Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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...I think the people involved might look at their views again if they re-read the piece replacing "anti-retrovirals" for "Lightning Process". I think they might not have made the statements they made e.g. would Esther Crawley and the ethics committee have agreed to a trial of antiretrovirals on children (first) just because some children might take it. Risks for pharmacological and nonpharmacological interventions appear to be assessed differently.
I was also concerned by the choice of category on the NHS IRAS REC application, with the project being identified as:
"Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology”.
Point 10] of my complaint dated 4 November was:
10] On the NHS IRAS REC Form Section: 2. "Select one category from the list below" the research is identified as: "Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology”. But one half of the projected cohort of 96 are to be randomised to a three consecutive day course of the Lightning Process as an intervention in addition to "specialist medical care". The study is not, therefore, restricted to "administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology" since an as yet untrialled intervention is being applied as an intervention.
It would seem appropriate for the study to have been identified as “Other clinical trial or clinical investigation” or “Other study”. Was this point raised by the committee at the meeting in July and what was the outcome of any discussion around this point? The application of Lightning Process as an intervention seems to be played down throughout the Protocol.
It would seem appropriate for the study to have been identified as “Other clinical trial or clinical investigation” or “Other study”. Was this point raised by the committee at the meeting in July and what was the outcome of any discussion around this point? The application of Lightning Process as an intervention seems to be played down throughout the Protocol.
As far as I can see, this point was not included within Dr Hugh Davies' collection of representations.