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[Not important] 2010 SMILE correspondance between Crawley and REC now seems to be off-line at Bistol Uni

Discussion in 'PsychoSocial ME/CFS News' started by Esther12, Jan 6, 2018.

  1. Esther12

    Esther12 Senior Member (Voting Rights)

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    I'd just noticed that this was available via Google cache, but not on the Bristol website, so thought I'd back up a copy here. Once I'd got through dong that, I realised I could just link t the waybackmachine copy:

    https://web.archive.org/web/2014030...gue/correspondencewithethics/letrep28july.pdf

    Original link: http://www.bristol.ac.uk/ccah/resea...gue/correspondencewithethics/letrep28july.pdf

    Nothing in this stood out to me, but it's annoying when things disappear from the internet.

    Page 1
    1
    Centre for Child and Adolescent Health
    Hampton House
    Cotham Hill
    Bristol
    BS6 6JS
    28th July 2010

    REC reference number 10/H0206/32

    Dear Mr Ashby,
    Thank you for the feedback received from the South West Research Ethics committee
    after the meeting on the 8th of July 2010. We are grateful for the time spent on this

    proposal by the Ethics committee which we feel has improved this study.
    We have answered the questions raised by the Ethics committee and enclose the
    documents with tracked changes and with changes accepted so you can easily see what
    the final documents will look like. A table at the end of this letter lists the documents
    changed with their new name, version number and date as applicable.

    Further information required or clarification required. Qs 3,7,10,14,16 and 17 above
    should be confirmed and addressed

    Q3. If they choose to be interviewed at the hospital will you pay their travel
    expenses?

    Yes, when required

    Q 7. Will the researchers and the Lightning people all have CRB checks?
    Yes. We have altered the Parent patient information sheet and the Teenager patient
    information sheet to reflect this. This now has the following section added before the
    privacy section:
    “Does everybody involved in the study have the appropriate police checks?
    Yes”

    Q 10. It should be made clear in the PIS that confidentiality will be broken if
    concerns are found with the child’s welfare and t will be reported to the Child
    Protection Officer at the Trust.

    If we have concerns over child protection, we will follow the hospital child protection

    pathway specified by the Royal National Hospital for Rheumatic Diseases. The pathway
    varies depending on the nature of the concern and on whether the concern is raised during
    working hours or out of hours. In some cases, it may be necessary to talk directly with the
    appropriate on call social worker. We have added the following to the Parent information
    sheets to cover all eventualities in the section entitled your privacy:
    “As with any child being seen in clinic, if we have concerns over your child’s welfare. we
    may have to break confidentiality In some cases, we may have to discuss your child with
    another professional such as a social worker or child protection officer.”
    I have added the following to the Teenager information sheet:
    “If you tell us something that makes us worried about your safety, we may have to discuss
    this with somebody else as we need to be sure you are safe. This means, what you say
    would not be kept completely private. We would do the same if you told us something in
    clinic.”

    Question 14. Could there be some 16-17 year olds who are married or employed.

    Although our service will provide assessment for young people aged 16 to 18, the service
    will only see young people in this age range if they are still in school or want to go back to
    school. Young people who are employed and not in school are offered assessment by the
    adult service as they are able to offer the appropriate advice about return to work.
    Our paediatric service has not previously assessed a married young person who has been
    at school. If this happened however, we do not believe this would affect the study.

    Question 16. Teenagers over 12 years old if competent are able to give their own
    consent, but all the forms are entitled consent when it should say Assent.

    We agree. We have changed the Consent to Assent in all the forms used for those aged
    under 16 (please see table at the end of this letter for details).

    Question 17. The PIS is very muddled, long and complicated some of which the
    children will struggle through. There is little difference in Adult and Children’s PIS.
    There should be a specific teenagers PIS and a flow chart would help to make the
    process clearer.

