1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
Discuss the article on the Forums.

Dr Esther Crawley: Transcript of Presentation: The Future of Research in CFS/ME

Discussion in 'General ME/CFS News' started by Dx Revision Watch, Oct 19, 2010.

  1. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Kermit, one of the reasons why it is important that I have sight of any information allegedly issued by the NRES is because, on 19 May, I was advised in writing by the NRES South West Regional Manager that:

    "Further to our telephone conversation earlier today, I have obtained advice regarding your query. It has been confirmed that there is no formal process for challenging the decision of the REC. Any concerns that you have should be raised directly with the Sponsor/Chief Investigator for the study."

    Which would appear not to accord with the information you say your contact has been given.

    If your contact is able to confirm to me that they have been given conflicting advice I shall need to challenge the advice that I was given, in May, and I cannot challenge this on the basis of hearsay.

    Suzy
  2. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Edited on 24 October.

    "Kermit Frogsquire's" template letter had been posted on Action for ME's (publicly accessible) Facebook Wall on or around 11 October by a third party (that is, not by me). The posting was subsequently deleted from Action for ME's Facebook Wall by that poster on 11 October.

    This morning (24 October) I have received a request to delete content of "Kermit Frogsquire's" template letter from this forum, including quotes from his template letter.


    Content deleted at the request of "Kermit Frogsquire"
  3. kermit frogsquire

    kermit frogsquire *****

    Messages:
    125
    Likes:
    37
    Fred/ Suzy - one does not need the information on which Dr Crawley submitted at all - one only needs to make an argument based

    *on the facts (that is the known independent risk/benefit ratio of the study, independent surveys, patient reports of harm etc,the claims of phil parker vis a vis adults and children etc etc etc)
    *the rules regardig trials on children (which are online),
    *and reasonable arguments.

    Arguments trying to pick holes in Dr Crawleys sumbissions are both pedantic and unhelpful and adversarial. This is not the best way to achieve any result and we would be best to make our submission and let the national research ethics service make their decision as they see fit. This is exactly how most legal systems in the world operate, they do dont operate an adversarial process, they operate a process of submissions, each side making their arguments independently and then a decision being made by people qualified to decide.

    It really is up to you what you choose to do, and how you choose to respond to such information - personally I would be pleased about such great news. For example I could say

    - did you tape that telephone conversation - perhaps its all nonsense - prove that's what they said - you are just trying to put everyone off the scent - saying there is no appeal process - dont trust this person

    But instead I believe you are trying to help people with ME.... and perhaps someone else just managed to say some things the right way to get the right response or perhaps it was due to many people, or the cumulative effects of all of us, who knows, I'm just happy they are responding. As I said before you could have just emailed me and I would have forwarded any questions to my contact - but I cannot tell you any more than I personally know.
  4. fred

    fred The game is afoot

    Messages:
    400
    Likes:
    1
    Who has told you this? Has this been confirmed by NRES or are you basing these assumptions on your own experience of challenging medical ethics approvals or on other unrelated experience?

    This is not a legal process. It is a medical ethics process.

    I would also request that you do not patronise me on legal matters. You do both of us a disservice by assuming that you have an expertise that others do not.

    I am lost as to the point you are making here.
  5. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Edited on 24 October.

    "Kermit Frogsquire's" template letter had been posted on Action for ME's (publicly accessible) Facebook Wall on or around 11 October by a third party (that is, not by me). The posting was subsequently deleted from Action for ME's Facebook Wall by that poster on 11 October.

    This morning (24 October) I have received a request to delete content of "Kermit Frogsquire's" template letter from this forum, including quotes from his template letter.


    Content deleted at the request of "Kermit Frogsquire"
  6. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Which appears to be very little and insufficient information on which to start encouraging others to pile in to NRES with letters.

    You were told today, right?

    You appear to know little more than that apparently someone has been told that:

    "a decision to review has been set in motion, by Joan Kirkbride."

    (But that you are assuming this is Joan Kirkbride because that's who you were told to write to.)

    It's not even clear to me whether your contact has instigated some kind of review (nature unknown) or whether your contact has been informed by NRES that some kind of review had already been set in motion by another interested party.

    Thing is Froggy, you do not know what this apparent review will involve, who it will involve nor what its time frame will be - so on what basis can you pronounce on what is or what is not an appropriate approach.

    This smacks of kneejerk Facebook activism.

    By the way, did you write to the Chair of South West REC 2, yourself, and have you received a response and if so when and what was that response?

