Lightning Process pilot study in children (SMILE): request for the funding application documents

Lightning Process pilot study in children (SMILE): request for the funding application documents

Shortlink: http://wp.me/p5foE-3cP

Dr Esther Crawley’s research team had secured funding for the controversial Lightning Process pilot study using children as young as 12 from the Linbury Trust and the Ashden Trust, last November. The study received ethics approval this September.

The breakdown for the funding is (from FOI request, 16 May 2010)

a) Value of grant awarded by the Linbury Trust: £120,000
b) Value of grant awarded by the Ashden Trust: £44,000
c) Any other sources of funding for the pilot study: No other funding sources

The Linbury Trust has funded a number of “CFS” studies in the past, including some previous studies by Dr Crawley’s research team.

But the Ashden Trust doesn’t appear to have a history of funding health/medical research. Both trusts are funding arms of the Sainsbury family.

http://www.ashdentrust.org.uk/

http://www.ashdentrust.org.uk/aboutus.html

“The trust’s long-term focus on climate change, sustainable development and improving the quality of life in poorer communities allows us to explore a range of ways to tackle these enormous challenges under six category headings:

•Sustainable Development International
•Sustainable Development UK
•Sustainable Regeneration
•People at Risk
•Arts and Sustainability
•Social Investment Fund”

 

On Monday, I requested the following documents from the University of Bristol’s FOI office, since this material had not been included with the 29 documents published by the University, on 16 September, at:

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html

so that part of my original FOI request, in May, remained unfulfilled:

1] Copies of the funding application documents submitted to

a) The Linbury Trust

b) The Ashden Trust

including any accompanying documentation that formed part of the applications for funding.

2] Copies of all correspondence associated with the applications for funding.

 

The response has been that there was  no “funding application”, as such; that the study protocol had been submitted to the funders and, in effect, was the funding application.

I have been provided with copies of three letters from the Linbury Trust and Ashden Trust in relation to the funding application (that had previously been disclosed under FOI in response to requests made by others) which I have already posted on this site.

I am advised that there is a typo in the Linbury Trust letter of 8 March 2010 and that the “£120,000” in the opening paragraph should have read “£44,000”.

I am further advised that there is a handwritten note on the Linbury Trust letter of 4 November 2009, stating that a confirmation email was sent on 5/11/09 and that this email from Dr Crawley had read:

“Thank you for your letter informing me that the trustees of the Linbury Trust have agreed to make a grant to support the project: Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for CFS/ME.

“I am delighted that we will be able to do this piece of work and I am very grateful to the Linbury Trust for supporting this work.

“I will be in touch shortly when I know more about who organises the contracts. When the contract is organised, I can start recruiting personnel for the study.”

“Thank you once again.”

 

These are the documents I have been provided with:

Document 1:

4 November 2009  |  Linbury Trust to Dr Esther Crawley  |  Open PDF:  Funding Linbury Trust 04.11.09

Note: The grant is conditional on the project commencing no later than October 2010.

Document 2:

24 November 2009  |  Ashden Trust to Dr Esther Crawley 

Document 3:

8 March 2010  |  Linbury Trust to Dr Esther Crawley

 

The research application had been reviewed by South West 2 REC at a meeting of the committee on 8 July.  Following the meeting, the committee had requested that the applicants make a number of amendments to the text of patient information sheets (PIS) and other documentation. Confirmation of approval of the revisions to the application was given in September.

Since this is all the information relating to the application for funding that has been made available to me, it remains unclear why the Linbury Trust was not in a position to award the full £164,000 for the project and why £44,000 has been provided by the Ashden Trust for a medical research study in children – a field which appears to lie outside the Trust’s usual areas of funding, which are listed on its website as “climate change, sustainable development and improving the quality of life in poorer communities”.

Other than a protocol document, it is unclear how much information about the Lightning Process and how it is carried out was available to the funders in order that they might make informed decisions about whether to fund this study.

 

The SMILE Protocol document (Final July 2010) [pdf (170kb)] can be read here:

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

 

Correspondence with Ethics Committee can be read here:

20] Initial covering letter to NREC 20th May 2010 [pdf (75kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/covlet20may10.pdf

Open here: covlet20may10

21] NREC Letter 14th June 2010 [pdf (108kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let14jun.pdf

Open here: let14jun

22] NREC Letter 19th July 2010 [pdf (272kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let19july.pdf

Open here: let19july

23] Covering letter in reply to NREC 28th July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/letrep28july.pdf

Open here: letrep28july

24] NREC Letter 13th August 2010 [pdf (72kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let13aug.pdf

Open here: let13aug

25] Letter re meeting notes in reply to NREC 19th August 2010 [pdf (45kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/letmetn19aug.pdf

Open here: letmetn19aug

26] Second covering letter reply to NREC 20th August 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/seclet20aug10.pdf

Open here: seclet20aug10

27] Letter in reply to NREC 13th September 2010 [pdf ( 80kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let13sep.pdf

Open here: let13sep

28] NREC Approval letter 14th September 2010 [pdf (213kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/applet14sep10.pdf

Open here: applet14sep10

29] REC Form [pdf (353kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

 

All other published SMILE documents including Patient Information Sheets, Consent forms and Assessment Form, can be read from this post:

SMILE – Specialist Medical Intervention and Lightning Evaluation documents

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