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ABSTRACT Henry K. Beecher was a pioneer of research ethics and a prominent whistleblower with regard to ethically problematic studies. Most of his work focused on research in adults, not children, but he did speculate about the implications of his ethical concerns for research in minors. This paper reviews Beecher's response to Krugman's studies of hepatitis at the Willowbrook State School and the debate that Beecher's article stimulated between Ramsey and McCormick. That debate shaped the terms that were used in current federal regulations for research in children. The paper then speculates about whether Beecher would have approved of our cur rent regulatory system.
Henry K. Beecher's famous 1966 article on ethically problematic medical research was a pivot point. It came at the end of two decades of soul-searching among researchers and philosophers. It ushered in an era of legislation and regulation to address the complex issues that had been extensively discussed by Beecher and others. That soul-searching began with the Nuremberg trials and the disturbing recognition of how far the Nazi doctors had strayed from professional ethical norms. It led, eventually, to the creation of the system of oversight that we have today.
During these years, there were heated arguments about what sort of research ought or ought not to be permitted and with what sort of oversight. Often, difPediatric ferent writers came to different conclusions after examining the same data and even while invoking the same moral principles. For example, when Paul Ramsey (2002) read about the Willowbrook hepatitis studies in Beecher's article, he came to the conclusion that all "non-therapeutic research (that is, research that did not have a reasonable prospect of benefit to the research subject) on children ought to be prohibited." In his book The Patient as Person, Ramsey wrote that such research on children was "a sanitized form of barbarism" (242). Parental consent, in his opinion was irrelevant because no parent was ethically permitted to give such consent. "Such use of captive populations of children for purely experimental purposes ought to be made legally impossible," he wrote. "We should expect no significant exceptions to this canon of faithfulness to the child" (244).
Beecher himself was not so sure. In a 1969 paper written with William J. Curran, Beecher...