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http://www.virology.ws/2018/01/03/trial-by-error-cope-to-bmj-open-more-details-please/
Trial By Error: COPE to BMJ Open: More Details, Please!
3 JANUARY 2018
By David Tuller, DrPH
Yesterday I reviewed an account of a publishing dilemma that had been submitted to the forum of the Committee on Publication Ethics. The COPE forum offers advice on thorny situations submitted anonymously by members. In this case, the submission appeared to be from BMJ Open and it appeared to be discussing Professor Esther Crawley’s school absence study. That study was exempted from ethical review on the specious grounds that it qualified as “service evaluation.” BMJ Open has defended its decision to publish the paper without ethical review.
I was pleasantly surprised by the COPE forum response, quoted in full below. It was reasonable, given the misinformation conveyed in the BMJ Open account. The COPE forum response also clearly justifies the concerns raised about the study’s lack of ethical review. My remarks, posted after the response, will focus on the first paragraph.
FORUM ANSWER: The Forum suggested that perhaps the issue is not whether or not the service evaluation is research, but was the evaluation carried out in human subjects (which would require a sound ethics approach) or were the data contained in registries where the patient data were anonymised. It would appear that the latter is the case and that this is a secondary data analysis, but the editor could ask for clarification from the author on the methodology as it needs to be adequately described. Was this a dataset developed out of a research project that had ethics approval for human subjects? If so, the secondary analysis might not need new ethics approval if additional analyses were covered in the initial approval. The methodology is confusing the issue of whether ethics approval was required. The Forum suggested these points need to be clarified before a decision on whether to add a correction on the article or to respond to the blogger.