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

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)