What is the purpose of the Biobank?
The aim of the Newcastle Hospitals Biobank is to store samples of swabs, blood, urine, saliva and any tissue samples that would otherwise not be collected or destroyed. Collected samples may be used straight away for a project that is already known to the biobank. Alternatively, samples may be stored for future projects, which are yet to be defined.
The success of a research project often depends upon having tissue or specific samples available to test. However, it can take several years to collect samples. It’s important that a bank of samples is available for use by researchers in their projects
These samples may also be used by commercial companies who hope to develop better, more specific tests, that will help to diagnose patients faster. We need samples like yours to test future diagnostic tests to ensure they are doing what they should be, and if they are any better than the tests we already use.
Why may I be chosen to donate a sample?
You may be chosen because you are about to have, or have already had, a procedure in Newcastle Hospitals where there may be excess tissue. There is an opportunity, with your consent, for this to be transferred to the biobank for use in research.
Do I have to take part?
Your participation is entirely voluntary. If you decide to take part, you are still free to withdraw at any time and without giving a reason. This will not affect the care you receive.
If you do decide to take part, we will give you this information sheet to keep and you will be asked to sign a consent form, which you will also receive a copy of to take with you.
The consent form consists of 12 questions for you to consider what you would like us to do with your sample. The first 4 sections of the consent form are essential for us to be able to process your sample for storage.
The remaining 8 sections give you the opportunity to explicitly tell us how we can use your donated sample. These include options regarding the use of your sample by commercial companies, in animal research, the use of your DNA, if we can transport your sample outside of the UK, or if we can access medical information about you.
What will happen to me if I take part?
If you do decide to take part, we will collect some of the following samples. We will not necessarily collect every sample listed below from all patients.
- Blood products (including whole blood, serum and/or plasma)
- Faeces / stool sample
- Fresh tissue
- Preserved tissue stored in wax blocks (formalin-fixed paraffin wax-embedded, FFPE, tissue)
- Saliva
- Sputum
- Swab (usually a nose and throat swab)
- Urine
After your sample(s) are collected, they will be transferred to the Newcastle Hospitals Biobank, where they may be stored until a project is identified. Alternatively, material may be released immediately for use in pre-approved projects.
The samples listed above have already been taken as part of your routine care, or they can be taken with minimal discomfort to you. We simply ask your permission to take a portion of what if left, once it has finished being tested by hospital laboratory staff.
How will we use information about you?
We will always need to keep a record of your name and your medical records number (MRN) in our biobank databases. This is because if you ever change your mind about wanting to be a part of our biobank, we can find your sample and dispose of it for you. But this information will only be accessible to members of the biobank and is never shared with anyone else. This information is also securely stored in a locked filing cabinet, or a password-protected spreadsheet, held securely on Newcastle Hospitals’ computers.
The clinical information about your sample is very useful to researchers and diagnostic test developers, because it helps them to understand how to make the test work better, or why one treatment is better than another. The information we would provide would be limited to the following:
- Laboratory results from any tests that were performed on your sample
- What your diagnosis was
- What treatment you received and how effective it was
- Did you have any side effects
- Your age when the sample was taken OR month & year of birth
- Ethnicity
- Sex at birth
In order to provide this information, we ask your permission to access your medical records to obtain it. However, this information is completely anonymised by the biobank. This means that it can never be traced back to you, and you will never be identified by anyone other than the Biobank staff.
We may look to store other diagnostic remnant samples taken from you as part of any follow up appointments, up to a period of five years following your original consent. However, we would like to reiterate that you can change your mind at any time.
Access to your sample
To use the samples that are stored in our biobank, we first obtain permission from a committee which oversees the running of the biobank. A combination of clinical, scientific and professional representatives make up this committee, in addition to members of the public. Individuals requesting samples are asked to complete an application form describing what they plan to do with them, which is reviewed by the committee. Each application to use samples will have to be approved by this committee before samples can be released from the biobank.
Applications will be considered from a variety of university research groups, internal and external clinical researchers and fully vetted and reputable companies. If samples are sent to an approved researcher, no personal details that allow you to be identified will be sent.
Storage of samples
We will store the samples taken from you in secure, lockable freezers, that are well-maintained so that they may be used for ongoing or new projects in the future. These samples are a precious gift, and we will store them in a manner which allows them to be utilised fully.
We store your samples for as long as you give us consent to do so.
You are free to withdraw your consent for the samples to be stored at any time.
What do I have to do?
All that is required is for you to take the time to read this information, ask any questions you may have and decide if you would like to participate. Then if you would like to participate, simply sign two copies of the consent form. One copy is for you to take away, the second copy is for the biobank team.
What are the side effects of taking part?
There will be no side effects other than those associated with the procedure which you will be having as part of your visit. These will be explained to you by the clinical team involved in your care.
If an additional blood sample is needed because we can’t take this at the same time as another blood sample, you may experience bruising where the needle was inserted, but this would be no different to any other blood sample you would usually have.
What are the possible benefits of taking part?
There is no direct clinical benefit from contributing to the biobank. The information we get from using these samples we hope will improve the healthcare and treatment of patients in the future.
Will my taking part in this study be kept confidential?
All information which is collected about you will be kept strictly confidential. Any information about you which accompanies the sample when it leaves the hospital will have your name, address and any other possible identifiable information removed so that you cannot be recognised from it.
We will ensure that all parties using samples from the biobank are aware and are subject to laws and regulations that protect patient confidentiality.
If any findings are found to be clinically significant, will I be told?
Your clinical team would continue to report any significant findings to you as part of your standard care pathway. But results from any other tests that use your biobank sample will not be made available. This is because these additional tests are not likely to have been properly validated yet. Therefore, we may not be able to trust the results the same as we would our normal hospital tests. But using your sample in these new tests helps to make them better.
What will happen to the results of the research studies?
The results of research that uses the samples stored in the biobank will be published in scientific journals. No patients will be identified in any of the reports but the use of the biobank will be acknowledged in any publication. Once published, the data are open to public access in specialised libraries.
This helps to inform the global scientific community of the latest scientific developments, shaping the direction of future research and accelerating the advancement of diagnostic test development.
Who is organising and funding the biobank?
This biobank is being run by Newcastle Hospitals laboratories. The biobank is self-financing; samples will be released on a ‘cost recovery’ basis i.e. only the cost of processing, storing and transporting of the samples will be charged. We charge researchers this small charge to cover the cost of running the freezers and the staff time needed to continue to look after your samples.
Who has reviewed the study?
This biobank has been reviewed and approved by a recognised Research Ethics Committee, North East – Newcastle and North Tyneside.
Newcastle Hospitals is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study, and will act as the data controller. This means that we are responsible for looking after your information and using it properly.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will immediately destroy your sample(s) and remove your sample details from our database. However, we will keep the research data that has been generated from testing your sample(s) up to the point it has been destroyed. To safeguard your rights, we will use the minimum personally-identifiable information possible. You can find out more about how we use your information by contacting our Data Protection Officer on [email protected]
For more information or to discuss how to become a donor please contact us.