Patient Information and Consent Form
University of WisconsinSchool of Medicine and Public Health
Department of XX
Madison WI 53792
Protocol Title:Emergency Use of XX for One Patient (Initials) with XX
Responsible Physician:XX, M.D.
Patient Name History Number
Background/Invitation
Yourphysician has determined that you have X condition. You are invited to receive an investigational drug called XXto treat XX. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA) and is available only in research studies or in emergency situations where each individual patient is reviewed and approved by the FDA.
What does the experimental treatment consist of?
- Describe the drug, its dose, how it will be given, when it will be given, and how long it will be given
Are there any benefits?
It is hoped that the treatment with XXimproves your XX,or stops its progression, but this cannot be guaranteed.
Are there any side effects or risks involved?
The most common side effect that occurs with XX are
Other side effects that are common with XX are
Other side effects not listed above may also occur in some patients.
Will compensation be made for any injury resulting from this experimental treatment?
In the event that you are physically injured as a result of taking XX, emergency care will be available. You will, however, be responsible for the charges for the emergency care. There will be no commitment to provide any compensation for injury related to this experimental treatment. You should realize that you have not released this institution from liability for negligence. Please contact the treating physician, Dr. XX, M.D., at (608) XXX-XXXor after 4:30 PM at (608) XXX-XXXX(page operator, pager #XXXX), if you are injured or for further information. For information on the rights of patients who receive experimental treatments, please call the University of Wisconsin Hospital and Clinics patient relations representative at (608) 263-8009.
Are there any costs involved?
The costs of all other medications, procedures, blood tests, and examinations are considered to be part of the standard care for treating your condition and will be billed to you and/or your insurance provider in the normal fashion. The cost for XXis estimated at $XX.00. The drug preparation and administration costs are also your responsibility.
Who will see my medical information related to my experimental treatment?
The medical team involved with treating you will have access to your medical records. To the extent possible by law, your identity in this treatment program will remain confidential. Medical information concerning your treatment may be made available to the Food and Drug Administration (FDA). The University of Wisconsin Health Sciences Institutional Review Board (IRB) may review unidentifiable information about you.
If I decide tostart the treatment, can I change my mind?
Receiving the experimental treatment is voluntary. You are free to refuse the treatment or discontinue the treatment at any time. If you decline to receive the treatment or stop the treatment, it will not affect the quality of the care you receive from this institution or any other relationship you may have with this institution.
Are there any alternative treatments available?
The reason youare being offered treatment with XXis because younot respond toother drug treatments. There are approved drugs that can be used to try to treatyour XX, and your doctor will discuss these options with you. If you decide not toreceive the experimental treatment, youwill receive therapy considered appropriate for your condition.
You may take as much time as you wish to think this over. Before signing this form, please ask questions about any aspect of this treatment that remains unclear. We will attempt to fully answer any questions you may have prior to, during, or following the treatment.
AUTHORIZATION:
I have read the information in this consent form, reviewed any questions with my physician, and I voluntarily agree to receive the experimental treatment described in this form. I have received a copy of this entire document.
Printed Name of Patient
Signature of Parent/GuardianDate
Signature of PhysicianDate
or Signature of Person Obtaining Consent
Version Date: XX/XX/XX(#X) Page 1 of 3 Document 155c