TITLE: [Insert Title or Name of Device and HDE #]
PRINCIPAL INVESTIGATOR(S):
SPONSOR/MANUFACTURER:
The [insert name of HUD] has been approved by the Food and Drug Administration (FDA) for use as a Humanitarian Use Device (HUD). A humanitarian use device is one which is used for conditions or diseases which typically affect fewer than 4,000 people in the United States per year, and when there is no comparable device marketed to treat and/or diagnose those conditions or diseases. The ability of this device to treat your condition has not been proven, but it is thought to be safe and may improve your condition. It has not been tested like other FDA approved articles.
This form serves two purposes. First, it provides specific information on the procedures and risks involved so that you can provide informed consent. Second, this form asks you to authorize the use and disclosure of medical information that will be collected if you decide to undergo surgery.
It is important that you read this entire consent carefully before you make your decision. Your doctor wants you to understand the risks, benefits and alternatives , so feel free to ask questions at any time. If you choose to give your informed consent and authorize the use and disclosure of your medical information, please sign this form on the last page.
Background Information
[This section will contain background information specific to the device]
Purpose of the Device
[This section will contain research specific to the device]
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Investigator:
Site:Page 1 of 5
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Investigator:
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What will happen if I decide to have the device implanted?
[This section will contain device specific information]
What are the risks?
[In this section, list the physical risks. The explanation of risks should be reasonable and should not minimize reported adverse effects.
If possible, the risks should be divided into two categories of: very likely and less likely but serious. If data exists that quantifies the risk or if the risk is serious, provide the likelihood of the risk as a percentage or absolute numbers. Risks that may be transient or permanent should be identified as such.
It is very important to minimize the use of technical terms – clarify medical terms in lay language whenever possible.]
[Include the following statement in all consents where subject population (men and/or women) will be instructed to use contraception: Mount Carmel, a Catholic affiliated institution, wishes to remind Catholic women and/or men of the official teachings of the Roman Catholic Church regarding contraception.]
What are likely benefits of being in this study?
[This section will contain device specific information]
What are the alternatives to being in the study?
[To enable a rational choice about whether to receive an unproven HUD, patients should be aware of the full range of options available to them. Consent documents should briefly explain any pertinent alternatives to the HUD. While this should be more than just a list of alternatives, a full risk/benefit explanation of alternatives may not be appropriate to include in the written document. The person(s) obtaining the patient’s consent, however, must be able to discuss available alternatives and answer questions that the patient may raise about them.
[Additional information will be added]
What are the costs?
This is not a research study. There are no grants or funding with this project. It is the commercial use of an FDA approved product. All costs for your care during this study are your or your insurance company’s responsibility. If you have no insurance, you will be responsible for the cost. This treatment, in most cases, but not all will be covered by your insurance plan.
[Additional information will be added]
Will information about me be kept confidential?
Under federal privacy laws you have the right to determine who has access to your personal health information (called "protected health information" or PHI). PHI collected for this procedure may include your medical history, the results of physical exams, lab tests, and other diagnostic and treatment procedures, as well as basic demographic information.
If you decide to have the , you will be asked to authorize use and disclosure of your PHI by signing this form.
The following sections provide a specific description of how your information will be used if you decide to have the surgery.
What information will be collected from me?
The medical information collected from you if you have the includes:
- Information obtained from procedures used to determine your eligibility to receive the implant, including a routine medical history, physical exam, and diagnostic testing.
- Information that is created or collected from you including your over-all medical condition, the results of office visits, and diagnostic testing.
- Information contained in your underlying medical records related to your medical history and treatment prior to receiving the device.
The above information may identify you by name, address, telephone number, social security number, health plan number, date of birth, dates relating to various medical procedures, or other identifying information.
How will my information be used and disclosed?
By signing this consent and authorization form, you are allowing access to your PHI collected as a result of you receiving the . You are also allowing your doctor to receive your PHI from other physicians and facilities where you have received health care.
