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CHILDS ASSENT FORM TEMPLATE

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CHILDS ASSENT FORM TEMPLATE

    CMH IRB Approved December 15, 2008

    CHILD’S/ADOLESCENT’S ASSENT FORM TEMPLATE

Italicized writing is guidance and should not be in the final document. The child’s assent

    form requires the same elements as the parental permission form. However, please

    modify the words used and length of sentences and paragraphs, as needed, to make them

    easily understandable to children

Guidance for Assenting Process: You should provide this form to children who are

    between the ages of 12 and 17 and who have adequate decision-making capacity, in the

    opinion of the study’s principal investigator and/or subject’s treating physician, with an

    explanation of the procedures they will undergo. Although there is no current legal basis

    in the state of Illinois for requiring the signature of individuals less than 18 years of age

    on assent forms, the IRB feels we should accord added protection and respect to children

    who may become subjects in research projects. Investigators have a special obligation to

    provide children with the opportunity to express any worries about participating in

    research or, when appropriate, the opportunity to decline to become a research subject.

    CHILDREN'S MEMORIAL HOSPITAL

     INSTITUTIONAL REIVEW BOARD

    Adolescent’s Agreement to Participate in a Research Study

     Ages 12- 17

We are asking you to be in a research study called:

    (Title of study)

The study is being done by (investigator’s name) at Children's Memorial Hospital.

WHY IS THIS STUDY BEING DONE?

    Make sure this information is very simple and clear. Use the statements below as guides:

We want to tell you about a research study at Children’s Memorial Hospital. Research

    studies help us find better ways to take care and treat children who are sick with a disease,

    to learn how medicines work, and how our bodies work. Research studies are voluntary,

    which means that you only have to participate in the study if you want.

We are asking you to be in this research study because you have (condition).

     AND/OR

    We are asking you to be in this research study because we want to learn more about

    (reason for study).

    Assent Version <<Date>> <<Page #>>

WHAT HAPPENS IN THE STUDY AND HOW LONG WILL I BE IN THE

    STUDY?

If you want to be in the study, this is what will happen:

    ? Clearly note the time frame for the whole study and how long each visit will take

    ? Describe what happens at the visits, what types of procedures or tests will take

    place.

    ? Describe restrictions on normal activities; and if relevant the possibility of

    receiving placebo or other control interventions in a trial.

    ? If appropriate, state clearly that the study involves an investigational/experimental

    drug or device or a marketed drug/device being used in a way for which it is not

    approved.

    ? If one (or the only) procedure is blood withdrawal, inform the child how much

    blood to be withdrawn in understandable words (e.g., tablespoons, teaspoons,

    ounces). As a general rule of thumb, 5.0 ml or cc equals one teaspoon, 15 ml

    equals 3 teaspoons or 1 tablespoon (or 1/2 ounce).

    WHAT ARE THE GOOD THINGS ABOUT THE STUDY? If there is no direct benefit to the study, include the following information:

Although you will not benefit directly from this study, we hope to learn something that

    could help other children in the future who have (condition).

    If a treatment is being given, please include the following information:

Being in this study may help you feel better or may make your (insert name for condition)

    go away, but we do not know this for sure. If the study (medicine/device/intervention)

    helps you, we do not know how long this will last. We also hope to learn something that

    could help other children or adolescents in the future who have (condition).

WHAT ARE THE NOT-SO-GOOD, BAD, OR HARMFUL THINGS THAT

    COULD HAPPEN TO ME IF I AGREE TO BE IN THIS STUDY?

    ? Use simple and general terms to explain the risks and what you will do to decrease

    them. Please note that there is a fine line and often a challenge to give an

    adolescent sufficient information for him/her to be able to give fully informed

    assent, while at the same time not overwhelming the adolescent who may have a

    fatal disease with more information than he/she can digest at the time the assent

    document is signed.

The following statements may be used or paraphrased, as appropriate, to begin this

    section:

Assent Version <<Date>> <<Page #>>

    You might have some side effects and discomfort while in the study. Some

    side effects are (state known side effects of the drug, device, treatment, etc.).

    If you have any of these side effects or feel pain, tell your parents and your

    study doctor. Your study doctor will check on you and try to help you feel

    better.

The following may be used or paraphrased, regarding blood withdrawal:

    When we take blood from your arm, the needle might hurt and you might get a

    bruise but we will (if applicable insert any measures taken such as numbing cream

    or spray that is applied to the arm or body part) so that it won’t hurt as much.

The following may be used if appropriate:

    The questions we ask you as part of the study might seem strange and maybe make

    you feel sad or embarrassed. If you don’t want to, you don’t have to answer these

    questions.

We will tell you if we learn new information that may make you change your mind about

    being in this study.

WHAT OTHER OPTIONS ARE THERE?

Describe the alternative courses of action open to the subject (such as usual treatment, no

    specific therapy, or supportive care, including palliative and hospice care as appropriate)

    instead of participation in the study. The following statement may be used verbatim or

    paraphrased to begin this section:

    If a treatment is being given, please include the following information:

    You do not have to be in this study if you don’t want to. Your doctor may

    be able to give you other treatments outside of the study. These treatments

    may include: (list information about other treatment options clearly and in

    simple terms).

    If you join the study and then change your mind, it is okay for you to leave

    this study. Your doctors (health care providers) will not be upset with you

    and will still try to help you feel better.

