Summary MEA Board of Trustees meeting 15-16 November 2010: Lightning Process

Extract from Summary of the ME Association meeting of the Board of Trustees which was held on 15 and 16 November and at which the issue of the controversial Bath/Bristol Lightning Process pilot study in children was discussed.

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

http://www.meassociation.org.uk/?p=3059

Summary of the MEA Board of Trustees meeting, November 2010
by tonybritton on November 20, 2010

This is a summary of key points to emerge from two routine meetings of The ME Association Board of Trustees.

These meetings took place at our Head Office in Buckingham on Monday afternoon, November 15th and on Tuesday morning, November 16th.

Informal discussion on some of the topics also occurred on the Monday morning.

This is a summary of the two Board meetings – not the official minutes.

The order of subjects below is not necessarily in the order that they were discussed.

Where appropriate, there is background information relating to the issue being discussed.

[…]

Lightning Process:

Trustees held a further discussion on a controversial new research study that has been announced into the use of the Lightning Process. Costing £164,000, the feasibility study will investigate how children and adolescents could be involved in a randomised controlled trial that will assess the Lightning Process and compare it to specialist medical care. Not surprisingly, a number of concerns and objections have been raised about the possible use of children and adolescents in this type of study and we are discussing these concerns with our colleagues in other ME/CFS charities. As a result of these discussion The MEA and the Young ME Sufferers Trust (Tymes Trust) issued a joint statement of concern: http://www.meassociation.org.uk/?page_id=1341

This statement was sent to the Department of Health with a request that it should be forwarded to the ethics committee that is dealing with the application but the DoH refused to do so. Following a Freedom of Information request we obtained the identify the ethics committee that was dealing with the application and our statement was then forwarded to the Chairman. Unfortunately, due to initial secrecy surrounding the identity of the ethics committee, the information did not reach them till after the application had been approved.

We have also passed our concerns to the National Research Ethics Service, who are considering whether the local ethics committee should review their decision. More information can be found on the MEA website: http://www.meassociation.org.uk/?p=2720

A BBC radio discussion from Thursday 11 November about the Lightning Process – which included contributions from Professor Leslie Findley, Dr Charles Shepherd and Phil Parker and was chaired by Anne Diamond – can be heard on YouTube: http://www.meassociation.org.uk/?p=2921. A transcript is also available on the MEA website.

[Extract ends]

 A few points:

The Bath/Bristol press release announcing the pilot study was published on 2 March 2010.

The ME Association and The Young ME Sufferers Trust did not issue a joint statement and press release condemning the pilot study until five months later, on 4 August.

Under FOI (in a response dated 27 August) I established that the REC responsible for reviewing the application was the South West 2 Research Ethics Committee. This information was provided by Jonathan Cramp, FOI Manager, NHS South West.

This information had been requested by me of the University of Bristol on 15 May but was denied in a response of 17 June.

It was denied a second time following a request for an Internal Review of the University’s decision to withhold almost all information that had been requested by me under the FOIA. The Internal Review was handled by Sue Paterson, Director of Legal Services and Deputy Secretary, Office of the University Secretary, from whom a response was received on 17 August.

Within the response of Jonathan Cramp, FOI Manager, NHS South West, was the information that the application for ethics approval had been received on 14 June 2010 and that South West 2 RE committee had met to consider the application on 08 July 2010.

As soon as I had received confirmation of the name of the REC which had (already) reviewed the application, this was passed to the ME Association, who had also been passed all previous communications I had been having with various FOI offices, with various parliamentarians, with the Department of Health and with the South West Regional Manager, National Research Ethics Service.

As recorded in the MEA’s meeting summary, above, it was the case that by the time it had been established which RE committee had reviewed the application for ethics approval, the committee had already met six or seven weeks previously (although a favourable opinion was not handed down until mid September since the CI had been asked to revise some content of the patient literature and also address other areas of concern which delayed a decision).

When the MEA and TYMES Trust did issue a statement on 4 August, condemning the pilot and calling for the study to be abandoned, this was widely welcomed, as has been the ME Association’s initiative in contacting Trading Standards offices, as is their continued interest in this issue.

It remains unclear, though, and of concern to me, why these two patient groups took five months to issue position statements and a joint press release.

RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 12 to 18 (SMILE study): Minutes of meeting of External Advisory Group held on 02.11.10: http://wp.me/p5foE-3er

Transcript BBC Radio Berkshire Anne Diamond Show, broadcast 11 November 2010: http://wp.me/p5foE-3dG

Related information:

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: https://meagenda.wordpress.com/category/lightning-process-smile-study/

Advertisements

Bath/Bristol Lightning Process pilot study: Minutes of meeting of External Advisory Group 02.11.10

RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 12 to 18 (SMILE study): Minutes of meeting of External Advisory Group held on 02.11.10

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

On 28 October, I submitted a requested for the following information under the FOI Act, from the University of Bristol:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The SMILE protocol document states on Page 7, under “Study management” that:

The study will be monitored by a Trial Monitoring Group which will meet every 4 to 6 weeks. The trial Monitoring Group will consist of: Dr Esther Crawley (PI), a member of the BRTC as well as applicants on the grant.

