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. 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: Each lesson in a Module begins with an overview slide that includes the Content Area, Essential Question(s) and the Enduring Understanding for that Module. The idea is that students’ abilities to answer the Essential Question(s) will lead to the development of the Enduring Epidemiological Understanding. The lessons in the Module are geared toward helping students uncover how to answer the Essential Question(s). In the lower part of the overview slide, you will find the Core Concepts for the Module and a listing of the lessons in the Module (with the current lesson highlighted). Revised Sept 14, 2011 1

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. Teacher Note: An enduring understanding is a big idea that resides at the heart of a discipline and has lasting value outside the classroom (Wiggins and McTighe, Understanding by Design). The Epidemiology and the Energy Balance Equation curriculum is based on two big ideas – enduring epidemiological understandings. (NOTE: There are other enduring understandings that have been identified as big ideas in epidemiology, but the ones primarily addressed in this curriculum are the two on this slide. . For examples of other listings of enduring epidemiological understandings, go to: http://www.montclair.edu/Detectives/ and click on “Overview,” or go to http://www.teachepidemiology.org/ and click on “Enduring Epidemiological Understandings.” The purpose of the eight lessons in Module 1 is to develop students’ comprehension of the first Enduring Epidemiologic 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. In Lesson 1-6: Respect, students will learn about the need to assure that prospective research participants are able to give informed consent. Based on informed consent criteria and critique, study teams will write and re-write an Informed Consent Script in preparation for asking their classmates questions about health-related behaviors. The script is an embedded assessment of students’ understanding of informed consent. In Module 1, students will compile all written information and assignments in a Surveillance Notebook. The teacher will pass out pages for the Surveillance Notebook as the lessons are taught. All written material for Lessons 1-1 through 1-4 will be distributed to individual students, and material for Lessons 1-5 through 1-8 will be distributed to the “Study Teams” consisting of 3-5 students each.

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. Teacher Note: The authentic assessment for Module 1 requires students, in study teams, to conduct surveillance studies among students in their class, and then among students in other classes. Lessons 1-1 through 1-6 provide learning experiences to prepare for the authentic assessment (in a sense, “teaching to the assessment”) and the studies are conducted as part of Lessons 1-7 and 1-8. 3

Teacher Note: Photos of Worksheets for Lesson 1-6 1-6b If desired, these photos of worksheets could be enlarged for viewing in Power Point. 4

(Estimate 2 class periods) Start of Lesson 1-6 (Estimate 2 class periods) 5

Review 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

Respecting Participants in Studies TV watching Eating in the school cafeteria Having a low-fat diet Tell students that they are almost ready to ask their classmates their health-related surveillance questions. Emphasize to students that before they do this, they will need to learn about the respectful treatment of people who are going to be asked to participate in research or, in this case, a simulation of research (explained on next slide). Teacher Note: As will be covered on the next slide, research, by definition, is activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge 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. The learning experiences in this curriculum have been created for educational purposes. They are carried out with relatively small samples of students who happen to be in a class or club, are not intended to create generalizable knowledge, and are for educational purposes only. Therefore, your students are not carrying out research but a simulation of research. That said, it is still important for students to learn about, and adhere to principles that have been developed to protect participants in human research. Because of the importance of protecting humans who participate in research the federal government has created an Office of Human Research Protection. (http://phrp.nihtraining.com/index.php) Playing on a sports team

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. Tell students that an investigator is anyone involved in conducting the research. Research is activity 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. Tell students that research, by definition, is activity designed to develop or contribute to generalizable knowledge. Ask students what they think “generalizable knowledge” means when it comes to research. (knowledge from a study population that also holds true for a wider population) Explain that when they ask their classmates to answer questions about behaviors such as having a high-fat diet, getting a good night’ s sleep, eating a good breakfast, and being physically active, they will not be conducting research but a simulation of research. Explain that simulation means the imitation of some real thing. It is something that is planned to be as “real-world” as possible. Explain that simulated research will not develop generalizable knowledge because the relatively small sample of students are just those who happen to be in your class or club. They have not been selected in a way that would make them representative of other students who will not participate in the simulation. Therefore what is learned about the students in the class or club does not apply to any other group of people, and, therefore, is not generalizable. Tell students that even though they will be conducting simulated research, not actual research, it is still important that they are aware of, and adhere to, principles that have been developed for protecting participants in human research. (http://phrp.nihtraining.com/introduction/01_intro.php) This class will be conducting simulated research for educational purposes and results will not be generalizable.