If no treatment is being given, please include the following information:

    You do not have to be in this study if you don’t want to. Your doctors

    (health care providers) will not be upset with you. If you join the study and

    then change your mind, it is okay for you to leave this study.

Assent Version <<Date>> <<Page #>>

WHAT ABOUT MY CONFIDENTIALITY?

We will do everything possible to make sure that your medical records are kept private.

Unless required by law, only representatives of the following groups or organizations can

    review your study records.

    ? [Name the study sponsor]

    ? The Children’s Memorial Hospital Institutional Review Board (IRB): This is the

    hospital’s board that is in charge of protecting the rights of all adults and children

    who participate in research studies.

    ? Government agencies with responsibilities to oversee research studies.

    They are required to keep your personal information private.

WILL I RECEIVE ANY PAYMENT OR GIFTS IF I AM IN THIS STUDY?

    This section should be included when appropriate to clarify if the adolescent will be

    compensated for his/her inconvenience, discomfort, etc… include the form of the compensation, such as gift cards, gift certificates, ITunes, etc...

WHAT IF I HAVE QUESTIONS?

You can ask questions whenever you have them. You can ask your doctor, nurse or other

    people working with them on the study (insert PI name and study team contact

    information). You can also ask your parents.

Your parents know about the study and said that it is okay if you want to be in the study.

    If you don’t want to be in the study, that is okay.

You can ask (PI name) anything about the study. If you are not happy with this

    study and want to talk with someone else, not the doctor or the people working

    with the doctor, you may contact Philip V. Spina, Senior Vice-President and Chief

    Operating Officer at Children’s Memorial Research Center, at 773-755-6301 or pspina@childrensmemorial.org. His address is 2300 Children’s Plaza, no. 205, Chicago, Illinois 60614-3394.

You will be given a signed and dated copy of this form.

Assent Version <<Date>> <<Page #>>

    SIGNATURES

Written assent must be sought from all adolescents (12-17 years). If written assent is not

    possible or the principal investigator and parent(s) or guardian(s) do not feel it is in the

    best interest of the child to obtain written assent, then verbal assent must be obtained. If

    verbal assent is not possible or the principal investigator and parent(s) or guardian(s) do

    not feel it is in the best interest of the child to obtain verbal assent, the IRB Chair must

    be consulted for approval of an assent waiver prior to proceeding with the research. An

    investigator may request a waiver of child assent for neurologically (comatose) or

    mentally incapacitated children at the time the protocol is initially submitted or as an

    amendment at any time thereafter. Please also see the instructions below regarding how

    to obtain assent from minors who do not speak English.

I have read this assent form, and I agree to take part in this study as it is explained

    in this assent form.

     Date Signature of Child or Adolescent (only 12-17 years old)

     ____________________________________________

     Printed Name of Child/Adolescent

    CMH requires that the date and the signature of the person (not necessarily the principal

    investigator) explaining the study to the subject(s) and parent(s) or surrogate(s) appear

    on the consent or assent document, and that that date be the same or an earlier date to

    that of the subject/parents/surrogate. The principal investigator also must sign the

    consent or assent form, if he/she is not the person explaining the study, but he/she does not

    necessarily need to do so on the same or prior date. The following paragraph should be

    used verbatim after the above subject signature:

Please indicate how assent was obtained by initialing the applicable line.

____ I certify that I have explained the above to this research subject and believe that the

    signature was affixed freely. I also agree to answer any questions that may arise.

____ Written assent was not obtainable because __________________. However, I

    certify that I have explained the above to this research subject and believe that

    verbal assent was freely given. I also agree to answer any questions that may arise.

____ Verbal assent could not be obtained because ___________________________.

    (Contact IRB Chair or his/her designee for approval of a waiver of assent

    prior to proceeding with research).

    Assent Version <<Date>> <<Page #>>

     Date Signature of Person Obtaining Consent

     Printed Name of Person Obtaining Consent

     Date Signature of Principal Investigator (if not

     listed above)

    STOP: The following signature lines must be completed if you unexpectedly consent a

    non-English speaking adolescent research subject and there is no IRB approved

    translation of the English consent form/assent form into a language understandable to the

    research subject. . In order to obtain consent, an interpreter must interpret the English

    assent form for the adolescent research subject and the adolescent research subject must

    sign the IRB approved short form consent document that has been translated into a

    language understandable to the research subject. ,. Copies of several IRB approved

    translated short form consents are available on the IRB Website.

    If the short form is not available in a language understandable to the research subject an

    interpreter must interpret the English assent form for the adolescent research subject and

    the subject signs the English assent form.

    In addition, the PI must fulfill the IRB requirements regarding parent/guardian consenting.

Please see the IRB Policy and Procedures Manual for the complete policy and specific

    IRB requirements, including signature requirements, when consenting/assenting non

    English speaking research subjects.

NOTE: If you anticipate that you will enroll non-English speaking subjects on a regular

    basis, the IRB-approved English language consent/assent form(s) must be translated and

    be IRB approved before being presented to subjects.

Printed Name of Interpreter: _____________________________

Note: the interpreter may not be a member of the study team (i.e. listed on the study

    personnel form) or be related to the research subject.

Printed Name of Witness: _______________________________

Signature of Witness: __________________________________

Assent Version <<Date>> <<Page #>>

Note: The witness should be fluent in both languages and may be the same person as the

interpreter.

Assent Version <<Date>> <<Page #>>

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