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Cleaning Up the Lab Cages: Healthy Human Phase I Trials and Animal Welfare Requirements

Abstract: In September 2007, the inspector general of the U.S. Department of Health and Human Services delivered a searing indictment of the oversight system in the United States for research with human subjects. Officials at the Food and Drug Administration (FDA) were inspecting fewer than 1 percent of sites where FDA-regulated products were being tested in human subjects, and on the rare occasions when inspectors made site visits, it was usually long after the trials were finished. The article by Jill Fisher and Rebecca Walker in the January-February 2019 issue of Ethics & Human Research raises the question, why don’t we upgrade human research protections to the level of those for rats and mice? Of course, Fisher and Walker are more careful with their words; they use the euphemism “model organism” for a human research subject. But how are human subjects in phase I trials like lab animals? Fisher and Walker see two points of comparison. First, just as lab animals are confined to cages, healthy subjects in phase I trials are generally confined to research units. Second, just as lab animals are physiologically different from humans, phase I study subjects are different from most of the population who will eventually take the drugs they are testing. But there is another point of comparison between lab animals and phase I study subjects. Both are used instrumentally, as objects of investigation.

Published on: March 21, 2019
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