1. New Lesson 1-6: Respect – Part I 1 Core Concepts: CDC Ethics Hypothesis Human subjects Prevalence rate Person, place, and time Surveillance Survey questions Lessons: 1-1 Introduction to Curriculum 1-2 Surveillance 1-3 Patterns and Hypotheses 1-4 Describing Health-Related Behaviors in Youth 1-5 Creating a Surveillance Question 1-6 Respect – Part I 1-7 Surveillance Studies – In Class 1-8 Surveillance Studies – In School Teacher Note: Module 1 Overview Content Area: Descriptive epidemiology, Surveillance, and Hypothesis-Generation Essential Questions: How is the health or disease outcome distributed in terms of person, place, and time? What are some possible explanations for this distribution? Enduring Understanding: Health and disease are not distributed haphazardly in a population. There are patterns to their occurrence that can be identified through surveillance. Analysis of the patterns of health and disease distribution can provide clues for formulating hypotheses about possible causes. Revised Sept 14, 2011

2. New Lesson 1-6: Respect – Part I 2 Teacher Note: Enduring Epidemiological Understandings for the Epidemiology and the Energy Balance Equation Curriculum 1.Health and disease are not distributed haphazardly in a population. There are patterns to their occurrence that can be identified through surveillance. Analysis of the patterns of health and disease distribution can provide clues for formulating hypotheses about their possible causes. 2.Causal hypotheses can be tested by conducting investigations of the exposures and outcomes of selected groups of people as they go about their lives. Information from these observational studies can be used to determine if an exposure and an outcome are associated. Because observational studies are complicated by factors not controlled by the observer, other explanations also must be considered.

3. New Lesson 1-6: Respect – Part I 3 Teacher Note: Authentic Assessment for Module 1 of the Epidemiology and the Energy Balance Equation Curriculum Students will conduct and interpret a descriptive epidemiological survey among students in their class and again among students outside their class. Working in teams, students will have the opportunity to demonstrate their abilities to request informed consent, ask questions about a health-related behavior, accurately record responses, calculate prevalence of the behavior, make accurate statements about the prevalence of the behavior among their classmates, look for patterns, and formulate hypotheses based on the patterns they observe. Deliverables will include either written reports or presentations about the surveys. Specific performance criteria will be used to help ensure that the experiences allow a genuine, realistic, and fair assessment of students’ comprehension of the Module 1 Enduring Epidemiological Understanding.

4. New Lesson 1-6: Respect – Part I 4 Teacher Note: Photos of Worksheets for Lesson 1-6 1-6b 1-6a

5. New Lesson 1-6: Respect – Part I 5 Start of Lesson 1-6 (Estimate 2 class periods)

6. New Lesson 1-6: Respect – Part I 6 Big Ideas in Lesson 1-5 Each study team should create a good surveillance question about a selected health behavior The question should be of interest and curiosity among team members The purpose of creating a good questions is to be able to count the frequency of a health-related behavior and make an accurate statement about its prevalence In order to make accurate statements about prevalence, a question must mean the same thing to everyone who reads it Review

7. New Lesson 1-6: Respect – Part I 7 Respecting Participants in Studies TV watching Eating in the school cafeteria Having a low-fat diet Playing on a sports team

8. New Lesson 1-6: Respect – Part I 8 Research Versus Simulated Research Research is designed to develop or contribute to generalizable knowledge, that is, knowledge that has been created in such a way that what was learned about a study group can be applied to others who were not studied. This class will be conducting simulated research for educational purposes and results will not be generalizable.