    We have added a patient flow chart to both the Parent PIS and the Teenager PIS.
    On the teenagers PIS, in addition to the changes detailed below we have also made the
    following changes to lower the reading age for younger teenagers: “alternative” to
    “different”, “opportunity” to “chance” and “observe” to “watch” on page 2; “the daily
    seminars” to “Each day the course”; on page 3. I have changed “intervention options” to
    “interventions” on page 3; deleted “intervention” paragraph 5 on page 3,”; changed
    “approximately” to “about” page 4; changed “interventions” to “sessions” page 4; and
    “evaluated” to “tested” on page 5, changed “anonymous” to “private” page 6.
    We have tried to explain “interventions” the first time it is used by adding “(ways to help)”.
    In the paragraph on randomisation (second paragraph page 3) we have added “(in other
    words, by chance)” after randomly allocated to explain this. We have changed “(in other
    words by chance)” at the end of the paragraph to “This is the same as rolling a dice”.

    The PIS 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.

    This may be a difficult study to understand and we have therefore allowed time for both
    clinicians and the research nurse to go through the PIS with both the young people and
    their parents to ensure full understanding of the study prior to taking part.

    You have also asked for responses to the following:
    1. Further clarification is required on how the young people and parents are to
    be recruited; when and where will they receive the PIS and how will
    willingness to participate be obtained.

    In the recruitment section of the protocol, we have changed “Children and their families
    will be identified ” to “Eligible children and their families will be identified”. We have then
    clarified that both the children and their parents will be given the patient information
    sheets by adding “give both the young person and their parents the relevant patient
    information sheets. The clinician will check that the young person and their family are
    willing to be contacted by the research nurse and the researcher and will obtain
    consent …”

    In the section on randomisation we have added “the research nurse will ascertain
    willingness to participate and will check that both the young person and their family
    understand the study.”

    2. There seems to be some explanations missing from the PIS; young people
    are asked to consent for schools to be contacted but there is no explanation
    of how and why this is to be done.

    We have added this sentence to the Parent patient information sheet on p4:
    “We will also contact your child’s school at assessment and at each of these follow up
    time points to find out how much school they are attending.”

    We have added this sentence to the teenager patient information sheet on p4:
    “We will ask your school about how much you have been at school when we first see
    you and at follow up.”

    3. It is still unclear how the consent forms are to be used and further
    clarification is required.

    We have added the following in the Protocol to the paragraph on Ethical issues which
    discusses the care we have taken to ensure there are rigorous procedures for
    obtaining further consent/assent:

    “In the clinic, the clinician will ask for consent/assent for contact by a research nurse
    and qualitative researcher from both the young person and their parents.
    Consent/assent to the study and to randomisation will be obtained by the research
    nurse after a full explanation of the study when both the young person and the family

    have had sufficient opportunity to ask questions. Young people and their families will
    be given as long as they need before giving consent/assent within the confines of the
    study. We will then obtain further consent/assent prior to each interview to check that
    young people and/or their parents continue to be willing to participate. We will also
    obtain consent/assent prior to recording any interventions from all present.”

    4. The title in the study is lost in all the print at the top of the page it needs to be
    differentiated from the rest.

    We have put extra spaces above and below the title and increased the font size to 16
    on both the Parent and the Teenager PIS to help differentiate the title from the rest of
    the print.

    5. The title of both parent and teenager PIS does not clearly say this is a trial or
    for which condition. It needs clarification in the heading.

    We have added the following sub heading to both Parent and Teenager PIS:
    “Feasibility randomised controlled trial for Chronic Fatigue Syndrome/ME”

    6. The adult version needs shortening.

    We have deleted the following from the adult version:
    Page 1, paragraph 1: “it is possible to do a study investigating” and “to do this, we need
    to know whether young people will take part in a study”.
    Paragraph 2 “more”; “we are particularly interested in” “of both interventions”
    Paragraph 3 “as part of this study” “also try and”
    We have changed the paragraph under the title “what we are asking you to do” which
    describes the interviews to include all three possible interviews by adding “and during
    the study (on no more than three occasions)…and then “and about your experience of
    each type of intervention. I have moved “your child will be interviewed at one of these
    time points for approximately 20 minutes” to this section. This then allows me to delete
    the first paragraph under Group 1 and Group 2.
    Page 4, paragraph 2: I have deleted “to find out more about both interventions”
    Page 7, paragraph 2: I have deleted “sometimes during the course of a research study,
    new information becomes available about the interventions that are being studied. If
    this happens,” and replaced this with “if new information becomes available”

    7. The invitation tells participants which is happening but gives no full
    description of CFS or ME at the first mention. In the introduction it presumes
    that they know what current treatment, the Lightning Process and the
    abbreviations are and although the Lightning Process is explained later it
    may be appropriate to give a brief outline at this point.

