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					                                  Consent Form Instructions

Many sections on the Consent Form template include brief instructions to provide the user with a
general overview of information required in the section. The instructions are shaded so that you
can tell the difference between the instructions and required information. Some fill in areas are
in red text. All red text must be deleted before submission to the IRB. The template language in
black text may not be changed, or deleted, unless approved by the IRB staff. Any changes you make
must be tracked or highlighted. Please delete all shaded instruction boxes before submitting to
the IRB. To delete, select (click in) a shaded box and hit the "delete" key.
Introduction:
The consent to be a research participant should be prepared according to the guidelines below.
Although the consent for certain very simple studies can be simplified, the majority of consent forms
must contain the elements listed below, in the order listed and phrased in the suggested language.
Any other language specifically required by the sponsor can be added, provided it is written (or re-
written) in simple, 6th to 8th grade language. Investigators should not deviate from these guidelines
without prior consultation with the Chair of the IRB or the IRB Manager. Once a consent form has
been approved by the IRB, it must not be revised in any way without written permission from the IRB.
Investigators must keep a complete paper trail of all communication with the IRB regarding their
consent forms, including copies of all versions of the consent.
Format:
There are specific requirements for how the consent form must be written. The consent form must be
written in the second or third person (you will be, your child will be). The consent form must be written
clearly and simply, in language that the average layperson can understand, usually in the sixth grade
reading level. Passive voice phrasing should be avoided. Do not use terms like “he/she”; gender
free references such as “your child” are preferred.
Please leave adequate top and bottom margins for the IRB stamps. The IRB staff will add the
approval and expiration stamp, to the final version of the form(s). PDF documents with IRB stamps
and unstamped Word documents will be e-mailed to the PI.
All consent forms must include the date of the latest revision in the lower left corner of the footer. At
continuing review, even if there are no changes, the form date should be updated (the version date
can remain if required).
All consent forms must be identified in the top left corner of the first page, e.g., "Adult" if the form is
only for age 18 or older; "Parent" if the form is for parental permission; "You/Your Child" if combined
consent is used. When the IRB staff receives the electronic copy, the IRB number will be put in the
header.
For any study that involves a medical/clinical intervention, the first page of the consent form must be
the "List of Rights of a Participant in a Medical Experiment." The subject must sign and date this page
before proceeding to the consent form. If the study does not involve a "medical experiment" as
defined below, do not include this.
“A medical experiment” is defined under section 24174 of the CA Health and Safety Codes as follows:
(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or
device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a
biological substance or organism, in or upon a human subject in the practice or research of medicine
in a manner not reasonably related to maintaining or improving the health of the subject or otherwise
directly benefiting the subject; (b) The investigational use of a drug or device as provided in Sections
111590 and 111595; (c) Withholding medical treatment from a human subject for any purpose other
than maintenance or improvement of the health of the subject.

Version 08-10
IRB #




                   LIST OF RIGHTS OF A PARTICIPANT IN A
                           MEDICAL EXPERIMENT
Under California law, a person participating in a medical research study
must be told:

 The purpose of the study,
 The procedures which will be followed in the study, and the drugs or
  devices, if any, which will be used,
 If there are any other possible treatments, procedures, drugs or devices
  which can be given (instead of those offered in the study), and the risks
  or benefits of those other possibilities,
 If there are any discomforts or risks that may reasonably be expected
  from taking part in the study,
 What medical treatment, if any, will be available if complications happen
  during or after the study,
 If there are any benefits that can be expected from taking part in the
  study, and if so, what the benefits might be,
 That any questions about the study can be asked, both before agreeing
  to be involved and during the study, and that answers must be given,
 That consent to participate in the study may be withdrawn at any time,
  without affecting the right to care and quality of care that would be
  received outside of the study,
 That the choice to take part in the study or not should be given freely,
  without pressure, deceit or other excessive influence on the decision
  made,
 That a copy of the written, signed and dated consent form will be given
  to the participant to keep.


