Parent/Guardian Consent Form

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Parent/Guardian Consent Form
[IRBNet Tracking Number] Title of Study
[Please note, guidance suggests that the parent/guardian informed consent document
should be written at the eighth grade reading level. Please simplify language and define
terms clearly. Directions and sample text are provided in italics and highlighted; please
revise and delete these directions accordingly.]
Your child is invited to participate in a research study about [insert general statement about the
study]. Your child was selected as a possible participant because [explain how child was identified as
a potential participant]. The following information is provided in order to help you make an informed
decision whether or not you would like to allow your child to participate. Please read this consent
agreement carefully and ask any questions you may have before you decide to allow your child
to participate in the study. If you give permission for your child to participate, I will ask your
child if they are willing to participate, too. They will receive an assent form that will be
discussed with them by the researcher; please review the assent form with your child.
This study is being conducted by [indicate the name of the primary investigator, all co-investigators (if
applicable), research advisors (if applicable), and the department and institution they are affiliated
with]. This study was approved by the Institutional Review Board at the University of St. Thomas.
Purpose of the Research Study
The purpose of this study is to [provide the purpose of the research in a concise summary. You may
describe your research questions, hypotheses, and present specific methods you will use to address your
hypotheses. You may also wish to explain the benefits of this research to people other than the subject].
What Your Child Will Do in the Research Study
If you agree to allow your child to participate in this study, I will ask him/her to do the following
things: [Consent forms must state specifically what the children will be doing. You must include the
approximate time commitment of participation for both the parent/guardian and child, the location
where the study will take place, and an estimated number of participants that will be in the study. The
parent/guardian and child should be told about frequency of procedures; whether the child will be
audiotaped, videotaped, or photographed; and whether you wish to follow-up with either the
parent/guardian or child after initial procedures are completed. If the study involves the child’s class or
instructional time, inform the parent/guardian if their child will miss any instructional time and what
the child will do if they don’t participate in the study].
Risks and Benefits of Being in the Study
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The study has risks. [Does the research involve any possible risks or harms to the child? The
parent/guardian consent form must describe all anticipated risks associated with the research study.
Describe the precautions used to minimize each risk. Be specific and be sure to include the likelihood of
the risk(s) and provisions made to minimize the risk(s). If the study has no risks, then state “This study
has no foreseen risks.”]
[The following statement must be included in the consent form if the research study involves either 1) a
physically invasive procedure or an exercise component where there is even a slight risk of injury, or 2)
more than minimal risk]:
In the event that this research activity results in an injury, emergency treatment will be available.
The University of St. Thomas does not have any policy or plans to pay for any injury received as a
result of participating in this research.
The direct benefits your child will receive for participating are: [List any anticipated direct benefits
for children that participate in this research project. Adding to existing knowledge or compensation are
not considered direct benefits. If there are no direct benefits for participation, please state “There are
no direct benefits for participating in this study.”]
Payment
You will receive no payment for participating in this study. [If you will offer the parents or guardians
compensation for allowing their child to participate in research, please describe that here. If you do offer
compensation, you must also state, “If your child chooses to withdraw, you will still receive
compensation due to you”].
Privacy
Your child’s privacy will be protected while they participate in this study. [Indicate how you will
protect the child’s privacy. If you plan to interview participants, indicate how they will control the
location, timing, circumstances of sharing their information. If privacy cannot be guaranteed, indicate
this by stating, “Due to the nature of the study procedures, privacy cannot be guaranteed while you
participate in this study”].
Confidentiality
The information that you and your child give in the study will be handled confidentially. In any sort
of report I publish, I will not include information that will make it possible to identify you or your
child in any way. The types of records I will create include [List each type of record that will be created
during the research study, including recordings, transcripts, master lists of information, and computer
records, and explain what will happen to each item (where it will be stored, who will have access, and
when it will be destroyed). If audio recordings or videotapes are made, explain who will have access, and
when they will be erased]. All signed consent and assent forms will be kept for a minimum of three
years upon completion of the study. Institutional Review Board officials at the University of St.
Thomas reserve the right to inspect the study records to ensure researcher compliance.
Voluntary Participation
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Participation by you and your child is completely voluntary. Your decision whether or not to allow
your child to participate will not affect your current or future relations with [any individuals,
employers, cooperating agencies, or institutions] or the University of St. Thomas. Even if you give
permission for your child to participate in this study, your child has the right to refuse to participate.
There are no penalties or consequences if you choose not to allow your child to participate.
How to Withdraw from the Study
If you decide to allow your child to participate, you are free to withdraw your child from the study at
any time without penalty or loss of any benefits to which you are otherwise entitled. Your child is
also free to withdraw themselves from the study at any time. Simply tell the researcher that you do
not want your child to participate any longer. [Indicate how a parent or guardian should withdraw
their child if they do not do so in person.] Should either you or your child decide to withdraw, data
collected about you [state whether or not you will use their data]. Any audio recordings, photography,
or video recordings will be deleted or erased if you choose to withdraw your child. Your child is
always free to skip any questions I may ask [state if and where there are any exceptions to this rule
and include a rationale for these exceptions].
Contacts and Questions
My name is [insert researcher’s name]. You may ask any questions you have now and any time during
or after the research procedures. If you have questions, you may contact me at [telephone number
and email address. If the researcher is a student, include advisor’s name and telephone number here,
too]. You may also contact the University of St. Thomas Institutional Review Board at 651-962-6035
or muen0526@stthomas.edu with any questions or concerns.
Statement of Consent
I have had a conversation about this study with the researcher and have read the above information.
My questions have been answered to my satisfaction. I consent to allow my child to participate in the
study described above. I agree to allow my child to be audio recorded.
You will be given a copy of this form to keep for your records.
_______________________________________________________________
Signature of Parent or Guardian
________________
Date
_______________________________________________________________
Print Name of Parent or Guardian
_______________________________________________________________
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________________
Signature of Parent or Guardian
Date
_______________________________________________________________
Print Name of Parent or Guardian
_______________________________________________________________
Signature of Researcher
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________________
Date
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