This document contains both information and form fields. To read information, use the Down Arrow from a form field.
Page 1 of 2
INSTRUCTIONS FOR USE OF SHORT FORM IN OBTAINING INFORMED CONSENT
PURPOSE OF THE INFORMED CONSENT SHORT FORM
This form is an option for obtaining informed consent or parental permission for a patient who is being offered
tre
atment under an expanded access investigational new drug protocol held by the Centers for Disease Control
and Prevention (CDC).
The Informed Consent Short Form should be used when the required elements of informed consent are presented
or
ally to a patient or the patient’s legally authorized representative (LAR). The short form and applicable written
summary are translated into the patient's preferred language. The short form describes the required elements of
informed consent and specifies that those elements, as they pertain to the treatment, will be presented orally to
the patient/LAR. Details pertaining to the specific treatment are included in the written summary.
Whenever possible, short form and written summary translations that are already approved by the CDC
In
stitutional Review Board (IRB) should be used. The CDC IRB-approved short form(s) should be used as is with
no changes, except to specify the following (in English):
2. Name of Treating Physician and Contact Information
3. Emergency Contact Person/Institution and Contact Information
When a CDC IRB-approved informed consent short form translation is not available in the language needed, the
E
n
glish version of the CDC IRB-approved informed consent short form must be used for translation by a certified
interpreter. If a certified interpreter is not available, another adult who is fluent in both English and the language
needed may interpret, provided the patient (parent/LAR) is comfortable sharing medical information (i.e., the
reason treatment is being offered). If a facility wishes to create a written translation of the short form, the CDC
IRB-approved informed consent short form must be translated by a certified translator and the translation must
be submitted to and approved by the CDC IRB prior to use.
HOW TO CONSENT WITH A SHORT FORM
The treatment provider presents the consent and written summary information to the patient (parent/LAR), using
an
interpreter as needed. The patient (parent/LAR) has an opportunity to ask questions. Consent/parental
permission is then documented on both the Informed Consent Short Form in the patient’s (parent’s/LAR’s)
preferred language and on the written summary.
Responsibilities of the Interpreter
The interpreter must be fluent in both English and the preferred language of the subject (parent/LAR). When the
tr
eatment provider presents the consent information to the patient (parent/LAR), the interpreter presents the
information in the subject's (parent’s/LAR’s) preferred language.
Witness to the Sho
rt Form Consent Process
Either the interpreter or a second individual (fluent in both languages) can serve as the witness. The witness
c
annot be otherwise involved in providing the treatment. The witness can be an adult family member, friend, a
clinic nurse who is not involved in providing the treatment, or anyone else 18 years or older with whom the
patient (parent/LAR) is comfortable sharing medical information (i.e., the reason treatment is being offered).
Attestation to the Sho
rt Form Consent Process
With t
heir signatures, the person obtaining consent and witness attest to the following:
INFORMED CONSENT SHORT FORM
Page 2 of
2
• The information in the Summary Document as well as any additional information conveyed by the
person obtaining consent was presented to the patient in a language preferred by and understandable
to the patient; and
• The patient's questions were interpreted and the responses of the person obtaining consent were
presented in a language preferred by and understandable to the patient.
• At the conclusion of the consent process, the patient was asked in a language preferred by and
understandable to the subject if s/he understood the information in the Summary Document as well as
any additional information conveyed by the person obtaining consent (including responses to the
patient's questions) and responded affirmatively.
Pat
ient Copies
The patient (parent/LAR) must be provided copies of both the short form and the written summary.
INFORMED CONSENT SHORT FORM
P
age 1 of 1
Title (In English): Use of Tecovirimat (TPOXX) for Treatment of Human Non-Variola Orthopoxvirus Infections in
Adults and Children
Treating Physician: Name and phone number
In the event of an emergency, you should go to an emergency room or call 911
You (or your child) are being offered a drug called [drug name] to [treat/prevent] [disease/condition/illness].
[Drug name] has not been approved to treat or prevent [disease/condition/illness].
Before you agree, your doctor must tell you about this drug. Your doctor will give you information to help you
decide if you want to use this drug or if you do not want to use the drug. Using this drug is your choice. Your
doctor will tell you:
• what this drug is normally used for and why they are using this drug to treat [disease/condition/illness]
• that they do not know how well this drug works to treat [disease/condition/illness]
• that they do not know if this
drug is safe for you
• that this drug may make you feel sick or feel pain and what to do if this happens
• if this drug might help you
• how they give this drug to you and how long it will take to give you the drug
• if they will have to do any tests before or after they give you this drug
• if there are other drugs or ways to [treat/prevent] [disease/condition/illness]
• if you must pay to use this drug
• what to do if you are hurt or injured by this drug
• what treatment is available if you are hurt or injured by this drug and if you will have to pay for it
• they will not tell anyone you got this drug unless they have to by law
• it is your choice if you want the get this drug or not and you will get the same care either way
• you can stop taking the drug at any time
• your doctor can stop the drug a
t any time, such as if the drug is hurting you
• you can ask questions and your questions must be answered
If you chose to get this drug, you must sign this form and you must sign another form. You will get a copy of
bot
h forms that you signed.
• You can call your doctor at [the phone number] if you have questions about this drug or if you think you
have
been hurt or injured by this drug.
if you have questions about
your rights. Tell them you are a patient that got [drug] and how to call you back.
By signing your n
ame below, you agree that you were told orally about all the things above and you choose
(choose for your child) to get [drug name]. You will get a copy of this form to keep. You will also get a copy of
the information that was given to you about the treatment program.
Signature of patient capable of consent Date
My signature documents that the information in the consent form and any other written information was
accurately explained to, and apparently understood by, the
patient or their legally authorized representative
and that consent was freely given by the patient or their legally authorized representative.
Signature of witness to consent process Date