    Signature of Participant or Legal Representative                    Date


                           747 Fifty Second Street ● Oakland, CA 94609-1809
                                               510-428-3000                    Page 1 of 15
                                      www.childrenshospitaloakland.org
IRB #




               CONSENT TO PARTICIPATE IN A RESEARCH STUDY – ADULT

              CONSENT TO PARTICIPATE IN A RESEARCH STUDY – PARENT

                           choose one of the above – delete the other
        Choose the paragraphs that are customized to apply either to "your child" or "you."
                                                  OR
You may combine adult and child consent by using the "you" formatted paragraphs and the
following box [delete if not used.]

If you are a parent, as you read the information in the Consent Form, you should put yourself in
your child’s place to decide whether to allow your child to take part in this study. Therefore, for
the rest of the form, the word “you” refers to your child.

If you are an adult reading this form, and deciding whether to take part in the study, the word
“you” refers to you.

NAME OF THE STUDY:



WHAT IS THIS STUDY ABOUT?

Describe the rationale for doing the study in simple terms. Be sure to state that this is a
research study. Include reasons for doing the study, such as safety and/or efficacy, etc.

Explain the medical and practical reasons the subject was selected as a potential participant
[why the subject may qualify to be in the study].



WHO IS SPONSORING THIS STUDY?

All consent forms should disclose which agencies or institutions (e.g., National Institutes of
Health, Center for Disease Control, State agencies), cooperative groups (COG, ACTG),
foundations or industry sponsors are funding the research or providing study drugs or
equipment for the study, and state what the sponsor is paying for. If the study is not being
funded by an external agency, then the internal funding source, i.e., Department funds,
investigator personal funds, should be identified.

This study is paid for by xxxxx. The medicine being studied, xxxxx, will be provided at no cost
to you or your insurance company by [name of sponsor], a pharmaceutical company.

                         747 Fifty Second Street ● Oakland, CA 94609-1809
                                             510-428-3000
                                                                                Page 2 of 15
                                    www.childrenshospitaloakland.org
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HOW MANY PEOPLE WILL BE IN THIS STUDY?

About state total accrual goal for CHRCO people, age state the age range of the participants
will be in this study at Children's Hospital & Research Center Oakland. For multi-center
studies, give figures both for the whole study and for local enrollment at CHRCO.

IS THERE ANY CONFLICT OF INTEREST?

If there is a perceived or actual conflict of interests, this information will be released to the IRB
and will be addressed in the consent form under this section. Financial ties to the sponsoring
company will not necessarily prevent the investigator from performing or participating in
research involving that company.
Examples:
Dr. _____________ has stock in a company that is doing research in the same area as this
study.
Dr. ___________________ has received an honoraria [or travel reimbursement] during the past
12 months from the study sponsor.
You may also add, This disclosure is [these disclosures are] made so that you can decide if this
relationship will affect your willingness to participate in this study. If there is no conflict of
interest, and unless you have specific language to include, the following statement
should be included:
No one on the study team has a significant financial interest related to this research study.
Dr. name is responsible for doing the study at Children’s Hospital & Research Center Oakland.
Dr. name has said that choose he or she does not have any significant financial ties or
interactions with the organization that is sponsoring the study that would influence the conduct
of the study or the reporting of results.
If there is no external sponsor and the study is being funded by CHRCO, CHORI or is
non-funded, use the following statement:
No one on the study team has a significant financial interest related to this research study.
Dr. name is responsible for doing the study at Children’s Hospital & Research Center Oakland.
Dr. name has said that choose he or she does not have any conflict of interest that would
influence the conduct of the study or the reporting of results.

WHAT WILL HAPPEN IN THE STUDY?

Explain the study procedure in simple terms. If appropriate, include a description of
randomization. List and explain each part of the study. Be sure to distinguish between
standard practice and what is done for the research study. Clearly outline what is
experimental.

If you agree to be in this study, the following will happen:



                                                                                 Page 3 of 15
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Before you begin the main part of the study...
You will need to have the following “screening” exams or tests to find out if you can be in the
main part of the study.

