Lesson 2-4: Respect - Part II 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 1 Revised Sept 14, 2011

Lesson 2-4: Respect - Part II 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. 2

Lesson 2-4: Respect - Part II Teacher Note: Authentic Assessment for Module 2 of the Epidemiology and the Energy Balance Equation Curriculum 3 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.

Lesson 2-4: Respect - Part II 4 Teacher Note: Photos of Worksheets for Lesson a 2-3a 2-4b

Lesson 2-4: Respect - Part II Start of Lesson 2-4 (estimate 1 class period) 5

Lesson 2-4: Respect - Part II 6 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. Review

Lesson 2-4: Respect - Part II 2-3a - Update Your Checklist 7 Notebook Study 2-3 Study Hypothesis - Statement of a hypothesized association between an exposure and an outcome 2-3 Study Variables - Developing questions about exposure and outcome, and additional questions about participants 2-3 Questionnaire - Preparing a one-page sheet that study participants will fill out (typed and copies made) 2-4 Draft Informed Consent Script - Preparing a script to be read to possible study participants (typed and copies made) 2-5 Plans for Study Conduct – Having assignments for study day

Lesson 2-4: Respect - Part II Part of 2-3a Expectations for Successful Completion of Activities in Lesson Notebook Study #Study Plan Component Met Some- what Met Not Met 2-4 Draft Informed Consent Script - Preparing a script to be read to possible study participants (typed and copies made)  Appropriately filled-out sections of script template and any additions as appropriate □□□

Lesson 2-4: Respect - Part II Review - Lesson 1-4 Respect – Part I 9 Review as needed and as time allows

Lesson 2-4: Respect - Part II In our school studies, we do not have a representative sample Simulated Research Review - Lesson 1-4 Respect – Part I 10 Review as needed and as time allows

Lesson 2-4: Respect - Part II Participants and Investigators Review - Principles for Protecting Human Research Participants 11 Review as needed and as time allows

Lesson 2-4: Respect - Part II Review - The Belmont Report 12 Review as needed and as time allows

Lesson 2-4: Respect - Part II 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. Review - Definition of Informed Consent 13 Review as needed and as time allows

Lesson 2-4: Respect - Part II Review - Elements of Informed Consent 14 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

Lesson 2-4: Respect - Part II 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) 15 Experience in Ethics Training OPTIONAL – may be best suited for high school

Lesson 2-4: Respect - Part II 16 Experience in Ethics Training OPTIONAL – may be best suited for high school

Lesson 2-4: Respect - Part II 17 Experience in Ethics Training OPTIONAL – may be best suited for high school

Lesson 2-4: Respect - Part II 18 Discussion of Experience in Ethics Training OPTIONAL – may be best suited for high school

Lesson 2-4: Respect - Part II Informed Consent Script Informed Consent Script for a Cross-Sectional Study 19

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

Lesson 2-4: Respect - Part II 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.

Lesson 2-4: Respect - Part II 2-4b Self-Assessment of Draft Informed Consent Script 22 Notebook Study Are the proper elements in our script?

Lesson 2-4: Respect - Part II 23 Typed and copies made for each study team member and the teacher

Lesson 2-4: Respect - Part II 24 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 Re-Cap