Lightning Process trial and the National Research Ethics Service

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.