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Aug2016

Among several seminal moments in the field of research ethics, Henry K. Beecher’s 1966 paper, Ethics and Clinical Research, stands out for its breadth and scope. In what has come to be known in the field as Beecher’s Bombshell, the paper reported on 22 prominent studies that contained serious ethical issues; the impact of the “bombshell” has been felt throughout the field ever since.

In an article (free with signup) published in The Lancet, PRIM&R contributor Laura Stark explores the context around the paper, Beecher’s personality, and how both came to shape the current regulatory climate of research ethics.

Beecher was a bombastic character, Stark reports, and not one to shy away from a fight; indeed, his career was characterized by a series of professional quarrels that left him a “media darling” but a pariah in the field. His personal inclination toward conflict undoubtedly shaped the manner in which he dropped his bombshell: he first brought the issue to the public a year prior to his paper’s publication at a conference of medical professionals—many of whom left the event decidedly upset with him.

It wasn’t just Beecher’s appetite for drama that spurred him to release the report, however. He spent much of his professional life committed to cleaning up what he considered some of the more odious aspects of the research profession. However, as Stark explains, his vision for how that would be done was starkly different from the reality that would come to pass not long after “Ethics and Clinical Resarch” was published.

The findings of the Beecher’s paper, along with other well-known historical events now in the pantheon of research ethics cases, led to the 1974 National Research Act. But providing a robust regulatory framework was hardly his goal; as an “elitist,” Stark says, Beecher “wanted to maintain a privileged place for professional discretion and judgment among peers.” Rather than change the rules by which researchers operated, he hoped to reform their ethical priorities (indeed, Beecher specifically left the studies in his paper uncited, in part to avoid potential liability for the researchers).

Beecher’s Bombshell is the topic of a plenary panel being offered at PRIM&R’s upcoming 2016 Advancing Ethical Research Conference. You can also find more coverage of the paper, both its history and enduring legacy, in PRIM&R’s Knowledge Center (member login required) and an episode of our podcast, More Than Meets the IRB.

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