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- Research ethics committees
- publication bias
- protection of research subjects
- systematic review
Death of a normal volunteer highlights problems with research review and protection of subjects
Healthy volunteer dies in asthma study
On July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections (OHRP) suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the study.1 Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment.
Ellen Roche was a 24 year old technician from the Johns Hopkins Asthma and Allergy Centre who volunteered to take part in a study designed to provoke a mild asthma attack in order to help doctors discover the reflex that protects the lungs of healthy people against asthma attacks. After inhaling hexamethonium, a medication used for treating high blood pressure in the 1950s and 60s, Ms Roche became ill. She developed a cough and her condition worsened over the next week until she was put on a ventilator. With her lung tissue breaking down, blood pressure falling and her kidneys beginning to fail, nothing could be done to save her.2 She died on June 2, about a month after entering the study.
The Office for Human Research Protections (OHRP) investigated the circumstances of Ms Roche's death and accused the Hopkins Institutional Review Board (IRB) of failing to take proper precautions. It also evaluated the human subject protection system at Hopkins. The OHRP found that prior to approving the study, Hopkins researcher …
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