Trial By Error: A Bit More About Bristol’s Investigation
1 FEBRUARY 2019
By David Tuller, DrPH
Yesterday I reported that Bristol University, at the request of the
UK Health Research Authority,
is investigating a number of studies conducted by Professor Esther Crawley. The results of this investigation are expected in two months or so.
Today I can disclose that the scrutiny involves papers linked to a specific research ethics committee (REC) reference: 07/Q2006/48. That is the number of a 2007 REC opinion issued for a study titled “What happens to children with CFS/ME? The study of a longitudinal cohort of children who access a paediatric CFS/ME service. Version 2.” The investigators were seeking permission to add some more questionnaires to those already being filled out by (or about) pediatric patients at the specialized Bath clinic run by Professor Crawley.
I have also been informed that this is an “independent” investigation. While the specific meaning of “independent” in this context is not fully clear, I interpret this to indicate that it is not an internal review under the direct control of Bristol. My assumption is that it involves an assessor unaffiliated with Bristol or a panel dominated by non-Bristol experts.
The HRA’s scope is relatively narrow. The agency does not assess scientific quality and the appropriateness of this or that methodological approach; rather, in cases like this, it focuses on whether proper procedures have been followed by investigators seeking ethical approval for studies as well as by RECs assessing such applications. The agency does not consider questions that it views as falling within the purview of study funders and journal editors. Any findings it makes must be assessed with that limited scope in mind.
I did not file formal complaints with the HRA but cc’d the agency on various open letters I sent to this or that person. Most of this cc-ing involved my concerns about two Bristol studies–the
school absence study published in
BMJ Open in 2011, and the
Lightning Process study published in
Archives of Disease in Childhood, another BMJ journal, in 2017. The school absence study, as it turned out, was one of 11 papers I have identified that cited REC reference 07/Q2006/48.
The concerns I raised about
the promiscuous use of REC reference 07/Q2006/48
