Illustration: A. Canamucio
The death of a young man, Jesse Gelsinger, in a 1999 gene therapy experiment has focused attention on the challenges of research with human subjects. This issue had been simmering just below the surface for the past eight years. The media reports on human subject abuses in a wide variety of research settings could sufficiently arouse public distrust of human research and endanger the recruitment of patients in future clinical trials.

The explosive growth in research with human subjects is attributable to an aging population, increased attention to health care issues, and an unprecedented increase in federal funding. Existing regulatory infrastructures at the federal and local levels, however, have not kept pace with this growth. As a consequence, protection of human subjects is lagging far behind the research needs.

There is no question that there is a great need for research using human subjects. Society demands improvements...

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