DAY 2

Human Subjects

1

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

________________

3

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

10

Protecting Human Research Participants

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Basic Ethical Principles

Respect for Persons

Protecting Human Research Participants

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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

Protecting Human Research Participants

14

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

Protecting Human Research Participants

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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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30

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

________________

32

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