Consent Checklist

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University of Illinois
at Springfield
Institutional Review Board
One University Plaza MS PAC 525
Springfield, IL 62703-5407
tel: 217-206-7409
fax: 217-209-7623
e-mail: [email protected]
Web: www.uis.edu/grants
ELEMENTS OF INFORMED CONSENT
Introduction
Identify who will be conducting the research (name and title) and their affiliation with UIS. Include information about coinvestigators as appropriate. Include information about the department, class, or division.
Include a statement that the study involves research.
Explain the purposes of the research and any procedures that will be followed along with the duration of the subject’s
participation.
When appropriate, identify whether any procedures are experimental in nature (Clinical or Medical).
When appropriate, describe any additional costs that the subject may incur as a participant.
When appropriate, state the approximate number of subjects that will be involved in the research.
Nature of the Subject’s Participation
Include a statement describing the extent to which confidentiality of data and records identifying the subject will be
maintained.
Include a statement that the subject’s participation is voluntary.
Include a statement that the subject may refuse to participate or discontinue their participation at any time during the
research without penalty or loss of benefits to which they would otherwise be entitled. If appropriate, include a statement
that their decision to participate, decline to participate, or to withdraw from participation will not affect their grades, status
at, or future relationship with the University.
When appropriate, include a description of any type of compensation that the subject may receive as a participant. If the
compensation is in the form of a chance to win or participate in a lottery, include the odds of winning. Also, describe any
potential reduction to the compensation or chance to win should the subject withdraw from the research.
When appropriate, include anticipated circumstances under which the subject’s participation may be terminated by the
Responsible Principal Investigator.
When appropriate, describe the consequences of the subject’s decision to withdraw from the research and the procedures
for orderly termination of participation by the subject.
Risks and Benefits
Describe any reasonably foreseeable risks or discomforts to the subject.
Describe any benefits to the subject or to others that may reasonably be expected from the research.
When appropriate, disclose alternative procedures or, if the research involves medical procedures if any that might be
advantageous to the subject.
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For Medical Research Only:
When appropriate, include a statement that the particular treatment or procedure may involve risks to the subject (or to an
embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.
When appropriate, include a statement that significant new findings developed during the course of the research that may
relate to the subject’s willingness to continue participation will be provided to the subject.
When research involves more than minimal risk, the consent must include the statement, “The University of Illinois at
Springfield does not provide medical or hospitalization insurance coverage for participants in this research study nor will the
University of Illinois at Springfield provide compensation for any injury sustained as a result of participation in this research
study, except as required by law.”
Confidentiality
Include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be
maintained. This statement should include how confidentiality will be maintained during collection, storage, and in any
final papers, reports, or presentations as appropriate. Include how audiotapes, videotapes, and transcripts will be managed
as appropriate.
State how results will be disseminated.
When appropriate, state who other than the Responsible Principal Investigator may have access to the data and records.
Contact Information
Include the name(s), title(s), and contact information (phone, email) of the person(s) to contact for answers to questions
about the research. Students should also include contact information about their Responsible Research Supervisor.
When appropriate, include the name, title, and telephone number of the person to contact in the event of a researchrelated injury or to voice a concern or complaint.
Include the following statement as a separate paragraph, “This research has been reviewed by the Human Subjects Review
Officer, Dr. James Klein. Dr. Klein can answer any questions about your rights as a volunteer participant in this project. He
can be reached at 217-206-6883.”
Signature Block
State that the subject will be given a copy of the consent document or may print a copy of the consent if it is online.
Include a statement such as, “I have read and understand the above consent document and voluntarily agree to participate
in this research,” above the signature lines.
When appropriate, include a statement that “I am 18 years of age or older.” Add line with instructions to initial next to the
statement.
When appropriate, add a statement that “I understand that I am being (audiotaped, videotaped, or photographed) and
voluntarily agree to participate in this research in this way.” Add line with instructions to initial next to the statement.
Additional Requirements
Information, requirements, and procedures described in informed consent documents should correlate with the same
information described in the application and all materials submitted to the IRB for approval. Continuity across these
documents should be checked before submitting the protocol.
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University of Illinois
at Springfield
Institutional Review Board
One University Plaza MS PAC 525
Springfield, IL 62703-5407
tel: 217-206-7409
fax: 217-209-7623
e-mail: [email protected]
Web: www.uis.edu/grants
No informed consent, whether oral or written, may include any exculpatory language through which the subject or
representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the
investigator, the sponsor, the institution, or its agents from liability for negligence.
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