Consent Form Sample - More Than Minimal Risk

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Lewis University
(State name of College and Department)
Consent Form for Research
Title: (The project title)
Principle Investigator: (faculty member in charge of research if it is a student project)
Co-Investigators: (names of other faculty or students if appropriate)
Supported (or funded by): ….
You are being asked to take part in a research study. This form has important information about
the reason for the study and what you will do if you choose to be in this research study.
Conflict of interest: A statement should be made regarding the relationship between the
investigator and subject. For example: Your instructor who is also the person responsible for this
research study is both interested in your learning as well as the conduct of this study. You have
the right to discuss this study with another person who is not part of the research team before
making your decision whether or not to be in the study.
What is the reason for the study?
You are being asked to take part in a research study. This form has important information about
the reason for the study, what you will do, and the way we would like to use the information we
obtain from you if you choose to participate in the research study.
This study is being done because:….
You are asked to take part in the study because:….
Include an explanation of the study purpose.
Include the number of subjects you intend to enroll.
What will you do if you choose to be in the study?
As a subject in this study you will be asked …
Your part in this study will last for ….. and will involve….visits. Each visit will last x hours.
Describe chronologically, the participants expected participation from the protocol.
A chart is helpful if there are many visits.
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At any time in the study, you may decide to withdraw from the study. If you wish to withdraw no
more information will be collected from you.
What are some of the risks and discomforts that may happen to people who are in the
study?
Your participation in this study does not involve any emotional or physical risk to you beyond
that of everyday life. OR Your participation does not involve any risks other than what you
would encounter in daily life. OR your participation may include the following risks:
Describe the possible risks include emotional, psychological, physical, financial, social risks that
may be related to breach of privacy or confidentiality.
You may withdraw from the study at any time.
What are some of the potential benefits that are likely to come from my being in this study?
You are not likely to have any direct benefit… OR
The possible benefits from being in this study are… OR
Taking part in this study may not benefit you but it may help obtain information to understand …
Explain how it might help understand the concept being studied.
What other procedures or treatments might be available to me?
You may choose to not participate in this research study.
This section is used to describe treatment alternatives—if not applicable then delete this
category.
How will my confidentiality be protected?
Participation in this study may result in a loss of privacy, since persons other than the
investigator might view your study records. Unless required by law, only the investigator,
members of the investigator’s staff, representative of the (sponsor-if there is not one delete), the
Lewis University Institutional Review board, and representatives from the Office of Research
Protections (OHRP) have authority to view your study records. They are required to maintain
confidentiality regarding your identity.
Describe provisions for confidentiality of subject and records…who will maintain the records
and for how long.
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Results of this research study may be used for teaching, other research, publications, or
presentations at professional meetings. If your individual results are discussed, your identity will
be protected by the use of a code number. No identifying information will be used.
Are there any financial costs to being in the study?
Participation will involve no cost to you. You will not be paid for participating in this study OR
provide specific information about payment and reimbursement.
Termination of participation by you or the Investigator
If you wish to terminate your participation in this study at any time you may do so by contacting
the investigator (by mail) ……….(provide the information needed to contact the investigator)
If there are any circumstances which the investigator may terminate the subject’s participation
then describe it here i.e. lack of compliance etc. If this does not apply, delete this section.
Audio/Video recording (if applicable)
At the end of the consent form, you will be given the option of allowing the investigator to take
pictures and/or make audio or video recordings. If you agree, these may be used in analyzing the
research data or in scientific publications or presentations. With your permission, we may
publish and present photographs, audio recordings, and videos of you (including/not including)
your face. No other personal information about you will be included in the presentation.
Use this if you have optional study elements such as photography, audio or videotaping. If one of
these elements such as audiotaping is required for the study it would be included in the
description of the study and would not have a separate consent here.
Whom should I call if I have Questions or Concerns about this Research Study?
If you have any questions, problems, illness, injury during your time on this study (alter if
needed) call the investigator promptly. (PI’s name) is in charge of this study. You can reach
him/her at (phone number) during (insert time available) with questions about this research. You
may also contact Lewis University’s Institutional Review Board. If you wish further information
regarding your rights as a research participant, you may contact the Lewis University
Institutional Review Board Administrator, Dr. Nan Yancey, Dean of Graduate Studies,
[email protected] 815-588-7084.
Optional Study Elements
_____ (initial) I agree to….
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_____ (initial) I do not agree to….
Consent (all components of the consent should be on one page)
I have read this form and the research study has been explained to me. I have been given the
opportunity to ask questions and my questions have been answered. If I have additional
questions, I know have been told whom to contact. I agree to participate in the research study
described above and will receive a copy of this form after I have signed it.
_____________________________________
___________
Subject’s Name (printed) and Signature
Date
_______________________________________
____________
Name (printed) and Signature of Person Obtaining Consent
Date
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