Why is the STRIDES BioResource needed?
Collecting blood samples and questionnaire data from whole blood donors will help NHSBT decide the best STRategies to Improve Donor ExperienceS (STRIDES).
In addition, joining the STRIDES BioResource will help researchers answer vital questions related to biomedical research relevant to blood donors and more generally public health.
Where is the study taking place
The study is taking place in all blood donor centers and mobile locations across England.
Do I have to join the STRIDES BioResource?
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 join the STRIDES BioResource?
At your next donation, all you need to do is let your donor carer know you would like to join the study.
How will my blood sample be used?
Your research samples will be processed and stored in a central laboratory (UK BioCentre, Milton Keynes). We will:
- count different types of blood cells in your blood.
- store a sample of your DNA.
- separate your blood into serum and plasma for storage.
- study your DNA to find out, for example, how genes may regulate blood cells and haemoglobin levels. We will also determine the sequence of part or all of your genetic information.
- measure biomarkers that reflect health status (for example, iron levels
We may also study other components of your blood such as cells, RNA and proteins.
Please see the STRIDES BioResource Participant Information Leaflet on this website for further information
How will my information be used?
Anonymous data about you (that is, with all identifying information removed) will be stored in an electronic data centre and made available only to approved researchers. This data may include:
- part of or all of your genetic information.
- results of other tests performed with your samples.
- information from the research database that does not identify you
Researchers will have to make a request to access this data and explain how they will use it, for example, which research question they are trying to answer.
This type of system is referred to as ‘managed access’.
‘Managed access’ requests could come from researchers who are working in the public and charitable sector (universities, research institutes) or in commercial companies, either in the UK or overseas.
Researchers share the results of their studies by means of reports or publications, which includes placing results on the internet, in press articles, in project leaflets and through other media. Under no circumstances will information that identifies you personally be disclosed in any of these documents.
Why should I join the STRIDES BioResource?
The STRIDES BioResource forms part of the NIHR BioResource (https://bioresource.nihr.ac.uk/): a growing network of research centres recruiting volunteers with and without health conditions. This setup provides a unique infrastructure to support studies looking at how genes and biomarkers influence disease. For example, samples from healthy volunteers can be compared to those from patients as differences may indicate the cause of the disease.
If you agree to join:
• you will become part of a national panel of thousands of volunteers who are willing to help with research.
• your samples and data will contribute to research focusing on blood donation as well as broader public health investigations looking into the links between genetic information and disease.
How do I withdraw if I want to?
You are free to withdraw from the study at any time without giving a reason
If you choose to withdraw:
- it will not affect your blood donation with NHSBT.
- you will have the choice of how you would like to withdraw:
1) no further contact. This will allow for the continued use of samples for analysis and retrieval of health records in the future, but you will not be contacted further about the BioResource, so you will no longer
receive newsletters, or be asked to participate in further research studies.
2) no further use. All samples stored will be destroyed and no new information will be collected from your health records. Any sample that has already been distributed for research cannot be retrieved or destroyed. No new information will be collected from your health records. However, information already generated from your samples cannot be erased.
- it will not be possible to destroy samples already prepared or already distributed for testing.
- your personal information will be retained in a secure archive so that a record remains of your initial consent and the withdrawal process.
Please contact the STRIDES study helpdesk on 0800 021 7182 (Monday to Friday 0900h – 1700h) or by emailing "firstname.lastname@example.org" to complete the relevant forms
Will you provide me with feedback on my results?
There are no plans to report back any research results to participants.
If you are contacted to take part in a future study, this does not mean that your health is at risk. All individuals carry both risk and protective DNA variants. We are a long way from understanding how they balance each other and what combination of variants interacting with other factors (such as age, gender, smoking and drinking habits) are needed to cause disease.
However, a test result would be communicated back to you if it showed an atypical result requiring immediate medical treatment (like anaemia). Should this happen, we would contact you and your GP. They may wish to invite you to give a further blood sample that will be tested in an accredited laboratory.
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 South Research Ethics Committee (REC ref: 18/EE/0284).
Who is organising and funding the study?
The University of Cambridge, NHS Blood and Transplant and National Institute for Health Research.
Who do I contact if I have any concerns?
If you have any concerns or complaints about anything to do with the STRIDES study then you can telephone the freephone number on: 0800 021 7182 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:
STRIDES BioResource coordinator, 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.
I am expecting a link to the questionnaire but have not received an email – what should I do?
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.
I have received a link to an online questionnaire but not the password – what should I do?
Please check that the email with the password is not in your junk/spam email folder. The email subject is “STRIDES key”. If you cannot locate the email then please contact us.
I have changed my email address, what should I do?
You can contact the study team on 0800 021 7182 or email firstname.lastname@example.org to let us know and we will update our records so you will continue to receive study correspondence.
Accessing Electronic Health Records
To understand the health of participants in our study—and to track how this change over time—we use medical and other health-related records (i.e. Hospital Episode Statistics).
The National Health Service (NHS) doesn’t have a single record system and thus information needs to be obtained from various sources.
The ‘link table’ is used to retrieve relevant health information. A single table linking participant’s study identification number to the Donor Number, NHS number and other information that directly identifies you is stored in a separate, password protected location.
The retrieved information is ‘de-personalised’ by removing personal details such as name or NHS number and replacing them with a unique anonymous study number. The de-personalised information is then stored in a restricted-access, study database.
The University of Cambridge is the Data Controller for this study. This means, we process personal data for scientific research purposes as part of the University of Cambridge’s public task under articles 6(1)(e) and 9(2)(j) of the General Data Protection Regulation.
Please see the NIHR Blood and Transplant Research Unit in Donor Health and Behaviour website for more detail.