive treatment for your condition. If you decide not to take part
in this study, your doctor will discuss other treatments available with you.
Confidentiality
Information obtained about you for this study will be kept private to the extent allowed by law. However, the
following groups will be able to view your medical records and have access to private information that identifies
you by name: your doctor and his study team; the U.S. Food and Drug Administration (FDA); the Office for
Human Research Protections (OHRP); and Meridian Health’s Institutional Review Board(s) (IRB). The results
of the treatment may be published for scientific purposes. These results could include your lab tests and X-rays.
However, your identity will not be given out.
By participating in this study, you should understand that we will be collecting your protected health information
(PHI) as referred to in the federal law (HIPAA 45 DFR. 164). This includes, but is not limited to, demographic
data (name, date of birth, etc.) and data on your health, your history, and physical finding, laboratory results any
other data collected or reviewed during the course of the study. The principal investigator and the study team
will analyze process and store your data with both electronic data processing systems and written documentation.
The authorization for use of your research data has no expiration date and may be subject to disclosure by
Meridian Health and therefore may no longer be protected. Your personal identity however that is your name,
address, and other identifiers will remain confidential. Only the study doctor and research team will be able to
link the study numbers to your name.
By signing this consent form, you are agreeing that the study team and other health care providers may provide
Meridian Health and the investigator with the PHI they request for purposes of the study. You are also agreeing
that Meridian Health and the investigators or their designees and affiliates may, for purposes of the study or for
the proper administration and oversight of research, use your PHI collected or created as part of the study and
share this information with the parties described. Additionally, you are agreeing that, during the study you may
not have access to the PHI obtained or crated as part of this study, although you will have access to this
information once the study is finished.
If you do not sign the consent form, you will not be able to take part in this research study. You can change your
mind and revoke this authorization at any time. If you change your mind, you must revoke your authorization in
writing. Beginning on the date you revoke your authorization, no new personal health information will be
collected for research. However, researchers may continue to use the health information that was provided before
you withdrew your authorization. This consent form will not expire unless you withdraw it. If you want to
withdraw this consent, please contact the PI and the Meridian IRB board at Jersey Shore University Medical
Center.
Because this study involves the treatment of a medical condition, a copy of this consent form will be placed in
your medical record. This will allow the doctors that are caring for you to obtain information about what
medications or procedures you are receiving in the study and treat you appropriately.

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Your health insurance carrier or other third party payor will be billed for the cost of this medical therapy.
Information relating to this study, including your name, medical record number, date of birth and social
security number, may be shared with the billing offices of Meridian Health, Jersey Shore University Medical
Center, Riverview Medical Center, Ocean Medical Center so that claims may be appropriately submitted to
your insurance company for clinical services and procedures provided to you during the course of this study.
Payment for Participation in Research
You will receive no payment for taking part in this study.
Research-Related Injuries
If you are injured as a direct result of your participation in this study, you may seek medical attention at the
medical provider of your choice. You or your insurance company/third party payer will be billed for all routine
medical, diagnostic, laboratory and pharmaceutical costs associated with the treatment of your illness or injury.
You will be responsible for any deductibles or co-payments that would normally be associated with your
insurance coverage.
Questions
If you have any questions, concerns, or complaints about the research or a research- related injury including
available treatments, please contact Dr. Andrew Elkwood. He will be glad to answer any of your questions. Dr.
Andrew Elkwood’s number is 732-741-0970.
If you have questions about your rights as a research participant, or concerns or complaints about the research,
you may contact the Meridian Health Institutional Review Board Chairperson at 732-776-4850 or the Corporate
Director of the Meridian Health Institutional Review Board at 732-776-4850. Regular hours for the Office of the
IRB are 8:00 a.m. to 4:30 p.m. EST, Monday through Friday. You may also call this number in the event the
research staff cannot be reached or you wish to talk to someone else.
In addition, you may also call the Meridian Health ComplyLine at 1-877-888-8030 to anonymously report any
concerns you have related to the Study or research.
Refusal or Withdrawal without Penalty
Your taking part in this study is your choice. There will be no penalty if you decide not to be in the study. If you
decide not to be in the study, you will not lose any benefits you are otherwise owed. You are free to withdraw
from this research study at any time. Your choice to leave the study will not affect your relationship with this
institution or your medical treatment.
Your study doctor, study sponsor, or applicable regulatory authorities have the right to stop your participation in
the study at any time, with or without your consent. You may be removed from the study without your consent
if the sponsor ends the study, if the study drug is approved by the FDA, if the study doctor decides it is not in the
best interest of your health, or if you are not following the study rules.
The sponsor may decide to stop the study and your access to the study under certain circumstances even if the
study drug appears to be safe and effective.

