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

ClosureAsk the class whether they think, based on this preliminary test,that researchers should test the asthma medication further and ifso, why. The asthma of most individuals assigned to the experimentalgroup improved. However, one person did get very ill, highlighting potentialharms and the difficulty of weighing harms and benefits.Some of the most important medications have come about through studiesof people who have volunteered as subjects. Note that the next few activitiesfocus on the value of that research as well as criteria that researchersmust keep in mind to ensure that studies do not exploit or harm people.HomeworkDistribute copies of Master 5.3: The Ellen Roche Case—Research withHealthy Volunteers to students, and ask them to read it and then answerthe reflection questions before Day 2.Extensions (Optional)If you’re interested in going further with students into the topics covered inthis activity, ask them to research the following questions.1. What kinds of clinical trials are going on right now near here?If students have Internet access, ask them to go to http://clinicaltrials.govand enter the name of the closest large city to see what trialsresearchers are conducting nearby. If you have Internet access in theclassroom and a projector, you may wish to do this for the whole class.2. What are the phases of clinical trials?Researchers conduct clinical trials of new treatments in three phases,followed by a fourth phase for post-marketing studies. Each phase hasa different purpose and helps scientists answer different questions.You may wish to have students explore the phases in terms of thepurpose of each.• Phase I: Researchers test an experimental drug or treatment in asmall group of people (20 to 80) for the first time to evaluate itssafety, determine a safe dosage range, and identify side effects.There is no need for a placebo or any kind of control. For manypeople, financial incentives provide motivation to participate inearly trials.• Phase II: Researchers give the experimental drug or treatmentto a larger group of people (100 to 300) to test its ability toproduce a desired effect (in other words, to test its efficacy) andto further evaluate its safety. Control groups are not part ofPhase II trials, either.5-16Exploring Bioethics