DRUG TREATMENT PLAN
INFORMATION AND CONSENT FORM
For Single Patient Under IND#xxxx
Patient [initials]
TITLE:
PROTOCOL NO.:
WIRB® Protocol #
SPONSOR:
INVESTIGATOR:
TREATMENT PLAN-RELATED
PHONE NUMBER(S):
What is a Consent Form?
This consent form is written to help you decide if you want to take an experimental drug for your
condition. An experimental drug is one that is not approved by the U.S. Food and Drug
Administration (FDA). Please read this form carefully. For you to receive this experimental
drug, you must give your ‘informed consent’. ‘Informed consent’ includes:

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Reading this consent form,
Having your doctor or your doctor’s staff explain the experimental treatment to you, and
Asking your doctor or your doctor’s staff about anything that is not clear.
In addition:
 You may take home an unsigned copy of this consent form.
 You can think about it or talk to family or friends before you decide.
You should not sign this consent form until all your questions have been answered and you are
satisfied with the answers.
Summary of this Single Patient Treatment Plan:
You have been diagnosed with [Name of condition] that has not responded to conventional
therapy. You are now considering the use of [name of drug]. This drug is experimental for your
condition and not all risks or side effects are known.
 Some of the side effects may be life threatening.
 Your insurance coverage may not cover the cost of this experimental drug.
 There is no promise that your condition will be helped.
 You do not have to take this experimental drug. Your decision about what to do must be
made voluntarily.
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More detailed information about [DRUG] and this single patient treatment plan follows. Please
read it carefully.
Details about this single patient experimental drug treatment plan:
What will I have to do?
What are the risks?
Experimental Drug
Procedures for this experimental drug treatment plan
There may be side effects that are unknown at this time.
Other Risks
What if there are new findings?
You will be told about any new information that might change your decision to take the
experimental drug.
What will be the benefit to me?
Your [CONDITION] may improve; however, there is no guarantee of this.
What will it cost me to take part in this single patient experimental drug treatment plan?
What alternatives are there if I don’t want to take the experimental drug?
If you decide that you don’t want to take the experimental drug, you may want to be given
“comfort care.” Comfort care includes pain medication and other support. It aims to maintain
your comfort and dignity rather than cure disease. Usually this care can be provided at home.
If you think you might prefer comfort care, please discuss with your family, friends and your
doctor.
Authorization to use and disclose information
Federal regulations give you certain rights related to your health information. These include the
right to know who will be able to get the information and why they may be able to get it. Your
doctor must get your authorization (permission) to use or give out any health information that
might identify you.
What information may be used and given to others?
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If you choose to take the experimental drug, your doctor will get personal information about you.
This may include information that might identify you. Your doctor may also get information
about your health including:
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

Past and present medical records
Treatment Plan records
Records about phone calls made as part of this experimental drug treatment plan
Records about your experimental treatment visits
Who may use and give out information about me?
Information about your health may be used and given to others by your doctor and staff. This
may include information obtained both during and after the experimental treatment.
Who might get this information?
Anyone working for or with your doctor may have access to your medical and experimental drug
treatment information.
Information about you and your health that might identify you may be given to:

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The U.S. Food and Drug Administration (FDA)
Department of Health and Human Services (DHHS) agencies
Governmental agencies in other countries
The Western Institutional Review Board® (WIRB®)
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry
out this single patient treatment plan. Information about how the experimental drug affects your
[CONDITION] and the side effects you experience may be given to the FDA and to
governmental agencies in other countries. The results from your participation in this
experimental drug treatment plan may be published in scientific journals or presented at medical
meetings, but your identity will not be disclosed.
The information may be reviewed by Western Institutional Review board (WIRB). WIRB is a
group of people who independently review research, including single patient treatment plans as
required by regulations.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health
information listed above for the purposes described above. If you refuse to give permission, you
will not be able to be treated with the experimental drug.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information.
May I withdraw or revoke (cancel) my permission?
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Yes, but this permission will not stop automatically. You may withdraw or take away your
permission to use and disclose your health information at any time. You do this by sending
written notice to your doctor. If you withdraw your permission, you will not be able to continue
taking the experimental drug.
When you withdraw your permission, no new health information that might identify you will be
gathered after that date. Information that has already been gathered may still be used and given
to others.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the
information may no longer be protected. There is a risk that your information will be released to
others without your permission.
What happens if I am hurt while taking the experimental drug?
[INSERT COMPENSATION LANGUAGE]
By signing this consent form, you will not give up any legal rights.
Do I have to agree to take the experimental drug?
Your participation in this single patient experimental drug treatment plan is voluntary. You may
decide not to take the experimental drug or you may freely withdraw from the single patient
treatment plan at any time. Your decision will not result in any penalty or loss of benefits to
which you are entitled.
In addition, your doctor may stop your participation in this single patient treatment plan at any
time without your consent for any reason, including:
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
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Your doctor thinks it necessary for your health or safety;
You have not followed the treatment plan instructions;
Your doctor has stopped the treatment;
[drug] is no longer available to your doctor.
If you stop taking part in this single patient experimental drug treatment plan before the final
visit, your doctor may ask you to have some final tests.
Whom do I call if I have questions or concerns?
Contact



at
for any of the following reasons:
if you have any questions concerning your participation in this single patient
treatment plan,
if at any time you feel you have experienced a treatment plan-related injury or a
reaction to the experimental drug, or
if you have questions, concerns or complaints about the treatment plan.
If you have questions about your rights as a patient in this experimental drug treatment plan or if
you have questions, concerns or complaints about the treatment plan, you may contact:
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Western Institutional Review Board® (WIRB®)
1019 39th Avenue SE Suite 120
Puyallup, Washington 98374-2115
Telephone: 1-800-562-4789 or 360-252-2500
E-mail: Help@wirb.com
WIRB is a group of people who independently review research, including single patient
treatment plans.
WIRB will not be able to answer some treatment plan-specific questions, such as questions about
appointment times. However, you may contact WIRB if your doctor or your doctor’s staff
cannot be reached or if you wish to talk to someone other than your doctor or doctor’s staff.
Do not sign this consent form unless you have had a chance to ask questions and have received
satisfactory answers to all of your questions.
If you agree to this single patient experimental drug treatment plan, you will receive a signed and
dated copy of this consent form for your records.
CONSENT
I have read the information in this consent (or it has been read to me). All my questions about
this single patient experimental drug treatment plan and my participation in it have been
answered. I freely consent to this single patient experimental drug treatment plan.
I authorize the use and disclosure of my health information to the parties listed in the
authorization section of this consent for the purposes described above. [if you used a Confidentiality
section rather than an Authorization section above replace this text with something similar to “I authorize the release of
my medical records for research or regulatory purposes to the sponsor, the FDA, DHHS agencies, governmental
agencies in other countries, and WIRB®.”]
By signing this consent form, I have not given up any of my legal rights.
________________________________________
Patient Name
CONSENT SIGNATURE:
________________________________________
Signature of Patient
__________________
Date
________________________________________
Signature of Legally Authorized Representative
__________________
Date
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(when applicable)
________________________________________________________________________
Authority of Patient’s Legally Authorized Representative or Relationship to Patient
________________________________________
Signature of Person Conducting Informed
Consent Discussion
__________________
Date
IF ASSENT IS REQUIRED BY THE BOARD, USE ASSENTSIGNA, ASSENTSIGNC, OR
ASSENTSIGNC1 AS APPROPRIATE.
Version: 12-03-20014
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