AML 17 Trial: Parent Information Sheet and Consent Form 9
(Ref: ISRCTN55675535)
Sample Donation to Research
You have agreed for your child to enter a clinical trial devised by the National Cancer Research Institute Haematological Oncology Study Group. You have already had an Information Sheet giving you an overview of the trial and also about the initial treatment options. You have and signed separate consent forms.
You are now being asked to consent to some of your child’s bone marrow and/or blood samples which are taken for assessment of the treatment to be stored and used in further research into leukaemia. You child is not being asked to have extra blood or bone marrow samples taken, but only for some of the sample from your diagnostic and monitoring tests to be stored after the tests we need to do have been done.
Normally any blood or marrow that is left over after doing the normal tests is destroyed. It is this left over bit of blood or marrow that we want to be able to keep so we can use it for research on how leukaemia develops or for testing new treatments.
Your child may also be asked to give a gentle scraping or rub from the inside of their cheek which would allow us to compare some changes in the leukaemia cells with normal cells from the same person. This is completely painless.
Background
Acute leukaemia is a form of cancer of the primitive or developing cells that would normally make the blood cells or cells of the immune system. The rules that allow these cells to develop normally are written in genes in DNA which is inside nearly all of our cells. DNA is chemical code that makes up the genes which code for the proteins and it is these proteins that tell a cell what to do or how to behave. Leukaemia (and other forms of cancer) are caused by changes in the DNA of a cell causing mixed up instructions.
Some of the changes that occur in leukaemia are known but the overall picture is still unclear. More research is needed to improve our understanding of what is wrong and hopefully to use better treatments.
The research currently in progress includes the analysis of gene abnormalities that can contribute to the development of leukaemia or affects its response to treatment. In addition some of the research focuses on how normal blood cells are made as understanding this better will allow us to understand what has gone wrong in leukaemia. Some other research is in the area of testing new drugs or combinations in the labs to see if the are likely to work in patients.
As part of the diagnosis and treatment monitoring of your child’s leukaemia a sample of bone marrow has been taken, and other samples will be taken as part of your child’s routine care. Your child is now being asked to donate what is left over of this and future samples for this type of research. This will be put into a “cell bank” for use at a later date by scientists working on leukaemia.
Your child’s sample will be given a code number so that their name will not be known to these scientists.
When the scientific results are analysed we may need to correlate the results with the clinical details that are collected as part of the trial that your child is already participating in these include age, gender, previous medical history, the characteristics of the leukaemic cells, and your child’s response to treatment. Strict confidentiality will be maintained at all times, by using the code number allocated to your child’s sample. Your child’s name will not be recorded on the stored sample.
As the samples are put into a 'bank' they could remain there for a long time and be used in future research many years hence. The custodian of this bank is ultimately the trial “sponsor” which is CardiffUniversity, who have devolved this to a storage facility at key reference labs in London and Cardiff. These cell banks are regulated and licensed under the Human Tissue Act for this purpose.
We do not know what questions will be asked about how leukaemia develops or is treated in the future but the research will relate to the understanding of blood formation, leukaemic change, response to therapy or the development of new treatments. Requests for use of material from the bank will receive scientific assessment from a group of expert haematologists with experience of research. It is possible that some of your child’s samples could be provided to commercial companies working in this area to develop new tests or treatments. If this happens, you will not benefit financially from this, and nor will the custodians of the leukaemia bank or the trial co-ordinators.
It is unlikely that your child as an individual will benefit from the research carried out because it often takes many years to move from the first scientific discovery to clinical application. Nothing will be done with these samples that is detrimental to your child’s interests. No attempt will be made to find out more details about your child’s medical history without explicit consent from you or your family.
You should also understand that:
Allowing your child’s sample and the coded information about your child to be used for research is entirely voluntary.
You may have your child’s sample removed from the bank at any time without giving a reason.
Declining to give your child’s sample for research, or asking for its subsequent removal from the bank, will in no way affect your child’s relationship with their doctor or the care your child receives, or their participation in the trial. In these circumstances the excess material will be discarded.
Contact for Further Information
Further information can be obtained from your local organiser (Principal Investigator) or the UK organiser (Chief Investigator) whose addresses are given below.
Chief Investigator:
Prof Alan Burnett
Department of Haematology
UniversityHospital of Wales
Cardiff
CF14 4XW
Tel: 029 2074 2375
e-mail:
CONSENT FORM 9
FOR
Acute Myeloid Leukaemia 17 Trial
(Trial Reference ISRCTN55675535)
Sample Donation to Research
(Please initial)
- I have read the attached Information Sheet version 2.1
dated December 2009
2.I have had an opportunity to discuss this study and ask questions
3.I have received satisfactory answers to all of my questions
4.I have received enough information about the study
5.I have spoken with Dr./ Mr./Ms.______
6.I understand that I am free to withdraw my child from the study:
- at any time
- without having to give reasons
- without affecting mychild’s future medical care
7.I understand that sections of mychild’s medical records relating to their participation in the study may be inspected by responsible individuals from the trial Sponsor who is CardiffUniversity. All personal details will be treated as STRICTLY CONFIDENTIAL. The information will be used for medical research only and my child will be identified only by trial number, initials and date of birth. My child will not be identified in any way in analysis and reporting of the results.
I give permission for these individuals to have access to my child’s records and to have my child’s clinical details recorded in this way?
8.I agree for my child to participate in this study
- I give permission to tell my child’s GP about my child’s participation in
the study
Patient’s Signature:______
Name in block letters:______
Date______
Doctor’s Signature:______
Name in block letters:______
Date______
Patient Representative’s Signature:
(if appropriate)______
Name in block letters:______
Relationship to patient: ______
Date______
Parent Information Sheet 9 Donation to Research 8-12 yrs
Version 2.1 December 2009
1