■ First-in-human studies: Investigators want to inject phage libraries into humans to map their distribution. Based on extensive preclinical work, they hypothesize that phage could be engineered to home in to specific targets, with the future potential of serving as therapy delivery systems. They initially considered a traditional phase I population but decided that the risk of diminishing quality of life was too high. They seek research ethics consultation to help them find, if possible, a suitable and ethically appropriate research population. ■ Studies that pose significant risk of harm: Investigators propose a phase I surgical trial that poses significant risks in people who have progressive neurological disease, characterized by communication difficulties and declines in cognition. They request advice from the research ethics consultation service about how to ensure that participants understand they will not benefit from the study. ■ Studies that raise ethical questions on which there is no consensus: A researcher conducts clinical trials with depressed children and adolescents. One of the difficulties is that new drugs for the treatment of adult depression quickly become used for off-label treatment of pediatric patients without solid empirical evidence. His new study involves comparing a new antidepressant drug to a standard drug and a placebo. All subjects are followed for suicidal ideation and withdrawn from the study if suicidal potential is evident. He argues a placebo control is required in order to answer the scientific question about the efficacy of the new drug. The IRB deferred his study by a narrow vote because it disagreed about the need for a placebo. The IRB recommended a research ethics consultation to address the issue.
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