Because shortages in the blood supply are projected for England, NHSBT is exploring different approaches to ensure adequate blood supplies for the future.
One way to increase the blood supply is to ask blood donors to give blood more frequently. However, some time is required between blood donations to allow the body to replace its iron stores.
Because no one knows what is the optimum interval between donations, blood donation services in different countries have developed varying customs. In England, NHSBT invites men to donate every 12 weeks and women to donate every 16 weeks. By comparison, some European countries invite people to donate blood as frequently as every 8 weeks.
The INTERVAL study aims to recruit about 25,000 men and about 25,000 women from NHSBT blood donation centres across England. If you choose to join this study, you will take part for a period of two years. During this time we will invite you to give blood either at your usual donation interval or more frequently. Men will be invited to donate every 8, 10 or 12 weeks and women every 12, 14 or 16 weeks. The donation interval you are allocated to will be decided by a process called ‘randomisation’, which is like a coin toss. As usual, you will be able to give blood only if you pass the screening haemoglobin finger-prick test.
At the end of the study, we will compare the amount of blood donated and measures of well-being in people asked to give blood at standard intervals versus those asked to give blood more frequently.
To find out whether certain people have capacity to give blood more frequently, we will be collecting an additional small blood sample at the beginning and end of the study to look at iron levels and DNA for relevant genes. Not all of the blood sample will be used immediately and some will be stored so that it can be used to assist future studies about the health of blood donors.
There are 25 permanent blood donation centres in England. Click here to see the locations.
Blood samples collected for the purposes of the research will either be used immediately, i.e. to perform a full blood count and measure substances related to your body’s iron stores (e.g. ferritin) or will be frozen for use in future research. Stored samples will include separate components of your blood (e.g. plasma, serum and DNA) which will be:
■ Kept securely at central laboratories. They will not be labelled with your name or contact details, but only with a unique study number.
■ Used by the study investigators for medical and health-related studies which have relevant scientific and ethics approval.
■ Used to measure biomarkers, which are substances in the body (e.g. haemoglobin) that can easily be measured and give a clue to health (e.g. iron deficiency).
■ Used to study your DNA and related substances. In particular, we want to know how genes regulate blood cells. Variations in genes influence the behaviour of the blood cells and so we need to analyse your DNA in detail. As part of this study, we will test your DNA for many genes and we may determine the sequence of part of or your entire DNA code.
You may be asked to give blood more frequently than usual during the study. The main risk of giving blood more frequently than is now standard is iron deficiency and the related anaemia because of a low haemoglobin level. This is why NHSBT will continue to follow its routine safety procedures to monitor your haemoglobin level before donation.
It is important to stress that your safety will be looked after by NHSBT in the same way as before. That is, you will receive the usual ‘finger-prick’ screening test for haemoglobin levels and you will need to be within the safe range to be eligible to donate. If you fall outside this range you will be invited to return again at your allocated interval.
We protect your privacy at all times. The steps taken to ensure confidentiality are detailed below:
■ At the donation session, your consent to take part in the study will be recorded on a form that will contain identifiers including your name, email address and mobile phone number. These forms will be stored in a secure location and separately from the study data.
■ Your samples and data will not include any personal identifying details; researchers working with your samples and data will, therefore, never know your identity. Your data will be stored using a unique, anonymous study identification number.
■ A single table linking your anonymous study identification number to your NHSBT Donor Number and your NHS number identity will be stored on a separate password protected location which may be accessed by the study data manager only.
■ The link table will be used to retrieve only relevant health information from your medical and other health-related records. The retrieved information will be anonymous as any personal identifying details will have been removed and replaced by the unique anonymous study identification number.
■ All study data will be stored in a restricted-access, study database. This study database will not be connected to the NHSBT database containing your personal details. The study data will be linked to your study identification number, but your personal details (surname, first name, date of birth, address) will never appear in this database. Access to the study database will be password protected and will be used only by named researchers working on this study under the direct supervision of the senior scientific investigators.
Your anonymised data is stored in the INTERVAL study database and used by the study investigators to, for example, understand characteristics (e.g. age and gender) that influence the frequency with which people can donate safely. Stored anonymised data may also be used for future medical and health-related studies which have relevant scientific and ethics approval. Information stored on the database is anonymised and includes:
■ Relevant information from your NHSBT donor record, e.g. gender, month and year of birth, details of your donation history and blood group.
■ Data from the online questionnaires, forms and assessments.
