Professor Andy Hall, a member of our board, explains what needs to be considered before setting up a biobank.
1. Why do I want to do it?
Setting up a tissue biobank can be time-consuming and challenging and will generally lead to neither fame nor fortune so it pays to think carefully about the reasons for starting such a project in the first place. The main question to consider is whether the collection of samples will enable research to be undertaken which would otherwise not be possible or take much longer. If samples are easy to obtain from common conditions it might be better to use prospective collections as it will be easier to ensure that they are fit for purpose and that you have all the appropriate associated data.
2. What do I want to collect?
For samples to be “fit for purpose” you need to have a fairly clear idea of what that purpose might be. For example if you are planning to undertake DNA analysis on peripheral blood it will not generally be necessary to take great care to ensure that samples are rapidly separated and frozen. Alternatively, if you are interested in measuring cell-free DNA much more care will need to be taken regarding the details of processing to ensure that results are robust.
It is also useful to consider how many samples you want to collect. If you plan to undertake genome-wide association studies you may need to collect many hundreds. If you want to collect a well-characterised cohort of cancer biopsies two to three hundred may suffice. Limiting the size of the collection will help to control costs.
Collection of data associated with samples is often more onerous than collecting the samples themselves, particularly if there is a need to update the database with details of clinical outcome. Samples without good quality metadata are generally of very limited value.
3. Is there a suitable biobank already available?
There are several hundred NHS REC approved Research Tissue Banks in the UK alone. The visibility of these is highly variable and access to external users may not always be possible but it is worth undertaking an internet search to determine if a bank already exists which contains the samples that you need.
4. What do I need to do to comply with the Human Tissue Act?
If human samples are to be kept which contain intact cells they will need to be stored in premises covered by a Human Tissue Act licence, issued by the Human Tissue Authority (unless they are being used as part of a NHS REC approved project). Compliance with the Human Tissue Act is not hugely onerous but you will need to be able to track samples in the laboratory and ensure that you can link them to evidence that they are have been obtained with appropriate informed consent. Samples will need to be stored in secure, well maintained, facilities. If samples are frozen you will need to demonstrate that there is a system in place to ensure that the relevant temperature is maintained and there will need to be adequate back-up systems in case of freezer or power failure. The Human Tissue Authority conduct periodic audits to ensure that the conditions of the Act are being observed. The licence will be overseen by a named Designated Individual who is responsible for ensuring that the conditions of the act are observed.
5. What ethical approval will I need?
It is not a legal requirement to have ethical approval to establish a research tissue bank but it is certainly good practice to do so. The REC will review the patient information leaflet and consent form and provide useful guidance if these are not clear or comprehensive. In addition to obtaining approval for the collection and storage of samples it is also possible to request that generic approval is obtained to conduct research on the samples, both within the host institution and elsewhere. This has proved to be a very useful facility for many research groups as it removes the need to submit multiple REC applications for very similar projects. However, it will be necessary to establish an access committee to evaluate projects and you will need to complete an annual report for the REC granting approval, setting out the nature of the projects undertaken. This requires administrative support to be done efficiently.
6. Do I have to make my samples available to other people?
It is not essential that you make your samples available to other groups but you will be asked to justify this if you are seeking ethical approval for your bank. Many funders will also require you to make your collection available to other researchers with high quality papers. (See, for example, the Funder’s Vision document). Visibility of biobanks can be improved by registering them on directories such as the one operated by the UKCRC. This is now mandatory for ethically approved biobanks.
7. How much will it cost?
Bioobanking can be very expensive if you plan to offer a comprehensive service. Apart from the costs of sample transport, processing, storage and backup there are administrative costs associated with undertaking audits, completing reports for ethics and the HTA and responding to requests for samples. Offsite storage is sometimes a cheaper alternative when it comes to storage- but this will not remove all the associated administration costs. It is not unusual for the full costs associated with the storage of individual samples to amount to several hundred pounds (this obviously depends on the nature of the sample and the number collected).
8. What will happen when I leave?
The question of sustainability is often neglected when a biobank is established. Most are set up because of the drive and initiative of an individual, and you won’t be there for ever. Good planning should include a clear sustainability strategy.