    Has anyone to your knowledge received a response from the Chair of REC 2?
  7. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Enquiries will be made, this coming week, of the NRES, in order to establish precisely what action the NRES is taking.
  8. Enid

    Enid Senior Member

    Messages:
    3,309
    Likes:
    840
    UK
    Glad to have looked in and seen all your works Suzy - all the recognised (experts) there in the relentless battle. Hope the Ethics Comittee prevails.
  9. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    http://www.rnhrd.nhs.uk/index_sub_menus/news/news_full_text.htm

    Latest Hospital News

    Medicine at the Min


    Medicine at the Min is series of public lectures taking place at our hospital. November and December 07 lectures are as follows:

    Thursday 8 November 2007: Dr Esther Crawley - Everything you need to know about CFS/ME in children

    Chronic fatigue syndrome or ME affects about 1% of children and is probably the largest cause of authorised school absence in this country and yet few doctors know how to make a diagnosis yet alone treat it. The Bath Paediatric CFS/ME team, based at the Min sees and provides treatment for over 150 children a year. 10% of the children seen are so badly affected they are unable to leave their house. 14% are still in primary school. The team is also involved in research investigating the epidemiology of CFS/ME, memory problems, anxiety and what factors predict outcome. This talk will discuss the size of the problem the UK, current treatment strategies and current research in the area of paediatric CFS/ME.

    Esther Crawley is a Consultant Paediatrician based at the Min. She represents the Royal College of Paediatrics and Child Health on the NICE guideline group for CFS/ME and is part of the National collaborative for CFS/ME. When she is not seeing patients Esther also leads a research group based at Bristol University investigating CFS/ME in children and works with YPNR (Young Peoples Neuro-rehabilitation) at the RNHRD. She trained in Oxford but did her PhD in London. She is married and has two children, a dog, 2 cats and an allotment.
  10. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Hi Enid,

    The application for ethics approval for the Lightning Process pilot study was submitted to South West 2 Research Ethics Committee on 14 June (this is a regional ethics committee based in Exeter).

    A favourable opinion on the study was given in September and final approval for the study was gained in late September. The pilot was due to start in September and the funders have a clause that the study must start by October, latest.

    Since so little information is currently available, it remains unclear what will be the nature and extent of any "investigation" into complaints that the National Research Ethics Service intends to undertake.

    This is why it is important that this is established.

    It has been suggested in this thread that we should be pleased about this development. But since it is currently unclear what this procedure will entail, it is not possible to assess how welcome this development might be.

    It cannot be assumed that any investigation into complaints about the (now already approved) pilot study will be a review of the entire process that resulted in its gaining approval (including scrutiny of the application documents and supporting materials, rationales etc).

    Or that those charged with looking into complaints and concerns will be in a position to take into consideration new material and information that stakeholders and interested parties might wish to bring to the attention of the NRES, in the context of an investigation into a number of complaints received from various individuals and organisations.

    It may be the case that the remit of whoever is charged with looking into this issue will be to assess whether the correct procedures had been adhered to throughout the life of the application process and may not encompass any form of wider evaluation of the merits or not of granting a favourable opinion on this particular study, based on the information presented to the RE committee, at the time, by the co-applicants.

    If an investigation of complaints is to be an evaluation of whether the NRES's own procedures were followed and the investigator or investigating team returns an opinion that procedures had been followed in accordance with the NRES's framework, then we could find that a line is drawn under this issue and there will be no further opportunity for challenging this decision apart, that is, by the study participants and their families. (There is a complaints process for participants of studies being undertaken on NHS premises.)

    The term "an investigation" is meaningless, unless we have an understanding of its scope - that is, what is going to be carried out, how it is going to be carried out and who it is going to be carried out by.

    It is disconcerting that some apparently appear not to have given these points consideration.

    Suzy
  11. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    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.
  12. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
  13. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Since this thread drifted away from the Crawley presentation transcript into the LP pilot issue, I am posting this information on developments following complaints to South West REC2 and the NRES that has been published by the ME Association, today.

    In order not to fragment the Lightning Process pilot in children issue, I suggest that any comments are made in the main Lightning Process pilot thread, here:

    http://www.forums.aboutmecfs.org/sh...dy-on-Children&p=132972&viewfull=1#post132972


    http://www.meassociation.org.uk/?p=2720

    Lightning Process trial and the National Research Ethics Service

    by tonybritton on October 28, 2010

    The ME Association has written to the National Research Ethics Service (NRES) to ask them to clarify what action they are taking, or may be taking, in relation to concerns that are being expressed about this trial.