    We have replaced CFS/ME with Chronic Fatigue Syndrome or Myalgic encephalopathy
    (CFS/ME) in the first sentence on both parent and teenager PIS.

    We have moved the description of Specialist Medical care in both PIS from the

    description of the two arms to page 1. We have also added the sentence “Specialist
    Medical Care is the current treatment children normally receive if they have CFS/ME.
    After their assessment, they”…..
    The Lightning Process is described at the earliest opportunity after Specialist Medical
    Care.

    8. Need to explain exclusions under “why has my child been asked to take
    part?” (is included in the but one paragraph but is better placed under the
    above heading)

    We have moved the paragraph about exclusions from the “Who should not take part in
    this study” to the “Why has my child been asked to take part” in the Parent information
    sheet and done the same move in the information sheet for Teenagers. We have
    deleted the heading “who should not take part” in both information sheets.

    9. They should be told they are free to withdraw and withdraw their information
    at any point in the study.

    We agree that we should clarify throughout that parents and children can withdraw at
    any stage. We have added this to the "consent for interview sheet" (see question 19
    below). At the moment, we discuss withdrawing from the study in detail in section 2 of
    the parent and the teenager information sheet under "what will happen if I don't want
    to carry on with the study".

    We agree that we should clarify the fact that parents and teenagers can withdraw at
    any point to section one of both the parent and the teenager information sheet and
    have added this to the section "does my child have to take part".

    We have considered carefully the issue of withdrawing information at any point in the
    study when a participant withdraws. We will accommodate this requirement as much
    as possible, but there are practical limitations to promising withdrawal of data at any
    stage of the research. For example, it would not be possible to withdraw information
    after publication, and withdrawal of qualitative information after analysis would be
    extremely difficult, if not impossible. This is because once thematic analysis has been
    performed, we cannot withdraw an individual quote and be sure it hasn't already
    affected the themes as each quote affects the thematic analysis.

    Withdrawal of demographic data would be highly problematic and would threaten the
    validity of the study. The primary goal is to look at whether the trial is feasible or
    acceptable. Because the main overall objective is to study is to study recruitment, if we
    were to withdraw demographic data (which is anonymised at source), we would be
    unable to achieve our primary goal. This is because we need to compare those that
    are recruited with those that are not recruited and look at post randomisation drop out.
    In addition, this demographic data are currently collected on all children who are seen
    by the service to enable us to evaluate the service. The North Somerset & South
    Bristol Research Ethics Committee decided that the collection and analysis of these
    data was part of service evaluation and as such did not require ethical review by a
    NHS Research Ethics committee or approval from the NHS R&D office (REC
    reference number 07/Q2006/48).

    We would be happy to withdraw the qualitative information collected at interview on
    children and parents prior to analysis if they wished us to do so.

    We have therefore added the following to the parent information sheet: "Your child can
    withdraw at any point in the study. Your child can withdraw their information collected
    at interview at any point in the study before analysis" to the second paragraph under
    "does my child have to take part."

    In the teenager information sheet in the same place I have added: "You can withdraw
    from the study at any point and if you want us to we will take out the information
    collected at interview at any point before we carry out data analysis"

    10. It should include possible benefits for parents e.g. may find it helpful to talk
    to others about their experiences.

    We have added “although some parents may find it helpful to talk to others about their
    experiences” to the section on “benefits of joining in” on the adult form only.

    11. Needs to explain why they are informing their GP.

    In the parent information sheet in the section “who will know I am taking part in the
    study” on the last page we have changed “we would like to let your GP know that your
    child is taking part in the study” to “we think your GP should know about the
    interventions your child receives”.

    In the same section for the teenager information sheet we have added the following:
    “because they need to know what happens to you”.

    12. Explains privacy/confidentiality well but need to warn potential participants of
    the situations which may mean that they have to break confidentiality.

    Please see the answer to question 10 on the first page of this letter.

    13. The teenager version needs significant modification for a young audience
    that starts at age 12 and the information needs to be much more concise.
    Words/phrases such as intervention, seminar, randomly allocated etc need to
    be explained or re phrased.

