Exploring Bioethics - NIH Office of Science Education - National ...

Key Science Knowledge*• Nature of science: research design, how experiments are done, the needto test one variable at a time, the need for comparison (or control)groups, and intervention vs. observational studies• Study design: control studies, placebos, randomization, and blinding*Bold items are explicitly addressed in this module.Teaching Sequence PreviewDay 1—Research with Humans: Why Should It Matter? What Shouldthe Guidelines Be?: Day 1 grounds students in scientific inquiry. They learnabout (or review) study design through a hypothetical asthma study and discusswhy it is important to involve human subjects in research. They thenturn to two major ethical considerations that are essential for assessing theethical appropriateness of proposed human research studies: 1) the importanceof showing respect for persons by ensuring fully informed, voluntaryconsent and 2) ensuring that prospective studies demonstrate an appropriaterisk-benefit ratio. Students decide whether or not to participate in the studythey’ve been assigned to, and the willing ones are randomly assigned to thecontrol or the experimental group.Day 2—Harms and Benefits of Research with Humans: Students brainstormthe great benefits that have resulted from medical research, drawing ontheir own experiences. Next, they examine the case of Ellen Roche, a healthy,young volunteer who died in an asthma clinical trial. They then create a list ofethical guidelines for research on people and learn that federal and local guidelinesgovern such research.Day 3—Analyzing the Willowbrook Case: Students debate the ethicalappropriateness of a study that some people consider ethically problematic:researching a vaccine at Willowbrook, an institution for mentally challengedchildren. They prepare arguments that either refute or defend the researchand then discuss them in a format called structured academic controversy(small-group discussion). Students complete an individual assessment thathighlights their understanding of the ethical criteria that should guidehuman-subjects research.In AdvancePreparing the Envelopes for Day 1, Activity 4For Day 1, each student will need an envelope containing an asthma simulationoutcome. Copy Master 5.2, cut it into sections, and put one section into eachenvelope. (If you plan to reuse the envelopes, make sure not to seal them.) Makeapproximately equal numbers of control and experimental outcomes. Be surethat most of the experimental group has a positive outcome but that at least onestudent has a very negative one. Make small, inconspicuous marks on the envelopesso that you can tell the control and experimental ones apart.5-4 Exploring Bioethics