    We have today received a reply from Joan Kirkbride, Head of Operations at NRES – part of which contains the following generic acknowledgement for correspondence relating to this trial:

    NRES has received the submissions from 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 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.

    We will also be seeking the views of our National Research Ethics Panel.

    Joan Kirkbride
    Head of Operations, England
    National Research Ethics Service (NRES), National Patient Safety Agency
    Darlington Primary Care Trust, Dr Piper House
    King Street, DARLINGTON, DL3 6JL


    MEA editorial note: REC – in paragraphs two and three of Joan Kirkbride’s letter – stands for Regional Ethics Committee.
  14. kermit frogsquire

    kermit frogsquire *****

    Messages:
    125
    Likes:
    37
    I see that you have finally accepted that there is a review - as I tried to tell you ME Agenda last week.

    "So unless or until "Kermit's" informant is prepared to place a copy of his or her communication in the public domain, we have no evidence that a review has been set in motion."

    That is not true, you had my evidence. I simply chose to trust and believe the people that informed me - perhaps rather than nay saying and arguing with people that quite honestly haven't got the energy to waste - you could be a little more helpful in the furture. Who cares who secured the review!

    All the information has also been forwarded to Professor Robin Gill by those involved and hopefully Professor Gill will be able to make more weighty representations to the NRES on this matter.

    Additionally letters are being written to the OFT, with the help of my MP, to try and have Phil Parker investigated. He makes a number of claims that are strictly in breach of the Consumer Protection from Unfair Trading Regulations 2008 - these breaches constitute a criminal offence. The more people that can help with this and the more MP's that are on board will also help push such an investigation through. The OFT has enforcement and investigative powers that mirror those of Trading Standards where a regional or national issue is involved - definitely the Lightning Process.
  15. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK

    I do not consider that it is a productive use of my time to engage further with you, either on or off list and I shall not be responding to any further comments from you.

    Suzy
  16. kermit frogsquire

    kermit frogsquire *****

    Messages:
    125
    Likes:
    37
    Yet you considered it productive use of my time to argue for 3 pages when I posted the news about the NRES review and call me (or at least my source) what was tantamount to a liar? Without apology. Perhaps think before you waste anyone elses time, ME Agenda. I think it a very good idea if you, or Fred, do not respond to any of my posts in the future, it would enable everyone else to get helpful constructive news without disruption.

    Thanks Kermit
  17. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    This post is a general note of clarification for readers of this thread and the associated thread and not addressed to Kermit Frogsquire, per se.

    On a general note, in order that there is no confusion around my previously stated concerns:


    The responses that the NRES has been giving out, that I have been advised of, are:

    "...there is to be an investigation into the ethical review of the project"​


    and

    “NRES has received the submissions from 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 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.

    “We will also be seeking the views of our National Research Ethics Panel."​



    Neither confirms to me that their investigation will automatically result in a review of the application and its outcome, only that they intend to return to the researchers, the sponsors and the ME charities in the development of the study, in the first instance, to seek their responses before asking the REC to review its favourable opinion.

    This could be taken to mean that the NRES will first seek responses from the above. Then they will decide whether NRES is prepared to review the application or whether NRES will be asking the REC to review the application and that they may decide that there is no case for either.

    That is not the same as the assertion that NRES has said it will be:

    "launching an investigation to undertake an ethical review of the project".


    Additionally, the responses being given out have thus far not confirmed that any and all information subsequently sent into the NRES will be taken into consideration as part of whatever process the NRES is currently in the midst of, which is not a transparent process.

    Nor do they give a deadline by which information sent to the NRES would need to be received in order to be considered.

    I therefore reserve the right to express my concerns that the responses being given out so far, that I have been advised of, lack clarity.

    I also reserve the right to consider that, personally, I would not be prepared to send information and concerns to the NRES, at this juncture, based on the information that has currently been placed in the public domain.

    Suzy Chapman
  18. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    Reported to moderator


  19. jen jen

    jen jen

    Messages:
    20
    Likes:
    0
    Thanks for that! I live in the UK and have suffered from M.E for 22 years shall I just shoot myself now!!!!!
  20. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

    Messages:
    1,787
    Likes:
    487
    UK
    jen jen, I'm sorry, but it's not clear to me which post you are referring to.

    Suzy

See more popular forum discussions.

Share This Page