An External Advisory Group will also meet: prior to the study starting, by phone conference 6 monthly and at the end of the study. This will be an independent group and will include experts in CFS/ME, including a representative from the Association of Young people with ME (AYME) and the Lightning Process.

Please provide the names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

 

Today, I have received the following responses from the University’s Information Officer:

That:

Details of collaborators/sponsors are included at sections A63 and A64 of the research ethics application, available online at:

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

from which I conclude that the only patient organisation involved in the planning/development of the SMILE pilot study has been the Association of Young people with ME (AYME).

That:

There was a meeting of the External Advisory Group on 2nd November, the minutes of which are online at:

http://www.bris.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smileminutesoctober.pdf

That:

The membership of the group is included in these minutes.

 

Text of Minutes, appended, or open on ME agenda site here: SMILE Minutes 02.11.10

Agenda External Advisory Group: November 2nd 5pm – 6pm.

Present:

Stuart Logan (Chair) (SL), Exeter University
Jane Coad (JC), Coventry University
Jenny Ingram (JI), University of Bristol.
Kamal Patel (KP), Paediatrician, Brighton
Alison Wearden (AW), University of Manchester*
Mary-Jane Willows (MJ W), CEO AYME

Also Present: Esther Crawley (PI) (EC)

(*Ed: Dr Alison Wearden was PI for the FINE Trial. No representative of the Lightning Process appears to have been present.)

Everybody introduced themselves. EC outlined the study.

Review of study documentation

SL invited comments on the study documentation. SL said the aims and objectives were clear and it was good to see documentation on the web. This comment was endorsed by other members of the meeting.

1. There was a general discussion about what would happen if either the Lightning Practitioner or the child/family felt that a LP course was not appropriate after discussion. It was agreed that understanding about drop outs was part of the study.

2. There was a discussion that the PIS wasn’t clear on the qualifications or registration of the practitioners. EC agreed and suggested that an amendment was put forward to ethics to add further information on the PIS about this.

[Action] EC to draft amendment for PIS

3. AW asked whether groups would be feasible given the wide geographical area. EC replied that there were concerns about this but that was why a feasibility study was so important.

4. AW asked why the Chalder trial was not included in the reference list. EC replied that it was published after initial submission to Ethics.

5. JC suggested that the teenager PIS was clearer to read then the adult PIS and could be used for both.

Information requests

EC informed the External Advisory Group that it was likely that FOI requests would be received

Minutes

EC suggested that the minutes were put on to the website. This was agreed.

[Action] EC: Minutes to go on web

AOB

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.

Date of Next meeting – due in 6 months time

[Action] EC to doodle date

[Minutes end]

*Ed: See:

Response from Joan Kirkbride, National Research Ethics Service (complaint in response to ethical approval of SMILE Lighting Process pilot study in children), 8 November 2010

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

Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children), 16 November 2010

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

Related material:

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:
https://meagenda.wordpress.com/category/lightning-process-smile-study/

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

November 1, 2010 by Suzy Chapman

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

In the November edition of LINK Newsletter (Issue 40), the Association of Young People with M.E. (AYME) has welcomed the decision by South West 2 Research Ethics Committee to grant ethical approval for the controversial pilot study around the application of the Lightning Process in children as young as 12.

Lead researcher for the SMILE study (Specialist Medical Intervention and Lightning Evaluation), Dr Esther Crawley,  is AYME’s Medical Consultant.

To date, no rigorous RCTs have been undertaken into the safety, acceptability, short and long-term efficacy of the Lightning Process in adults.

In a joint press release issued in August, two national ME patient organisations – The ME Association and The Young ME Sufferers Trust –  condemned the study as “unethical” and called for the project to be abandoned.

In a position statement issued in March, Action for M.E. had said it saw “no reason to oppose this pilot study”.

But in August, Sir Peter Spencer, CEO of Bristol based Action for M.E., disclosed that “Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.”

Sir Peter Spencer is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust – Dr Esther Crawley’s employer and the hospital where this research study is being undertaken.

The study hopes to recruit around 90 children aged between 12 to 18 and is expected to start this month. Half the patient cohort will undergo a three day course of the Lightning Process.

According to the NHS REC IRAS application form, the SMILE study Protocol and other SMILE study documents published on the University of Bristol website in September:

Ethical issues   The Lightning Process is popular with over 250 children with CFS/ME attending courses each year. There is therefore an urgent need to study this intervention properly.”

“There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to be brought into mainstream practice.”

“CFS/ME is different in children and adults with different risk factors [15-17], course and outcome [18]. It is therefore not possible to complete a study in adults and extrapolate the results to children.”

“The need for doing a study properly evaluating the Lightning Process came from patients and service users. Representatives from the Association of Young people with ME (AYME) have read, and suggested changes to the protocol and methodology. Service users publicized the research project and are keen to disseminate the findings.”

“The PIS [Participant Information Sheet] follows the NRES recommended layout and has adopted the NRES recommendations for children. We have also tested the PIS on healthy teenagers who reported that it was clear to read. Members of the patient charity AYME have scrutinised the PIS and also felt it was clear to read.”

“Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group.”

