Esther12
Senior Member (Voting Rights)
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]
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]
