The following observations have been sent to me by the individual who has been investigating these areas of concern.
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The following is a summary of the points that come out of this case and other cases that use the same REC reference number. (Some new material here).
· Crawley AND HER COLLEAGUES (who may too be culpable for any proven ethical misconduct) used
the same REC number – 07/Q2006/48 - for many published studies (list provided in thread). This REC number appears to be entirely unmatched/inappropriate for some of these studies.
· The most notable of these was the school absence study
http://bmjopen.bmj.com/content/1/2/e000252 where it was used to negate the need for ethics approval/review for a study which many would consider to be definitely ‘research’ rather than ‘service evaluation’. It is great that
David Tuller has taken this up
http://www.virology.ws/2017/08/28/trial-by-error-no-ethical-review-of-crawley-school-absence-study/ and is investigating further along with
Steven Lubet -
http://www.virology.ws/2017/08/30/10013/
· BMJ Open, published this study despite being warned about ethical concerns by the peer reviewer Matthew Hotopf. BMJ Open has been a leading light in promoting transparency and openness in the publication of medical research yet in this case appears to have failed to properly scrutinize ethical approval statements and to have failed to take heed of its own peer reviewers. When concerns were raised with BMJ Open about this paper they were not satisfactorily addressed.
BMJ Open is part of the BMJ group of journals. BMJ journals are regarded as high-quality around the world. As part of an organisation (BMJ.com) that seems to set much store by questioning answers and answering questions -
https://twitter.com/bmj_latest?ref_src=twsrc^google|twcamp^serp|twgr^author - BMJ Open have, in my opinion, failed miserably in answering the important questions raised about this paper, and appear not to have questioned or scrutinized the ‘answers’ provided by Bristol University in the course of the ‘investigation’ into this case.
· BMJ Open is a member of COPE – Committee on Publication Ethics. COPE advises journals and journal editors on ethical matters and on how to deal with cases of misconduct. Member journals/publications should abide by
COPE’s retraction guidelines - PDF]
Retraction Guidelines - Committee on Publication Ethics – and consider issuing an ‘Expression of Concern’ when investigations will take some time or when there is evidence that suggests (rather than proving) misconduct. It took BMJ Open more than 4 months to reply to this complaint. In that time, they did not issue an ‘Expression of concern’ about this paper, even though the person who submitted the complaint repeatedly reminded them of these COPE guidelines.
· Another complaint was submitted to QJM over this
White and Crawley paper -
https://academic.oup.com/qjmed/article-lookup/doi/10.1093/qjmed/hct061 - that uses the same REC number.
The REC number does not seem to match in this case because this study is with adults only - the REC number given refers to a longitudinal paediatric study.
Also raised in this complaint was the issue of whether patients attending ME/CFS clinics across the UK were misinformed when asked to complete questionnaires for the National Outcomes Database and whether they completed the questionnaires without informed consent regarding what they were for or how they would be used in the future. There is some patient documentary and circumstantial evidence to support this hypothesis. Also, Action for ME accounts seem to show that from as early as 2008/2009 there was the intention to use the NOD for future research purposes to support ‘large scale biomedical research such as Genome Wide Association studies’ and the NOD project was one of 2 projects reviewed by Professor Holgate of the MRC ‘to assure the scientific quality of the proposals’. It was considered that the NOD had ‘considerable potential for acting as a catalyst for much larger research programmes underwritten by the major funding bodies’. [Last 3 quotes from Action for M.E. Report and Accounts for the year ended 31st March 2009 – obtained via FOI request to the Charity Commission.]
(The NOD was at least part-funded by the ‘Cathery Fund’, a fund set up from money raised by a celebrity-style fund-raiser to support biomedical research into ME/CFS. This fund is recorded as an ‘Unrestricted Fund’ in Action for ME Accounts.)
However, it would appear that some patients, at least, were not informed of this intended use of the NOD at the time they were asked to complete the NOD questionnaires, i.e. after this intention was documented by the Action for ME charity. Crawley, White et al claimed that this study was a service evaluation and as such did not require REC review/approval.
But, according to the HRA -
http://www.hra.nhs.uk/resources/res...-arrangements-for-research-ethics-committees/ :
“Subject to any overriding legal requirements, REC review is not required for the following types of research:
Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection), provided that the patients or service users are not identifiable to the research team in carrying out the research”
(IF this transcription of Dr Crawley’s talk on the Future of ME/CFS research-
https://meagenda.wordpress.com/2010...presentation-the-future-of-research-in-cfsme/ [go to slide 16 ] is accurate, then it would also lend support to the idea that Crawley and colleagues intended to use the NOD for future research purposes.)
QJM dismissed the issues raised in this complaint following a ‘substantive investigation of the issues’ raised, finding that ‘no corrections to this article are required at this time’. QJM is also a COPE member; it took them more than 3 months to reply with the outcome of their investigation and no ‘Expression of Concern’ was applied to the paper during that time.
· A third, (and broadly similar complaint to the last one), was made to the Biomed Central Health Service Research journal about this Crawley and Collin (et al) paper -
https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-217 . This is clearly an adult study so
the quoted REC number that refers to the paediatric study doesn’t appear to match here either. This study also utilises the NOD which may well have been collected without the informed consent of the patients that took part.
To date this journal has not replied with the outcome of the investigation it has said it is conducting; more than 6 months have now elapsed. BMC Health Services Research is a member of COPE, so COPE’s Retraction Guidelines should apply here also, but no ‘Expression of Concern’ has so far been raised.
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It seems that many people and organizations may now have important questions to answer about all this – Professor Crawley and her co-authors, the Royal National Hospital for Rheumatic Diseases (Bath)’s R&D manager/department, the University of Bristol, 3 health journals (BMJ Open, QJM and Biomed Central Health Services Research), COPE (who were contacted via a general enquiry and were asked to remind the member journals of their obligations), and the HRA and South West – Central Bristol REC (who were both informed of the multiple use of this REC number but apparently have not taken the matter further).
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