Transcript Informed Consent - Indiana State University

Vicki Hammen, Vice Chair, IRB
IRB Brown Bag
February 9, 2009
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The Code of Federal Regulations (CFR)
addresses the process separately from
documentation
◦ 45 CFR 46.116 and 21 CFR 50.20, 50.23, 50.24 &
50.25 covers the process
◦ 45 CFR 46.117 and 21 CFR 50.27 deals with
documentation
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“Except as provided elsewhere in this policy,
no investigator may involve a human being as
a subject in research covered by this policy
unless the investigator has obtained the
legally effective informed consent of the
subject or the subject’s legally authorized
representative.”
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According to the Belmont Report, informed
consent falls under the principle of ‘Respect
for Persons’
◦ “…requires that individuals, to the degree that they
are capable, be given the opportunity to choose
what shall or shall not happen to them.”
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It has been stated that a signed document
without an effective informed consent
process is not worth the paper it is written on
(Cohen, J. , personal communication, 2008)
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The three important elements that must be
address in the informed consent process are:
◦ Information about the research study
 Full disclosure of the nature of the research and the
subject’s participation
◦ Comprehension
 Does the potential participant fully understand the
information presented to him/her?
◦ Voluntariness
 Process must be free from any form of coercion or
undue influence
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Tampa Tribune article, March 2000
◦ A lawsuit accusing USF doctors of experimenting on
pregnant women without their consent is settled for
3.8 million dollars
 The experiment was not considered risky and no
adverse events were recorded
◦ The failure of the physicians to obtain informed
consent from the pregnant women cost their
hospital
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Women were given a 3 page, densely written
document to read
Document was given while women were in
active labor
None of the women thought they were
participating in a research study
There were no benefits to participation for
the mothers or their babies
A law firm specializing in clinical research
problems filed suit on behalf of the unwitting
participants
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Information about the Research Project
◦ Purpose: Why are you conducting this research?
◦ Duration: How long will you need the subject?
◦ Experimental: If the procedure is experimental are
there any other approved methods of choice?
 Usually only necessary in biomedical or pharmaceutical
clinical studies
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Information, con’t
◦ Procedures: Method to convey the information may
vary depending on the type of research, the
complexity, and prospective participant
 Must be thorough but avoid MEGO (My Eyes Glaze
Over)
 Sometimes too much information is worse than too little
 Consider using pictures, demonstrations, or videos
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Risks
◦ Are there any risks to participating?
 What are the reasonably foreseeable risks—not all
possible
 How likely are the risks?
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Benefits
◦ Do not feel that you have to provide substantial
benefits for the subjects
◦ Payment for participation is not a benefit
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Alternatives to participating
◦ Typically included in biomedical studies
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Confidentiality
◦ Very rare to be able to guarantee complete
confidentiality, even with anonymous Internet
surveys
◦ Address how you will protect the confidentiality of
the subject’s data
 during the project, if they wish to withdraw, and
following
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Compensation for Injury
◦ Not typically required, only for studies with greater
than minimal risk
◦ May need to address how any reactions will be
handled
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Contact information
◦ Who to contact with addition questions or concerns
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Right to refuse or withdraw
◦ Need to explain what will happen to the individual if
they decide to withdraw participation during the
experimental session or afterwards
◦ Will there be any consequences?
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Informed consent is not valid unless the
prospective subject understands the
information that has been presented
It is the investigator’s responsibility to insure
comprehension
Simply stating that the subject is to ask
questions if they do not understand is not
sufficient
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Most subjects will not ask questions so as not
to appear unintelligent or that they were not
listening
The researcher needs to insure the potential
subject has the answers to who, what when,
where, and how as they pertain to the
research study
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Informed Consent Evaluation Feedback Tool
◦ A list of 10 questions posed to the subject
◦ Provides information about subject’s level of
understanding
◦ Subject is given the questions to review at the start
of the informed consent interview
◦ Question address: Purpose, benefits, risks, other
options, costs, alternatives, withdrawal,
voluntariness, record review, questions for the
researcher
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The provision of consent must be free from
any form of coercion or undue influence
◦ Particular concern when seeking students as
research participants
 A faculty member cannot recruit subjects from
students in their classes or advisees
◦ Implied authority
 Individual obtaining consent in a medical setting
wearing a lab coat
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Only legally competent adults can give
consent
◦ Minors can give assent, not consent
◦ Incompetent adults cannot give consent, but their
legally authorized representative can
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Must be sensitive to more subtle forms of
coercion
◦ Social pressure
 Especially from vulnerable populations: children,
prisoners
◦ Request from authority figures
◦ Undue incentives for participation
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The subject gives their ‘knowledable
agreement’ to participate
Must have sufficient capacity to understand
what is happening and feels free to express
his/her wishes
◦ Children above age 7 must provide assent
◦ Can be a very simplified description
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If they object this can veto parental or
guardian consent
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Informed consent is a process in which the
outcome is an informed choice regarding the
voluntary participation in a research project.
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