Title:
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USE YOUR DEPARTMENT LETTERHEAD
INVESTIGATOR INSTRUCTIONS ARE IN ITALICS (in blue) – The instructions are included to
assist in your submission and must be deleted prior to submission
SUGGESTED LANGUAGE (in green) – When a section is optional, suggested language has
been included, but may be altered as appropriate.
You can us I or YOU (First or Second Person) language throughout, but, be consistent. Second
person is preferred. The entire consent document should be at a 6th to 8th grade reading level.
EMERGENCY PERMISSION CONSENT FOR THE USE OF (Name of drug or device)
TITLE OF STUDY: (Add the Title of the project/treatment here.)
Principal Investigator: (Add the PI’s name here.)
This consent form is designed to provide you with information regarding the use of (name of
drug or device) that will be used in the emergency treatment/procedure that will be performed.
Please take your time reviewing this information before you consent to its use.
If you have questions at any time, you should feel free to ask them and should expect to be given
answers that you completely understand.
Background
Provide the background information regarding the drug or device including manufactures
information, a description of the drug or device and its uses.
Purpose
In lay terms describe the purpose for the emergency use of the drug or device. Where possible
limit length of sentence to twelve words (or fewer).
Description of Procedures
Clearly describe all procedures that will take place during the use of the drug or device. Use lay
language and provide details.
Benefits / Risks
Describe in lay language the risks and/or discomforts associated with the use of the drug or
device.
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Describe those that are: potential, immediate, and/or long-term. Include physical,
psychological, social, and reproductive risks. Incidence of these risks should be state as: rare,
occasional, or common; providing examples such as: 1 out of 5 or 20%.
Add information on reproductive risks of harm from drugs, devices or procedures.
Reproductive Risks of Harm
For Women:
The study drug in this research may…
For Men:
The study drug in this research may…
Clearly lists all potential benefits from the use of the drug or device.
Alternatives
Provide information regarding any alternative treatments
Follow-up / Participation
Explain follow-up procedures, including the duration of participation
Injuries
Use the text listed below, making it specific to the proposed emergency treatment/procedure
Patients seeking treatment using (name of the drug or device) will be exposed to certain risks of
personal injury in addition to those associated with standard forms of therapy, which include:
(provide a complete description if not provided elsewhere in the consent form, or refer reader to
appropriate section of form). In addition, it is possible that during the course of this treatment,
new adverse effects of (fill in name of drug, device) that result in personal injury may be
discovered. The University will make appropriate referrals for medical and/or dental treatment
for patients who sustain personal injuries or illnesses as a direct consequence of the treatment.
The patient's health insurance carrier or other third-party payer will be billed for the cost of this
treatment; provided that the University shall not submit to federally funded programs, e.g.,
Medicare, Medicaid or CHAMPUS, for reimbursement first if submission to such programs is
prohibited by law. No financial compensation will be provided by the University and no other
type of assistance is available from the University.
Costs to Participants
Explain in lay language what the cost to participate will be, if any.
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Confidentiality
Explain confidentiality methods put in place to protect the participant’s personal information.
All efforts will be made to keep your personal information confidential, but total confidentiality
cannot be guaranteed.
Voluntary Participation
In agreeing to take part in this emergency use project, you acknowledge that participation in this
project is voluntary and can be withdrawn at any time. You may choose not to participate or you
may change your mind at any time.
If you do not want to participate in the project or decide to stop participating, your relationship
with the study staff will not change, and you may do so without penalty and without loss of
benefits to which you are otherwise entitled.
You may also withdraw your consent for the use of data already collected about you, but you
must do this in writing to (enter doctor’s name and mailing address).
Questions / Rights
If you have any questions about taking part in this project or if you feel you may have suffered
an injury related to your participation in this project, you can call the study doctor:
(Provide investigator’s name)
Department
Contact Number
If you have any questions about your rights regarding the emergency use of (name of drug or
device), you can call:
The Institutional Review Board (IRB) / 973-972-3608
PARTICIPANT ACKNOWLEDGEMENT
By signing this form, I give my consent and acknowledge that I have been informed of the
purpose of the (name of drug or device) possible benefits, risks, and complications that might
come from receiving the (enter one - drug or device) and the alternatives. I understand that the
(enter one - drug or device) has not been cleared or approved by the FDA for this use. I
understand the risks that I am taking and I have had the opportunity to ask questions, all of which
have been answered to my satisfaction. I have read the consent form, received answers to my
questions, fully understand the consent form and authorize my receipt of (name of drug or
device). By my signature below, I acknowledge that I have read each section of this consent form
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carefully and have had all my questions answered. I acknowledge that I have been given a copy
of my signed consent form to keep for my records.
Participant’s Name:
Participant’s Signature:
Date:
Signature of Investigator/Individual Obtaining Consent
To the best of my ability, I have explained and discussed the full contents of the project
including all of the information contained in this consent form. All questions of the participant
have been accurately answered.
Investigator/Person Obtaining Consent:
Signature:
Date:
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