“As this is only a feasibility study, participants will not be individually informed of the outcome. However, the results from the feasibility study will be disseminated through patient charities.”

In a response to the ME Association, published on 28 October, Joan Kirkbride, Head of Operations, NRES (National Research Ethics Service), has written:

“Given that this treatment is currently available, 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.”

I have submitted a FOI request, due for fulfilment on or before 25 November, for the provision of:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

AYME LINK Issue 40

www.aymelink.org

November 2010

Association of Young People with M.E.

Research study to investigate a chronic childhood condition

A favourable Ethical opinion has been given to a feasibility study which will see if it is possible to look at two different approaches to the intervention and treatment of chronic fatigue syndrome/ME (CFS/ME) in children.

The project called SMILE (Specialist Medical Intervention and Lightning Evaluation) aims to find out if it is feasible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The research team will be led by AYME’s medical advisor, Dr Esther Crawley, Consultant Senior Lecturer in the University of Bristol’s Centre for Child and Adolescent Health and Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and is funded by the Linbury Trust and the Ashden Trust.

AYME is aware that there are concerns from families about The Phil Parker Lightning Process®.

However, around 250 children a year are already receiving the treatment, and it seems clear that large numbers will continue to do so. Many of the families that AYME supports have asked us about LP and it has been frustrating for us to be able to give them only limited information.

We therefore, welcome this feasibility study to see whether a future study is possible. In addition, AYME is pleased to see the study group are looking at how much health resources young people with ME use and are also investigating the measures clinicians use to look at outcome. If the study is successful, not only will the team be able to apply for funding for a larger study to look at effectiveness, but they will also have a lot of data on the cost of CFS/ME as well as what we need to measure in future research.

It is important to realise that only a larger study in the future will be able to investigate whether LP is effective or not which will enable children and young people and their parents and carers and to make an informed choice about LP. The study is using a mixture of interview techniques to understand what young people think about both interventions, including actually observing and comparing both interventions in order to understand more about them. The fact that all young people will be closely monitored by both the clinical and research team is reassuring.

Esther Crawley said: “We are doing this study because so many young people with ME and their families asked us for this. We are very grateful we can now go ahead and start to answer some of the questions they have been asking”.

The Phil Parker Lightning Process® is an intervention that is used for a variety of conditions including CFS/ME and has been developed from osteopathy, coaching and neuro-linguistic programming. It is a three-day training programme run by registered practitioners and designed to teach individuals a new set of techniques for improving life and health.

Phil Parker, designer of the Lightning Process said: “It is vitally important that all interventions that could assist children with CFS/ME to return to school and improve their health are explored”.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee has looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project, including frequently asked questions can be found at the URL:

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

 

Key SMILE documents

SMILE Research Protocol

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

Open here: smprotv6final

Research Ethics  Application Form

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

Open here: recfrmrfs

All published SMILE documents here:

Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

Which patient organisations were involved in the development of the SMILE pilot study?

Which ME and CFS patient organisations were involved in the development of the SMILE Lightning Process pilot study in children 12 to 18 years?

Shortlink: http://wp.me/p5foE-3c8

In her response to the ME Association, Joan Kirkbride, Head of Operations, NRES, has said:

Given that this treatment is currently available, 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.

It is already known from the SMILE Research Protocol document that AYME has a seat on the External Advisory Group. But Ms Kirkbride’s statement suggests that more than one patient organisation may have been involved in the planning and development of this controversial pilot study.

On 24 August, I had written to Sir Peter Spencer (CEO, Action for M.E.) with a query in relation to two published position statements issued by the organisation on the proposed Lightning Process pilot study:

I had asked:

[…]

To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sir Peter Spencer’s response (24 August):

Our position derives from our detailed reading of the MRC Ethics Guide for medical research involving children and from our understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.”

Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.

We do, of course, want to see research into LP in adults too – but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, we can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

Yesterday, 28 October, I submitted a request for information to the University of Bristol’s Information Rights Office and will update when this request has been fulfilled.  I have asked for:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

Key SMILE documents

SMILE Research Protocol

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

Open here: smprotv6final

Research Ethics  Application Form

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

Open here: recfrmrfs

All published SMILE documents in this post:

Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

SMILE – Specialist Medical Intervention and Lightning Evaluation documents

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

Shortlink: http://wp.me/p5foE-37x

See also previous ME agenda post:

“Unethical” Lightning Process pilot study in children receives ethics approval

Update: Key documents

3] SMILE Research Protocol

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

Open here: smprotv6final

29] Research Ethics  Application Form

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

Open here: recfrmrfs

University of Bristol website

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

Source: Protocol document

 

SMILE – Specialist Medical Intervention and Lightning Evaluation

What is SMILE?

SMILE is a feasibility study to see whether it is possible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The study will also look at how we should measure outcomes and the health economic impact on the families of young people with CFS/ME.

Young people will be observed completing the questionnaires that we use to look at how unwell they are before they see us and what happens to them after an intervention. We will also talk to young people and their parents to understand what they think about the questionnaires and to determine the most acceptable and sensitive ones to use. This study is the first to work out which questionnaires we should be using to understand outcome in paediatric CFS/ME.

