Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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Response from Joan Kirkbride, NRES
On Thursday, 4 November, I wrote to Ms Joan Kirkbride, Head of Operations, National Research Ethics Service (NRES).
Re: Concerns in response to the favourable opinion handed down by South West 2 REC in September 2010 to the application from Dr Esther Crawley, Principal Investigator for the SMILE (Specialist Medical Intervention and Lightning Evaluation) pilot study
Study Refs: 10/H0206/32, ASH106264, LIN1750
My letter expanded on some of the concerns I had raised with the Director of Legal Services, University of Bristol, in August, in a formal request for an Internal Review of the Information Rights Officer's decision (17 June) to decline to provide certain information in response to my request for information on the basis that this information was exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication). I also included other concerns.
I gave Ms Kirkbride permission for my concerns to be forwarded, in full, to any individuals charged with the scrutiny of complaints in response to the decision to grant the Lightning Process pilot study ethics approval, within the NRES, within South West 2 REC and including the sponsors, PI, co-applicants and study funders, by paper or by electronic means, redacted or unredacted of name and contact details, according to NRES protocols.
I requested confirmation that my communication had been received and my concerns noted.
I may publish a copy of my concerns as submitted on 4 November at some future point on my website.
This morning, I have received an acknowledgement from Ms Kirkbride which she has CCd to a colleague who is understood to be involved with the scrutiny of complaints.
I am advised by Ms Kirkbride that:
The standard response being issued by Ms Kirkbride is:
Suzy Chapman
On Thursday, 4 November, I wrote to Ms Joan Kirkbride, Head of Operations, National Research Ethics Service (NRES).
Re: Concerns in response to the favourable opinion handed down by South West 2 REC in September 2010 to the application from Dr Esther Crawley, Principal Investigator for the SMILE (Specialist Medical Intervention and Lightning Evaluation) pilot study
Study Refs: 10/H0206/32, ASH106264, LIN1750
My letter expanded on some of the concerns I had raised with the Director of Legal Services, University of Bristol, in August, in a formal request for an Internal Review of the Information Rights Officer's decision (17 June) to decline to provide certain information in response to my request for information on the basis that this information was exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication). I also included other concerns.
I gave Ms Kirkbride permission for my concerns to be forwarded, in full, to any individuals charged with the scrutiny of complaints in response to the decision to grant the Lightning Process pilot study ethics approval, within the NRES, within South West 2 REC and including the sponsors, PI, co-applicants and study funders, by paper or by electronic means, redacted or unredacted of name and contact details, according to NRES protocols.
I requested confirmation that my communication had been received and my concerns noted.
I may publish a copy of my concerns as submitted on 4 November at some future point on my website.
This morning, I have received an acknowledgement from Ms Kirkbride which she has CCd to a colleague who is understood to be involved with the scrutiny of complaints.
I am advised by Ms Kirkbride that:
She is appending a copy of the standard response which NRES is sending to all respondents on this matter.
That she advises that NRES "do feel that they now have sufficient information available to [them] and that no new issues are being raised in correspondence which is being sent to [them] for consideration".
That she has copied my email to the Chief Investigator and Sponsor as I had given permission to do so.
That I "had raised a number of specific questions outside the remit of NRES where [they] cannot provide a response and the answer to my questions would need to come from either the CI [Chief Investigator] or the sponsor".
That she advises that NRES "do feel that they now have sufficient information available to [them] and that no new issues are being raised in correspondence which is being sent to [them] for consideration".
That she has copied my email to the Chief Investigator and Sponsor as I had given permission to do so.
That I "had raised a number of specific questions outside the remit of NRES where [they] cannot provide a response and the answer to my questions would need to come from either the CI [Chief Investigator] or the sponsor".
The standard response being issued by Ms Kirkbride is:
"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 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."
"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 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."
Suzy Chapman
