The process for submitting applications to regional research ethics committees is set out on the NRES site and also within two framework documents, a
Researcher Training Pack document and an
Application Process Flowchart.
There are procedures within the NRES framework whereby principal researchers can appeal against the handing down of an unfavourable opinion or submit further information:
http://www.nres.npsa.nhs.uk/applications/resubmission-and-appeals/
Several of us (including the ME Association) have received responses from the Department of Health (in some cases from Bill Davidson, Research Governance Manager, Department of Health) that:
"New treatments are not generally tried out first in children before there is evidence of their safety and efficacy in adults, but sometimes it is appropriate to do so. It is a matter for a research ethics committee to be assured that the evidence supports the extension of the new treatment to children."
"We require the decisions of research ethics committees to be independent and free from bias and particular stakeholder interests. It would therefore be inappropriate to have a mechanism through which particular stakeholders might seek to affect a research ethics committee's decision." Bill Davidson, by email to Suzy Chapman, 30 July 2010
So there is no mechanism whereby material can be placed before an REC during the application process and Bill Davidson wrote to the MEA and told them that he was not able to forward the MEA and TYMES Trust joint statement of concerns on to the appropriate regional ethics committee.
(At that point, the name of the South West RE committee had not been identified, because the University of Bristol was withholding this information from me under FOIA Clause 22(1)(a). When I did obtain the name of the committee (there are four or five for the South West region) under FOI, via NHS South West, the name of the committee and the contact details for its Chair were then passed on to the MEA. This was in late August. The MEA was then in a position to write to the REC Chair, directly.
The RE committee had already met to consider the application on 8 July but a decision was pending.)
The NRES has apparently advised a number of people who had contacted them that an investigation is to be carried out in response to complaints received.
I had been told in May, by the NRES South West Regional Manager, in writing, that there is no formal process for challenging the decision of an REC, and there is no documentation available online which sets out the procedure for investigating complaints relating to the decisions of RECs.
An investigation can mean anything the NRES wants it to mean, since the process is not transparent.
And so, at the moment, we do not know how the NRES intends to set about investigating the complaints it has received - we do not know the nature or scope of its investigation process.
Now that this investigation has been set in motion, it isn't clear whether any additional letters sent in by others will be treated as individual complaints, responded to and fed into an investigation process (however that may be carried out), or whether any new letters and any other information sent in in support of concerns will receive any consideration at all or whether these will receive a standard response that an investigation has already been set in motion and be placed, unread, in a file.
This is not a public consultation exercise and I would not be prepared to submit any complaint solely on the basis of the information on this investigation as it currently stands.
