Dr David Tuller: Who Has the School Study Documents?

Countrygirl

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Trial By Error: Who Has the School Study Documents?
4 MARCH 2019
By David Tuller, DrPH
I first wrote about BMJ Open’s 2011 school absence study in August, 2017. The investigators, all from Bristol University, exempted the study from ethical review on the grounds that it qualified as “service evaluation.” The study included a hypothesis, generalizable conclusions and in-person interviews with participants. Since these are all features of “research” that requires ethical review, the study did not qualify as “service evaluation” under known definitions. It should not have been conducted or published without ethical review.
Two days after I posted that first of many blogs about the study, Northwestern University law professor Steven Lubet and I sent a freedom of information request to Bristol for some documents related to the research—specifically, the letters sent by schools to families, and information leaflets and consent forms provided to participants. We were concerned that the school letters could possibly have been coercive, especially given the apparent involvement of school attendance officials in the study’s outreach effort. Also, since this research was conducted without ethical review, we wanted to know what, if anything, the participants were told about the study and what, if anything, they consented to.
Bristol wrote back that it did not have such documents, noting the following: “This study reports on a pilot clinical service set up with the school attendance service in Bath to try and improve school attendance. This was a clinical project and no documents are held by the University.”