Why is the study needed?
To help protect the health of donors, it’s a requirement to find out whether a donor’s blood haemoglobin levels are adequate. The blood service in England screens potential donors with an initial finger prick (“copper sulphate”) test. For people suspected of having inadequate haemoglobin levels, a more precise (“HemoCue”) test is then immediately done using a venous blood sample. However, blood services in different countries use different screening approaches. We are leading a study of 31,000 donors to compare different methods. The goal is to help safeguard the well-being of future blood donors and define best practice for NHSBT.
Where is the study taking place?
Ten NHSBT teams are involved in the study. Recruitment will take place in and around Coventry, Herts, Lancaster, Leeds, Norwich, Oxford, Sheffield, South Anglia, Sutton Coldfield and Teesside.
Do I have to take part?
No, it is completely up to you. If you decide to take part you will be asked to sign a consent form. You are free to withdraw at any time, without giving a reason. Your decision will have no influence on your blood donation now or in the future.
What should I do if I want to take part?
At your next donation, all you need to do is let your donor carer know you would like to join the study. Your carer will take you through the consent form and answer any questions you might have.
How will my blood samples be used?
Research samples will be measured within one day of collection for a “gold standard” full blood count and then frozen. Stored samples of separate blood components (e.g., plasma, serum, DNA) will be kept securely at a central laboratory, labelled only with a unique study number, and used for medical and health-related studies that have relevant scientific and ethics approval
How will my study information be used?
Your study information will be used to compare different haemoglobin testing methods, and serve as a resource to help answer wider health questions in approved studies.
Are there any benefits for me in joining the study?
You will not receive an immediate benefit. However, the study’s findings should help safeguard the well-being of future blood donors and define best practice for England’s blood service.
Are there any additional risks for me in joining the study?
No. Your safety will be looked after by NHSBT in the usual way. That is, you will receive the usual screening test for haemoglobin levels and you will need to be within the safe range to be eligible to donate. If your haemoglobin levels are not adequate, you will not be allowed to donate blood. However, you will be asked to give a small research blood sample (about 20 ml) because it’s important to compare the different screening methods in people with lower haemoglobin levels.
How will information about me be kept confidential?
We will protect your privacy and ensure confidentiality through measures described in the participant information leaflets for Stage 1 and Stage 2.
What will be stored on the study database?
Confidential information that will be stored on the database will include: relevant information from your NHSBT donor record, such as sex, month and year of birth, details of your donation history and blood group data from the study’s online questionnaire results from laboratory measurements using your blood sample, including DNA information on health outcomes collected from routine medical and other health-related records.
How do I withdraw if I wish to do so?
The study will be most valuable if few people withdraw from it, so it is important to discuss any concerns you may have with a member of the study team before you agree to participate. However, you can withdraw from the study at any time and without giving a reason but we hope that you will continue to give blood as a regular donor. You can withdraw by telephoning us on freephone 0800 021 7182 Mon to Fri: 9:00 – 17:00, or by emailing helpdesk@comparestudy.org.uk or by writing to the coordinating centre. This will allow us to discuss your concerns with you and determine the desired level of withdrawal from the following options:
“No further contact”: This means that the COMPARE team would no longer contact you directly, but would still have your permission to retain and use information and samples provided previously and to obtain and use further information from your health records.
“No further use”: This means that, in addition to no longer contacting you or obtaining further information about you, any information and samples collected previously would no longer be available to researchers. Please note that we will not be able to remove results of any tests already performed with your samples from the study database but we will prevent your records from being used in any future research. We can also assure you that your blood samples will be removed from the central study repository after we have received your written notification. It will, however, not be possible to remove small volumes of your samples which already have been distributed to research laboratories but results which are generated after you have withdrawn will not be uploaded to the study database. Your signed consent and withdrawal forms will be kept as a record of your wishes.
If, having discussed the options and your concerns, you did decide to withdraw then we would send you a withdrawal form to confirm your wishes in writing. Examples of this form can be viewed here. This form can be completed by you or, if you are not able to do so for some reason (such as illness), by someone able to act on your behalf. In the unlikely event of a loss of capacity to decide on continued participation in the study, the study team would retain blood samples and personal data collected and continue to use it confidentially in connection with the purposes for which consent has been granted.
Who will be able to use my information and samples?
Your information and samples will be available only to researchers who have relevant approvals for their planned research. There will be a requirement to publish the results of any research arising out of the samples and data collected during the study to ensure others can benefit from it. Our website will include a list of reports arising from the study. The website will not contain any personal information.
Will you provide me feedback on my results?
We generally do not plan to provide feedback of results. However, we would communicate results to you that would have an immediate impact on your healthcare (such as finding cells in your blood that may suggest a significant health problem e.g. leukaemia). In this case, we will inform an NHSBT medical professional about the nature of the problem, and about who you are. An NHSBT medical professional would then use the routine procedures applicable in the NHS to get in touch with you and offer advice, which may involve contacting your GP.
Who is organising and funding the study?
The University of Cambridge, NHS Blood and Transplant and National Institute for Health Research.
Who has approved the study?
Research in the NHS is reviewed by independent groups of people (“Research Ethics Committee”) to protect your safety, rights, wellbeing and dignity. This project has been reviewed and was given a favourable review by the Cambridge East Research Ethics Committee.
When will I find out the results?
Recruitment to the study will continue until Spring 2017. Only once the last person has completed their involvement in the study will we be able to analyse the results; it is expected that the main findings of the study will be available at the end of 2017.