    Please see the response to comment 17 on the first page of this letter.

    14. A flow chart for each group would make clear what is happening and when.

    This has been added.

    15. There is no information of who is conducting the Lightning Groups and where
    they will be held.

    We have added the following information to the first section on the parent information
    sheet in the first section about the Lightning Process (page 2):
    The course is run by a Lightning Process Practitioner who is trained and licensed to run
    the course. The courses will be held somewhere near you, either in a clinic or hospital,
    or in a hotel or community hall.
    We have added the following information to the same section of the teenagers
    information sheet:

    “The course is run by a Lightning Process Practitioner who is trained and licensed to
    run the course. The courses will be held somewhere near you, either in a clinic or
    hospital, or in a hotel or community hall. Where ever it is held, it will be suitable for the
    course and for young people your age.”

    16. It is suggested that the PI be broken down into two elements to aid
    understanding: First stage: the interview to obtain knowledge about what
    people know about Specialist Medical care and Lightning, and an opportunity
    to hand out information on the main study. Second stage: the work looking at
    the two groups

    We have broken down the “What are we asking you to do” section on the PIS for both
    the teenagers and the parents to two elements and inserted “First stage” to the first
    paragraph.

    We have then added the following before the second stage in the teenagers PIS:
    “Second stage: In the second stage you will be part of group 1 which is Specialist
    Medical Care) or group 2 which is Specialist Medical Care plus the Lightning Process”
    In the parental PIS we have added the following:

    “Second stage: In the second stage you child will be part of group 1 which is Specialist
    Medical Care) or group 2 which is Specialist Medical Care plus the Lightning Process.”

    17. Consent for under 16 years needs permission to inform their GP

    We have changed “I know that you will tell my GP…” to “I agree that you will…”

    18. Consent to record intervention – the title is not clear for whom this is
    intended.

    We have added the following in to the title “ for participants, parents and those
    delivering interventions”

    19. Teenager consent to interview – 1. Whilst it says that participant can stop the
    audiotape or ask for the interview to stop without explanation, it does not tell
    them explicitly that they can withdraw at any time.

    After the sentence on stopping the audiotape, we have added the following: “I know that

    I can withdraw from this study at any time.”


    2. The title does not clarify specifically what age group is included in this. Meant
    for 16 to 18 years whereas the definition of teenager is anyone older that 12
    years.

    We have clarified in the title that this is for those aged 12 to 18 by adding (12 to 18) in the title

    [continued in next post]
     
    TiredSam, Cheshire, Valentijn and 3 others like this.
  2. Esther12

    Esther12 Senior Member (Voting Rights)

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    20. Teenager consent to study – “I know that my school records will be checked”
    needs to be replaced with “I agree for my school records to be checked”.

    We have changed “I know” to “I agree”.


    21. Child Consent form for evaluation – 1. Needs to be entitled “Assent”.

    We have changed all the consent forms for those under 16 to Assent in both the title of
    the file and in the title at the top of the form.

    2. I know that my school records will be checked”/”I know that you will tell my
    GP…” needs to be replaced by “I agree for my school records to be checked.
    And “I agree that you may inform my GP…”

    We have changed “I know” to “agree” in both places

    3. Do 13, 14, 15 years olds really want to be called children as title, would it not
    be better to entitle “assent for under 16 years”.

    We have changed the title from “Child Consent form” to Assent form for those under
    16”

    22. Child consent to Contact – 1. Needs to be entitled “Assent”. 2. Again do
    13,14, and 15 year olds really want to be called children as title, would it not
    be better to entitle “assent for under 16 years”.

    We have changed Child consent to contact to Assent to contact for under 16s:

    23. All Consents/Assents for under 16years and over 16 years need to include
    something which allows them to give their permission for their
    parents/guardian/carer to give their views about them.

    We have added the following sentence to the Assent to contact for under 16s, the
    Assent to study for under 16 year olds; the consent to contact for 16 to 18 year olds
    and the consent to study for 16 to 18 year olds:


    “I agree that you may talk to my parents/guardian/carer about me”


    All consents are given overall headings of “CFS/NHS/Paediatrics – specialist
    help for ME. This is confusing (CFS versus ME) and may not be readily
    understood by all. (E.g. will everyone know what “paediatrics” means.