Frequently Asked Questions

Why is research in children needed?

Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions. If SMILE can recruit enough people to participate in the study then further research could look at whether it is helpful or not.

Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

How can we take part in the study?

Young people are eligible if they are between 12 and 18 years of age, have CFS/ME and are from the region covered by the Bath/Bristol specialist CFS/ME service. Young people are recruited at assessment so you will not be eligible if you have already been seen by the service.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee have looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project can be found in the following documents:

Smile Study Documents

[Ed: I have numbered these documents for ease of reference – they are not numbered on the University of  Bristol website.]

Note: some of the documents on this page are in PDF format. In order to view a PDF you will need Adobe Acrobat Reader

1] SMILE Information sheet for teenagers August 2010 [pdf (150kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/infoshtteensv4aug10.pdf

Open here: infoshtteensv4aug10

2] SMILE Information sheet for parents September 2010 [pdf (147kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/infoshtprntsv7sept10.pdf

Open here: infoshtprntsv7sept10

3] SMILE Protocol Final July 2010 [pdf (170kb)]

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

Open here: smprotv6final

4] SMILE Under 16 assent to contact July 2010 [pdf (109kb)

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/u16asscv4july10.pdf

Open here: u16asscv4july10

5] SMILE 16 to 18 consent to contact July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/16to18confinaljuly10.pdf

Open here: 16to18confinaljuly10

6] SMILE Parental consent to contact 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconsv310may10.pdf

Open here: parconsv310may10

7] SMILE Under 16 assent to study July 2010 [pdf (112kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/u16assv4july10.pdf

Open here: u16asscv4july10

8] SMILE 16 to 18 consent to study July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/16to18constjuly10final.pdf

Open here:  16to18constjuly10final

9] SMILE Parental consent to study 10 May 2010 [pdf (113kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconssv310may10.pdf

Open here: parconssv310may10

10] SMILE teenager consent/assent to teenager interview August 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/tcontinvv5aug10.pdf

Open here: tcontinvv5aug10

11] SMILE Parental consent to child interview 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconcinv10may10.pdf

Open here: parconcinv10may10

12] SMILE Parental consent to parental interview 10 May 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconinvv310may10.pdf

Open here: parconinvv310may10

13] SMILE Consent to record intervention for participants, parents and those delivering interventions July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/conrecintjuly10final.pdf

Open here: conrecintjuly10final

14] SMILE Lightning process assessment form July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/lipcassfrmv2july10.pdf

Open here: lipcassfrmv2july10

15] SMILE letter to GP 10 May 2010 [pdf (49kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/letgpv110may10.pdf

Open here: letgpv110may10

16] SMILE WPAI [pdf (135kb)]

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

Open here: wpai

17] SMILE Health resource use questionnaire 10 May 2010 [pdf (232kb)]

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

Open here: healthresuseq

18] SMILE SF-36 [pdf (165kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smilesf36.pdf

Open here: smilesf36

19] SMILE Interview topic guide 10 May 10 [pdf (178kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/topgdev210may10.pdf

 Open here: topgdev210may10

Correspondence with Ethics Documents

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

“Unethical” Lightning Process pilot study in children receives ethics approval

“Unethical” Lightning Process pilot study in children receives ethics approval

Shortlink: http://wp.me/p5foE-36W

Update on the Dr Esther Crawley led Royal National Hospital for Rheumatic Diseases (RNHRD) NHS FT, Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18 (now 12 to 18)[1].

For background to this pilot study issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Source: Protocol document

“Unethical”

A pilot study on the controversial Lightning Process using children as young as eight has received the go ahead from a South West Region Research Ethics Committee (REC), despite widespread public concern and condemnation by two UK national patient organisations.

In August, ME patient charities, The ME Association and The Young ME Sufferers Trust, issued a joint press release describing the study as “unethical” and calling for it to be abandoned [2].

The organisations said:

“We are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children.

“The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care.

“It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.

“The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups [3].

“The document ‘MRC Medical Research Involving Children’ is quite clear on this issue. It poses the question: ‘Does the research need to be carried out with children?’ In answer, the MRC states: ‘Research involving children should only be carried out if it cannot feasibly be carried out on adults.’

“The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process…

“…We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.”

Today, information received from University of Bristol Information Rights Officer, Matthew Morrison, confirms that the pilot study has now been granted ethics approval. Recruitment to the study, which is being funded by the Linbury Trust and the Ashden Trust, was scheduled to start in September.

 

What has been published?

A large number of documents are published today on the University of Bristol website.

Information on accessing the research protocol and other published material can be found in the next post.

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and  ME)

Shortlink: http://wp.me/p5foE-37x

 

Advertising Standards Authority (ASA) ruling

In June, ME agenda reported that Alastair Gibson, who had previously identified himself as one of two Lightning Process coaches involved with the NHS study, was the subject of an Advertising Standards Authority (ASA) ruling [10].

The ASA upheld a complaint about unsubstantiated claims made for the efficacy of the Lightning Process in ME and CFS in an advertisement for Mr Gibson’s “Withinspiration” company.

At least one Lightning Process company has made changes to the wording on its website following the ME Association’s discussions with Trading Standards.

