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Lightning Process to be Evaluated in Research Study on Children

Discussion in 'General ME/CFS News' started by Jenny, Mar 4, 2010.

  1. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Hi Bob,

    I think it would be helpful if you could PM fingers as he's already engaging with some of the key players involved with this study, as are one or two others - he'll be able to bring you up to speed with who has been contacted so far, and by which individuals.

    Suzy


  2. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Thanks for adding a comment, Bob, I know John Greensmith will be pleased however brief comments are - as long as they are constructive and don't degenerate into ad hominem (not that I am suggesting that any of the lovely folk here would resort to ad hominem).

    I'm afraid it is. She is very influential:

    Clinical lead for the Bath CFS service.

    Senior Lecturer at the University of Bristol and a Consultant Paediatrician.

    Chair of the CFS/ME Clinical Research Network Collaborative (CCRNC).

    A member of the MRC's "CFS/ME Expert Panel" and had been a member of the NICE Guideline Development Group.

    She presented at the Bristol Royal Society of Medicine regional CFS Conference, in 2008.

    Medical Adviser to the children and young person's organisation AYME.

    She's held the position of Clinical lead for Bath for some time now and the NICE Guideline Development Group would have been assembled in when - 2006, perhaps? Over the past year or two she has attracted significant sums of funding for research into CF and CFS in children. Over 700k for one set of studies and other funding, too.

    You've seen some of my earlier posts so you know that the national patient orgs have already been discussing concerns (according to the summary of the MEA's last meeting of the Board of Trustees).

    Also, as I've noted on WPI Facebook Discussion, in July, last year, Dr Crawley and Dr Hazel O'Dowd gave a presentation at a meeting of the Countess of Mar's group - Foward-ME.

    Minutes of the Meeting held on 21 April 2009:

    Agenda item 4: Presentation

    4. Dr Esther Crawley, FRCPCH; PhD, Senior Lecturer at the University of Bristol and a Consultant Paediatrician, Chair of the CFS/ME Clinical Research Network Collaborative (CCRNC)

    and

    Dr Hazel ODowd, MSc, D Clin Psych, Consultant Clinical Psychologist, Clinical Champion for CFS/ME services for Avon, Gloucester, Wiltshire and Somerset.

    [Write up of presentation]

    Presentation slides: http://www.forward-me.org.uk/Presentations.htm

    CFS/ME Clinical and Research Network and Collaboration by Esther Crawley - PowerPoint Show file


    also at Agenda item 5:

    "5. Lightning Process:
    Charles Shepherd had been made aware of a meeting which was to take place at University College London in conjunction with Great Ormond Street Hospital which appeared to promote the Lightning Process for patients with CFS/ME. As Dr Crawley knew something about the subject, she was asked to remain and to contribute to the discussion. Of particular concern was the promotion of the programme to vulnerable clinicians who had just started to practice. After some discussion about the pros and cons of the programme, it was agreed that Mary-Jane Willows would talk to the organisers on behalf of Forward-ME highlighting our concerns."


    (The above minute refers to a Workshop for professionals working with children with CFS and ME.)

    The upshot of this was not reported on at the next meeting of Forward-ME.

    You may also have seen from earlier posts (and there are now three or four separate threads on LP and this children's research pilot - so it is hard to keep track of which posts are in which thread) that Mary Jane Willows of AYME and Jane Colby have been approached by one ME advocate and that Fingers is engaging with selected patient org reps and with other key players.

    The study already has a source of funding and ethics approval.
    What action the patient orgs are taking isn't known - but I suspect it will be a question of "we'll be monitoring closely" rather than "we will move heaven and earth to stop this pilot for children going ahead and that if any research is going to be done into LP we'll be calling for it to be done with adults first."

    So we need think strategically about how best to approach this. One thing that is required is for a comprehensive FOI to be put in for the study design and other information, like patient literature. The funders will not be subject to the FOI Act - but the institution that is undertaking the study will be.

    But if you are really interested in working on this - you do need to talk to Fingers and possibly a contact of Fingers who has already discussed their concerns with AYME and with Jane Colby, in order that efforts can be co-ordinated.

    Form letters have their place but if the recipients are going to respond by advising that the study has full ethics approval it is going to be hard to get beyond that - so other approaches need to be considered.
  3. fingers

    fingers Senior Member

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    SW Endland
    Hi folks, sorry I've been a bit quiet, you may think I've given up an this one, but certainly not.