9. New Lesson 1-6: Respect – Part I 9 Participants (“research subjects”) and Investigators Principles for Protecting Human Research Participants Ethics in Human Research – the right thing to do according to established principles of how to treat people well

10. New Lesson 1-6: Respect – Part I 10 What’s wrong with this picture?

11. New Lesson 1-6: Respect – Part I 11 Nazi Human Experiments What’s wrong with this picture?

12. New Lesson 1-6: Respect – Part I 12 Accepted Principles Doctors Trial What happened after World War II was over?

13. New Lesson 1-6: Respect – Part I 13 Tuskegee Syphilis Study What’s wrong with these pictures?

14. New Lesson 1-6: Respect – Part I 14 What can we do to prevent these events/pictures?

15. New Lesson 1-6: Respect – Part I 15 Principles for Protecting Human Research Participants

16. New Lesson 1-6: Respect – Part I 16 Respect for Persons

17. New Lesson 1-6: Respect – Part I 17 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

18. New Lesson 1-6: Respect – Part I 18 “… all relevant information needed to make a decision about participating in a study.” Informed Consent

19. New Lesson 1-6: Respect – Part I 19 Information Needed to Make an Informed Decision to Participate in a Study 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 (participation is VOLUNTARY)

20. New Lesson 1-6: Respect – Part I 20 Informed Consent Script I am about to give you a Question / Answer Form on which a question is written. Do not write your name on the form. I am going to ask you to answer the question by circling your answer with a No. 2 pencil and then immediately folding the form in half so that no one else can see your answer. You do not need to answer the question. If you do not wish to participate, simply fold the form in half. Your participation is voluntary, anonymous, and confidential. Let me repeat – You are not required to participate and nothing will happen to you if you do not. I will pass several large envelopes around the class into which you can place your folded form regardless of whether or not you answered the question. Does this Script have all the Information Needed? 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 (participation is VOLUNTARY)

21. New Lesson 1-6: Respect – Part I 21 Comprehension Additional Requirement Informed Consent Script I am about to give you a Question / Answer Form on which a question is written. Do not write your name on the form. I am going to ask you to answer the question by circling your answer with a No. 2 pencil and then immediately folding the form in half so that no one else can see your answer. You do not need to answer the question. If you do not wish to participate, simply fold the form in half. Your participation is voluntary, anonymous, and confidential. Let me repeat – You are not required to participate and nothing will happen to you if you do not. I will pass several large envelopes around the class into which you can place your folded form regardless of whether or not you answered the question. 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 (participation is VOLUNTARY)

22. New Lesson 1-6: Respect – Part I 22 Worksheet 1-6a Criteria for Informed Consent Surveillance Notebook Items are similar to disclosure requirements in the Belmont Report Criteria can be used to assess completeness of an informed consent script/form

23. New Lesson 1-6: Respect – Part I 23 Informed Consent Scripts for Our Studies Eating in the school cafeteria TV watching Having a low-fat diet Playing on a sports team

24. New Lesson 1-6: Respect – Part I 24 Worksheet 1-6b Informed Consent Script Assignment Surveillance Notebook Teams should read assignment 1-6b about how to write an informed consent script for their surveillance study Teams should use 1-6a, Criteria for Informed Consent, as a guide in writing their script. Scripts should be started during this class if there is time, and completed during the next class

25. New Lesson 1-6: Respect – Part I 25 Possible break point between class periods

26. New Lesson 1-6: Respect – Part I 26 Assessing the Informed Consent Scripts Self-assessment using the criteria in Worksheet 1-6a, Criteria for Informed Consent Reading scripts aloud to classmates for comments and suggestions

27. New Lesson 1-6: Respect – Part I 27 Final Revisions as Needed Following Class Discussion Does our informed consent script meet the criteria?

28. New Lesson 1-6: Respect – Part I 28 Big Ideas in Lesson 1-6 Participants in research or simulated research need to be protected by investigators from any harm or disrespect Re-Cap This is part of ethics – the “right thing to do” according to established principles of how to treat people well The Belmont Report (US) establishes principles of treating study participants with respect, including the idea of informed consent An informed consent script allows classmates (or other research participants) to make a voluntary decision about whether or not they wish to participate based on their own goals and values