[This template is designed to help you create a PARENTAL
PERMISSION document to facilitate obtaining permission from
parents for their minor-aged child(ren) to participate in a research
study. The State of Georgia defines minors as those persons younger
than 18 years of age. Federal regulations specify the required
elements of consent, and this Parental Permission template includes
those required items.
If enrolling Georgia Tech students who are minors, use the ADULT
CONSENT TEMPLATE unless the study poses greater than minimal
risk. In those cases, please consult the Office of Research Integrity
Assurance for guidance.
Note that the average person reads at the 8th grade level, so prepare
this document accordingly. Investigators are encouraged to use
computer software applications or other techniques to assess reading
level of the finished document; use a large font (at least 12 point); use
short, simple sentences and avoid technical language; define all
abbreviations and acronyms when they first appear in text; write the
documentError! Bookmark not defined. in second person as though
you are verbally giving instruction; and follow the format, including
headings, given below.
Instructions are included in brackets, and examples are bulleted in some
sections.]
PARENTAL PERMISSION DOCUMENT FOR ENROLLING
MINORS IN A RESEARCH STUDY
[In the State of Georgia, persons under 18 years are minors (children)
and are generally not permitted to give consent/assent to participate
in research. In some cases, emancipated minors do not need parental
permission. Consult the Office of Research Integrity Assurance for
guidance if enrolling emancipated minors or wards of the state or
other children whose parent(s) will not be available to give permission.
Guidance is also available in cases where a legal guardian gives
permission].
Georgia Institute of Technology
Project Title:
Investigators: [List the Principal Investigator (John Doe, Ph.D.) and
all personnel named on the research team.]
Protocol and Consent Title: [Include version number and date (Main
00/00/00v1)]
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You are being asked to allow your child to be in a research study.
[The word RESEARCH is required. Protocols proposing experimental
medical treatments or that pose greater than minimal risk to
participants must include the following two sentences: “You are
encouraged to take your time in making your decision. Discuss this
study with your friends and family.” Do not include these two
sentences in minimal risk studies.]
Purpose:
[This section is required. Give a brief description of the background
and purpose of the study. Include an estimate of the number of
children expected to participate.]
 [An example of a Parental Permission Purpose Statement
follows:] “The purpose of this study is to evaluate whether
our test prosthetic boot can help children with an
amputated lower limb more safely walk on unlevel surfaces.
We expect to enroll 24 children in this study.”
Exclusion/Inclusion Criteria:
[This section is required for studies that, based on a scientific
justification, are limited to certain categories of participants.]
 [An example of a Parental Permission Exclusion/Inclusion
Criteria statement follows: ] “Children in this study must
have one lower extremity amputation and be currently
utilizing a prosthetic device. Those who have severe skin
irritation or other problems with their residual limb may
not be in this study. Those with bilateral amputations may
not be in this study.”
Procedures:
[This section is required and must include a description of all research
procedures; the frequency, scheduling and time commitment of each
procedure and visit; and the total time commitment. Any audio- or
video-taping should be addressed in this section as well.


If participants are being randomly assigned to different
groups, this should be disclosed with a statement such as
"Your child will be randomly (by chance, like flipping a coin)
assigned to one of…."]
[An example of a Parental Permission Procedures Statement
follows:] “If you decide to allow your child to be in this
study, his part will involve two visits one week apart. You
are asked to be in the laboratory during the visits, and we
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believe that your presence will be reassuring to your child.
In the initial visit, which will take about one hour, we will
ask your child to tell us about the problems, if any, he has
walking with his current prosthetic device. We will then fit
him with our test prosthetic boot, and he will walk on a
treadmill in the laboratory for three five-minute trials. He
will be given a clean sock or stocking to wear. A research
assistant will be with your child to ensure that he does not
fall. With your permission and that of your child, we will
videotape his lower body as he walks. Your child’s face will
not be videotaped, and his identity will not be revealed to
anyone who sees the video. Your child may stop at any time
and for any reason. After he completes the treadmill
walking, we will ask your child some questions about how
the boot helped or hindered his walking. At the second
visit, which will take place the next week, your child will be
asked to wear the prosthetic test boot again and to step up
and down some steps in the laboratory while we videotape
him. He will go up four steps and back down five times.
With your permission and that of your child, we will
videotape his lower body as your child uses the steps. After
he finishes the steps, we will ask your child some questions
about how the boot helped or hindered his going up and
down the steps. This visit will take no more than one hour.
The total amount of time you and your child will be in the
laboratory is no more than 2 hours. Remember, your child
may stop if he wants to quit, and you may withdraw your
permission at any time.”
Risks or Discomforts:
[This section is required and must disclose any reasonably foreseeable
risks and discomforts that the child may experience. Risks and
discomforts should be grouped according to probability of occurrence,
whether rare or common. If there are special risks to pregnant or
nursing women, women of childbearing potential, or to fetuses, these
should be disclosed in bold print, with special instructions regarding
need for acceptable birth control. Similar disclosure should be made
for studies in which effects on sperm are possible. If there are no
known or anticipated risks or discomforts associated with
participation, the consent form should include such a statement.]
 [An example of a Parental Permission Risks or Discomforts
Section follows:] “The following risks or discomforts may
occur as a result of your child’s participation in this study.
Although we will carefully fit the test prosthetic boot, it
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Adult Consent Template February 2012