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If you decide to withdraw before the end of the study, there may be risks associated with this decision that you
should discuss with your study doctor. You may need to return to see the study doctor for safety reasons so you
can be taken off the study drug appropriately and referred for follow-up care.
Cost of Participation
There will be no cost to you from taking part in this study. The costs of your standard medical care will be billed
to you and/or your insurance company in the usual manner while enrolled in this study.
Significant New Findings
If there is significant new information found during the course of the study or the study plan is changed in ways
that might affect your decision to participate in the study, you will be informed, and your consent to continue
participating in the study may be obtained again.
Legal Rights
You are not waiving any of your legal rights by signing this informed consent document. As part of the consent
process, you will receive a signed copy of this informed consent document.
Signatures
SIGNATURE (print name, sign name and date) OF RESEARCH SUBJECT, LEGAL
REPRESENTATIVE AND/OR IMPARTIAL WITNESS
Your signature below indicates:
 You have read this document and understand its meaning;
 You have had a chance to ask questions and have had these questions answered to your satisfaction;
and
 You consent to participate in this research study.
__________________________
Name of Subject (please print)
__________________________ _________________________
Signature of Subject Date
__________________________ _________________________
Name of Legal Representative, Relationship to Subject
if applicable (please print)
__________________________ _________________________
Signature of Legal Representative Date
__________________________

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Name of Impartial Witness,
if applicable (if subject unable to read and write)
(please print)
__________________________ _________________________
Signature of Impartial Witness Date
SIGNATURE OF THE PERSON OBTAINING INFORMED CONSENT (print name, sign name, and
date)
I have explained the research to the subject and answered all of his/her questions. I believe that he/she
understands the information described in this document and freely gives consent to participate. I have
given a copy of this signed informed consent form to the research subject.
__________________________________________________
Name of Person Obtaining Informed Consent (please print)
_________________________________________ ___________________________________
Signature of Person Obtaining Informed Consent Date (must be the same date as subject’s)
SIGNATURE OF PRINCIPAL INVESTIGATOR (Required when someone other than the Principal
Investigator obtains Informed Consent) (print name, sign name, and date)
(affirming subjects eligibility for the Study and that informed consent has been obtained)
______________________________________
Name of Principal Investigator (please print)
_____________________________ ____________________________________________
Signature of Principal Investigator Date (must be within 30 days of subject’s signature)

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Meridian Health
AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION
FOR RESEARCH
What is the purpose of this form? You are being asked to sign this form so that Meridian Health may use
and release your health information for research. Participation in research is voluntary. If you choose to
participate in the research, you must sign this form so that your health information may be used for the
research. If you choose not to sign this form, you cannot participate in the research study.
Principal Investigator:
Sponsor:
Research Protocol (Title):
What health information do the researchers want to use? All medical information and personal
identifiers including past, present, and future history, examinations, laboratory results, imaging studies and
reports and treatments of whatever kind related to or collected for use in the research protocol.
Why do the researchers want my health information? The researchers want to use your health
information as part of the research protocol listed above and described to you in the Informed Consent
document.
Who will disclose, use and/or receive my health information? The physicians, nurses and staff working
on the research protocol (whether at Meridian Health or elsewhere); other operating units of Meridian Health,
as necessary for their operations; the IRB and its staff; the sponsor of the research and its employees; and
outside regulatory agencies, such as the Food and Drug Administration.
How will my health information be protected once it is given to others? Your health information that is
given to the study sponsor will remain private to the extent possible, even though the study sponsor is not
required to follow the federal privacy laws. However, once your information is given to other organizations
that are not required to follow federal privacy laws, we cannot assure that the information will remain
protected.
How long will this Authorization last? Your authorization for the uses and disclosures described in this
Authorization does not have an expiration date.
Can I cancel the Authorization? You may cancel this Authorization at any time by notifying the Director
of the IRB, in writing, referencing the Research Protocol and IRB Protocol Number. If you cancel this
Authorization, the study doctor and staff will not use any new health information for research. However,
researchers may continue to use the health information that was provided before you cancelled your
authorization.
Can I see my health information? You have a right to request to see your health information. However,
to ensure the scientific integrity of the research, you will not be able to review the research information until
after the research protocol has been completed.

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Participant name (please print): ______________________________________
Signature of participant: ______________________________ Date: __________________
or participant's legally authorized representative: ______________________________ Date:
_________________
Printed Name of participant’s representative: ______________________________
Relationship to the participant: _______________________________________