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INSTITUTIONAL REVIEW BOARD
INDIANAPOLIS, INDIANA
SINGLE PATIENT EMERGENCY USE TREATMENT
INFORMED CONSENT FORM
Note: for purposes of this document “Surgeon” refers to the surgeon or physician treating
the patient receiving the emergency use treatment.
Doctor:
(Surgeon Name)
Hospital:
(Hospital Name)
Patient:
(Patient Name)
Device Manufacturer:
(Manufacturer Name)
Customized Device(s):
Part Number
(Part Numbers)
Description
(Descriptions)
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DESCRIPTION OF EMERGENCY USE TREATMENT PROCEDURE & CUSTOMIZED
DEVICE(S)
(Describe use of device and use in procedure)
REGULATORY STATUS OF CUSTOMIZED DEVICE(S)
The above customized device(s) is not an approved medical device by the Food and Drug Administration
(FDA) but is being provided via emergency use approval for single patient use. It is not an
investigational device as no clinical study is being performed on it. It is a modification of a standard
product that the FDA has not approved for sale on the US market except for your specific use.
POTENTIAL RISKS
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You will be asked to sign a separate consent form for the surgical procedure which describes potential
risks and side effects. There are potential risks associated with any (describe procedure) which will be
discussed with you by Dr. (Surgeon Name).
The main risk of the (describe device) is (describe main failure – failure to reconstruct/correct problem).
The following are potential risks associated with the customized device:
 Detail device specific risks
These potential problems may require medical attention or additional surgery. There may be additional
risks and side effects that are unknown at this time.
ALTERNATIVE SURGICAL OPTIONS
You may decide not to take part in this emergency use treatment. Your alternative options as detailed by
Dr. (Surgeon Name) include: (Detail alternative surgical options as outlined in medical rationale)
CONFIDENTIALITY
Efforts will be made to keep your personal information confidential. We cannot guarantee absolute
confidentiality. Your personal information may be disclosed if required by law.
Organizations that may inspect and/or copy your emergency use treatment records for quality assurance
include groups such as the surgeon, his associates, and staff, the St. Vincent Hospital Institutional Review
Board or its designees, and (as allowed by law) state or federal agencies (specifically the Office for
Human Research Protections (OHRP)) and the Food and Drug Administration (FDA).
COSTS TO YOU
This device will NOT be provided free of charge. The device cost and all procedures including , but not
limited to, drugs, devices, office visits, tests and radiologic exams related to putting the device in or
removal of the device will be submitted to your insurance company (if applicable). Any co-pays or
deductibles required by your insurance company will be your responsibility. You are responsible to
check with your insurance company if the cost of the device is covered.
All standard medical expenses relating to the treatment, surgery, and follow-up of your disease will be
your responsibility or that of your insurance company (third party carrier). They will be charged in the
usual manner. If you have any questions regarding your insurance coverage, you are encouraged to speak
to your insurance carrier.
PAYMENT
You will NOT receive payment for taking part in this emergency use treatment.
COMPLICATIONS AND COMPENSATION
Every effort to prevent a device related injury will be taken by your doctor and his staff. If you think you
have been injured or if you experience a medical problem you should contact
Dr. (Surgeon Name) at (Surgeon Phone) and appropriate medical treatment will be provided to you and
billed as part of your medical expenses. Costs not covered by your health care insurer will be your
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responsibility. Also, it is your responsibility to determine the extent of your health care coverage. There
is no program in place for other monetary compensation for such injuries. However, you are not giving
up any legal rights or benefits to which you are otherwise entitled.
QUESTIONS OR CONCERNS
In the event that medical assistance is required or if you have any questions, concerns, or complaints
about your emergency use treatment you may contact (insert surgeon name) at (insert surgeon address)
or by phone at (insert surgeon phone numbers)
In the event of an emergency, you may contact Dr. (Surgeon Name) at (Surgeon 24-hour emergency
phone number).
This emergency use treatment is subject to oversight by the St. Vincent Hospital Institutional Review
Board. If you have questions about your rights or any unresolved question, concern, or complaint, you can
contact them at (317) 338-2194.
VOLUNTARY NATURE OF COMPASSIONATE USE PARTICIPATION
Taking part in this emergency use treatment is voluntary. You may choose not to take participate.
Choosing to not participate will not result in any penalty or loss of benefits to which you are entitled.
Your decision whether or not to participate in this compassionate use treatment will not affect your
current or future relations with Dr. (Surgeon Name) or St. Vincent Hospital.
CONSENT:
 I have read this consent form or it has been read to me.
 All of the questions that I had were answered to my satisfaction.
 I have been told that I will receive a signed copy of this consent form for my records.
 I have not waived any of my legal right by signing this document.
Please keep a copy of this Informed Consent for your records.
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I hereby consent to all of the above.
Patient’s Printed Name
Patient Signature
Date
Witness Printed Name* (if applicable)
Witness Signature
Date
* A witness is not required unless the patient is unable to read (e.g. such as blind or illiterate). If a witness
is present, however, the witness must observe the entire informed consent process.
Person Conducting Informed Consent Discussion Printed Name
Person Conducting Informed Consent Discussion Signature
(if other than surgeon listed below)
Date
Surgeon Printed Name
Surgeon Signature
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Date
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EMERGENCY USE TREATMENT
PATIENT BILL OF RIGHTS
I have been asked to participate in a emergency use treatment. Before I make a decision on
whether or not I want to participate in this treatment, I have the right:
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1.
To be told the reason why this emergency use treatment is being done.
2.
To be told how the emergency use treatment will be done and what kind
device will be used
3.
To know the different types of risks associate with my participation in the
emergency use treatment.
4.
To know what benefits I will receive from my participation in this
emergency use treatment.
5.
To be told what other treatment is available for me, including the risks and
benefits.
6.
To be told what other treatments are available to me after the emergency
use treatment has been completed.
7.
To be given an opportunity to ask any questions concerning the
emergency use treatment and the procedures involved.
8.
To stop the emergency use treatment at any time and know I will continue
to receive good care.
9.
To receive a copy of the patient rights and the signed and dated informed
consent form.
10.
To make up my mind about being part of the emergency use treatment
without feeling forced to participate.
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