We have published the report of an investigation into concerns raised about eleven publications on CFS and ME all of which cited the same National Health Service Research Ethics Committee reference number 07/Q2006/48.
This review was commissioned by the HRA and undertaken with the support of the University of Bristol in line with the HRA’s third party complaints procedure. An expert panel reviewed a specific set of questions sent to them by the HRA. The panel was chaired by an independent expert selected by the HRA and included members with expertise in NHS academic research and service evaluation who were independent of the study subject matter. No conflicts of interest were reported by any panel member.
The scientific content of the eleven publications on CFS/ME and the study findings were outside the remit of the HRA and were not covered by this review.
Process
Terms of Reference setting out the purpose and principles of the review were agreed in advance between the HRA and the expert panel.
The panel were provided with a number of reference documents, including:
- the Governance Arrangements for Research Ethics Committees (GAfREC)
- the UK Policy Framework for Health and Social Care Research
- HRA decision-making tools.
The University of Bristol provided administrative support to the panel.
Key Findings
The panels’ findings were unanimous and the Chief Executive of the HRA has accepted its recommendations in full. These were
(a) Research Ethics Committee (REC) documentation was incomplete and was, in some respects, lacking in clarity and open to interpretation
(b) No favourable ethics opinion was obtained in respect of any of the papers reviewed
(c) In all eleven papers, the REC reference, as cited in the ethics statement, was either inappropriate or inadequate to cover the activity described
However,
(d) No additional ethical review was required. Each study was assessed against a number of reference documents including the relevant editions of GAfREC and the UK Policy Framework for Health and Social Care Research to establish whether the study required an ethics opinion. Certain types of research do not require ethical review. It was recommended that the ethics statement should be reworded and clarified in all eleven cases
(e) In two papers, additional minor textual changes in the main body of the publication would improve clarity.
The panel did not recommend the withdrawal of any publication, but made separate specific recommendations for corrections to the ethics statements of all eleven papers. There were suggested minor amendments to the text of two papers, to be notified to the relevant journal editors for each of the publications reviewed.
The panel recommended that funding bodies be notified, where appropriate.
Conclusions
On the basis of these findings, the Chief Executive and Chair of the HRA have confirmed to the University of Bristol that a number of actions need to be completed by both parties but that there is no requirement for any action under the University of Bristol Disciplinary Procedure or any other University procedure.
The HRA has already made changes to the way in which the outcome of REC minutes are recorded, and has updated procedures to ensure that communications between applicants seeking advice in advance of the committee meeting itself, and with the chair of the committee, are archived.
The review is now complete. The HRA will write to complainants outlining the findings above, and confirming actions agreed during a meeting between the Pro-Vice-Chancellor for Research at the University of Bristol and the HRA in August 2019 to ensure that recommendations are followed.
The full report can be found here.