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The Ellen Roche Case—Research with Healthy VolunteersCopyright © 2009 Education Development Center, Inc. Exploring Bioethics.Permission granted for classroom use.Ellen Roche was a 24-year-old healthy technician ata university asthma and allergy center. A researchercalled her one day to ask her to participate in an asthmastudy because she had participated in studies before.Asthma is a serious disease that is on the rise, especiallyin urban areas. The purpose of the study Roche volunteeredfor was to better understand how asthma affectsthe body. First, she took a drug designed to mimic theeffects of asthma. Next, she inhaled a chemical (hexamethonium)that was supposed to block nerves theresearchers believed were involved in asthma attacks.The consent form called the hexamethonium a “medication”that had been “used during surgery, as a part ofanesthesia”—giving the impression that it was approvedby the Food and Drug Administration (FDA) asa medicine and was, therefore, safe. There was no mentionthat inhaling the chemical was experimental.The day after receiving the experimental treatment,Roche developed a cough and started to feel ill. Fourdays later, she was hospitalized with a fever and abnormalchest symptoms, and the study was placed onhold. The air sacs in her lungs collapsed, then her lungsbecame stiff, and, finally, her other organs stoppedworking. Less than a month after the treatment, Rochedied. If she had completed the study, she would havereceived up to $365.Research involving humans must be reviewed by aninstitutional review board (IRB). The IRB determineswhether studies are both scientifically sound and ethical.The university’s IRB had reviewed and approved theoriginal research proposal.One of the biggest criticisms of the IRB is that it didnot request more careful review of the chemical. Manycritics believed that researchers should have reevaluatedthe study when the first subject had troubling symptoms(before Roche’s treatment). That subject reportedmild shortness of breath and coughing, but the symptomsgot better on their own.Before the experiment, the scientist who led the studylooked at research going back 50 years and did notfind any sign that hexamethonium would be harmful.However, after Roche’s death, investigators foundearlier papers that warned about possible toxic effects.The chemical was also not approved by the FDA for theway it was used in this study. The role of the FDA inapproving studies at research universities is not clear,but many people felt that the researchers should havesought the FDA’s opinion.The U.S. Office for Human Research Protectionsstopped all research at the university for several days,until the university came up with a plan that includedfunding for more IRBs. Until then, the university hadonly two committees that were responsible for reviewing2,400 proposals. The university accepted responsibilityfor the death and reached a financial settlementwith Roche’s family four months later.About 50,000 individuals participated as subjects inresearch at the university the year Roche died. Theuniversity was one of the most highly regarded medicalcenters in the nation. It had conducted trials for 100years without any deaths of healthy volunteers. In anarticle about the case in the February 28, 2002, issueof the New England Journal of Medicine, the dean of themedical school expressed the difficulty of balancing thepotential for learning new information that can helpimprove human health and the risks of harming peopleinvolved in experiments: “At a certain point somepatient is going to die in clinical trials. There is no questionabout it.” But, he noted, the alternative is “not todo any clinical investigation…and still have children onventilators after polio.”Master 5.3 (Page 1 of 2)
Name(s)Reflection Questions1. Aside from its focus on asthma, how is this case similar to or different from the experimentconducted in class?2. What is the role of an institutional review board (IRB)?3. Some ethicists noted that because Roche was an employee at the university, she may have feltunduly induced* to volunteer. A doctor called to ask her if she wanted to take part because she hadparticipated in other studies. Do you think this is a concern? Why or why not?Copyright © 2009 Education Development Center, Inc. Exploring Bioethics.Permission granted for classroom use.4. How does this case illustrate the challenge of balancing research that may have health benefits andthe risks that research participants face?*Undue inducement refers to a situation where people are pressured into doing something harmful by the use of incentives. When inducements distort a person’s judgment, leading them to agree to do what they would not otherwise do, the inducements are considered undue.Master 5.3 (Page 2 of 2)
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NIH CurriculumSupplement SeriesGrad
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Education Development Center, Inc.D
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This material is based on work supp
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About the National Institutes of He
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Introduction
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activity of assessing different rea
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teaching strategies that will help
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2. The ability to distinguish an et
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quence of choosing one path over an
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Table 1. Assessing Student Justific
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Challenges in TeachingBioethics and
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How Exploring Bioethics Can HelpFor
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Prompts to encourage students to re
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Table 2d. Students say they already
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Resources forTeaching BioethicsBeau
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Table 3. Ethical Issues and Curricu
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Each module is divided into three d
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Table 4. Alignment with NSES Life S
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About the Web SiteThe Web site for
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1Module 1Bioethics Concepts and Ski
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• apply important ethical conside
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In Advance1Copies, Equipment, and M
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Teaching Sequence1Day 1: What’s i
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new medication, she is able to stay
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6. Read the list of Round 1 questio
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• With respect to performance enh
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LE/LE/LLE/LPoint out that some of t
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Organizer for Day 1: What’s in a
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Day 2: Four Key Questions1PurposeDa
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4. Emphasize that when bioethicists
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15. Ask students to list as many et
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Organizer for Day 2: Four Key Quest
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Encourage students to share example
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Activity 7:Using Ethical Considerat
