Teacher Note: Module 2 Overview Content Area: Hypothesis-Testing: Cross-Sectional Study

1. Teacher Note: Module 2 Overview Content Area: Hypothesis-Testing: Cross-Sectional Study Essential Questions: How can I select groups of people and collect data/evidence from them that will test my hypothesis? If my causal hypothesis is correct, how would the exposure and outcome be distributed in these groups? Enduring Understanding: 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, when an association is found, other explanations in addition to causality also must be considered. • Core Concepts: • Testing hypotheses • Association • Exposure/outcome • Control group • 2x2 table • Observational studies • Study design/study plan • Study samples • Prevalence rate • Prevalence ratio • Statement of effect Lessons: 2-1 Looking for Associations 2-2 Cross-sectional Studies 2-3 Developing Hypothesis and Study Questions 2-4 Respect – Part II 2-5 Planning Study Conduct 2-6 Cross-Sectional Study - In Class 2-7 Cross-Sectional Study – In School Revised Sept 14, 2011

2. Teacher Note: Enduring Epidemiological Understandings for the Epidemiology and the Energy Balance Equation Curriculum 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. 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. Teacher Note: Authentic Assessment for Module 2 of the Epidemiology and the Energy Balance Equation Curriculum Students will conduct, analyze, and interpret observational, cross-sectional studies among students in their class and then among students outside their class. Working in teams, students will have the opportunity to demonstrate their abilities to select a reasonable hypothesis of interest to them, design study questions about exposure and outcome, obtain informed consent, collect and manage data, calculate and compare prevalence rates, make accurate statements about whether their data support that hypothesis, and consider alternate explanations for what they observed. Reporting of results will be required, such as a written report, an item for the school newspaper, or an oral presentation or poster for students, teachers, and/or parents. 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 2 Enduring Epidemiological Understanding.

4. Teacher Note: Photos of Worksheets for Lesson 2-4 2-4a 2-4b 2-3a

5. Start of Lesson 2-4 (estimate 1 class period)

6. Review • Big Ideas in Lesson 2-3 • A good study plan includes careful thought about choice of exposure and outcome variables and high-quality questions to measure them. • Additional questions about other characteristics of participants can be asked in order to better understand study results. • A well-planned study has a user-friendly questionnaire to administer to participants.

7. 2-3a - Update Your Checklist Study Notebook

8. Part of 2-3a Study Notebook Expectations for Successful Completion of Activities in Lesson 2-4

9. Review - Lesson 1-4 Respect – Part I Review as needed and as time allows

10. Review - Lesson 1-4 Respect – Part I In our school studies, we do not have a representative sample Review as needed and as time allows Simulated Research

11. Review - Principles for Protecting Human Research Participants Review as needed and as time allows Participants and Investigators

12. Review - The Belmont Report Review as needed and as time allows

13. Review - Definition of Informed Consent Review as needed and as time allows 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.

14. Review - Elements of Informed Consent • 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) Review as needed and as time allows

15. Experience in Ethics Training OPTIONAL – may be best suited for high school • The National Institutes of Health (NIH) has a website with ethics training for professionals who conduct human health research • Completion of this training and passing several quizzes is mandatory for any human health research funded by a federal grant • Organizations that are not using federal funding see the value of this training and participate voluntarily (for example the National Science Foundation (NSF)

16. Experience in Ethics Training OPTIONAL – may be best suited for high school http://phrp.nihtraining.com/users/login.php

17. Experience in Ethics Training OPTIONAL – may be best suited for high school http://phrp.nihtraining.com/users/login.php

18. Discussion of Experience in Ethics Training OPTIONAL – may be best suited for high school

19. Informed Consent Script for a Cross-Sectional Study Informed Consent Script

20. 2-4a Study Notebook Developing an Informed Consent Script for a Cross-Sectional Study How should we fill in the blanks and perhaps further adapt this script to fit our cross-sectional study?

21. My name is __________________________ and I am participating in the conduct of a brief survey among students in our school. The survey is about behaviors that may affect your health. To conduct this survey, I would like you to consider completing a brief questionnaire. It has ________ questions and will take approximately __________ minutes to complete. We would like to ask you some question regarding ___________________________ and ________________________________. This study is being carried out for educational purposes only. It is not an actual study from which firm conclusions will be made. If there are any risks assumed by participating, they are no greater than those you encounter in daily life. There are no benefits to you for participating and there is no compensation. DO NOT write your name on this survey. The answers you give will be kept private. No one will know what you write. To further protect your privacy, all questionnaires will be destroyed at the end of the analysis. Our study team wants you to know that your participation is voluntary, and that you can stop participating at any time without consequence. If you are not comfortable answering a question, just leave it blank. You can refuse to participate now; you can change your mind after starting to participate; or, after completing the survey, you can decide not to submit it. . Make sure to read every question. Circle one answer for each question. When you are finished, fold your paper in half so your answers cannot be seen, and wait for us to collect the surveys. Do you have any questions? Thank you very much for your help.

22. 2-4b Study Notebook Self-Assessment of Draft Informed Consent Script Are the proper elements in our script?

23. Typed and copies made for each study team member and the teacher

24. Re-Cap • Big Ideas in Lesson 2-4 • Participants in research or simulated research need to be protected by investigators from any harm or disrespect • The Belmont Report (US) establishes principles of treating study participants with respect, including the principle 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 • The National Institutes of Health (NIH) has online training to teach researchers about the importance of informed consent and other ethical principles