1. DAY 2 Human Subjects 1

2. EPI CHALLENGE Proposal 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. 3 Why? Office for Human Research Protections National Institutes of Health

4. Nazi Human Experiments Protecting Human Research Participants

5. Doctors Trial Protecting Human Research Participants

6. 6 The voluntary consent of the human subject is absolutely essential.

7. 7 Tuskegee Syphilis Study Protecting Human Research Participants

8. 8 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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10. 10 Protecting Human Research Participants

11. 11 Basic Ethical Principles Respect for Persons Protecting Human Research Participants

12. 12 To acknowledge an individual’s autonomy and the requirement to protect vulnerable individuals who have diminished autonomy Respect for Persons

13. 13 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. 14 The right of individuals to decide things form themselves Autonomy

15. 15 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

16. 16 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

17. 17 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

18. 18 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

19. 19 Protecting Human Research Participants Voluntariness Comprehension Disclosure Informed Consent Office for Human Research Protections

20. 20 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

21. 21 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

22. 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

23. 23 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

24. Clinton Regrets “Clearly Racist” U.S. Study New York Times May 17, 1997 Protecting Human Research Participants

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26. 26 Research / Simulated Research Protecting Human Research Participants Generalizable Knowledge

27. 27 Informed Assent / Consent Script Protecting Human Research Participants

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29. Day 4 Breakout Writing an informed consent script 29

30. 30 Breakout Assignment

31. EPI CHALLENGE Proposal 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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