    I'm currently awaiting further response to an e-mail I sent to the Ashden Trust, which I'll follow up by phone if not forthcoming. It has taken many phone calls and e-mails so far, all a bit knackering, but the dialogue with the trust is constructive.

    Via the trust, I have requested an explanation from EC why she believes that the next thing to do is to conduct a study involving children. My message includes my view that such a study may have value, but only once we understand who and what the LP might help......and we certainly do not have that knowledge yet. This is the first study that should be undertaken......with adults....even with those who have undertaken LP training already, both "successfully" and unsuccessfully.

    As I said before, may not report back until I have something of interest.

    Best wishes to all, and thanks again for all the great posts, information and discussion.

    F
  4. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Thanks for the update, Fingers.

    Some cheery news:

    PULSE:

    RCGP names new chair


    Dr Clare Gerada has been elected as the 21st chair of the RCGP, the college's first female chair for 50 years.

    (Dr Gerada is married to Professor Simon Wessely.)
  5. Daisymay

    Daisymay Senior Member

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    Grief that's awful news! But thanks for letting us know Suzy.
  6. Dolphin

    Dolphin Senior Member

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    Yes, this is something I'm interested in also. I think it is also likely to be disproportionately an issue with children/young people.

    We already know from studies like this one that lots of adolescents with infectious mononucleosis-induced CFS recover in time.

  7. valia

    valia Senior Member

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  8. kaazoom

    kaazoom

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    AfME have just replied on Facebook to a question asking whether they oppose the clinical trial of LP on children. This is what they have said:

    "Action for M.E. sees no reason to oppose this pilot study.

    As was made clear when it was announced, the research at this stage is simply a
    pilot designed to see if it would be possible to set up a trial that can
    independently assess the Lightning process against specialised medical care.

    It is a fact that many parents are already taking their children to LP
    practitioners and so there are urgent questions that need to be addressed in
    order to assure the safety of those children. Dr Crawley’s initiative aspires to
    find a way of answering some of those questions."



    http://www.facebook.com/actionforme?v=feed&story_fbid=396757703208
  9. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Action for M.E. position statement on Crawley on Facebook Wall

    Action for M.E. position statement on Crawley on Facebook Wall


    http://www.facebook.com/actionforme

    Suzy Chapman

    Does Action for M.E. intend to oppose ethics approval for the Dr Esther Crawley pilot study on LP and children 8 to 18 years old, due to start in September 10? What action does this organisation intend to take? No rigorous, independent trials of LP for adult ME/CFS patients have been published. The MRC's guideline o...n ethics and medical research in children is clear:

    MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)

    http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430

    “4.1 Does the research need to be carried out with children? Research involving children should only be carried out if it cannot feasibly be carried out on adults.”

    Comments:

    Suzy Chapman

    See also: Topic thread:
    Dr Esther Crawley study into LP and children
    about an hour ago


    Tony Golding
    As you know AfME has no connection with this proposed piece of research. It will, in any event, have to obtain Ethics Committee aproval like any other medical research project involving patients. And that committee will have to abide by the standards in the MRC document you cite. There is no guarantee that approval will be forthcoming. Why don't you wait until we have a decision? If it does go ahead, your recourse is to complain to the MRC. It's their rules that govern the ethics of research using children.
    about an hour ago Report

    Paul Winter
    I don't think a general statement from AFME about their policy on LP is good enough. Vulnerable children, who cannot give informed consent will be recruited for this trial. LP has not undergone clinical trials on adults, to use children as guinea pigs is wrong. Will AFME raise concerns or are they too worried they might upset Esther Crawley?
    about an hour ago Report

    Paul Winter
    So you don't think AfME should express a view on this then Tony? I thought the charity was set up to advocate for patients. Why wait until it has been approved? Now is the time to raise concerns not after it is approved.

    Could the reason AfME wont say anything is because, as Suzy has pointed out,

    "Dr Crawley Chairs the CFS/ME Clinical Research Network Collaborative (CCRNC)

    Dr Crawley is clinical lead for the Bath CFS service.

    Dr Crawley is a member of the MRC's "CFS/ME Expert Panel" and had been a member of the NICE Guideline Development Group.

    Dr Crawley has recently been awarded considerable sums of funding for other CF and CFS studies in children.