might rub your child’s residual limb. Your child will be
urged to inform the researcher immediately if the boot is
uncomfortable or rubs. It is also possible that your child
could fall, although research assistants will be at his side
whenever he is using the boot.”
[An example of a Risks or Discomforts Section when no risks
or discomforts are associated with participation follows:]
“The risks involved are no greater than those involved in
daily activities such as ….”
Benefits:
[This section is required and must include a description of any
benefits expected for the participants or for society. It is okay NOT to
expect the participant to benefit; in such a case, you should describe
possible eventual benefits of this research to society. Note that
compensation is not a benefit of being in the study.]
 [An example of a Benefits Statement follows:] “Your child is not
likely to benefit in any way from joining this study. We hope
that what we learn will someday help other children with lower
extremity amputations to benefit from improvements in
walking safety with prosthetic devices.”
Compensation to You:
[This section is required and should specify participant compensation
and reimbursement, whether monetary, gift card, or something else.
Compensation should be prorated in cases where participants may
make several trips or go through a number of sessions. It is generally
inappropriate to pay bonuses for completion or to withhold payment
until the study is completed. You should disclose that full
compensation will not be given to those who withdraw early or do not
complete the study. If there is no compensation at all, this should be
disclosed. In studies such as this example, the IRB recommends that
full compensation be given when participants must stop due to a
physical inability to complete the study. For example, if the test boot
causes irritation, the child should be compensated for his time and
effort anyway. Investigators are cautioned not to offer PARENTAL
compensation that might cause parents to enroll their children in
studies merely because of the compensation that accrues to the
PARENT.]

[An example of a Parental Permission Compensation to You
Statement follows:] “Your child will be given a $20 gift
certificate to McDonald’s for each laboratory visit. He will
make two visits to the laboratory for one hour each time, so his
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

total compensation is $40 in gift cards. If your child does not
come for the second visit, he will receive no additional
compensation.”
[An example of a Parental Permission Compensation to You
Statement when there will be no compensation follows:] “Your
child will not be compensated for his participation in this
study.”
[Finally, U.S. Tax Law requires a mandatory withholding of 30% for
nonresident alien payments of any type. Therefore, the following
statement should appear in the compensation section of any protocol for
which compensation will be provided]: “U.S. Tax Law requires a
mandatory withholding of 30% for nonresident alien payments of any
type. Your address and citizenship/visa status may be collected for
compensation purposes only. This information will be shared only
with the Georgia Tech department that issues compensation, if any, for
your participation.
Confidentiality:
[This section is required and should describe the extent, if any, to
which confidentiality of records identifying the participant will be
maintained. Also, see guidance from Office of Information Technology
at http://www.compliance.gatech.edu/protecting-sensitive-data/].
 [An example of a Confidentiality statement follows:] “The following
procedures will be followed to keep your child’s personal information
confidential in this study: The data collected about him will be kept
private to the extent allowed by law. To protect his privacy, your
child’s records will be kept under a code number rather than by name.
Your child’s records will be kept in locked files and only study staff will
be allowed to look at them. Your child’s name and any other fact that
might point to him will not appear when results of this study are
presented or published. Your child’s privacy will be protected to the
extent allowed by law. To make sure that this research is being
carried out in the proper way, the Georgia Institute of Technology IRB
may review study records. The Office of Human Research Protections
and/or the Food and Drug Administration may also look over study
records during required reviews.”

[If applicable, add the following sentence: “The sponsor of this
study, National Institutes of Health, has the right to review
study records as well.”]

[If the study involves use of video- or audio-taping of
participants, specifically address who has access to the
tapes, how tapes are stored, for what purposes they will be
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used, and what happens to the tapes once the study ends.
Disclose whether tapes are erased after all the necessary
information is collected from them and whether tapes are
kept for archival purposes.]