■ Results from all laboratory measurements using your blood components. This includes your genetic information.
■ Information on health outcomes collected from routine medical and other health-related records at the time of joining the study and from time to time thereafter.
Your anonymous information and samples are available only to researchers who have relevant scientific and ethics approvals for their planned research. This could include researchers who are working in other countries and in commercial companies who are looking for new treatments or laboratory tests.
Insurance companies and employers will not be given any individual’s information, samples or test results, and we will not allow access to the police, security services, relatives or lawyers, unless forced to do so by the courts.
There will be a requirement to publish the results of the research arising out of the samples and data collected during the study so that people can benefit from it.
The results will also be made available to participants and anyone else who might be interested on this website.
There are no plans to feedback results from genetic tests. The only scenario where blood-based test results would be communicated to you would be if we discover anything that has an immediate impact on your healthcare (e.g. in case cells are present in your blood that may point to leukaemia or a very high count of platelets). In this case, the researcher will inform a medical professional about the nature of the problem, and about who you are. The 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.
The INTERVAL study has been set up by the Universities of Cambridge and Oxford in collaboration with NHSBT, and funding has been provided by NHSBT.
Once funding for the study comes to an end, data and samples collected during the study will be maintained, as a national collection, by the lead academic institution, the University of Cambridge, in partnership with NHSBT.
All research in the NHS is reviewed by an independent group of people, called a Research Ethics Committee which is there 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.
The risk of participants suffering harm as a result of taking part is minimal, and INTERVAL has insurance in place to provide compensation for any negligent harm caused by participation.
If you have any concerns or complaints about anything to do with the INTERVAL study then you can telephone the freephone number on: 0800 064 0089 Mon to Fri: 9:00 – 17:00 or email us at:email@example.com
Alternatively, if you would like to write to the person in charge, please send your letter to:
Professors John Danesh and David Roberts The INTERVAL Study University of Cambridge Department of Public Health and Primary Care Wort’s Causeway, Cambridge CB1 8RN
We will reply to your letter promptly in writing, unless you enclose your telephone number and wish to discuss your concerns with us.
Absolutely. Your blood donation is used in exactly the same way as normal, to save and improve lives. An additional small blood sample (approximately 3 teaspoons) will be collected when you join the study. Another research sample will be collected after 2 years. These samples are used or stored for research purposes
Yes, INTERVAL study donations count towards your total number of donations, as normal (i.e. in the same was as all whole blood donations given to NHSBT are currently counted).
Yes, you can continue on the study if you are able to donate at one of the permanent centres. To see a list please click here.
0300 numbers are charged at the same rate as a local landline call.
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 064 0089 Mon to Fri: 9:00 – 17:00, or by emailing firstname.lastname@example.org 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 INTERVAL 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.
If you have not yet received the email please make sure to check your junk/spam email folder. If the email is not in there then please contact us as we may not have your correct email address.
Please check that the email with the password is not in your junk/spam email folder. The email subject is “INTERVAL key”. If you cannot locate the email then please contact us.
No, participants must be randomly allocated to the different groups. If participants chose which group they went into, this could introduce bias in the study results, which would then mean that they are not applicable to the wider blood donor population.
We need a control or ‘usual’ group (i.e. the 12-week group for men and the 16-week group for women) against which to compare the impact of reduced interval groups. Without a control group we will not be able to produce conclusive evidence on the safety and feasibility of more frequent blood donation. This group is therefore very important for the study.
You can contact the study team on 0800 064 0089 or email email@example.com to let us know and we will update our records so you will continue to receive study correspondence.
We want the study to reflect reality as much as possible so you will still remain on the study even though you cannot donate blood. This means you will still be sent the online questionnaires. If you want to avoid receiving appointment reminders whilst you are pregnant please call the appointment line on 0300 0200 333.
All donors will complete their participation in the study in June 2016. Around this time researchers will start to analyse the study data to look at differences in the amount of blood donated and measures of well-being between groups of donors who have been giving blood at the various intervals. This analysis will take several months and therefore the main findings of the study are expected to be available early in 2017.
This will not affect your participation in the study. We ask that you stick to your allocated intervals as best you can over the 2-year study period, but we recognise that it may not always be possible for you to do this.
The main findings of the study are expected to be available early in 2017. At this time we will widely publicise the results for example in scientific journals, donor communications (e.g. the Donor Magazine) and on the INTERVAL study website.