List tests and procedures as appropriate. Use bulleted format.
For example:
Physical exam: You will have a physical exam, like those done for regular medical care.
Medical record review: The study doctors will look at your medical record.
Urine sample: You will be asked to give a urine sample for lab tests.
Blood drawing (venipuncture): You will be asked to give a blood sample for lab tests. [name
the types of tests/reasons for tests] This will be done by putting a needle into a vein in your
arm.
When describing procedures, use lay terms. For example, if blood is to be drawn, estimate the
amount in teaspoons, tablespoons or cups.
During the main part of the study...
If the screening exams, tests or procedures show that you can continue to be in the study, and
you choose to take part, then the following will be done:

List tests and procedures as appropriate. Use bulleted format. Estimate the amount of time
required for participation in the study.

If a placebo is to be used, indicate that the subject may receive a placebo, with an explanation
that a placebo is an inactive substance which looks like an active drug [a "sugar pill"]

 For randomized studies:
You will be "randomized" into one of the study groups described below. Randomization means
that you are put into a group by chance. A computer program will place you in one of the
groups. Neither you nor your doctor can choose the group you will be in. You will have an
 equal/one in three/etc. chance of being placed in any group.

If you are in group 1 (often called "Arm A")... [Explain what will happen for this group with clear
indication of which interventions depart from routine care.]
If you are in group 2 (often called "Arm B")... [Explain what will happen for this group with clear
indication of which interventions depart from routine care.]
For studies with more than two groups, an explanatory paragraph containing the same type of
information should be included for each group.


Examples:
CT scan: You will have a computed tomography (CT) [/computerized axial tomography (CAT)]
scan of your [XXX], done [XXX], to check . . . A CT scan uses special x-ray equipment to make
detailed pictures of body tissues and organs. For the CT scan, you will need to lie still on a
table with your [XXX] inside a large doughnut-shaped machine. [Explain what will happen
during the procedure, what the patient will experience, how long it will take, etc. If a contrast


                                                                               Page 4 of 15
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material will be used, explain what this is and how it will be given.] [This makes tissue and
organs more visible in the pictures.]

MRI: You will have a Magnetic Resonance Imaging (MRI) exam. For the MRI exam, you will lie
down on a narrow bed [explain what the MRI is like, the need to lie quietly, how long it will take,
whether general anesthesia will e used, etc.]
WHAT ARE THE RISKS OR POSSIBLE SIDE EFFECTS OF THIS STUDY?

Be sure to distinguish between the risks of standard treatment (if applicable) and the
risks of the research study. Include the following paragraph:

You may have side effects while on the study. Everyone in the study will be watched carefully
for any side effects. However, doctors do not know all the side effects that could happen. Side
effects may be mild or very serious. Your health care team may give you medicines to help
lessen side effects. Many side effects go away soon after you stop taking [drugs/interventions].
In some cases, side effects can be long lasting, or may never go away.

This sentence should be included if appropriate: There is also a risk of death.

Risks and side effects for the [procedures, drugs, interventions, devices] include those that are:

Likely
    
Less Likely
    
Rare but serious
    

Describe each risk, discomfort, or inconvenience (e.g., having to make extra visits to the
hospital or doctor’s office, blood drawing, experimental medicines). Include an explanation of
the clinical significance of the risk (what will actually happen to the participant, how the
participant will feel) and a statement about the likelihood of occurrence of side effects.

Example: The risks of drawing blood include temporary discomfort from the needle stick and
bruising.

[If appropriate to the study, include the following risk statement(s):]

       Randomization risks: You will be assigned to a treatment program by chance, and the
        treatment you get may prove to be less effective or to have more side effects than the other
        study treatment(s) or other available treatments.

       Placebo risks: If you are in the group that gets the placebo, your condition will go without
        the active (study) treatment for [XX weeks].

HOW LONG WILL I [MY CHILD] BE IN THE STUDY?



                                                                                  Page 5 of 15
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State expected time on the study, including any follow-up time.




ARE THERE RISKS TO AN UNBORN BABY?


The consent form must specifically address any treatment or procedure which might involve
risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant),
which are currently foreseeable. Include only if this is an exclusion criterion in the protocol.
– Delete if not applicable, heading included. Delete sentence about males if not applicable.