Currently, the ASA’s remit does not extend to website content but from May 2011, the ASA will broaden its remit and will be able to consider complaints about:

Advertisers’ own marketing communications on their own websites and;

Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.

On 1 September, the Advertising Standards Authority issued a news release setting out its extended remit: 

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

 

Department of Health responses

Concerns about the pilot study have been taken up with Earl Howe (Parliamentary Under-Secretary of State for Quality). Earl Howe is a Patron to The Young ME Sufferers Trust. An unsatisfactory response was received from Bill Davidson, Research Governance Manager, Department of Health, on 30 August, who responded on behalf of Earl Howe.

In July, Annette Brooke, MP, Mid Dorset & North Poole forwarded my concerns and documents to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health. Paul Burstow MP, Minister of State for Care Services, responded briefly on behalf of the Secretary of State for Health, on 12 August.

Mrs Brooke is Vice-chair of the newly reformed APPG on ME (Acting chair, David Amiss, MP).

The ME Association had also written to the Department of Health requesting that their joint press release be forwarded to the ethics committee reviewing the application. The DoH refused to do so – a decision which the ME Association considered unacceptable.

The name of the South West Research Ethics Committee, which had met to review the application on 8 July, was identified on 27 August in a response to my request for information under the Freedom of Information Act. The contact details for this regional RE committee chair have been passed to the ME Association.

The South West Regional Manager for the National Research Ethics Service (NRES) confirmed to me, in May, that there is apparently no process through which REC decisions might be challenged by the public.

 

References:    

[1] Press Release, University of Bristol, 2 March 2010
Media article

[2] Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

[3] MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007)   

[4] Request for information under FOI and FOI Office responses  

[5] Action for M.E. article on Lightning Process, InterAction magazine, March 2007   

[6] Patient Survey 2008, Action for M.E. and AYME   

Patient Survey May 2010, ME Association  

[7] LP Doesn’t Work for ME: Personal accounts from LP “trainees”

Letter: Lightning process for ME didn’t work for me

Personal account of Lightning Process technique as applied to patient with ME

Personal account of Lightning Process as applied to patients with ME and MS  

[8] Sample Lightning Process application form

[9] ASA adjudication against “Withinspiration” 

[10] RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People

[11] Lightning Process website

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

Shortlink: http://wp.me/p5foE-35z

It is of considerable public concern that Dr Esther Crawley has sought to obtain the advice, guidance and involvement of a Lightning Process practitioner who, in June, was subject to an Advertising Standards Authority ruling in relation to claims made in an advertisement about the efficacy of the Lightning Process for CFS and ME [1].

In July, in this background posting, I reported that Bournemouth Lightning Process instructor, Alastair Gibson, had already identified himself, on the “Withinspiration website”, as “one of the two practitioners working with the NHS and the young people” in the Dr Crawley led pilot study into Lightning Process for children aged 8 to 18 [2].

At 29 March, Mr Gibson’s website had carried this information:

http://www.withinspiration.co.uk/index.php

Breaking News – NHS and Lightning Process research collaboration.

“A new pilot study involving the Lightning Process and the NHS has been awarded £164,000 for research into the treatment of CFS/ME in children and adolescents. Alastair Gibson is one of the two practitioners working with the NHS and the young people in this exciting research study. Find out more.”

That statement no longer appears on his website and it is unclear whether Mr Gibson retains an involvement with this proposed pilot study.

At 27 August, according to the University of Bristol’s FOI officer, the study had yet to obtain ethics approval. A research protocol and other information was supposed to have been published on the University of Bristol’s website by the end of August – regardless of whether the study gained approval [3].

This material has failed to appear.

The Old Bailey Online site is a fully searchable collection of 197,745 criminal trials held at London’s central criminal court:

In the 1700s, Old Bailey court reports included advertisements and this one caught my eye:

Old Bailey Proceedings, 27th February 1712

“All Melancholy, Hysterical and Hypochondriacal Distempers, which variously affect the Mind with strange Fears, and dismal Apprehensions, Paintings, and Sinkings of the Spirits, great Hurries, Restlesness and Disquietment (little understood, and seldom cured by any common Means) also Pains and Giddiness of the Head, Risings to the Throat, Sick-fits, Tremblings, Oppressions of the Heart, or any other Disorders caus’d by Vapours, are successfully cured (with God’s Blessing) by a Physician well experienc’d therein, and of more than 20 Years Practice in those deplorable Cases; who also cures all kind of Fits, tho’ strange and violent, if curable; which he informs on sight of their Water. Living next door to Shadwell Coffee-House in Upper-Shadwell, near London; where those that have occasion, and live remote, may direct their Letters, and they shall be speedily answer’d, or attended on, if desired.”

Well little changes, because in 2010, the sites of some Lightning Process practitioners are still making the following claims:

What does it work for?

“People using the Lightning Process® have also recovered from, or experienced significant improvement with the following conditions: –

“Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More”

“Using the Lightning Process® has proven effective for clearing ALL the debilitating physical and mind based symptoms of ME, chronic fatigue syndrome, and post viral syndrome.

