DAY 2
Human Subjects
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EPI CHALLENGE
Proposal Form
5. Informed Consent Script
EPI Challenge
Master Proposal
Form
Name of Team Member
________________
Write the informed consent script that you will read aloud to potential
study participants so that they are able to make informed judgments
about whether or not to participate in your investigation.
National Institutes of Health
Office for Human Research Protections
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Protecting Human Research Participants
Nazi Human Experiments
Protecting Human Research Participants
Doctors Trial
Protecting Human Research Participants
The voluntary consent of the human subject
is absolutely essential.
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Protecting Human Research Participants
Tuskegee Syphilis Study
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Protecting Human Research Participants
Syphilis Victims in U.S. Study Went Untreated for Years
“For 40 years the United States Public Health Service has conducted a study
in which human beings with syphilis, who were induced to serve as guinea pigs,
have gone without medical treatment for the disease and a few have died of its
late effects, even though an effective therapy was eventually discovered.”
Jean Heller, “Syphilis Victims in U.S. Study Went Untreated for 40 Years,” New York Times, July 26, 1972
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Protecting Human Research Participants
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Protecting Human Research Participants
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Protecting Human Research Participants
Basic Ethical Principles
Respect for Persons
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Respect for Persons
To acknowledge an individual’s
autonomy and the requirement
to protect vulnerable individuals
who have diminished autonomy
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Protecting Human Research Participants
Basic Ethical Principles
Respect for Persons
To acknowledge an individual’s autonomy
and the requirement to protect vulnerable individuals
who have diminished autonomy
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Autonomy
The right of individuals to decide
things form themselves
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Protecting Human Research Participants
Respect for Persons / Autonomy
To respect an individual’s autonomy is to allow an individual
to develop opinions, make choices, and act as they please,
unless their actions are clearly detrimental to others
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Protecting Human Research Participants
Respect for Persons / Autonomy
To respect an individual’s autonomy is to allow an individual
to develop opinions, make choices, and act as they please,
unless their actions are clearly detrimental to others
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Protecting Human Research Participants
Office for Human Research Protections
To respect an individual’s autonomy is to allow an individual
to develop opinions, make choices, and act as they please,
unless their actions are clearly detrimental to others
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Informed Consent
An agreement that is given by a
potential research participant
following an explanation of all
relevant information needed to
make a decision about
participating in a study
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Protecting Human Research Participants
Office for Human Research Protections
 Voluntariness
 Comprehension
 Disclosure
Informed Consent
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Protecting Human Research Participants
Informed Consent - Voluntariness
• While the language and tone of the script invites students
to participate in your investigation, it does not assume
they will. It is stated in a “participate neutral” manner.
There is no attempt to coerce students into participating.
• Right to refuse or withdraw
• Invites potential participants to ask questions
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Protecting Human Research Participants
Informed Consent - Comprehension
• Is written so it is understandable to all potential
participants
• Includes nothing that is unneeded or superfluous
• Invites potential participants to ask questions
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Protecting Human Research Participants
Informed Consent - Required Disclosures
• Purpose of the study
• What study participants will experience
• Reasonably foreseeable risks
• Potential benefits to participant
• Potential benefits to others
• Confidentiality protections
• Compensation
• Contact information for questions
• Right to refuse or withdraw
Informed Consent
An agreement that is given by a
potential research participant
following an explanation of all
relevant information needed to
make a decision about
participating in a study
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Protecting Human Research Participants
Clinton Regrets “Clearly Racist” U.S. Study
New York Times
May 17, 1997
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Protecting Human Research Participants
Research / Simulated Research
Generalizable Knowledge
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Protecting Human Research Participants
Informed Assent / Consent Script
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Day 4
Breakout
Writing an informed consent script
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Breakout Assignment
30
EPI CHALLENGE
Proposal Form
5. Informed Consent Script
EPI Challenge
Master Proposal
Form
Name of Team Member
________________
Write the informed consent script that you will read aloud to potential
study participants so that they are able to make informed judgments
about whether or not to participate in your investigation.
32
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