    Sir Peter has a non executive director link with the RNHRD."

    Would this be a reason for keeping quiet? No one is saying AfME are involved in the trial, but we are saying they should ask questions and raise concerns.
    about an hour ago Report


    Tony Golding

    You are missing the point Paul. This project has to pass strict MRC ethical standards. It may not. If it does that will be the time to raise objections.
    about an hour ago Report


    Action for M.E.
    Action for M.E. sees no reason to oppose this pilot study.

    As was made clear when it was announced, the research at this stage is simply a pilot designed to see if it would be possible to set up a trial that can independently assess the Lightning process against specialised medical care.

    It is a fact that many parents are already taking their children to LP practitioners and so there are urgent questions that need to be addressed in order to assure the safety of those children. Dr Crawley’s initiative aspires to find a way of answering some of those questions.

    -----------------

    Edit:


    @ Mr Golding

    In what capacity are you commenting, please? On a personal basis, or for and on behalf of Action for M.E?

    If you are commenting as a spokesperson for Action for M.E. are you in a position to confirm whether this pilot (for which funding has apparently already been secured) requires ethics approval; whether ethics approval has been applied for and if so, whether approval has been obtained or is pending.
  10. Min

    Min Senior Member

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    AfME, who support the NICE guidelines (Dr Crawley helped draw these up!) that only permit psychological interventions for our physical illness, and who fully support the psychological PACE and FINE trials, are not going to object to more yet psychological studies being done, even on children.

    The MRC, who have funded only psychological research, aren't going to listen to objections either.

    The whole thing stinks.
  11. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    I've added the following

    (Note: Golding was/may still be a Trustee/Director of Action for M.E.)


    @ Mr Golding

    In what capacity are you commenting, please? On a personal basis, or for and on behalf of Action for M.E?

    If you are commenting as a spokesperson for Action for M.E. are you in a position to confirm whether this pilot (for which funding has apparently already been secured) requires ethics approval; whether ethics approval has been applied for and if so, whether approval has been obtained or is pending.
  12. Jerry S

    Jerry S Senior Member

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    Thanks for this, valia! I can only read in little bits and pieces these day so videos are helpful.

    Ciaran Farrell really says it all. It's inconceivable to me that anyone would promote LP as a treatment for children with a neuroimmune disease. Yet, it's being done. Mind boggling!

    I also enjoyed the shots of Hyde Park in the background. :Retro smile:

    Best wishes,
    Jerry
  13. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    http://www.facebook.com/actionform

    Facebook Wall


    Paul Winter
    One thing is for certain when it comes to AfME - They are predictable!

    Suzy Chapman
    @ Mr Golding

    In what capacity are you commenting, please? On a personal basis, or for and on behalf of Action for M.E?

    If you are commenting as a spokesperson for Action for M.E. are you in a position to confirm whether this pilot (for which funding has apparently already been secured) requires ethics approval; whether ethics approval has been applied for and if so, whether approval has been obtained or is pending.


    Tony Golding
    You may calll me Tony Suzy! You have asked me this question before and my answer remains the same. I post and comment here in my personal capacity, as I imagine you and everyone else does.


    Tony Golding
    I should have added, as a personal view again, that I know from my local group work several people who have benefited from LP. And these were definitely people who had had full-blown ME for some time. I am naturally sceptical of LP but I can't deny the evidence of my own eyes and ears that it does seem to work for some PWME. I believe one should keep an open mind on the subject. Just my opinion, nothing more!

    Suzy Chapman

    @ Tony

    In a personal capacity, then, are you in a position to confirm whether this pilot (for which funding has apparently already been secured):

    a) requires ethics approval;
    b) whether ethics approval has been applied for;
    c) whether ethics approval has been obtained or is pending?


    Tony Golding

    I have absolutely no idea of the answers to these questions in any capacity....why should I? You need to ask the researchers proposing the project.

    Personally I'm signing off for Easter.....


    Suzy Chapman

    RNHRD is being approached for clarification, but you had written:

    "It will, in any event, have to obtain Ethics Committee aproval like any other medical research project involving patients. And that committee will have to abide by the standards in the MRC document you cite. There is no guarantee that approval will be forthcoming. Why don't you wait until we have a decision? If it does go ahead, your recourse is to complain to the MRC. It's their rules that govern the ethics of research using children."

    which suggested that you were informed around the current status of the pilot's ethical approval. Since you are evidently not then you are not in a position to comment on its status.... See More

    Enjoy your Easter. Don't bite the heads off too many chocolate bunnies...