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4. Ask a representative from each g
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Organizer for Day 3: Core Ethical C
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References and Resources1Informatio
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What Type of Question? ROUND 1—Et
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What Type of Question? ROUND 3: Eth
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Round 4Q9Should embryonic stem cell
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Oscar Pistorius—The Fastest Man w
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Four Key Questions and Statementof
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Carl’s CaseCarl listened to his t
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1Module 2Balancing Individual and C
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adopting vaccination policies that
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In Advance1Copies, Equipment, and M
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Teaching Sequence1Day 1: Exploring
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the key stakeholders, and taken int
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You may wish to highlight the dange
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ClosureAsk students to reflect on t
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Day 2: Community Immunity1PurposeOn
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10. Ask all students in the class t
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• While an unvaccinated person’
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ClosureRecap for students that the
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Tell only the students who were tag
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5. Divide students into pairs, and
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17. Share with students that becaus
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13. Note that the Boston and Dublin
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Teaching StrategiesYou may want to
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Ask each member of the pair to read
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1Centers for Disease Control and Pr
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Get Kids Vaccinated or ElseGet Kids
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Name(s)Station 2—Vaccine RisksDir
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Station 1: Vaccine-Preventable Dise
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MumpsBefore the mumps vaccine was i
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Station 2—Vaccine RisksNote: Like
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Smallpox VaccineThe smallpox vaccin
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Station 4—ExemptionsExemptions vs
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State Exemptions Allowed as of Fall
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Name(s)What are the ethical conside
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Vaccination Status CardsVaccinated
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Opting Out of a Vaccine—Variables
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Measles in DublinIn 2000, an outbre
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What are some of the different pers
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Issues Explored• What is the fair
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Day 3—What Is Your Recommendation
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Teaching SequenceNoteAssign this ho
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Teaching Strategies: Jigsaw Techniq
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Some students might think that the
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11. Explain to students that they w
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Inform students that they will now
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2. Tell them that one liver has bec
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6. If it does not naturally arise,
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Criteria relevant to allocating liv
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Organizer for Day 2: Identifying St
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Day 3: What Is Your Recommendation?
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Activity 9:Understanding Past and C
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ClosureReinforce to students that t
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Ask students whether they think the
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Liver Function and FailureHepatitis
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Name(s)Banting decided that he woul
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Name(s)The COC distributed the peni
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Name(s)The Admissions and Policy Co
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Liver and Liver-Transplant Fact She
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The Liver and Liver Transplants—C
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Patient ProfilesAnitaAnita is a 19-
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Additional Patient InformationAnita
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The United Network for Organ Sharin
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Comparing the Past and Current UNOS
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1Module 4Weighing Benefits and Harm
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An optional extension activity incl
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In Advance1Preparing the Envelopes
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Teaching Sequence1Day 1: Deciding t
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6. Explain that each student should
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Activity 2:Introducing Max’s Thyr
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See Teacher Support MaterialsSupple
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ClosureTo close the class, remind s
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1Activity 2: Introducing Max’s Th
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Activity 5:Who or What Will Be Affe
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Activity 6:Exploring the Relevant E
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11. Give each student a copy of Mas
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1Ask students, “What are some rea
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5. Have students, in pairs, quickly
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ReflectionDisplay the posters from
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1Reflection: Have students view the
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1Retinitis PigmentosaFoundation Fig
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Alzheimer’s Disease and Genetic T
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Spider-Silk GoatsSpider silk is str
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VealVeal is meat from calves that i
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Assessing Harms, Benefits, and Pote
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Final Assessment of Alba’s CaseRe
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This curriculum supplementwas devel
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