    This is the title used on letters and information sheets from our service. An explanation
    is given in the introductory leaflet that is sent to the families prior to the clinic visit. All
    young people and families recruited will have received clinic letters and the introductory
    leaflet prior to being recruited to the study.

    Training Assessment Form for Participants:

    24. Page 4 Q12 asks young people “are you analytical?” This needs further
    explanation especially for the younger age range.

    We have added the following after the word analytical as an explanation.

    (do you spend a lot of time questioning and examining things)?

    The paragraph afterwards also elaborates on the meaning of the question.


    25. Page 5 states at the top “if you are 18 years or under please ask your
    parent…and they also agree…to sign the form too”. This should state “under
    16 years”.

    We have changed both the title at the top and the paragraph below on page 5 from
    under 18 to under 16.

    26. The pages should be numbered

    We have numbered the pages

    Health Survey

    27. Some of the activities do not relate to young people (especially for the
    younger participants) e.g. Q4 pushing a vacuum, bowling, playing golf, lifting
    or Q5 carrying groceries, Q13 time spent on work, Q22 normal work. This
    needs to make items more young person focused or add a column to say
    “never done this”.

    Thank you for your thoughts on this. We initially tried to use the CHQ on children
    (developed for children but not tested head to head with the SF36) with CFS/ME but
    they told us the activities were not relevant and it did not adequately reflect their
    disability. We therefore changed to the SF36 on the request of the children in our
    service and have now used this for 6 years in over 1000 children with CFS/ME. We
    rarely have missing data on this reflected in our publications.

    We understand that changing the SF36 has in the past provoked the threat of legal
    action and we remain concerned about changing a validated inventory that we have
    already used extensively on this cohort both clinically and for our previous research.
    There are risks to interpreting findings and comparing with other published work if we
    change the inventory.

    During this study we will examine young people’s views and understanding on
    completing the SF36 (and other inventories) and will be able to find out if there are
    issues over the interpretation of the questions. If there are, we intend to use this to
    apply for further funding to develop a CFS/ME measure of severity.

    We would respectfully request that we are allowed to continue to use this well
    recognised and validated inventory in this group of patients.

    Please find below a table listing the original and revised version numbers and dates of the
    documentation that has been changed in the order listed your original letter:


    Original title
    Version Date
    New title
    New
    version
    New date
    Protocol
    5
    10 May 2010
    v6
    July 2010
    Phil Parker Training
    assessment form
    20 May 2010
    v2
    July 2010
    Information leaflet for
    parents
    v4
    10 May 2010
    v5
    July 2010

    Teenager consent to
    study
    v3
    10 May 2010
    v4
    July 2010
    Information leaflet for
    teenagers
    v4
    10 May 2010
    v5
    July 2010
    Teenager Consent to
    interview
    v3
    10May2010
    Teenager (12 to 18)
    consent/assent to teenager
    interview
    v4
    July 2010
    Child consent to study
    v3
    10 May 2010
    Assent to study for those
    under 16
    v4
    July 2010
    Child consent to
    contact
    v3
    10 May 2010
    Assent to contact for under
    16s
    v4
    July 2010
    Consent to record
    intervention
    V3
    10 May 2010
    Consent/assent to record
    intervention for participants,
    parents and those delivering
    interventions
    v4
    July 2010
    Teenager consent to
    contact
    v3
    10 May 2010
    v4
    July 2010

    Thank you again for considering this study and for the Ethics Committee’s input in
    improving this study.
    Yours
    Esther Crawley
    Senior Clinical Lecturer, Centre for Child and Adolescent Health, University of Bristol
     
  3. Luther Blissett

    Luther Blissett Senior Member (Voting Rights)

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  4. Amw66

    Amw66 Senior Member (Voting Rights)

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    I am a little dumbfouded by this. From a research team who have conducted the volume of research with children that they have, i would not have expected these kinds of questions to be raised? Ethics are clearly an issue.

    Is this just me?
     
  5. Adrian

    Adrian Administrator Staff Member

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    I think this was the first trial they had done.

    But they do seem somewhat basic and I would have thought should have been picked up with an internal review. I think sloppy stuff should raise issues with the ethics committee and mean they look more carefully but in this case they didn't seem to look carefully at all.
     

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