IRB Sample Consent Form - College of Coastal Georgia

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College of Coastal Georgia
Institutional Review Board
SAMPLE CONSENT FORM
Title of the Study: (Insert title)
Researcher: (Insert name of researcher, department, phone/e-mail, and advisor if
necessary)
Introduction:
For a faculty or staff project state the following:
You are being asked to participate in a research study being conducted by (Principal
Investigator’s name), a faculty member in the Department of (department) at the College
of Coastal Georgia Principal Investigator may be a student supervised by faculty member
- refer to CGA IRB Distinguishing Classroom Projects from Research with Human
Participants.
You have been approached to participate because (Explain why the person is being asked
to participate. For example, if the person is being asked because he or she is a member
of a particular group or has had a particular experience, explain this).
Purpose:
The goal of this project is to (give specific purpose and scope).
Procedures:
The [study] will take approximately (indicate length of time). During the interview you
will be asked questions about (give general information about subject matter and nature
of questions).
If tape recording used:
The interview will be audio-taped (if videotaped, state that as well) and transcribed. The
results of your interview will be (give information about how the interview might be used
in thesis or dissertation work, publications, or other scholarly work).
[Note: If the study involves deception or incomplete disclosure which necessitates a
debriefing process, a general statement may be added here or in the Benefits discussion
that more information will be given to subjects at the conclusion of the study, e.g., "At
the end of the study, we will explain in greater detail what we hope to learn from this
research." If the investigator believes that such a statement would bias study results,
he/she should discuss this in the protocol as part of the justification for use of deception
or incomplete disclosure.]
Risks/Benefits:
Explain any benefits to the participant or to society. If the participant will not benefit
directly, simply state: “There are no direct benefits to you from participation, but your
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willingness to share your knowledge and experiences will contribute to (indicate how the
results may be helpful to others or to society).” Any financial compensation should not be
discussed here, but should be in a separate section.
Explain any foreseeable risks or discomforts. If necessary, provide resources in which
participants may access such as a counseling center or hotline.
(If there are no foreseeable risks, you may simply state: “The risks associated with
participation in this study are minimal.”
Confidentiality:
(Since there is no legal privilege between investigator and subject, a "guarantee" of
“complete” or "strict” confidentiality should not be given or implied in the consent form.
This section should explain how the researchers will minimize the risk of breach of
confidentiality. Any regulatory or other agencies that may have access to the research
records should also be noted, e.g. court subpoena.)
Your data will be handled as confidentially as possible. Note that Georgia is an "Open
Records State" and confidentiality cannot be guaranteed. If results of this study are
published or presented, individual names and other personally identifiable information
will not be used (if appropriate, add phrase such as "unless you give explicit permission
for this below.").
To minimize the risks to confidentiality, we will...(Explain data security measures to be
taken, e.g., storage, coding, encryption, limited access to study records, etc.)
Sensitive/reportable research information:
If data obtained contains personally identifiable sensitive information, a signature
documenting informed consent must be obtained.
If there is a reasonable expectation (from the topic under study and/or the subject
population) that reportable information may be disclosed to the investigator during the
study, an appropriate statement should be added, e.g.: We will keep your study data as
confidential as possible, with the exception of certain information that we must report for
legal or ethical reasons, such as child abuse, elder abuse, or intent to hurt yourself or
others.)
Deception:
If deception is used and the full purpose of the investigation will not be disclosed to
participants until after data collection as a control measure, then you should include a
statement similar to the following: Because the outcome of the investigation might be
jeopardized if the purpose of the investigation is revealed to me prior to data collection, I
understand that the purpose cannot be explained to me at this time. I further understand
that I will have an opportunity to receive a complete explanation of the investigation's
purpose following data collection and completion of the investigation.
Voluntary Participation:
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Your participation in this study is entirely voluntary. Even if you decide to participate,
you may withdraw from the study without penalty at any time during or after the study.
You may have the results of your participation, to the extent that they can be identified,
returned to you, removed from the research records or destroyed.
Contacts and Questions:
If you have any questions about this research project or interview, feel free to contact
(give name of primary investigator) at (insert business phone or email).
Statement of Consent:
I agree to participate in this research investigation, and to the use of data obtained from
me as described above. My signature below indicates that I have read the information in
this document and have had a chance to ask any questions I may have about the study.
__________________________________________
Participant’s Name (please print)
__________________________________________
Participant’s Signature
_____________
Date
__________________________________________
Principal Investigator’s Signature
_____________
Date
Research at the College of Coastal Georgia that involves human participants is overseen
by the Institutional Review Board. Questions or problems regarding your rights as a
participant should be addressed to:
Institutional Review Board Chair
College of Coastal Georgia
Office for Academic Affairs
One College Drive
Brunswick, GA 31520
Telephone: IRB Administrator (912) 279-5965
Email: IRB Chair [email protected]
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Rev. 1 October 2014
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