[Web-based consent documents should include the following
language:] “You should be aware that the experiment is not
being run from a ‘secure’ https server of the kind typically used
to handle credit card transactions, so there is a small
possibility that your child’s responses could be viewed by
unauthorized third parties such as computer hackers. In
general, the web page software will log as header lines the IP
address of the machine your child uses to access this page,
e.g.,102.403.506.807, but otherwise no other information will
be stored unless your child explicitly enter it.”
Costs to You or Your Child:
[This section is mandatory and must disclose the cost, if any, that
parents will bear as a result of their child being in this study. If there
are no costs, this information should be specified.]
 [An example of a Parental Permission Costs to You Statement,
when there is no cost to the participant or parent, follows:]
“There are no costs to you or your child, other than your time,
for being in this study.”
 [An example of a Costs to You Statement, when there IS cost to
the participant, follows:] “If your child participates in this
study, you will be responsible for the cost of his doctor’s visit.”
Alternative Treatments:
[This section is only used when the study involves clinical or medical
treatment, and is not needed for social and behavioral studies. If
applicable, describe other medical treatments or procedures available
if the parent chooses not to allow his child to participate or later
withdraws permission for his child to be in the study.]
 [An example of an Alternative Treatments Statement
follows:] “If your child does not participate in this study,
the only alternative is to continue with his current
program of medical treatment. If you withdraw
permission for your child to finish the study, you must
consult your child’s personal physician regarding your
child’s continuing treatment and care….”
In Case of Injury/Harm:
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[This section is mandatory, even for minimal risk studies, and must
inform participants whom to inform if they are injured due to being in
the study. The Principal Investigator, not a student researcher, must
be named here. If the study is taking place in another country, include
the PI’s email address and telephone number, including international
dialing information.]
 [An example of a Parental Permission In Case of Injury/Harm
Statement follows:] “If your child is injured as a result of being
in this study, please contact Principal Investigator, Ph.D., at
telephone (XXX) XXX-XXXX. Neither the Principal
Investigator nor Georgia Institute of Technology has made
provision for payment of costs associated with any injury
resulting from participation in this study.”
If This Is A Clinical Trial:
[Per 21 CFR 50.25(c), the following statement must be reproduced word-forword in informed consent documents for applicable clinical trials:
“A description of this clinical trial will be available on
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will
not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any time.”
Additional guidance, including the definition of applicable clinical trials may
be found at www.compliance.gatech.edu, under the link to Informed Consent.]
Participant Rights:
[This section is mandatory and must include the following language:]
 Your child’s participation in this study is voluntary. He does
not have to be in this study if he doesn’t want to be, even if you
give your permission. Your child will be asked separately if he
wants to be in the study. If he decides not to participate, he
will not be enrolled even if you have agreed that he may.
 You have the right to change your mind and remove your child
from the study at any time without giving any reason and
without penalty.
 Any new information that may make you change your mind
about allowing your child to be in this study will be given to
you.
 You will be given a copy of this Parental Permission form to
keep.
 You do not waive any of your legal rights or those of your child
by signing this Parental Permission form.
Questions about the Study:
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[This section is mandatory and must provide the name and contact
information of the Principal Investigator or other person who can
address questions about the study. If the study is taking place in
another country, include an email address and telephone number for
the PI.]
 [An example of a Questions about the Study Statement follows:]
“If you have any questions about the study, you may contact
Dr. P. Investigator at telephone (XXX) XXX-XXXX) or
Principal.Investigator@dept.gatech.edu.”
Questions about Your Child’s Rights as a Research
Participant:
[This section is mandatory and must provide the name and contact
information of the Compliance Officer in the Office of Research
Integrity Assurance, so that parents have someone to contact regarding
their child’s rights as a research participant. Provide contact
information for the Compliance Officer assigned to your department,,
as follows:]
“If you have any questions about your child’s rights as a research
participant, you may contact
Ms. Melanie Clark, Georgia Institute of Technology
Office of Research Integrity Assurance, at (404) 894-6942.”
[or]
“Ms. Kelly Winn, Georgia Institute of Technology
Office of Research Integrity Assurance, at (404) 385- 2175.”
[Finally, include the following signature language:]
If you sign below, it means that you have read (or have had read to
you) the information given in this Parental Permission form, and you
would like for your child to be in this study.
______________________________________________
Child’s Name (printed)
______________________________________________
Parent’s Name, Printed
______________________________________________ ______________
Parent’s Signature
Date
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Adult Consent Template February 2012
[In studies posing significant risk to the child, the signatures of both
parents will be required. In such cases, please insert a second
parental signature line, as shown below. Do not include this second
parental signature unless required].
______________________________________________
Second Parent’s Name, Printed
______________________________________________
Second Parent’s Signature
______________
Date
[All forms must show the name of the person obtaining consent.]
______________________________________________
Signature of Person Obtaining Consent
______________
Date
[Before uploading the Parental Permission document, be sure to delete all of
the instruction language from the document. Documents will be returned
without review if instruction language is not removed.]
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