Update on NRES (National Research Ethics Service) scrutiny of complaints received in response to the granting of ethics approval for the Dr Esther Crawley led Bath/Bristol SMILE Lightning Process pilot study using children and young people with ME and CFS
Update: Letter issued today by National Research Ethics Service:
Open PDF here: 05.01.11 Letter SMILE
Yesterday, I wrote to Joan Kirkbride (Head of Operations, England National Research Ethics Service (NRES), National Patient Safety Agency) to ask whether there is a date by which she anticipates contacting those who have written to her in connection with the SMILE Pilot study with an update on the progress of the scrutiny of complaints and concerns.
Ms Kirkbride has confirmed to me, today, that she plans to issue a letter this week. I will update when this letter has been received.
Because there is no formal procedure through which decisions of Research Ethics Committees can be challenged, this exercise undertaken by the NRES in response to the considerable number of complaints received is not a process open to public scrutiny.
The “standard response” being issued by Ms Kirkbride in October and November in response to the receipt of complaints had been:
“NRES has received the submissions from the ME society [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 society [The 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.”
Complaints were being passed by Ms Kirkbride to am NRES colleague and to Dr Esther Crawley where permission had been given for communications to be forwarded.
The study, which was granted ethics approval by South West 2 REC in September, last year, was expected to start recruiting last September. According to documents obtained under the FOIA, the study funders, The Linbury Trust and The Ashden Trust, had stipulated that the study must begin by October latest.
A meeting of the SMILE Pilot External Advisory Group, for which the patient organisation AYME has a seat, was held on 2 November. A copy of the Minutes of that meeting is posted on the website of the University of Bristol website, on the dedicated page for the SMILE Pilot study or open a PDF here on ME agenda: Minutes SMILE Pilot External Advisory Group 02.11.10
Under AOB (Any Other Business):
“1. SL asked how the study was going to date. EC replied that recruitment was going well, parents and teenagers appeared to be enthusiastic and there was a higher recruitment rate then envisioned.
“2. EC informed the group that she needed to respond to complaints made to NRES about the study. She suggested that she drafted a response, discussed this with co-applicants and sent the response to the External Advisory Group before submission. This was agreed.*
“[Action] EC to draft response for NRES, show co-applicants and then send to External Advisory Group before submission.”
SMILE Protocol Flowchart and Time plan
Source: Protocol document
1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x
2] Background to this issue: http://wp.me/p5foE-2Vt
3] All posts on Lightning Process pilot study in children issue:
4] Minutes, meeting of the SMILE Pilot External Advisory Group: 2 November 2010: http://wp.me/p5foE-3er