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November 24, 1999

Keeping Research Subjects Out of Harm's Way

Author Affiliations

Author Affiliation: Office for Protection from Research Risks, Office of the Director, National Institutes of Health, Bethesda, Md.

JAMA. 1999;282(20):1963-1965. doi:10.1001/jama.282.20.1963

Observers of human experimentation in biomedicine and behavior are sounding cautionary notes that demand attention. In scientific research, "continued vigilance [is] critical to protecting human subjects," reports the US General Accounting Office.1 "The effectiveness of IRBs is in jeopardy," concludes an analysis of institutional review boards (IRBs) by the US Department of Health and Human Services' Office of Inspector General. "With this report, we offer a warning signal," says the inspector general.2 In this issue of THE JOURNAL, Woodward identifies trends that "erode" human subject protections.3 These are strong words that connote peril. Given that the inspector general also declares, "We do not document, nor do we suggest that widespread harm is being done to human subjects,"2 the words are, perhaps, too strong. It is, after all, by any probabilistic measure, relatively safe to be a human research subject. This is precisely the time to take constructive account of the notes of caution being sounded and to reform, correct, revise, and improve the dynamic and evolving system that keeps those who are enrolled in research out of harm's way.