Adults only There may be a risk to an unborn baby. Females cannot be in the study if pregnant.
They should not breastfeed a baby while on this study. Females able to become pregnant will
be asked for a urine sample before starting the study to make sure they are not pregnant. One
or more pregnancy tests are absolutely required to be in the study. Males should not father a
baby while on this study.

 Combined Adult/Child There may be a risk to an unborn baby. Females cannot be in the study if
pregnant. They should not breastfeed a baby while on this study. Females 12 years or older, or
who have had their first menstrual period, will be asked for a urine sample before starting the
study to make sure they are not pregnant. One or more pregnancy tests are absolutely required
to be in the study. Only the participant (person who is enrolled in the study) will be told the
results of the pregnancy test, except as required by law. Males should not father a baby while
on this study.

 Child only – signed by parent/guardian There may be a risk to an unborn baby. Females cannot
be in the study if pregnant. They should not breastfeed a baby while on this study. Females 12
years or older, or who have had their first menstrual period, will be asked for a urine sample
before starting the study to make sure they are not pregnant. One or more pregnancy tests are
absolutely required to be in the study. Only your child will be told the results of the pregnancy
test, except as required by law. Males should not father a baby while on this study.
Add sponsor-specific language, including contraception, if required.

ARE THERE BENEFITS TO BEING IN THE STUDY?

The potential benefits of participating in the study, if any, should be described in simple terms.
If there are no benefits, that should be stated. Clearly state whether there is an expected direct
benefit or an indirect benefit.

Example: The information we get from this study may help future patients if… or It is possible
that the experimental treatment will work better than the treatment usually given or There will
be no benefit to you from being in the study.




WHAT OTHER CHOICES DO I HAVE?


                                                                               Page 6 of 15
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Describe appropriate alternatives, including their relative risks and benefits. If the treatment,
device or an FDA-approved drug can be prescribed/obtained outside of the study this must be
stated.
Example: If you choose not to [have your child] be in this study, your child [you] will be treated
with standard therapy including [briefly state what is standard therapy] Include no treatment or
palliative care if appropriate.


PRIVACY SECTION BELOW: For most studies, the following statement [either the paragraph
for adult or child] should be used. If there is other information specific to the protocol, include
the specifics within the CHRCO language below. For example, identifying data may be collected
or be sent to someone outside of CHRCO, so the statement "for records shared outside of
Children's Hospital & Research Center Oakland" would not apply.


Adult and Combined Adult/Child HOW WILL MY PRIVACY BE PROTECTED?

Study records that identify you will be kept confidential as required by law. Federal Privacy
Regulations protect your privacy, restrict who is allowed to look at your records, and require
security to protect your records. The Federal Food and Drug Administration (FDA) may inspect
your research records. Except when required by law, you will not be identified by name, social
security number, address, telephone number, or any other direct personal identifier in study
records shared outside of Children’s Hospital & Research Center Oakland. For records shared
outside of Children’s Hospital & Research Center Oakland, you will be given a code number.
The list that can match you to the code number will be kept in a locked file in the Principal
Investigator's office. The people whose job is to make sure the study is being done properly will
come to the hospital and look at our records that can identify you. Any data released for
monitoring the study will not use your name or any identifying information.

Child only HOW WILL MY CHILD'S PRIVACY BE PROTECTED?

Study records that identify your child will be kept confidential as required by law. Federal
Privacy Regulations protect your child's privacy, restrict who is allowed to look at your child's
records, and require security to protect your child's records. The Federal Food and Drug
Administration (FDA) may inspect your child’s research records. Except when required by law,
your child will not be identified by name, social security number, address, telephone number, or
any other direct personal identifier in study records shared outside of Children’s Hospital &
Research Center Oakland. For records shared outside of Children’s Hospital & Research
Center Oakland, your child will be given a code number. The list that can match your child to
the code number will be kept in a locked file in the Principal Investigator's office. The people
whose job is to make sure the study is being done properly will come to the hospital and look at
our records that can identify you. Any data released for monitoring the study will not use your
name or any identifying information.

DO I HAVE TO PAY TO BE IN THE STUDY?

