UNIVERSITY OF PENNSYLVANIA
INFORMED CONSENT FORM
HUMANITARIAN USE DEVICE
Protocol Title:
Insert Title
Physician:
Insert Name of the Physician
Address
Insert Phone Numbers
Emergency
Contact:
Insert Emergency Contact
Insert Phone Number/Pager, etc.
What is a Humanitarian Use Device?
Your medical care will involve the use of (specify device), which has been
approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian
Use Device (HUD). A Humanitarian Use Device is a device used to diagnose or
treat a disease or condition that affects fewer than 4,000 individuals in the United
States per year and for which no comparable device is available. The U.S. Food
and Drug Administration (FDA) approves the use of Humanitarian Use Devices
based primarily on evidence that it does not pose a significant risk of injury to the
patient and that the potential benefit of the device is to the health of the patient
and outweighs the risks of its use. Note that the use of the Humanitarian Use
Device, “[name of device]” for [name of disease or condition] is approved by the
FDA. The use of [name of device] will be limited to the indication listed in the
protocol labeling by the FDA. Its use does not involve research.
[Insert a paragraph addressing a description of the Humanitarian Use Device and
how it will be used.]
What will be involved with the use of this device?
Your doctor has told you that you have [name the disease or condition] and
because of this s/he would like to use the Humanitarian Use Device.
During your surgical procedure your physician would like to use the Humanitarian
Use Device [name of device], to aid in the repair of your [state the disease or
indication for use].
What are the possible risks, side effects and discomforts
associated with the use of this device?
Based on the results of the prior research studies on this device and experience
with its approved use, the possibility of adverse events or side effects from the
[name of the device] are the following:
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Provide quantitative information (using percentages AND number of people out
of 100) on the frequency of possible adverse events. Use the following
categories: Likely – occurs in more than 25% of people (more than 25 out of 100
people); Common – occurs in 1% to 25% of people (1 to 25 out of 100 people);
Rare occurs in less than 1% of people (less than 1 out of 100 people). In
addition, we suggest that the risks are listed within the three categories in order
of severity (i.e., death would be listed before hives).
There may be adverse events or side effects that are currently unknown and it is
possible that certain of these unknown risks could be permanent, serious or lifethreatening.
What are the possible benefits associated with the use of this
device?
It is felt that the use of this [name of device] during your [add name of the
procedure] may benefit you in terms of [list all benefits of the device].
What alternative treatments or procedures are available?
If you decide not to take part in this treatment protocol, you may choose to have
[add list of alternatives].
Will my insurance provider or I be charged for the costs of this
device or any procedure associated with its clinical use?
You or your insurance provider will be responsible for any costs or charged
associated with the use of the [add the name of the device] and the surgical
procedures needed to insert the device. All other costs relating to your normal
care will be billed in the usual manner.
What happens if I am injured or hurt as a result of this treatment
protocol?
Provide contact information for protocol related injury (i.e. can refer to the
contact information noted in Consent header, if appropriate)
Describe what treatment will be provided for protocol related injuries
Explain how treatment for protocol related injuries would be paid
Describe procedure for emergency care
If you have a medical emergency you should go to the nearest emergency
room. You may contact the Principal Investigator or Emergency contact listed
on page one of this form. You may also contact your own doctor, or seek
treatment outside of the University of Pennsylvania. Be sure to tell the doctor or
his/her staff that you are in a treatment protocol at the University of
Pennsylvania. Ask them to call the telephone numbers on the first page of this
consent form for further instructions or information about your care.
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In the event of any physical injury resulting from this treatment protocol, medical
treatment will be provided without cost to you, but financial compensation is not
otherwise offered from the University of Pennsylvania. If you have an illness or
injury that is not directly related to your participation in this procedure, you
and/or your insurance will be responsible for the cost of the medical care of that
illness or injury.
Who can I call with questions, complaints or concerns about my
rights about my participation in this treatment protocol?
If you have questions, concerns or complaints about your participation in this
treatment protocol, you should speak with the Physician listed on page one of
this form. If the physician or physician’s team cannot be reached, or you want
to talk to someone other than the treating physician, you may contact the Office
of Regulatory Affairs with any concerns or complaints at the University of
Pennsylvania by calling (215) 898-2614.
When you sign this form, you are agreeing to participate in this treatment
protocol. This means that you have read the consent form, your questions have
been answered, and you have decided to volunteer. Your signature also
means that you are permitting the University of Pennsylvania Health System
and the School of Medicine to use your personal health information collected
about you. You are also allowing the University of Pennsylvania Health System
and the School of Medicine to disclose that personal health information to
outside organizations or people involved with the operations of this protocol.
A copy of this consent form will be given to you. You will also be given the
University of Pennsylvania Health System and School of Medicine’s Notice of
Privacy Practices that contains more information about the privacy of your
health information.
________________________
____________________________________
Name of Subject (Please Print) Signature of Subject
Date
________________________
Name of Person Obtaining
_____________________________________
Signature
Date
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Consent (Please Print)
(optional) Use only in studies which are approved by the IRB to use
representatives to authorize a subject’s participation in research. Delete if not
applicable.
For subjects unable to give authorization, the authorization is given by the
following authorized subject representative:
________________________
Authorized subject
representative [print]
_____________________________________
Authorized subject
Date
representative Signature
Provide a brief description of above person authority to serve as the subject’s
authorized representative.
______________________________________________________________
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