LESSON 1: Historical Context of Humans in Research INTRODUCTION LEARNING OBJECTIVES In this lesson, students gain insight into the historical Student will know: context of human participants in research. Students • Ethical judgments are required when research is done participate in an activity in which they analyze four with human participants. historically notable case studies where ethics remain unclear. Students develop their own list of ethical • Researchers must follow ethical guidelines that result in the guidelines by creating a concept map and then consideration of populations that are used for research. comparing their guidelines to the principles outlined in Students will be able to: the Belmont Report: Respect for Persons (including autonomy), Beneficence, and Justice. This lesson provides • Formulate a set of “rules that should guide the use of a preliminary understanding of the difficulties and humans in research,” compare the list against current considerations that need to be taken into account when internationally used principles, and summarize key involving humans in research. ethical principles. • Analyze and discuss the ethical use of human participants CLASS TIME in historical research cases, select the principle that was most violated, and defend their choice. One to two class periods of 55 minutes. MATERIALS KEY CONCEPTS Materials Quantity Ethics is a discipline that focuses on questions of values, Student Handout 1.1a—Case Study A: 3–4 and a practice that requires reasoned judgments. Some Henrietta Lacks and HeLa Cells per group ethical considerations related to human participation in Student Handout 1.1b—Case Study B: 3–4 research include: The Havasupai Indians per group • Autonomy. Student Handout 1.1c—Case Study C: 3–4 • Informed consent. The Tuskegee Syphilis Study per group • Assessment of risks and benefits. Student Handout 1.1d—Case Study D: 3–4 per The Willowbrook Study group • Selection of subjects. Student Handout 1.2—Guiding Questions 1 per student • Identification of vulnerable populations. for Historical Case Studies • Possible compensation for participants. Student Handout 1.3—Concept Mapping 1 per student Possible Answers for Student Handout 1 1.3—Concept Mapping Vocabulary words used in each lesson are in bold. Definitions can be found at the end of each lesson and Student Handout 1.4—The Belmont 1 per student in the Master Glossary in the Appendix. Report LESSON 1 © Northwest Association for Biomedical Research HUMANS IN RESEARCH | 17 NOTE TO THE TEACHER PROCEDURE To teach this unit, knowledge of ethical theories is helpful Activity One: Guiding Questions but not necessary. Additional background, one-page summaries, and a comparison chart on ethical theories 1. Tell the students that in this lesson they will use real-life can be found in An Ethics Primer: Lesson Ideas and Ethics medical case studies to explore the ethical implications of Background at http://www.nwabr.org. humans in research. 2. Have the students form groups of three or four. The Belmont Report (http://ohsr.od.nih.gov/guidelines/ belmont.html) provides the ethical guidelines governing 3. Pass out one copy of the Student Handout 1.2—Guiding human research as a result of committee deliberations Questions for Historical Case Studies to each student and after the National Research Act was signed in 1974. These assign each group a case study to read together. Ask each documents were crafted, in part, in response to the emerging group to answer the Student Handout questions for their public understanding of the treatment of the men involved case. [Note: Teachers may also choose to run a “jigsaw” in the U.S. Public Health Service Study (Tuskegee Study). exercise using the case studies (where one case study is The basic ethical principles outlined are: respect for persons passed out to each group for in-depth discussion, then new (including autonomy), beneficence, and justice (see Student groups are formed in which students familiar with each Handout 1.4—The Belmont Report). case share what they have learned with the others in the new group).] The historical case studies used in this lesson are U.S. cases and span a time period from the 1930s to the 1970s. 4. Now ask each student group to share information from However, the issues surrounding each case continue to their case study with the class. Encourage the class to ask be discussed today. To further study different vulnerable clarifying questions. populations, consider using the following studies: 5. As a class, ask students to help brainstorm a list of shared • Elderly patients—Jewish Chronic Disease Hospital Study. themes among the studies. To help students generate their list, have them review their notes on Student Handout • Prisoners—Guatemalan Syphilis Study/Nazi concentration 1.2—Guiding Questions for Historical Case Studies and use camp studies leading to the Nuremberg Trials. these prompts: • Decision-impaired individuals—The Terri Schiavo case. • What similarities did you notice between two or [Note: This case is not research-oriented, but provides a more cases? clinical