Lightning Process trial and the National Research Ethics Service

October 28, 2010

The ME Association has written to the National Research Ethics Service (NRES) to ask them to clarify what action they are taking, or may be taking, in relation to concerns that are being expressed about this trial.

We have today received a reply from Joan Kirkbride, Head of Operations at NRES – part of which contains the following generic acknowledgement for correspondence relating to this trial:

NRES has received the submissions from the ME Association and others concerning the SMILE study, a children's study investigating treatment of ME in this age group.

Following our Standard Operating Procedures, we have collated the information we've received and will work with the REC to consider it.

Given that this treatment is currently available, ME Association survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning), we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.

We will also be seeking the views of our National Research Ethics Panel.

Joan Kirkbride
Head of Operations, England
National Research Ethics Service (NRES), National Patient Safety Agency
Darlington Primary Care Trust, Dr Piper House
King Street, DARLINGTON, DL3 6JL

MEA editorial note: REC – in paragraphs two and three of Joan Kirkbride's letter – stands for Regional Ethics Committee.

2 thoughts on “Lightning Process trial and the National Research Ethics Service”

  1. I’m interested in these so-called ‘Split Opinions’ since I’m yet to talk any other sufferers who have even tried, let alone benefited from LT.

    Only 101 people on the MEA survey tried LT. More than half reported no benefit from the treatment, with 20% claiming it to have made them worse.

    On top of this, of those people on the survey, there was no impartial doctor on hand to clarify their diagnosis, nor any assurance that health measurements have been taken over a long period (since many people have good periods with their M.E and later relapse, mere serendipity of timing could make LT appear to work in the short term).

    In my opinion, Joan Kirkbride has optimistically used the term split-opinion when in reality, the demographic of whom she speaks would be better described as a small and not hugely vocal.

    If that is how she chooses to justify subjecting children to what is, ostensibly, to many M.E Sufferers the kind of medicine offered by a Frontier Tincture Salesman, it is hard to feel anything but disgust.

  2. Hi Tony. Any chance you could post the actual letter you sent to the Ethics Committee? I for one would be interested to read it as their response does not reveal your position.

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