day 2 human subjects 1. epi challenge proposal form 5. informed consent script write the informed...
TRANSCRIPT
DAY 2
Human Subjects
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EPI CHALLENGEProposal Form
5. Informed Consent Script
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.
EPI Challenge
Master Proposal Form
Name of Team Member
________________
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Why?Office for Human Research Protections
National Institutes of Health
Nazi Human Experiments
Protecting Human Research Participants
Doctors Trial
Protecting Human Research Participants
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Protecting Human Research Participants
The voluntary consent of the human subject is absolutely
essential.
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Tuskegee Syphilis Study
Protecting Human Research Participants
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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
Protecting Human Research Participants
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Protecting Human Research Participants
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Basic Ethical Principles
Respect for Persons
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To acknowledge an individual’s autonomy and the requirement to protect vulnerable individuals who have diminished autonomy
Respect for Persons
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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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The right of individuals to decide things form themselves
Autonomy
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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
Protecting Human Research Participants
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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
What do you
need to tell
potential
participants
in your study,
that will allow them
to develop opinions,
make choices, and
act as they
please?
Protecting Human Research Participants
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Protecting Human Research Participants
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
Office for Human Research Protections
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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
Informed Consent
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Protecting Human Research Participants
Voluntariness Comprehension Disclosure
Informed Consent
Office for Human Research Protections
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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
• 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
Protecting Human Research Participants
Informed Consent - Required Disclosures
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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
Informed Consent
Clinton Regrets “Clearly Racist” U.S. Study New York Times
May 17, 1997
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Research / Simulated Research
Protecting Human Research Participants
Generalizable Knowledge
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Informed Assent / Consent Script
Protecting Human Research Participants
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Day 4
Breakout
Writing an informed consent script
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Breakout Assignment
EPI CHALLENGEProposal Form
5. Informed Consent Script
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.
EPI Challenge
Master Proposal Form
Name of Team Member
________________
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