Institutional Review Board
HUD Informed Consent Template
Maine Medical Center
Authorization to Participate in an HUD Project
HDE TITLE: Insert name of HUD
CONSENT VERSION DATE: Insert current version date
HOSPITAL OR INSTITUTION: Insert name of where research will take place
PHYSICIAN: Insert principal investigator name
PARTICIPANT’S NAME (printed): ______
You are being asked to try a new product, called a insert name of HUD. You are being asked to try this new product, because you have a explain reason for use for this HUD and the subject population. In order to decide whether you should agree to try this new product, you should understand enough about its risks and benefits to make an informed judgment. This process is known as informed consent. Please take your time to make your decision.
HOW MANY PEOPLE WILL BE OFFERED THIS NEW PRODUCT?
Up to 4000 people per year may use this new Humanitarian Use Device (HUD) because it is marketed by Name of sponsor/drug/device company., under a Humanitarian Device Exemption (HDE) from the US Food and Drug Administration (FDA).
WHAT IS A HUMANITARIAN DEVICE EXEMPTION (HDE)?
An HDE is a type of marketing exemption (giving permission to sell and use the product) granted by the FDA when a manufacturer (like name of drug/device company.) chooses not to do formal research studies to test a product because the product will be used to treat fewer than 4000 people a year. Before the FDA granted this type of exemption, they looked at information provided by insert name of drug/device company and decided that the likely risks of using this new product are reasonable, compared to the possible benefits of using the product, and compared to other treatments for intracranial aneurysms.
WHAT IS INVOLVED?
Prior to your procedure, standard tests will be performed to evaluate your general state of health. These may include a chest x-ray, an EKG (electrocardiogram, which is an electrical tracing of your heartbeat), neurological examinations, urinary pregnancy test (for females of child bearing potential), and laboratory testing of your blood. Approximately 2 tablespoons of your blood will be drawn for the following tests: electrolytes; sugar; kidney and liver functions; blood type; blood count and the ability of your blood to clot. You will be asked to take aspirin and other blood thinning medications such as clopidogrel or ticlopidine for one to three days prior to being admitted to the hospital. You will also receive another blood thinner, heparin, intravenously throughout the procedure.
During your endovascular procedure, a cerebral angiogram is performed to visualize the blood vessels in the brain. An angiogram is an x-ray procedure, which shows the blood vessels in the body. After determining the anatomy of your aneurysm, your physician will place the device inside the catheter (plastic tube) in your blood vessel. The device will then be advanced (“threaded”) through the inside of the catheter to the aneurysm. Next, the device will be softly pushed out of the catheter across the neck of the aneurysm. Upon exiting the catheter, the device will expand within the vessel. A catheter will then be used to access the aneurysm through the device for coil delivery. The coils will be delivered through the catheter until your physician determines the aneurysm has been satisfactorily embolized (filled with coils to block the aneurysm).
When the placement of the stent is completed, a final angiographic examination will be performed and the catheters will then be removed. This entire procedure is expected to last 2 to 3 hours.
After the procedure you will go to a hospital room where medical staff will closely monitor your heart rate and blood pressure. You will need to remain flat in bed for several hours. The next day you will be able to sit up and move around. During the first day of recovery, approximately one teaspoon of your blood will be drawn every 6 hours to check your blood’s ability to clot. You will also be given a blood thinner medication (heparin) intravenously for 24 hours during recovery from the procedure. In addition, you will be asked to take other medications (clopidogrel or ticlopidine) orally for 30 or more days, and an aspirin tablet daily for the rest of your life. Your doctor will limit your activities for the next few days and will advise you when you can return to normal activities.
All these procedures are considered standard of care. You will be asked to return 6 months after your (insert name of the device) procedure for a follow up neurological exam and angiogram to evaluate the treated artery. The neurological exam and angiogram may be done on an outpatient basis. Your doctor may require a blood test prior to your angiogram.
WHAT ARE THE RISKS?
There are potential risks involved with the use of this device and some may be serious enough to require surgery. Risk associated with this type of procedure includes failure to deliver the device (due to technical difficulties not being able to place the device in the proper location), in which case surgery may be necessary.
Other possible adverse events (side effects) that may be associated with the use of the this device (you should ask your physician to explain any of these complications that you do not understand) These possible adverse events are alphabetic order and not in order by incidence:
· Aneurysm recanalization
· Allergic reaction including, but not limited to, contrast, Nitinol metal, and medications
· Arrhythmia
· Arteriovenous fistula
· Coil migration / prolapse into normal vessels adjacent to the aneurysm
· Death
· Dissection
· Emboli (air, tissue or thrombotic emboli)
· Emergent neurosurgery
· Hemorrhage
· Hematoma
· Hypotension / Hypertension
· Incomplete Aneurysm Occlusion
· Infection
There may be adverse events or side effects that are currently unknown and it is possible some of these unknown risks could be permanent, serious or life threatening.