Principles for Protecting Human Research Participants Participants (“research subjects”) and Investigators Tell students that participants in research or simulated research must be treated with respect by investigators. Explain to students that when people participate in research, they are called research subjects, and that research subjects need to be protected from any harm or disrespect. This is called the ethical treatment of people who participate in research. Ask students what is meant by ethical treatment. (One way to express this is to say it is the “right thing to do” according to established principles of how to treat people well.) Ask students how they would protect human research participants. Ask students what would be some examples of not treating research participants with respect. (http://phrp.nihtraining.com/history/02_history.php) Ethics in Human Research – the right thing to do according to established principles of how to treat people well

What’s wrong with this picture? Ask students to look at this picture and point out things that are “wrong.” Teacher Note: Try to elicit responses such as: “she does not look like she’s there of her own free will” (coercion?), or “does she understand the risks involved with what she’s a part of?” (informed consent?)

Nazi Human Experiments Ask students what’s wrong with this picture. Note that the children pictured here are horribly emaciated. Ask students how they thing these children got this way? Teacher Note: Introduce a brief discussion of life in concentration camps during WWII in Nazi Germany. Suggest that doctors have always been thought of as the caretakers of our health. Patients trust their doctors. If your doctor tells you to do something, your assumption is that it is for your own good! Explain as needed that this is why the medical experiments by Nazi doctors are shocking. These doctors violated the trust placed in them. Even more shocking is the fact that they claimed they did not believe they were doing anything wrong. It was their belief that such experiments were serving a higher good (such as saving lives of air force pilots by helping them survive in cold water). What’s wrong with this picture?

Accepted Principles What happened after World War II was over? Doctors Trial Explain that as a result of the cruel and inhumane experiments carried out by the Nazis during World War II, the following happened: A Nazi Doctors Trial, held from 1946 to 1947 in Nuremberg, Germany, charged 23 defendants with murder, torture, and other atrocities. Fifteen were found guilty, of whom seven were sentenced to death. Tell students that to prevent such human atrocities from happening again, the 1947 judgment included a set of rules known as the Nuremberg Code. This code marks the beginning of the modern era in protecting human subjects. The Nuremberg Code includes the following principles: Totally voluntary, informed consent Based on prior animal experiments Justification of benefit to individuals or society Absolute avoidance of physical and mental suffering and injury Conducted only by qualified scientists Ability of subjects to withdraw at any time Teacher Note: For elaboration of these principles, visit the Detectives in the Classroom curriculum at http://www.montclair.edu/Detectives/curriculum/Investigation2-3.htm (Investigation 2-3, “What’s wrong with this picture?”).

Tuskegee Syphilis Study What’s wrong with these pictures? Tell students that there is an irony about all this. While the Nuremberg Code was established in 1947, the United States was itself in the midst of its own cruel experiment. Explain that preliminary studies, begun in 1929, proposed to improve the health status of Blacks in the rural South by testing and treating them for syphilis. However, the Great Depression ultimately led to a loss in funding and the treatment phase of the study was never reached. Grossly unethical decisions were made to continue the study, denying participants important health-related information, and, upon the discovery of penicillin as a treatment for syphilis, refusing them that treatment option. Tell students that the Tuskegee Study and the Nuremberg ethics violations both inform our current practices when dealing with human subjects. For more information, see http://www.tuskegee.edu/global/story.asp?s=1207598 In the United States, from the Tuskegee revelation came the Belmont Report: Teacher Note: The report says, “Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to ethics of research involving human subjects: the principles of respect for persons, beneficence, and justice.” Teacher Note: These principles form the basis of current government regulations for the protection of human subjects in research. If these principles are followed, it is believed that human subjects will be treated in a fair and humane way and will be protected from physical, mental, and sociological harm. What’s wrong with these pictures?

What can we do to prevent these events/pictures? Encourage students to talk about what we can do to prevent such pictures/events from ever occurring again.