    -----------------
  14. fred

    fred The game is afoot

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    Is there not some ethical conflict here between Sir Peter Spencer's role as CEO of AfME (for which he receives a salary) and his role as non Executive Director of the Royal National Hospital for Rheumatic Diseases (the MIN) (which has been awarded funding for the proposed study) ? How can AfME remain impartial in assessing the effectiveness and relevance of a research proposal if its own CEO is on the board of an institution which is handling that research proposal?

    It is also confusing to find that both Sir Peter and Dr Crawley are members of the CFS/ME Expert Group of the Medical Research Council (which provides funding for psychosocial ME research only) and yet the funding for the LP research has been granted by the Ashden Trust and Linbury Trust, two charitable trusts of the Sainsbury family.

    In addition, AfME has awarded 49,650 to Esther Crawley (at the MIN) for "Creating a National Outcomes Database for adults and children with chronic fatigue syndrome or ME (CFS/ME) (2009-2010)". Would a more effective use of this funding not have been to trial biomedical research that could have been used to convince the MRC of the need for, and value of, such studies?

    Here is a list of grants to Esther Crawley taken from the Univeristy of Bristol website.

    http://www.bris.ac.uk/ccah/grants/

    In particular, one might question the 'value for money' of the NIHR Clinician Scientist Fellowship grant in the event that XMRV is proven to be a biomarker for ME.

    E Crawley (PI) 12,000 from Bath Unit for Research in Paediatrics (BURP). Memory and concentration/attention problems in children with CFS/ME (2007-2008).

    E Crawley (PI) 150,000 from The Linbury Trust. Chronic fatigue syndrome (CFS/ME) in young people (2007 – 2008).

    E Crawley (PI) 5,000 from the RNHRD charitable funds. The impact of CFS/ME on families (2008 to 2009)

    E Crawley (PI) 49,650 from Action for ME (AfME). Creating a National Outcomes Database for adults and children with chronic fatigue syndrome or ME (CFS/ME) (2009-2010)

    E Crawley (collaborator, PI Prof Lewis)) 648,184 from Welcome “Depression at 17: ALSPAC” (2008-2009) not started yet

    E Crawley (PI) 873,579. NIHR Clinician Scientist Fellowship “Evidence based prevention identification and treatment of CFS/ME” (2009 – 2014)
  15. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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  16. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    I'll be putting in an FOI over Easter.
  17. Dolphin

    Dolphin Senior Member

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    Apologies if this was highlighted before but that looks like the silver bullet which could stop the trial. Esther Crawley is a paediatrician so will want to do it on children. She also has the 700,000 to be a researcher which is possibly one of her motivations - other NHS professionals might be less interested in running such a trial.
  18. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Seeking SACHS Research Ethics Approval

    The only information we have so far on the design of this pilot study is:

    "Esther and her team will carry out a pilot project to investigate whether it is possible to look at two different approaches to the intervention and treatment of Chronic Fatigue Syndrome/ME (CFS/ME) in Children."

    "The team will carry out a pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care. This will be the first study of its kind in this area, and the team hopes to establish a basis for a larger scale multicentre research project."

    "The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Royal National Hospital for Rheumatic Diseases."

    It remains to be established which Research Ethics Committee(s) this pilot is obtaining/has obtained ethics approval through. I'm told that more than one body might be involved.

    I have this week made enquiries of the South West Office of the National Research Ethics Service.

    I have asked:

    "If a member of the public, a patient organisation or other stakeholder in the project (other than individuals directly involved with the carrying out of the project or involved as potential participants in the project) had concerns about whether that project should have received ethics approval is there a mechanism through which a review of the decision that led to approval can be requested?"

    I may approach the lady who started one of the other LP threads to enquire whether her child was expected to complete the application form and if not, whether the parent was required to complete on the child's behalf and if not, on what basis their "coach" assesses a child for "readiness" and how a child's health status prior to commencing the "training" was assessed by the "coach" (see last section of Application form) - if this member would be comfortable providing this information.

