Tipping Point, Over the Top, Or Just Noncompliance As Usual?(Essays‪)‬

As soon as I read the headline, I thought, here we go again. As a former director of the Office for Human Research Protections at the Department of Health and Human Services, I was hardly surprised when several colleagues sent me the op-ed by Atul Gawande in the New York Times last December called "A Lifesaving Checklist." (1) Dr. Gawande, a surgeon at Brigham and Women's Hospital in Boston and staff writer at the New Yorker, suggested that the federal agency responsible for protection of human subjects in research had gone too far--over the bureaucratic edge. Perhaps he was right, but his representation of the facts was not, as OHRP was quick to point out in a statement of its own. (2) OHRP's statement did not evoke the energetic public response that Gawande's did, but then facts have a way of being complicated and nuanced, making drama a bit harder.