Trial By Error: How Bristol Investigators Avoided Ethical Review (Reprise)

By David Tuller, DrPH

Last November 12, I published a post called “How Bristol Investigators Avoided Ethical Review.” That post addressed the series of eleven studies conducted by Bristol investigators and exempted from ethical review on questionable grounds. The lead investigator of these studies was Professor Esther Crawley, Bristol’s methodologically challenged pediatrician, whose work was the subject of a report released last week by the National Health Services’s Health Research Authority.

That investigation confirmed my argument that these studies all qualified as “research” and not “service evaluation.” Professor Crawley has now been directed to make corrections to the ethics statements in all eleven studies. While this remedy falls significantly short of what I believe is appropriate, it would nonetheless be a humbling and perhaps humiliating task for any serious investigator to have to correct so many studies at one go. And of course this mandate comes just a few months after Archives of Disease in Childhood appended a 3000-word correction to the dung-heap known as the Lightning Process trial–also from Professor Crawley and her colleagues.

I will address my concerns about the new report on Professor Crawley’s work at another time. For now, I thought it might be useful to reprise last year’s post (published in full below). The post offers an in-depth explanation of the issues involved, including the distinction between “research” and “service evaluation.”

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