“Some of the symptoms that people have cleared are listed here…

“Addictions, adrenal problems, allergies and intolerances, anxiety, balance problems, bloating, blurry vision, brain fog, candida, chemical sensitivity, compulsive behaviours, concentration problems, confusion, constipation, depression, diarrhoea, dizziness, electrical pulsing sensations, excessive sleeping, exhaustion, fatigue, fear, feeling detached or disconnected, fever and chills, flu-like symptoms, frequent coughs and colds, fybromyalgia, hallucinations, head pain or pressure, heartburn, indigestion, insomnia and other sleep disturbances, irritability, irritable bowel syndrome, itching and rashes, itchy eyes, joint pain, light sensitivity, loss of vision, malaise, memory loss, migraines, muscle pain, nausea, noise sensitivity, oedema, panic attacks, painful and/or swollen glands, pins and needles, restless leg syndrome, runny nose, sensitivity to electrical fields/computers/mobiles etc, shaking, shooting pains, skin sensitivity, stomach pain, sun burn sensation, swelling, temperature control problems, thrush, thyroid problems, unrefreshing sleep, vertigo and similar sensations, vomiting, water retention, watering eyes, weakness…..and probably many more

“We advise you to consult your GP, have the necessary tests and obtain a diagnosis before applying for the Lightning Process® training programme”

The Phil Parker Lightning Process website and the sites of some Lightning Process practitioners have a “FAQ” page which includes the following:

Can my doctor assess me for readiness?

“If your doctor or health care specialist is trained as a Lightning Process Practitioner then of course they can assess you for readiness to take the programme. If they are not trained in the programme they will not have the requisite skills or knowledge base about this very specialised field to assess you.

“A large part of the training for LP practitioners is to train them to appropriately assess potential trainees for their suitability for the process, as it is essential to ensure, as far as is possible, that only those who are ready to get benefits from the training program are enrolled in the training.”

So, according to Mr Parker, your doctor is not capable of assessing patients for “readiness” to undertake the Lightning Process.

How and by whom are the potential child participants in the RNHRD NHS FT Bath/University of Bristol pilot study going to be assessed for “readiness” and suitability to undertake the “training”?

We don’t know, because the University of Bristol is withholding virtually all information requested by me under Clause 22(1)(a) of the FOI Act.

 
The Lightning Process is controversial and untrialled. It is marketed by the Phil Parker organisation not as a therapy or a treatment but as a “training program” delivered by “instructors” or “practitioners” or “coaches”.

Instructors are trained and licensed by the Phil Parker organisation and are not accountable to any regulatory professional body. If individuals have complaints about a practitioner or about the Lightning Process, itself, which cannot be resolved directly with the practitioner or through the Phil Parker complaints procedure, their only recourse is Trading Standards.

Currently, the Advertising Standards Authority’s remit does not extend to website content. But this is to change in March 2011.

The Advertising Standards Authority has issued this news release today:

Landmark agreement extends ASA’s digital remit

http://asa.org.uk/Media-Centre/2010/ASA-digital-remit-extension.aspx

1 September 2010

The digital remit of the Advertising Standards Authority (ASA) is to be extended significantly to deliver more comprehensive consumer protection online.

The ASA’s present remit online includes ads in paid-for space and sales promotions wherever they appear. But from next year, the rules in the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code) will apply in full to marketing communications online, including the rules relating to misleading advertising, social responsibility and the protection of children. The remit will apply to all sectors and all businesses and organisations regardless of size.

The Committee of Advertising Practice (CAP), the body responsible for writing the CAP Code, has decided to extend the digital remit of the ASA in response to a formal recommendation from a wide cross-section of UK industry. CAP has today published a document detailing the new remit and sanctions.

( Open PDF here: CAP Digital Remit Extension[1] )

In summary:

The new remit will ensure the same high standards as in other media and will cover:

Advertisers’ own marketing communications on their own websites and;

Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.

Journalistic and editorial content and material related to causes and ideas – except those that are direct solicitations of donations for fund-raising – are excluded from the remit.

Sanctions
In addition to the ASA’s present sanctions, which already achieve a high level of compliance, CAP member bodies have agreed new sanctions to apply to the extended remit such as:

Removal of paid-for search advertising – ads that link to the page hosting the non-compliant marketing communication may be removed with the agreement of the search engines.

• ASA paid-for search advertisements – the ASA could place advertisements online highlighting an advertiser’s continued non-compliance.

Funding
The industry has agreed to apply the standard 0.1% levy on paid-for advertisements appearing on internet search engines through media and search agencies. This is an extension of the existing funding mechanism in other media that pays for the ASA and it will be supplemented initially with seed capital from Google.

Implementation
The remit will come into force on 1 March 2011 after a six month period of grace to allow the ASA and CAP to conduct training work to raise awareness and educate business on the requirements of the CAP Code, particularly amongst those who may not previously have been subject to ASA regulation. Website owners and agencies are urged to sign up to CAP Services to receive guidance and training to help ensure their sites comply with the new rules
before 1 March 2011.

ASA Chairman Lord Chris Smith said, “This significant extension of the ASA’s remit has the protection of children and consumers at its heart. We have received over 4,500 complaints since 2008 about marketing communications on websites that we couldn’t deal with, but from 1 March anyone who has a concern about a marketing communication online will be able to turn to the ASA.”