    From the website of University of Bristol (refer to site for clickable links):

    http://www.bristol.ac.uk/sachs/research/ethicsapproval.html

    Seeking SACHS Research Ethics Approval

    Which Committee should I apply to?

    Procedures for applying to the SACHS Research Ethics Committee

    What will the Committee be looking for?

    Research Governance Policy and insurance

    Dates of Committee Meetings

    Examples of materials

    Which Committee should I apply to?

    Ethical approval is normally required for all research carried out in the SACHS. This includes research involving face-to-face interaction, postal surveys, telephone interviews, and internet surveys.

    However, projects that involve participants recruited through the NHS, involving NHS staff, or using NHS premises must seek ethical approval through NRES (now IRAS). SACHS REC cannot grant approval for NHS-related research.

    In reality, ethical approval can be obtained from any formal research ethics committee and where research is conducted away from the university such as in another city this may be worth consideration.

    SACHS staff
    All staff research projects requiring ethical approval need to be submitted to SACHS REC. Some projects, usually where they cross international boundaries, may be referred to the Faculty research ethics committee.

    Research students
    All PhD, EdD, and MPhil projects requiring ethical approval need to be submitted to SACHS REC. An exception is EdD first year projects which are dealt with by the Norah Fry REC.

    Masters and undergraduate students
    Masters and undergraduate dissertations requiring ethical approval need to be submitted to the relevant department REC. Details are available on departmental websites.

    Other considerations
    Researchers collecting data overseas must obtain evidence that they have satisfied research ethics approval requirements for that country.

    No recruitment or data collection can take place until an ethics registration number or letter of approval has been received.

    (Back to top)

    Procedures for applying to the SACHS Research Ethics Committee
    Applicants must submit one electronic copy by email and one unstapled, single sided paper copy of their application form and all accompanying documentation to Luana Gaddeo (L.S.Gaddeo@bristol.ac.uk) by 4.30pm on the deadline date. Application received after this time will not be considered until the following months meeting. Please ensure that all relevant signatures on the application form are in place BEFORE submitting your application.
    (Back to top)

    What will the Committee be looking for?
    Does the application satisfy the following criteria?

    26 pointers you should consider before submission:

    1. The application is clear, complete, easy to understand, and competently written enabling the committee to make its judgements

    2. The application indicates where the research involves participants from vulnerable groups which include children, older people, those with mental illness.

    3. The application establishes that overall the likely benefits of the research outweigh the risks (if any) to the participants.

    4. The research address a worthwhile question.

    5. The quality of the research design and procedures is good enough to justify the burden placed on the participant

    6. In the case of students or an inexperienced researcher, the investigation has an identified supervisor or experienced co-applicant.

    7. The possible risks to participants are no greater than they would normally encounter in their life outside research. If they are greater, then participants are adequately informed and safeguards are in place to minimise any harm.

    8. The degree of discomfort, distress or deception, if any, are fully foreseen and explicitly described.

    9. Where participants have diagnosed illnesses or conditions, particularly with children, adequate care is taken not to label the individual or assume that they are aware of their condition.

    10. Where an approach to participants is being made through an existing data base of contact points, there is a guarantee that participants have given permission to be approached by a third party If not, any invitations to participate must first be through the keeper of the data base (such as head teacher) rather than the researcher.

    11. There is no coercion in the recruitment of participants (as might occur where researchers are in a position of authority or power over participants) and right to withdraw is made clear.

    12. Sufficient consideration has been given to power imbalances where participants may feel obliged to please or comply with the researchers requests.

    13. There are clear boundaries made between professional/clinical and researcher roles. The participant must be in no doubt that the research is separate from any professional service they may also be involved with.

    14. Appropriate referral or back up procedures are in place where material is sensitive and potentially upsetting for the participant.

    15. Appropriate procedures and materials (ie information sheet) are in place for informing participants about the research study and their part in it. It is critical that the material is presented in a form and at a level that can be clearly understood by participants.

    16. Appropriate procedures and materials (ie consent form) are in place for obtaining consent from participants. Children can provide assent (agreement) but consent is also obtained from parents or guardians.

    17. Each procedure that the participant is being asked to take part in (interviews, questionnaire, observations) has a separate indication through a check box format.

    18. Additional materials including data collection tools such as questionnaires and interview protocol are provided so that the committee can make a judgement of ethical implications.

