Trial By Error: How To Avoid Ethical Review

 

David Tuller

By David Tuller, DrPH

I have written many posts about BMJ Open’s 2011 school absence study,
which reported that school absence records could be useful in identifying children with chronic fatigue syndrome. However, for reasons not yet adequately explained, the investigators exempted the study from ethical review on the grounds that it qualified as “service evaluation.” To support the claim, they cited a 2007 letter from the regional research ethics committee (REC), which was unrelated to the study in question.

Studies involving data from human subjects are often categorized as either “service evaluation” or “research.” Those in the former group are generally supposed to evaluate the provision of health care or other services through analyses of anonymous data; they are exempt from ethical review. If a study is testing a hypothesis, produces generalizable conclusions and/or involves data collected from participants known to the investigators, it falls under the category of “research,” not “service evaluation,” and requires ethical review.

The school absence study was conducted by investigators from the University of Bristol. It featured a formal hypothesis, generalizable conclusions, and in-person collection of data from participants. It was clearly “research,” as understood by the Health Research Authority, the arm of UK the National Health Service that serves as the arbiter of research ethics. The study should never have been defined as service evaluation and published without ethical review. Yet BMJ Open has repeatedly defended the decision to publish it.

 

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Link to Research story

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