Virginia International University Institutional Review Board
Consent Form Checklist & Example
Federal guidelines (§46.116; http://www.hhs.gov/ohrp/policy/consentckls.html) require that
the following items be included in each informed consent document:
A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject’s participation
A description of the procedures to be followed
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be expected
from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained
For research involving more than minimal risk, an explanation as to whether any
compensation, and an explanation as to whether any medical treatments are available, if injury
occurs and, if so, what they consist of, or where further information may be obtained
An explanation of whom to contact for answers to pertinent questions about the research
and research subject’s rights, and whom to contact in the event of a research-related injury to
the subject
A statement that participation is voluntary, refusal to participate will involve no penalty or
loss of benefits to which the subject is otherwise entitle, and the subject may discontinue
participation at any time without penalty or loss of benefits, to which the subject is otherwise
entitled
Additional elements are prescribed as appropriate:
A statement that the particular treatment or procedure may involve risks to the subject or
to the embryo or fetus, if the subject is or may become pregnant), which are currently
unforeseeable
Anticipated circumstances under which the subject’s participation may be terminated by
the investigator without regard to the subject’s consent
Any additional costs to the subject that may result from participation in the research
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The consequences of a subject’s decision to withdraw from the research and procedures for
orderly termination of participation by the subject
A statement that significant new findings developed during the course of the research,
which may relate to the subject’s willingness to continue participation, will be provided to the
subject
The approximate number of subjects involved in the study
The checklist need not be included with the informed consent that is provided to participants.
It is provided as a tool for the researcher only.
An example template for an informed consent is found on the next page. Researchers may
make formatting changes to the informed consent document as appropriate to their research
study (such as font and font size). However, no sections should be deleted or rearranged.
J. Wendt; 2/26/2015
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Informed Consent
*Researchers may make formatting changes to this document as appropriate to their research
study (such as font and font size). However, no sections should be deleted or rearranged.
Title of Study: (add the title of the study here)
Principal Investigator’s Name: (add the principal investigator’s name here)
University: Virginia International University
Academic Department:
You are invited to be a part of a research study that examines (add general statement about the
study here). You were selected as a possible participant because (add statement regarding
reason for selection here). Please read this form and ask any questions that you might have
prior to agreeing to participate in this study.
The purpose of this study is (add the purpose of the study here). The study is being conducted
by (add the researcher’s name, university affiliation, and academic department here). The study
is expected to last for (add duration of the study here).
Procedures:
If you agree to participate in this study, you will be asked to do the following:
(Describe the procedures that participants will be asked to take part in here. Be as specific and
as detailed as possible. Include information on assignment to study groups, types and
frequencies of procedures, video and audio recording, etc. Be sure to identify any procedures
which are experimental.)
Risks and Benefits:
The study has several risks, which include:
(Describe known and potential risks here, including the likelihood of the risks. No study is
without risks. However, if the risks are minimal, please be clear in stating this. Minimal risks
are defined as those that are no more than the participant would encounter in everyday life. If
the study may provide information that entails mandatory reporting requirements (such as for
child neglect, child abuse, elder abuse, intent to harm others, or intent to harm self), this must
be disclosed to study participants and included as a risk).
The benefits of participating in the study are:
(Describe the benefits of the study here, including benefits to society).
Injury or Illness:
J. Wendt; 2/26/2015
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(Describe whether any medical treatments are available if injury or illness occurs as a result of
participation in this study. Describe what these treatments consist of and/or where further
information may be obtained. If this study does not involve more than minimal risk, state that
fact here.)
Virginia International University will not be held responsible nor provide medical treatment or
financial compensation if you are injured or become ill as a result of participation in this
research project. However, this does not waive any of your legal rights nor release any claim
that you might have based on negligence.
Compensation:
You will receive payment by (describe payment information here. If no compensation will be
provided, state that fact here).
Confidentiality:
The records for this study will be kept private and confidential. In any published report, all
efforts will be provided to make identification of participants impossible. Research records will
be stored securely. Only the research will have access to the records.
(Describe what procedures will be taken to protect participants’ privacy and confidentiality.
Include where data will be stored and how and when it will be disposed of. If any limits to
confidentiality occur, state that here. An example of this would be when focus groups are used.)
Voluntary Participation:
Participation in this study is voluntary. Your decision to participate or not participate will not
affect your current or future relations with Virginia International University or the researcher.
If you decide to participate, you may choose to withdraw from the study at any time with no
penalty.
Contacts and Questions:
The study is being conducted by (add the researcher’s name, university affiliation, and academic
department here). You may ask any questions you have now. If you have questions later, you
are encouraged to contact (add the researcher’s name) at (add contact information here. If the
researcher is a student, include the faculty advisor’s name and contact information here.)
If you have any questions or concerns regarding this study and would like to talk with someone
other than the researcher, you are encouraged to contact the Institutional Review Board, 3957
Village Drive, Fairfax, Virginia, 22030 or email at irb@viu.edu.
You will be given a copy of this information to keep for your records.
Statement of Consent:
J. Wendt; 2/26/2015
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(For research that qualifies for a waiver of signed consent, the researcher may remove the
signature lines from the bottom of this document. An example of when this might occur is when
anonymous surveys or research that involves secondary data is utilized. A waiver of signature
requires that no more than minimal risk be posed, a breach in confidentiality would be the
principal risk to participants, the signed consent form would provide the only link to participant
identity, and the research does not include participation in any activities that would require
signed consent in any other context. A consent form must still be provided to participants (such
as posting the informed consent online). However, the participants would not need to sign and
return the informed consent to the researcher.)
I have read and understood the above information. I have asked questions and have received
answers. I consent to participate in the study.
Signature of participant:
Date:
Signature of parent or guardian (if minors are involved):
Date:
Signature of investigator:
Date:
J. Wendt; 2/26/2015