    19. Anonymity and confidentiality is assured and appropriate procedures are in place, particularly where small groups are involved or observation is used and the potential for identification is high.

    20. Procedures for obtaining express permission are in place where access to confidential records is involved.

    21. Evidence that the project has been registered for governance and sponsorship (where appropriate) with Research and Enterprise (RED) (see governance and sponsorship guidance).

    22. Unless sponsored by an organisation other than University of Bristol, all relevant letters and materials are on UoB headed paper.

    23. Additional safe guards (such as CRB check, option for parents to withdraw children) are in place for vulnerable populations including children, people with learning and communication difficulties, patients in hospitals, in care, custody, or probation, and engage in illegal activities such as drug abuse.

    24. Where the research requires one individual to conduct data collection on remote sites such as homes, a lone worker policy is described.

    25. Feedback from the research is provided for participants in an appropriate form that is brief and accessible.

    26. Statements about anonymity being maintained or assured may need qualifying. If there is disclosure by participants that individuals are harming or being harmed, then appropriate authorities need to be informed. Similarly, if research reveals previously unknown medical problems then doctors may need to be informed.


    Further sources:

    The British Psychological Society: Ethical Principles for Conducting Research with Human Participants http://www.bps.org.uk/the-society/ethics-rules-charter-code-of-conduct/

    ESRC Research Ethics Framework. http://www.esrc.ac.uk/ESRCInforCentre/Images/ESRC_Re_Ethics_Frame_tcm6-11291.pdf

    Public Health: Ethical Issues. Nuffield Council on Bioethics. http://www.nuffieldbioethics.org

    (Back to top)

    Research Governance Policy, sponsorship and insurance
    Ethical approval is not the only thing you need to consider before starting your research!

    The university ultimately is responsible for governance, sponsorship and insurance of research conducted by staff and enrolled students and so needs to know about any research project that:

    Involves human subjects (in the case of SACHS this means just about everything).

    Where research funders require a formal sponsor.

    The form for registering your research with Research and Enterprise Development (RED) can be downloaded from http://www.bris.ac.uk/research/support/governance/ .

    All SACHS research ethics committees require evidence that research projects have been considered for governance, sponsorship and insurance. The procedure for most ethics applications will be:

    1. Complete and submit the registration form to RED before ethics submission.

    2. RED will issue a registration e-mail.

    3. Submit a copy of the RED email with your ethics submission.

    Insurance issues are paramount where there is significant risk to participants.

    You must inform Ginny Hope (ginny.hope@bris.ac.uk) if your research falls in one of the following categories:

    1. It involves NHS staff, patients or premises and therefore is requiring an NRES research ethics submission

    2. Research where the university is acting as the formal sponsor

    3. Research involving children under 5 years old, pregnant participants, pregnancy, contraception or conception

    4. Research into HIV/AIDS or CJD

    5. Research involving the design and/or manufacture of a product to be tested

    6. Research involving genetic engineering

    7. Research involving prohibited substances such as cannabis, ecstacy.

    8. Clinical research overseas

    9. Any other research that you feel may present a significant risk (eg running participants to maximum on a treadmill).

    If your research is a masters or undergraduate dissertation, your department may have a system where your department ethics committee is able to offer governance clearance on behalf of RED

    (Back to top)

    Dates of meetings & deadlines for applications
    Date of meetings
    Deadline for applications
    21st September 2009 14th September 2009
    12th October 2009 5th October 2009
    16th November 2009 9th November 2009
    7th December 2009 30th November 2009
    18th January 2010 11th January 2010
    15th February 2010 8th February 2010
    15th March 2010 8th March 2010
    19th April 2010 12th April 2010
    17th May 2010 10th May 2010
    14th June 2010 7th June 2010
    12th July 2010 5th July 2010

    (Back to top)

    Examples of materials
    SACHS Research Ethics Application Form

    Research Registration Checklist

    Self Assessment Questionnaire for Researchers Using Personal Data

    Information Sheet Template

    Consent Form Template
  19. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    She has apparently secured separate funding of 164,000 (Linbury Trust and Ashden Trust) for this proposed trial which will also (according to the Press Release):

    "...This research also incorporates the first study on health economic cost of this condition in children."
  20. valia

    valia Senior Member

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    UK

    You are most welcome Jerry, I have the same problem.

    I only had a vague idea what LP was about, but Ciaran Farrell paints a very clear picture

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