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Dr David Tuller: A Recap of the School Absence Study

Countrygirl

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http://www.virology.ws/2019/02/03/t...VF_JY3Eg5kFwvGX5YLejhR0ezzUcqk2MzfhUpeJPN6AFY

Trial By Error: A Recap of the School Absence Study
3 FEBRUARY 2019
By David Tuller, DrPH

Last week I broke the news that Bristol University is conducting an independent investigation of a number of studies that were exempted from ethical review on the grounds that they qualified as “service evaluation.” Because the issues involved are confusing and complex, I thought it would be helpful to repost here part of my initial investigation of one of those exempted studies–the 2011 school absence paper published in BMJ Open.

That paper–“Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics”–turned out to be one of at least 11 studies that were exempted from ethical review based on a single 2007 opinion from the local research ethics committee. The school absence study included a formal hypothesis, generalizable conclusions, and in-person data collection activities. In fact, the title is itself a generalizable conclusion.

Since all three characteristics are hallmarks of “research” requiring ethical review, the presence of any one of them should have disqualified the paper from being published as service evaluation. This problem should have been obvious to any experienced investigator and journal editor. I continue to be perplexed at why BMJ Open not only published the paper in the first place but has continued to undermine its own reputation and credibility by consistently defending its indefensible decision.