For an industry-sponsored study, the sponsor is required to pay for the study drugs or device (if
applicable) and all tests done only for research purposes. What will be paid should be
specified. If there are any additional costs to the participant that may result from involvement


                                                                               Page 7 of 15
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with the research, state each expected cost. If there are no costs involved, the following
statement [either the paragraph for adult or child] should be included:

Adult and Combined Adult/Child No, there will be no cost to you to be in this research study.
Care that would be given to you if you were not in this research study will be charged under
your usual payment method. There will be no charge to you or your insurance company for any
of the costs directly related to this study.

Child only No, there will be no cost to you for your child to be in this research study. Care that
would be given if your child were not in this research study will be charged under your usual
payment method. There will be no charge to you or your insurance company for any of the
costs directly related to this study.

WILL I BE PAID FOR BEING IN THE STUDY?

If any reimbursement is to be provided (e.g. to offset travel expenses) that should be clearly
stated. The amount of reimbursement must not be large enough that it would, by itself, influence
parents to include their child in the study.
Example: In return for [your] you and your child’s time and travel expenses, you will be
reimbursed…. State the pro-rated amount to be paid if not all visits are completed.
If there is no reimbursement state:
You [or your child] will not be paid to be in this study.

INJURY SECTION BELOW: Industry sponsors need to be contractually required to pay for
treatment for injury caused by the study. This is usually clearly stated in the language in the
contract between the hospital and the sponsor of the study. State what the sponsor will pay
for in event of injury, as stated in the contract or protocol. However, if you are not doing
an industry-funded study you should use the following paragraph to complete this section, only
if the study is greater than minimal risk. If the study is minimal risk, or no risk, the injury
section should be omitted.


choose either the paragraph for adult ("I") or child ("MY CHILD") – delete other

Adult and Combined Adult/Child WHAT DO I DO IF I AM INJURED?

If you are injured because of something done in this study, Dr. name should be told
immediately. If this happens at Children's Hospital or an associated location, we will notify your
doctors. If this happens somewhere else, please call the study doctor at (510) phone number .
You will be treated at Children's Hospital Oakland or an appropriate facility. However, neither
CHRCO nor the study sponsor have set aside funds for compensation and treatment will not be
free of charge. If you want more information about this, please speak with Dr. name at (510)
 phone number . In the case of injury from this study, you do not lose any legal rights to seek
payment by signing this form.

Child only WHAT DO I DO IF MY CHILD IS INJURED?

                                                                              Page 8 of 15
IRB #



If your child is injured because of something done in this study, Dr. name should be told
immediately. If this happens at Children's Hospital or an associated location, we will notify your
child's doctors. If this happens somewhere else, please call the study doctor at (510) phone
 number . Your child will be treated at Children's Hospital Oakland or an appropriate facility.
However, neither CHRCO nor the study sponsor have set aside funds for compensation and
treatment will not be free of charge. If you want more information about this, please speak with
Dr. name at (510) phone number . In the case of injury from this study, you do not lose any
legal rights to seek payment by signing this form.

Optional paragraph below – When there is the possibility of mental discomfort from
participation in the study, the following heading and paragraph should be used. Be sure to
contact the mental health professional before offering this service. The cost of the counseling
will need to be covered by CHRCO, your grant or industry contract:


choose either the paragraph for adult ("I") or child ("MY CHILD") – delete other


Adult and Combined Adult/Child WHAT DO I DO IF I AM UPSET BY BEING IN THE STUDY?

If being in this study causes you distress, or makes you uncomfortable or upset, and you would
like to meet with a mental health professional, please call name at (510) phone number . One
hour of professional counseling and consultation will be offered without charge.

Child only WHAT DO I DO IF MY CHILD IS UPSET BY BEING IN THE STUDY?

If being in this study causes your child distress, or makes your child uncomfortable or upset, and
you would like to meet with a mental health professional, please call name at (510) phone
 number . One hour of professional counseling and consultation will be offered without charge.

WHAT IF I HAVE QUESTIONS OR PROBLEMS?

