Consent Form
[IRBNet Tracking Number] Title of Study
[Please note, guidance suggests that the 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.]
You are invited to participate in a research study about [insert general statement about the study]. I
invite you to participate in this research. You were selected as a possible participant because [explain
how subject was identified]. You are eligible to participate in this study because [explain why the
subject is eligible to participate]. The following information is provided in order to help you make an
informed decision whether or not you would like to participate. Please read this form and ask any
questions you may have before agreeing to be in the study.
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.
Background Information
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].
Procedures
If you agree to participate in this study, I will ask you to do the following things: [Consent forms must
state specifically what the subjects will be doing. You must include the approximate time commitment
of participation, the location where the study will take place, and an estimated number of participants
that will be in the study. Subjects should be told about frequency of procedures; whether they will be
audiotaped, videotaped, or photographed; and whether you wish to follow-up with them after initial
procedures are completed].
Risks and Benefits of Being in the Study
The study has risks. [Does the research involve any possible risks or harms to subjects? The consent
form must describe all anticipated risks associated with the research study. You should reiterate the
risks that you identified in the Application for Initial Review. Describe the precautions used to minimize
each risk. Be sure to include the likelihood of the risk(s) and provisions made to minimize the risk(s). If
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the study has no risks, please delete “The study has risks” and instead state, “This study has no known
risks.”]
The direct benefits you will receive for participating are: [List any anticipated direct benefits for
subjects 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.]
Compensation
[Explain if participants will receive any compensation for participation, such as monetary
compensation, gift cards, or being entered into a drawing for a prize. Omit this section if neither
payment nor cost is involved. The consent form must explain when the compensation will be given to the
participant. Participants must receive compensation even if they withdraw from the study.]
[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 is not able to offer financial compensation nor absorb the costs of
medical treatment should you be injured as a result of participating in this research.
Privacy
Your privacy will be protected while you participate in this study. [Indicate how you will protect the
participant’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 records of this study will be kept confidential. In any sort of report I publish, I will not include
information that will make it possible to identify you. 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 or video recordings will be
made, explain who will have access, and when they will be erased. If you will be collecting data while
traveling, indicate how all data will be kept confidential while traveling]. All signed consent 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 all research records to ensure
compliance.
Voluntary Nature of the Study
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Your participation in this study is entirely voluntary. Your decision whether or not to participate will
not affect your current or future relations with [any individuals, employers, cooperating agencies, or
institutions] or the University of St. Thomas. There are no penalties or consequences if you choose
not to participate. If you decide to participate, you are free to withdraw at any time without penalty
or loss of any benefits to which you are otherwise entitled. Should you decide to withdraw, data
collected about you [state whether or not you will use their data]. You can withdraw by [Provide
directions for participants who wish to withdraw]. You are also 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 later, 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 651-9626035 or muen0526@stthomas.edu with any questions or concerns.
Statement of Consent
I have had a conversation with the researcher about this study and have read the above information.
My questions have been answered to my satisfaction. I consent to participate in the study. I am at
least 18 years of age. I give permission to be audio recorded during this study.
You will be given a copy of this form to keep for your records.
_______________________________________________________________
Signature of Study Participant
________________
Date
_______________________________________________________________
Print Name of Study Participant
_______________________________________________________________
Signature of Researcher
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________________
Date