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As we race toward the as yet unimagined scientific and medical triumphs of the 21st century, no one is more hopeful about the journey than I am. Nevertheless, moving ahead with cutting-edge research must not mean leaving behind well-established international standards for protecting human subjects in clinical trials. None of these principles is more important than the protection of research subjects by informed consent based on full disclosure of potential risks and benefits. I did not expect, or want, to complete my tenure as secretary of health and human services by raising questions about the safety of patients in clinical research. However, recent developments leave me little choice. Much brilliant biomedical research is being done in universities and academic health centers, and the federal government supports a substantial portion of this research. So we have a responsibility to make sure the money we invest-money that comes from U.S. taxpayers-is not used in ways that harm people participating in clinical trials or that unnecessarily risk harming them. The vast majority of government-supported studies adhere to strict protocols and the highest ethical standards. But even one lapse is one too many. The American people expect that clinical researchers will never compromise or neglect the safety of human subjects. The moral and ethical reasons for paying heed to this demand require no explanation. However, there are also practical reasons. To put it simply, if we cannot guarantee sound research in general-and patients' safety in particular-public support for gene therapy and other potentially lifesaving treatments will evaporate. Volunteers will not show up, and the generous stream of research dollars that Congress and President Bill Clinton have provided in recent years may shrink. So clinical researchers and the institutions that support them must, without exception, maintain the public's confidence in our work, our competence, and most important, our ethics. Unfortunately, the public's confidence in all three has been seriously shaken by the death of 18-year-old Jesse Gelsinger in a gene-transfer trial at the University of Pennsylvania in which human subjects were not adequately protected and which presented the appearance of substantial financial conflicts of interest.

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