Venipuncture: The risks of drawing blood include temporary discomfort from the needle stick and bruising.
Radiation: The amount of radiation you will be exposed to is relatively small. Such doses of radiation may be potentially harmful, but the risks are so small that they are difficult to measure. If you have already had many x-rays, you should discuss this with your own doctor or Dr. Kwan before agreeing to receive this HDE.
Confidentiality: Treatment with a Humanitarian Use Device may involve a loss of privacy, but information about you will be handled as confidentially as possible. Your name will not be used in any published reports by Dr. Kwan or his colleagues.
ARE THERE BENEFITS TO RECEIVING THIS NEW PRODUCT?
It is felt that the use of the this device may benefit you because by helping to hold the coils in place, there will be less chance of a coil(s) moving from the aneurysm into the normal artery than if you did not receive the stent. You should also understand that there may or may not be a benefit to you
WHAT OTHER OPTIONS ARE THERE?
If you decide not to take part in receiving this Humanitarian Use Device – enter the name of the device, the other options for treating your aneurysm include list other options.
WHAT ABOUT CONFIDENTIALITY?
Efforts will be made to keep your personal information confidential. You will not be identifiable by name or description in any reports or publications about this device. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law.
All of your medical records related to the use of this HDE will be available to only the insert invesigator name, his staff, the drug/device manufacturer, and overseeing authorities, such as the Food and Drug Administration (FDA) and the Maine Medical Center IRB.
WHAT ARE THE COSTS?
CMS (Medicare) and most commercial insurance carriers may cover the equipment and professional services for this procedure. The insert device name is not an experimental device. However, because this is a new device, it is possible that your insurance carrier will refuse to pay for the device. You or your insurance carrier will be responsible for the cost of your hospitalization and all procedures you have during your hospitalization. The estimated total cost (professional, hospital and equipment) for this procedure is enter the estimated cost. Prior to booking the procedure, the research staff will contact your insurance regarding coverage.
If your insurance carrier refuses to pay, you will be responsible for the cost of the device and your treatment. Financial counselors are available through the hospital accounting department to discuss this with you.
In the case of injury or illness resulting from the use of insert name of the device, emergency medical treatment is available, but will be provided at the usual charge. Maine Medical Center will not compensate you or your insurance company in the event of any injury.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
If you have any comments or concerns about your treatment, you should first talk with principal investigator. He can be reached by calling (XXX) XXX-XXXX.
For Questions about your rights as a recipient of a HUD, you may contact the Maine Medical Center Institutional Review Board (MMC IRB), which is concerned with the protection of volunteers in research projects. You may reach the Board office between 8:00am and 5:00pm, Monday through Friday, by calling (207) 396-8183.
You have the right to decline treatment with a Humanitarian Use Device without jeopardy to your medical care.
If you wish to be treated with the insert name of HUD, you should sign below.
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Signature of person obtaining consent Date
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This section is for the Parent/Guardian giving permission for the child, AND the person obtaining consent to sign
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Signature of person obtaining consent Date
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Parent(s) Signature Date
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Parent(s) Signature Date
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Signature of Witness Date
A copy of this consent form must be given to each patient.
(Signature Lines for a Child’s Consent Document)
Child’s Assent
I have agreed to participate in this research project. I understand the purpose of the procedure(s) and the risks/benefits involved in its performance.
______
Signature of Patient Date 24 hr time
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Printed Name of Patient
______
If the patient is too young, the patient refuses to sign, or the parent/guardian/s request that the child not sign, indicate reason on the line above.
I have fully explained to (subject's name) the nature and purpose of the above-described procedure and the risks/benefits involved in its performance. I have answered and will answer all questions to the best of my ability. I will inform the subject of any changes in the procedure or the risks and benefits if any should occur during or after the course of the study.
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Signature of person obtaining consent Date 24 hr time
______
This section is for the Parent/Guardian giving permission for the child, AND the person obtaining consent to sign
______
Signature of person obtaining consent Date 24 hr time
______
Parent(s) Signature Date 24 hr time
______
Parent(s) Signature Date 24 hr time
______
Signature of Witness Date 24 hr time
Page 1 of 5 / SOP # SC 502-B Effective Date: 10/01/2010 Supersedes: 09/22/2010