Virology blog post, by David Tuller, 28 August 2017: Trial By Error: No Ethical Review of Crawley School Absence Study
This is a complicated post. Here are the key points. The rest is details:
*Professor Esther Crawley and co-authors claimed a 2011 study in BMJ Open was exempt from ethical review because it involved the routine collection of data for “service evaluation.” Yet the 2011 study was not an evaluation of routine clinical service provision–it was designed to road-test a new methodology to identify undiagnosed CFS/ME patients among students with records of chronic absence.
*To support the claim that the study was exempt from ethical review, Professor Crawley and co-authors cited a 2007 research ethics committee opinion that had nothing to do with the data-collection activities described in the 2011 paper.
*For the 2011 study, school letters were sent to families of 146 student, inviting them to meet with Professor Crawley. In the end, only 28 were identified as having CFS/ME–meaning more than 100 families of students without CFS/ME received potentially disconcerting letters inviting them to a medical meeting about a sensitive issue. This type of pilot program is beyond the scope of what many would consider to be service evaluation.
*A pre-publication reviewer, noting the data collection activities described in the paper, raised serious questions about the lack of ethical review. In her response, Professor Crawley did not provide satisfactory answers to the concerns raised by the reviewer, but BMJ Open published the paper anyway, without ethical review.
*BMJ Open’s recent response to the concerns has been confused, contradictory and inadequate. In separate e-mails, the editor and editor-in-chief have provided two distinct and incompatible justifications for the decision to publish without ethical review. Neither explanation is convincing.
Virology blog, by David Tuller, 30 Aug 2017: Trial By Error: Seeking More Details on Crawley School Absence Study
FOI request from Dr Tuller and Prof Steven Lubet:
Under the UK’s Freedom of Information law, we are requesting a copy of the letter sent to these families—or copies of the letters, if the different schools used different versions. Of course, the copy or copies of the letter or letters shared under this FOI request should be fully anonymized. Given the provenance of the study, we presume that Bristol holds copies of the letters in its files. We are also requesting copies of the information about the 2011 school absence study that was provided to the families and students contacted through these letters. This information might have included printed or online leaflets, for example, or other material.
Finally, we are requesting a copy of the consent form or forms these families and students might have been asked to sign as participants in the 2011 school absence study. Of course, any such forms should be fully anonymized.