Author Affiliation: Office for Protection from Research Risks, Office of the Director, National Institutes of Health, Bethesda, Md.
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.
Ellis GB. Keeping Research Subjects Out of Harm's Way. JAMA. 1999;282(20):1963-1965. doi:10.1001/jama.282.20.1963