This section should include a phone number so participants or parents/guardians can contact
one of the CHRCO investigators at any time. This should be phrased as follows:

If you have any questions about the research, either before deciding whether to participate or
during this study, please call Dr. name at (510) phone number . If you wish to speak to
someone not associated with this study about complaints or your rights as a research
participant, you may contact the Institutional Review Board (that reviews the research to protect
your rights) at:
    Children's Hospital & Research Center Oakland
    IRB Office
    747 52nd Street
    Oakland, CA 94609
    (510) 428-3754

WHAT ARE MY RIGHTS? DO I HAVE TO AGREE TO THIS STUDY?

                                                                              Page 9 of 15
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The following paragraph [either the paragraph for adult or child – delete the other] must be
included in the consent form:

 Adult and Combined Adult/Child You do not have to be in this research study. It is your choice.
If you agree to be in this study and later change your mind, you may stop at any time. No
matter what your decision is, including if you withdraw, there will be no penalty. You will not
lose any of your medical benefits and the quality of your medical care at Children's Hospital will
not be affected. If you wish to be in the study, please sign this form.

Child only Your child does not have to be in this research study. You have the right to refuse to
have your child take part at all. You may withdraw your child at any time. No matter what your
decision is, including if you withdraw your child, there will be no penalty. Your child will not lose
any medical benefits and the quality of your child’s medical care at Children’s Hospital will not
be affected. If you want your child to be in the study, please sign this form.

WILL I BE TOLD ABOUT NEW INFORMATION?

Unless the subject's participation in the study will be so brief that no new findings can be
expected, the following paragraph [either the paragraph for adult or child – delete the other]
must also be included – otherwise delete this section. Do not use this section if the subject
will have a one-time intervention, or the study is very short duration.

 Adult and Combined Adult/Child Yes, we will tell you as soon as possible about any new
information learned in the study, both good and bad, which might affect your wanting to stay in
this study.

Child only Yes, we will tell you as soon as possible about any new information learned in the
study, both good and bad, which might affect you wanting your child to stay in this study.

CONSENT TO BE A RESEARCH PARTICIPANT:

Although the majority of studies require the signature of only one parent, both parents’
signatures may be required if the IRB specifies this. The following statement must be used in
this section (choose one paragraph only – delete all the others)

Adult only Your signature below indicates that you agree to be in this study. You will be given a
signed copy of this form to keep, which includes the "List of Rights of a Participant in a Medical
Experiment".

 Combined Adult/Child Your signature below indicates that you agree, or give permission for
your child to be, in this study. You will be given a signed copy of this form to keep, which
includes the "List of Rights of a Participant in a Medical Experiment".

Child only Your signature below indicates that you give permission for your child to be in this
study. You will be given a signed copy of this form to keep, which includes the "List of Rights of
a Participant in a Medical Experiment".



                                                                               Page 10 of 15
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If the study is not a "medical experiment" the List of Rights is not required. The following
statement [either the paragraph for adult or child – delete the others] must be used:

Adult only Your signature below indicates that you agree to be in this study. You will be given a
signed copy of this form to keep.

Combined Adult/Child Your signature below indicates that you agree, or give permission for
your child to be, in this study. You will be given a signed copy of this form to keep. Child
only Your signature below indicates that you give permission for your child to be in this study.
You will be given a signed copy of this form to keep.

If the form is for parental permission only, include the following signature block (delete the
other signature block below this one).


Participant's Name [PLEASE PRINT]



Parent's or Guardian's Name [PLEASE PRINT]



Parent’s or Guardian's Signature                           Date


If the form is for an adult or the combined adult/child, include the following signature block
(delete the other signature block above):


Participant's Name [PLEASE PRINT]



Participant's or Legal Representatives Name [PLEASE PRINT]



Participant’s or Legal Representative's Signature                 Date


Signing the consent form should take place only after the consenting parties have read the “List
of Rights” (if applicable). The List of Rights should be on a separate page, incorporated as the
first page of the consent form.
The IRB will determine if assent is required, how assent should be documented, and the age
range of the assenting children. Generally, children age 7 or older should be asked for ass ent
(agreement to participate), and a separate written Assent Form should be provided, with only
the child's signature and date. [see Assent Form template] The IRB can approve a waiver of
child assent, or allow oral assent in certain circumstances.