Principles for Protecting Human Research Participants Tell students that the Belmont Report was published in 1979, and it identified three principles essential to the ethical conduct of research with human beings: respect for persons, beneficence, and justice. Teacher Note: The circumstance under which the Belmont Report was written are also included in the aforementioned investigation from the Detectives in the Classroom curriculum, Investigation 2.3: What’s Wrong with this Picture? (http://www.montclair.edu/Detectives/curriculum/Investigation2-3.htm) Here is a synopsis of that lesson: “Students learn to distinguish between the ethical and unethical conduct of human experiments by uncovering the circumstances under which it is ethical to conduct human experiments (trials).  The lesson begins by asking students to list principles that would assure that human experiments are done ethically.  Next, students learn about the history of the development of ethical standards for human experimentation by reading articles about human rights abuses in human experimentation, for example, the Nazi medical experiments and the Tuskegee Study.  Based on the readings, students develop a set of principles for conducting human experiments and compare their principles to the Belmont Report.  Students also learn the main elements of, and the need for, informed consent.” (http://phrp.nihtraining.com/codes/02_codes.php)

Respect for Persons Tell students that this lesson will focus on respect for persons. Ask students how they show respect for others. (http://phrp.nihtraining.com/respect/02_respect.php)

Informed Consent Ask students if they can explain what informed consent means, as shown in these pictures. Probe. Tell students that informed consent is an agreement by a prospective research participant to be in the study, following an explanation of all relevant information needed to make an informed decision about participating in a study. That information includes the purpose, risks, potential benefits and alternatives to the research that allows people to make a decision about whether or not to participate based on their own goals and values. (http://phrp.nihtraining.com/respect/03_respect.php) (http://phrp.nihtraining.com/respect/07_respect.php) Ask students to express this in their own words. 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 “… all relevant information needed to make a decision about participating in a study.” Ask students what kind of information they would need to know in order to make a decision about participating in a study. Write students’ suggestions on the board. (http://phrp.nihtraining.com/respect/03_respect.php)

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) Tell students that this is a list similar (not exactly the same) as what the Belmont Report requires investigators to disclose the following information to potential research participants: 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 Teacher Note: In this lesson we have taken the liberty of adding the second bullet (“what is expected of participants”) and removed one item (“compensation in case of injury”), to improve the alignment with simulated research in the classroom. Ask students to compare the things they wanted to know (and wrote on the board) in order to make a decision about participating in the study, with the list of disclosure items on this slide. Compare, contrast, and explore.

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) 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. Remind students that in Lesson 1-4, you (the teacher) read them a statement before you asked them to answer a question about their TV-watching. Ask students if they remember this statement. Ask students if they felt that you, the teacher, forced them to participate in the research simulation. Did they agree to participate freely? Was their participation truly voluntary?” Tell students that there will now be an in-class discussion of that statement in light of the Belmont Report disclosure requirements. Teacher Note: The script you read the students in Lesson 1-4 is on this slide, along with the Belmont Report disclosure requirements. Read the Informed Consent Script aloud and discuss with students how this statement did or did not follow each of the requirements, and if there are any ways it could be improved. Teacher Note: These notes below offer suggested points to discuss. The purpose of the study – not stated (its purpose is to create an educational experience during which students become aware of the process and challenge of measuring health-related behavior). Description of what the study participants will experience (the script explains this quite well) Any reasonably foreseeable risks to the individual – not clearly stated. The primary risk of participating is that someone else may learn about a student’s personal behavior. Potential benefits to the participant – not stated. It should be said that there is no potential benefit to the participant. Potential benefits to others – not stated. In this case there are not benefits to others. Confidentiality protections - this is addressed by not writing names on surveys, using 2 pencils, folding surveys and putting in large envelopes. Compensation for participation - not addressed. It can be stated that there is no compensation for participation. Contact information for questions regarding the study – not stated. Should give a contact name in case of questions or concerns. Conditions of participation, including right to refuse or withdraw without penalty – clearly stated in this script. This establishes the voluntary aspect. (http://phrp.nihtraining.com/respect/03_respect.php)

Additional Requirement 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) 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. Tell students that in addition to the disclosure requirements, the Belmont Report also requires that potential participants comprehend what has been disclosed. Ask students what they think is needed to ensure comprehension (simple language, non-English for some, potential participants not mentally impaired) Explain to students that the Belmont Reports also emphasizes the importance of absolutely voluntary participation that is not influenced by anyone conducting the research. Ask students if they understood the information presented to them in the Informed Consent Script well enough to make an informed decision about participation in research. (http://phrp.nihtraining.com/respect/03_respect.php) Comprehension

