Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children)
On 3 November, I submitted a complaint to Joan Kirkbride, Head of Operations, England, National Research Ethics Service (NRES), in response to the decision of a South West Region Ethics Committee to grant ethics approval to the SMILE pilot study.
A response was issued by Ms Kirkbride on 8 November, which can be read at the link above.
Today, I have asked Ms Kirkbride:
I am not familiar with the Standard Operating Procedures that NRES works within when dealing with complaints from members of the public in relation to the handing down of favourable opinions following applications to regional ECs or what kind of timeframe scrutiny of, or investigation into complaints might be conducted within.
Can members of the public expect to receive any form of notification as to the progress or outcome of your colleagues’ consideration of the concerns you have received and following the gathering of responses from the various parties cited below?*
*The “Standard Response” being issued by Ms Kirkbride on behalf of the NRES had stated that it was felt that a fair way forward would be initially “to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study”.
I am advised by Ms Kirkbride that NRES are collating a list of all the people/organisations who have contacted them about this study; that they have received considerable correspondence about this matter which will take them some time to consider and take forward but that it is their intention to advise everyone who has written to them about the process and the outcome.
So, an open-ended process with no clear procedural timeline.
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
3] Background to this issue: http://wp.me/p5foE-2Vt
4] All posts on Lightning Process pilot study in children issue on ME agenda: http://meagenda.wordpress.com/category/lightning-process-smile-study/