The PHI collected may be shared with other persons involved in the oversight of this humanitarian use device:
- the Food and Drug Administration (FDA);
- the Department of Health and Human Services;
- your medical insurance carrier
- which manufactures the humanitarian use device;
The FDA requires that a yearly report about the use of the humanitarian use device be submitted to the Mount Carmel Institutional Review Board (IRB), the human subject protection committee that oversees research done at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann’s Hospitals. Any reports of problems associated with the use of this humanitarian use device will also be reported to the Mount Carmel IRB, and this report could identify you.
Your PHI will not be used or disclosed to any other person or entity, except as required by law, or for authorized oversight by other regulatory agencies. The PHI collected will be used only for the purposes described in the Background Information and Purpose of the Device section of this consent form.
Any publications about this humanitarian use device will not include your name or a description of you. Information received will not be used to market to you. Your name will not be placed on any mailing lists or sold to anyone for marketing purposes.
Once your information is disclosed to the manufacturer of the device, the IRB, or the government agencies described above, there is a potential that your medical information will be re-disclosed and will no longer be protected by federal privacy regulations. The laws of your state may provide further protection.
Will I have access to the information in my study record?
You have the right to see and obtain a copy of the medical information collected from you.
How long does my authorization remain in effect?
Your authorization does not have an end date. You can end your authorization at any time by withdrawing your permission in writing. Beginning on the date your permission ends, no new health information will be used. Any health information that was shared before you withdrew your permission will continue to be used.
Withdrawal of your permission should be made inwriting to the person whose name is listed here:
What if I am injured as a result of the humanitarian use device?
If you require immediate medical care, you should go to the emergency room. Otherwise, the doctor in charge of the study will take care of you or help you get care. This care will be provided at the usual charge. No funds have been set aside to compensate you in the event of injury.
You should not expect anyone to pay you for pain, worry, lost income, or non-medical care costs that occur from taking part in this research study.
If you feel you have been injured as a result of this research study, you should contact Dr. at.
What if I decide not to receive the humanitarian use device?
Your decision to allow your doctor to use is entirely voluntary. You may withdraw your approval to use the humanitarian use device at any time prior to your surgery. If you decide that you do not want to receive the humanitarian use device, your decision will in no way affect the care or the quality of care that is available to you.
If you decide that you do not want to receive the humanitarian use device, you will continue to have access to health care at Mount Carmel. If you do decide to withdraw, we ask that you contact and let him know that you are withdrawing your approval to use the humanitarian use device.
How can I get more information?
You may ask questions about the humanitarian use device and the procedure to implant the device at any time. Your doctor will provide his telephone number so that he is available to answer your questions or address your concerns.
If you wish to discuss your decision with someone who is not directly involved, or if you feel undue pressure to receive the humanitarian use device, you may contact the Mount Carmel Institutional Review Board Chairperson at (614) 546-4325, or by writing to The IRB Chairperson, c/o Human Subject Protection Office, Mount Carmel Health, Corporate Services Center, 6150 E. Broad Street, Columbus, OH 43213.
Statement of Consent and Authorization
I hereby freely and voluntarily consent to receive the described in this consent. This consent is given based on the verbal and written information provided and the understanding that I am medically and physically qualified to receive the device. I am free to ask questions at any time.
I have the option to refuse to participate or to withdraw at any time without incurring any penalty or loss of benefits otherwise available, including medical care at this institution.
I understand that if my physician thinks that being treated with this product may cause me harm, or for any other reason, he or she may decide to stop my treatment without my permission.
I understand that if there are any new findings before or after my treatment that may affect my decision to continue to take part, I will be told about them.
If I have any further questions, I may call at .
I understand that I may withdraw at any time without affecting my medical care.
My signature below indicates that I voluntarily agree to receive and that I authorize the use and disclosure of my protected health information (PHI). I will receive a signed copy of this informed consent and authorization form.
Patient – Print NamePatient – Signature Date
Legally Authorized RepresentativeLegally Authorized Representative - Date
Of Patient - Print NameSignature
If this form is signed by a legal representative of the patient (for example, the parent or legal guardian if the patient is a minor), a description of such representative's authority to act for the patient/research subject must also be provided.
Provide description of authority:
Consent Taken By – Print NameConsent Taken By – Signature Date
Treating Physician – Print NameTreating Physician – Signature Date
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Investigator:
Sites: Patient Initials Page 1 of 5