October 22, 2019
The Health Research Authority (HRA) has published a report on its investigation into concerns relating to 11 M.E./CFS research papers.
With a remit from the UK government to “protect and promote the interests of patients and the public in health and social care research,” the HRA looked specifically at the ethics approval for these papers; scientific content and study findings are outside its remit, and were not covered by this review.
The HRA found that Research Ethics Committee (REC) documentation was incomplete and was, in some respects, lacking in clarity and open to interpretation. It also found that no favourable ethics opinion was obtained in respect of any of the papers reviewed and, in all 11 papers, the REC reference, as cited in the ethics statement, was either inappropriate or inadequate to cover the activity described.
Nevertheless, the HRA has concluded that no additional ethical review is required, and that “the position could in all the cases considered be rectified by rewording and clarification of the ethics statement.”
Sonya Chowdhury, Chief Executive, Action for M.E., comments: “We expect research to be of high quality, including transparency in terms of ethics, the responsibility for which sits with the research team, led by the principal investigator. It’s essential that, when questions or concerns are raised, researchers have the opportunity to respond, through appropriate channels like the HRA.”
The role of Action for M.E. for three out of the 11 papers reviewed by the HRA relates to the charity’s funding of the National Outcomes Database.
Funded by Action for M.E. and maintained by the Department of Community-Based Medicine at the University of Bristol, the National Outcomes Database was a register of clinical assessment and patient-reported outcome data, routinely collected by specialist NHS M.E. services in England between 2006 and 2013.
Action for M.E. was a member of the Steering Group for the National Outcomes Database and was involved in decisions on which data should be collected for these studies. The charity did not contribute to the study design, data analysis, interpretation of the results, or writing of the manuscript and was not involved in the decision to submit the manuscript for publication.
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