CAP Chairman Andrew Brown said, “Extending the online remit of the ASA has been a top priority for UK industry  over the last couple of years. Our aim has been to extend further in the online world the principles that are already well established in our system, namely those of effective consumer protection and fair competition.”

[Ends]

[1] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

[2] Background to this issue:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
http://wp.me/p5foE-2Vt

[3] Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18:
http://wp.me/p5foE-341

Accessing a copy of MRC National Archives material via PDF

Accessing a copy of MRC National Archives material via PDF

Shortlink: http://wp.me/p5foE-34g

NB: If the link isn’t working for you, try this:

Go to this URL:

http://www.nationalarchives.gov.uk/documentsonline/default.asp

which is the National Archives Documents Online page

Put this Catalogue reference code into the Search box

FD 23/4553

Select date range 1950-99

that should bring up the page. Then pick up my instructions from there.

Instructions:

Go here:

http://tinyurl.com/NationalArchivesMRC

that is:

http://www.nationalarchives.gov.uk/documentsonline/details-result.asp?queryType=1&resultcount=1&Edoc_Id=8553429

The National Archives Documents Online

Description Myalgic encephalomyelitis (ME)/postviral fatigue syndrome (PFS) : papers and journal articles; correspondence and enquiries with MRC replies

Date 1988-1997
Catalogue reference FD 23/4553
Dept Records created or inherited by the Medical Research Council
Division General Records of the Medical Research Committee and Medical Research Council
Series Medical Research Council: Registered Files, Scientific Matters (S Series)
Image contains complete documents usually loaded

———————

Click “Add to shopping” (there will be no charge, so don’t worry)

Click “Check out”

An email address will be requested.

Fill in a working email address.

Click “Proceed with your download”

An auto generated email will be sent to you.

The email you receive will include an order number and the date up until which the file will be available to you. (This was 28 days.)

Beneath the words:

“Your images are now available. If you have not already downloaded them, please go to the download screen at”

There is a clickable link “Download my documents now”.

Click the link which will take you to a PDF URL. The URL will be specific to your email address.

The URL will open a PDF of approximately 30 MB which you can save to your hard drive in the usual way.

The file consists of a 143 page bundle of copies of letters, responses, papers, notes of meeting and handwritten notes.

Some pages, extracts, names and addresses have been redacted and are marked:

“REDACTED UNDER
FOI EXEMPTION
SECTION 40 (2)
CLOSED UNTIL 2071”

———

(Note: This is a very large file which is why National Archives do not supply it via an email attachment. I accept no responsibility for the consequences of anyone being inconsiderate enough to forward the file as an email attachment which may cause considerable problems for some email account holders.)

Related material

28 December 2009

Response from Public Services Development Unit, National Archives

http://wp.me/p5foE-2yP 

11 December 2009

The Medical Research Council’s secret files on ME/CFS: Margaret Williams

http://wp.me/p5foE-2vm

Update on ethics approval: Dr Esther Crawley Bath/Bristol Lightning Process pilot study for children 8 to 18

Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18

Shortlink: http://wp.me/p5foE-341

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

I was advised by the University of Bristol Director of Legal Services on 17 August that

“The Information Rights Officer has been assured by the leader of this project that the information requested will be published on the University’s website by the end of this month. The published information will include the research protocol and related material, including information about the ethics approval process.”

“May I therefore suggest that you await publication of the information and then come back to the Information Rights Officer if there are any aspects of your original request which you consider have not been fulfilled through publication.”

On 26 August, I was advised by the University’s Information Rights Officer that:

“The study is at the final stage of the ethics proposal. The information will be published regardless.”

 

On 3 August, I had submitted a request for information to the National Research Ethics Service (NRES) under the Freedom of Information Act around the application for ethics approval and application timeline.

This was fulfilled yesterday, 27 August.

I received the following responses provided by the FOI Manager, NHS South West. Responses are highlighted in blue:

27 August 2010

Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and the University of Bristol

Funders: £164,000 awarded by Linbury Trust and the Ashden Trust

Lead researcher: Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, Senior Lecturer, University of Bristol.

Study: Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.

Ethics Approval:

1] Any reference numbers attached to the application for ethics approval: 10/H0206/32

2] Names of Research Ethics Committee(s) responsible for reviewing application: [A South West region Research Ethics Committee is identified]

Status of application for ethics approval:

3] Date application received: 14 June 2010

Has a Research Ethics Committee already met to consider this application? Yes

On what date did this meeting take place? 08 July 2010

Was an unfavourable ethical opinion or a favourable ethical opinion given? A decision is awaited on the ethical opinion.

If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received? Not applicable

Were any clarifications requested? This information is exempt under Section 22 of the Act (information intended for future publication) as it will be published by the University of Bristol in the foreseeable future.

Was a modified application submitted to a different REC and if so, which REC? No

If an appeal was submitted was the application reviewed by a different REC and if so, which REC? Not applicable

What was the outcome of any re-submission, modification or appeal and on what date was the Principal Investigator/lead researcher applicant notified of the outcome? Not applicable

If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified? Not applicable

If the application has yet to be considered, which Research Ethics Committee is responsible for considering this application and on what date is the committee expected to meet to consider the application? Not applicable

By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion? This date is not yet known.

Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.

Please provide copies of any ethical opinions already handed down, with any requests for resubmissions, modifications, requests for clarifications.

This information is exempted under Section 22 (information intended for future publication) as the University of Bristol plans to publish this information in the foreseeable future.  

I am advised that I have the right to complain about this response by reference to the complaints procedure of the South West Strategic Health Authority in which case I should write to the Chief Executive at NHS South West, South West House, Blackbrook Park Avenue, Taunton, Somerset TA1 2PX. That if I remain dissatisfied with the decision of the Authority following my complaint, I may write to the Information Commissioner, whose address is:
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.

 

Related information:

REC Application flowchart

 REC Application Researcher Training Pack

 FOI request 16 May 2010 to University of Bristol, fulfilled 17 June

Background to this issue

ME Association and The Young ME Sufferers Trust joint Press Release, 4 August 10

Archive for all Lightning Process posts on ME agenda

Questions for Action for M.E. (Lightning Process pilot study in children)

Questions for Action for M.E. (proposed Lightning Process pilot study in children with CFS and ME aged 8 to 18)

Shortlink: http://wp.me/p5foE-31X

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Update @ 24 August

I have received a response from Sir Peter Spencer, this afternoon.

Sir Peter writes that [Action for M.E.’s] position derives from their detailed reading of the MRC Ethics Guide for medical research involving children and from their understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.

That Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.

That [Action for M.E.] does, of course, want to see research into LP in adults too – but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, [they] can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

 

I have written, today, to Action for M.E. requesting clarification of what information they have relied on when formulating their position on this controversial RNHRD NHS FT, Bath/University of Bristol Lightning Process pilot study.

Action for M.E. has now issued two position statements on this proposed Lightning Process pilot study for children.

Although funding for the study had been secured last November and a press release published in early March, by 17 June, the research team were still waiting on an ethics committee decision.

According to information posted on Action for M.E.’s Facebook site on 23 August, the project’s lead researcher, Dr Esther Crawley, has apparently confirmed that the pilot is still waiting to receive ethics approval.

University of Bristol Information Rights Officer and the Director of Legal Services had already confirmed to me (on 10 and 17 August) that the project lead had given assurances that “information requested will be published on the University’s website by the end of this month” and that “the published information will include the research protocol and related material, including  information about the ethics approval process”.

It appears then that Dr Crawley is very confident her project will be approved.

The University FOI office has told me that I will be notified when the material is published. 

A request for information and documents relating to the application for approval and the approval process timeline is due for fulfilment on or before 31 August.  Information requested of the National Research Ethics Service can be read in this posting:

Freedom of Information requests: South West Strategic Health Authority and National Research Ethics Service

To: Policy Officer; Heather Walker, Communications Manager; Sir Peter Spencer, CEO

Sent: Monday, August 23, 2010 4:18 PM
Subject: Query on position statements

This is a query in relation to Action for M.E.’s two published position statements on the proposed Lightning Process pilot study for children.

It was reported, back in March, by the regional Bristol newspaper:

http://www.thisisbath.co.uk/news/Money-Min-children-s-study/article-1885785-detail/article.html

“Money for Min children’s study
Thursday, March 04, 2010, 15:29

“A project looking into a chronic childhood condition has been given a £164,000 boost.

[…]

“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.

“The system is derived from osteopathy, neuro-linguistic programming and life coaching.

“Its creator, osteopath Phil Parker said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team.”

———

As you are aware, the University of Bristol’s FOI office is withholding virtually all information and documents under FOIA Clause 22(1)(a). Some limited documents relating to the funders have been made available.

When the University of Bristol issued its press release published on 2 March 2010 announcing the Lightning Process pilot study, the study had not, at that point, obtained ethics approval.

At 17 June, the University FOI Office confirmed that the study was still going through the ethics approval procedure and that information requested was expected to be published around August/September 2010.

I am recently advised by the FOI Office that Dr Crawley has assured them that information around the study and the research protocol is now planned to be published by the end of August. It is unconfirmed, but this suggests that the study may now have received approval.

So there is very little information in the public domain about the study design and methods.

The only information that is currently publicly available is:

1] The press release announcing the study on 2 March:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf

2] The media article in “This is Bath” (URL above).

3] An article in the May issue of AYME’s Link Newsletter (a copy can be provided but no URL).

4] The information that Alastair Gibson is one of two LP practitioners involved with the NHS study (was on his website in March but has since been removed).

The “This is Bath” article states:

“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.”

In five months, this has not been corrected by the lead researcher if this information is misleading.

The press release states that the primary outcome measure will be “school attendance after six-months”.

It seems unlikely, then, that the pilot participants and their families are going to be subjected solely to the application of “in-depth interviews”.

To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sincerely,

Suzy Chapman
_____________________

http://dxrevisionwatch.wordpress.com
https://meagenda.wordpress.com
http://twitter.com/MEagenda
http://www.facebook.com/MEagenda