Worksheet 1-6a Criteria for Informed Consent Items are similar to disclosure requirements in the Belmont Report Criteria can be used to assess completeness of an informed consent script/form Give each study team 1-6a, Criteria for Informed Consent, in the Surveillance Notebook. Explain that these criteria consist of the disclosure requirements from the Belmont Report, as shown on the previous slides. Tell students that the criteria are to be used at any time during the curriculum when they need to refer to the required elements in an informed consent.

Informed Consent Scripts for Our Studies Eating in the school cafeteria TV watching Having a low-fat diet Tell students that each study team is going to write its own Informed Consent script that can be used when asking their classmates to answer their surveillance question about a health-related behavior. Teacher Note: The remaining portion of this lesson is an embedded assessment of students’ understanding of informed consent. Playing on a sports team

Worksheet 1-6b Informed Consent Script Assignment 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 Give students 1-6b, Informed Consent Script Assignment, from the Surveillance Notebook. Ask students to read the instructions out loud, and then address any questions they have. Tell students that this assignment will be done collectively by each study team. Tell students when this assignment should be completed during this class, or before or during the next class, depending on your circumstances). Remind students that the informed consent scripts that they create will be used later in Module 1 when they ask their surveillance questions in class and then among other classes. As such, tell the study teams to write an Informed Consent script that they, as the investigative team, will read during a research simulation. Tell the study teams to make sure that their Informed Consent scripts address the Belmont Report requirements of disclosure, is comprehensive, and emphasizes voluntariness. To make sure, they should be referring to 1-6a, Criteria for Informed Consent as they develop their informed consent script. Ask students what their Informed Consent script should accomplish when they read it to their classmates. (It will allow their classmates to give or not give their informed consent; in other words, to make a voluntary decision about whether or not they wish to participate based on their own goals and values.) Teacher Note: Be sure students understand that the informed consent is an agreement that is given by a potential research participant following an explanation of all relevant information, stated in a way that the potential participant understands, needed to make a decision about participating in a study. This information includes the purpose, risks, and potential benefits of the research so that people can make a voluntary decision about whether or not to participate based on their own goals and values.

Possible break point between class periods 25

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 Teacher Note: If teams have not written their scripts before this class, ask them to do so now (allow at least 20 minutes). Teacher Note: There will be a two-step process of assessment of the quality and completeness of scripts. 1) teams will self-assess using the criteria in Worksheet 1-6a; and 2) teams will read their scripts aloud to the rest of the class, and classmates will politely offer their comments and suggestions. After the teams have finished writing their scripts and assessing them according to the criteria in Worksheet 1-6a, have each study team stand in front of the class and read their informed consent script to the class. Elicit constructive comments from the other students. (Also encourage discussion about the quality of the reading itself – are students speaking clearly, at a reasonable pace, and sufficiently loudly.) Teacher Note: As students comment, reiterate the point that they should consider the criteria in 1-6a, Criteria for Informed Consent in their Surveillance Notebook. Teacher Note: You may notice confusion about what the Informed Consent script should say about the purpose of the study. Advise students that they should tell enough about the purpose, so potential subjects understand what they are consenting to. But also, they do not want to reveal too much about the exact purpose of the question so that it gives a hint as to what answers might be expected. For example, the purpose of a study could be stated as “to learn about health-related behaviors in participants” “to learn more about physical activity habits of participants,” “to examine television-watching behaviors among participants.” An example of a purpose NOT to say would be “to find out how many students watch TV 3 or more hours a day.”

Final Revisions as Needed Following Class Discussion Does our informed consent script meet the criteria? Based on the critiques and class discussion, give students an opportunity to make final revisions and again self-evaluate their scripts by placing checks in the appropriate “Met,” “Somewhat Met,” or “Not Met” boxes in 1-6a, Criteria for Informed Consent. Teacher Note: Assess students’ understanding of informed consent based on the quality of their scripts and the accuracy of their self-evaluations.

Re-Cap Big Ideas in Lesson 1-6 Participants in research or simulated research need to be protected by investigators from any harm or disrespect 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