decision-making context.] • Did anything repeat itself? FRAMING THE LESSON • What was fair/not fair? In this activity students will use case studies to explore • How should study participants expect to be treated? the ethical implications of humans in research. Explain 6. Record student answers on the board. to students that the case study stories are real historical situations where researchers involved human participants in their studies. Stress that these particular cases are The full title of the Tuskegee Syphilis Study is included because they illustrate questionable practices “U.S. Public Health Service Tuskegee Study of involving humans in research. Though the methods may Untreated Syphilis.” (or may not) have been acceptable at the time, they do not represent current ethical practices. [Note: Information on supplementary resources and additional case studies can be Activity Two: Creating a Concept Map found in Resources at the end of the lesson.] 7. Tell students that they will now create a concept map that shows relationships among the common ideas found in the LESSON 1 TEACHER PREPARATION case studies. • Make copies of Student Handouts. 18 | HUMANS IN RESEARCH © Northwest Association for Biomedical Research 8. Ask students to group the answers to the questions in CONNECTION TO FORMATIVE Step Five into similar themes, working either individually ASSESSMENT or in their small groups. Have them use Student Handout 1.3—Concept Mapping to record the major concepts from Revisit the statements students sorted in the Formative the class discussion, case study table, and brainstorming Assessment. After completing Lesson One, students should activity. Ask students to consider what they recorded on understand that Statement C is accurate. Careful reading Student Handout 1.2—Guiding Questions for Historical of the Henrietta Lacks case also shows Statement D to be Case Studies, and have them organize the guidelines accurate (this concept will be revisited in the next lessons). further, possibly narrowing them down to three or four major categories complete with specific examples from GLOSSARY each of the case studies to support their themes. The goal Antibody: A substance made by the body as an immune is to arrive at themes that parallel those of the Belmont response that attacks and destroys foreign agents, such as principles (see Possible Answers for Student Handout viruses and bacteria. 1.3—Concept Mapping). 9. Working as a class, invite students to share their concept Autonomy: A person’s freedom and ability to make his or map themes. Generate a class concept map that includes her own decisions. examples from each of the case studies. [Note: A useful Autopsy: An examination conducted on a dead body to website for how to turn a text outline into a concept map determine the cause of death. can be found at http://www.text2mindmap.com. Teachers may use this resource to create their class concept map.] Belmont Report (Belmont principles): Created in 1978 by the U.S. Department of Health, this report established 10. Ask students to go back and fill in any missing three basic ethical principles to be considered when elements on their own concept maps (Student Handout humans participate in research. 1.3—Concept Mapping). Remind students to include specific examples from each of the case studies to support Beneficence: Minimizing all potential harms and maximizing their themes. all potential benefits to the subject as well as to society. Activity Three: The Belmont Report Cervical cancer: Cancer of the cervix, which is the lower, narrow end of the uterus. 11. Pass out Student Handout 1.4—The Belmont Report. Have students compare their concept map guidelines Clinical research: Medical research involving human to these ethical principles that were developed to guide participants to test new medications, treatments, methods human research. of prevention, and therapies. 12. Review each of the Belmont principles with the class, Coercion: The act of pressuring someone to do something and encourage students to note similarities or differences using force, intimidation, or threats without respect for between these principles and those on their concept maps. individual choice. This includes the idea that a person with few choices may find participation in a study to be so 13. Using Student Handout 1.4—The Belmont Report, appealing that they feel they cannot decline, even if being ask students to give a concrete example from one of in the study is not a good decision for other reasons. the case studies for each of the principles found in the Belmont Report. Conflict of interest: A situation in which someone is responsible for making a decision in an official capacity Closure (e.g., someone holding public office) that could benefit 14. Have students compare their class concept map principles them personally. to those found in the Belmont Report. Tell students that the Ethics: A field of study that looks at the moral basis of principles described in the Belmont Report are sometimes human behavior and attempts to determine the best referred to as the Belmont principles.