Exculpatory Language and Informed Consent

Greg E. Manship, M.Div., MT(ASCP), CIM, CIP
IRB Coordinator, University of Indianapolis
Co-Vice Chair, Community Health Network IRB
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“Exculpatory” from “exculpate”
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“Exculpate” (Latin) ex (from) + culpa (blame)
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“to clear from alleged fault or guilt”*
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*Merriam-Webster’s Online Dictionary (http://www.merriam-webster.com/dictionary/exculpate)
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45CFR46.116 and 21CFR50.20
◦ “No
informed consent, whether oral or
written, may include any exculpatory
language through which the subject or the
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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“. . . the subject or the
representative is made to
waive . . .or releases . . . ”
Restricts meaning to
etymological definition of
“to clear from blame or
fault”
Limits prohibition to
statements about release
from liability
Meaning limited to not
holding researchers at
fault for wrongful acts
“Narrow Interpretation”
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“ . . . subject or the
representative is made
to waive or appear to
waive any of the
subject's legal rights,
or releases or appears
to release . . .”
Researchers many NOT
use language whereby
a subject waives
actually or apparently
any legal rights
“Broad Interpretation”
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The prohibition of exculpatory language is to preclude
exploitation of voluntariness and vulnerability of participation
in research.
Respect for autonomy
◦ Rational human being has inherent value
◦ A human being is not a means only to an end
Beneficence
◦ Promotion and protection of human well being
◦ Provide opportunity for subjects to seek legal relief
Justice
◦ Fair and equitable treatment of all human beings
◦ Protect rights to recover losses due to negligence
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By agreeing to this use, you should understand that you will
give up all claim to personal benefit from commercial or other
use of these substances.
I voluntarily and freely donate any and all blood, urine, and
tissue samples to the U.S. Government and hereby relinquish
all rights, title, and interest to said items.
By consent to participate in this research, I give up any
property rights I may have in bodily fluids or tissue samples
obtained in the course of the research.
I waive any possibility of compensation for injuries that I may
receive as a result of participation in this research.
Copyright © 2003 Georgetown University
(http://www.ehcca.com/presentations/ressummit3/5_02.pdf)
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Tissue obtained from you in this research may be used to
establish a cell line that could be patented and licensed. There
are no plans to provide financial compensation to you should
this occur.
By consenting to participate, you authorize the use of your bodily
fluids and tissue samples for the research described above.
This hospital is not able to offer financial compensation nor to
absorb the costs of medical treatment should you be injured as a
result of participating in this research.
This hospital makes no commitment to provide free medical care
or payment for any unfavorable outcomes resulting from
participation in this research. Medical services will be offered at
the usual charge.
Copyright © 2003 Georgetown University
(http://www.ehcca.com/presentations/ressummit3/5_02.pdf)
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I agree that the medical center will not pay me for any injuries I
may sustain as a result of participating in this research.
You must provide blood samples that will be kept in a "bank" for
future research. Once you have provided these blood samples,
you cannot change your mind about being in the research and
have the sample removed from the "bank.“
By agreeing to this use, you should understand that you will give
up all claims to personal benefit from commercial or other use of
these substances.
You volunteered to have your child be in this research study, so
you cannot hold the hospital or the doctors responsible if
anything bad happens to your child.
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Federal regulations prohibit use of language that
actually or apparently waives any legal rights of
research participants.
Federal regulations prohibit use of language that
actually or apparently releases investigators,
sponsors, institutions and their agents from
liability of negligence.
Sgt. Friday’s Rule of Thumb: Avoid ALL language
that implies or requires understanding or
agreement by subject. “Just the facts, ma’am.”
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Banker, E. A., & Amdur, R. J. (2006).
Institutional review board: Management and
function (2nd ed.). Sudbury, MA: Jones and
Bartlett Publishers.

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