                                                                              Page 11 of 15
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If the study is not complicated and can be understood by an adolescent, you may add a
signature block to the parental consent, instead of asking the adolescent to sign a separate
assent form.
ASSENT OF ADOLESCENT AGE 13-17 TO BE A RESEARCH PARTICIPANT:

Your parent or legal guardian has given permission for you to be in this study. You do not have
to be in this study. If you do not understand something, please ask the researcher to explain it
to you again. You can say yes now and change your mind later. It is up to you. Signing your
name below means that you want to be in the study.



Participant’s Signature                                      Date


STATEMENT OF INVESTIGATOR (or person obtaining consent):

This section must contain the following paragraph, as well as lines for signature and date.
[either the paragraph for Adult only, Combined Adult/Child or Child – delete the others]

Adult only I have carefully explained to the participant all of the information in the consent form.
 Combined Adult/Child I have carefully explained to the participant, or the parents/guardians of
the participant, and the minor participant if assent is appropriate, all of the information in the
consent form.
Child only I have carefully explained to the parents/guardians of the participant, and the minor
participant if assent is appropriate, all of the information in the consent form.
The person who is giving consent to be in this study:
    •   Understands the language that is used, reads well enough to understand this form, or is
        able to hear and understand when the form is read.
    •   Was encouraged to ask questions and that all questions were answered.
    •   Does not have any medical problems and/or is not taking prescribed medications that
        could make it hard to understand what it means to be in this study.
To the best of my knowledge, when this person signs this form, it is understood:
    •   What the study is about.
    •   What needs to be done.
    •   What the potential benefits might be.
    •   What the known risks are.
    •   That taking part in the study is voluntary.


________________               _____________________________________________
Date                           Signature of Investigator (or person obtaining consent)


                                                                               Page 12 of 15
IRB #




The IRB determination of the assent requirement for a study must be complied with or a minor
subject cannot be enrolled without first obtaining an assent waiver for a specific subject from the
IRB. The following checkbox must be completed by the person obtaining child assent.




Assent was obtained for a minor subject, age ____________ as follows:

    Assent Form signed and placed in study file.                            Date:
    Assent obtained orally and discussion documented in study file.         Date:
   Assent is not required. Subject is an adult or under the age of . Specify the minimum age
of assent you believe is appropriate.


STATEMENT OF INTERPRETER/WITNESS:

This section is for use only if consent will be obtained from parents and/or participants who are
not fluent in English or participants who cannot read English. The oral presentation
(interpretation) and the short form written addendum should be in a language understandable to
the subject. The Spanish short form addendum is on the IRB website. Contact the IRB if you
would like this other specific languages for your patient population.
At the time of consent the following must be done:
1. The short form document should be signed and dated by the subject (or the subject's legally
     authorized representative) and by the witness.
2. The IRB-approved English language informed consent document should be signed and
     dated by the person obtaining consent as authorized under the protocol (e.g., the principal
     investigator) and by the witness.
The witness should be fluent in both English and the language of the subject. When a
qualified/certified interpreter assists the person obtaining consent, the interpreter may serve as
the witness.
If the participant understands English but does not read or write, the participant can make a
mark [ X ] if capable.


Interpreter’s Name and/or ID#:
                                  [PLEASE PRINT]
    In the presence of the Principal Investigator (or authorized person obtaining consent), I have
    witnessed the discussion and accurate oral interpretation of this document to the participant
    by an individual fluent in English and _______________ (state language), the participant’s
    or legal representative’s primary language.

                 See the attached short form addendum for documentation.




                                                                              Page 13 of 15
IRB #



    In the presence of the Principal Investigator (or authorized person obtaining consent), I have
    witnessed the discussion and accurate oral presentation of this document to the participant,
    who understands English but does not read or write.


To the best of my knowledge, the discussion and oral presentation were unders tood. The
participant or legal representative has voluntarily agreed to enroll in the research study by
signing the document in my presence.



Name of Witness [PLEASE PRINT]



Signature of Witness                                        Date




                                                                             Page 14 of 15

				
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