Frequently Asked Questions for Patients, Healthy Volunteers and Public

The Human Biomaterials Resource Centre (HBRC) a biobank run the University of Birmingham College of Medicine and Health. It is licensed by the Human Tissue Authority (HTA), and it has generic ethical approval from a Research Ethics Committee run by the Healthcare Research Authority.

In essence, the HBRC collects, stores, and distributes human samples and data in an ethical and secure way, so that scientists can discover how diseases start, or how to diagnose and treat diseases in future.

That depends. It may be that scientists are looking into your condition, disease, or illness right now. They may be interested in finding out how it starts, or how it progresses, or even how it might be related to other conditions, diseases, or illnesses.

Sometimes, a disease is classified as “rare” – fewer than 1 person in 10,000 has it. When diseases are rare, it can be difficult to collect enough samples to perform meaningful science in a timescale suitable for funding. This doesn't mean that your disease is unimportant – it means we have to try for longer to collect enough for the scientists. For this reason, you may be approached about consent, even if scientists are not currently looking at your disease.

If you agree to donate, we will usually ask only for “leftovers” or “waste” (material not needed for your diagnosis, or which is being removed anyway and would normally be disposed of).

Sometimes we may ask for a little extra blood, or perhaps some urine or faeces. You don't have to agree on the day, and if we ask you on more than one occasion, you don't have to agree every time.

Very occasionally, we may ask for an extra biopsy (if you're being biopsied anyway) – but again, only if you agree on the day, and only if the clinical staff think there is no significant extra risk to you.

If you say no on any one occasion, that's perfectly alright. It won't affect your treatment or care.

No, not directly. You will be helping scientists understand what's going on with your condition, disease, or illness, or perhaps that of others. The results that the scientists generate from their investigations are unlikely to have any direct impact on you – but one day, they may help improve the diagnosis or treatment of other patients like you.

No. Like your clinicians, we have your best interests at heart, and we're not going to put research ahead of you. Your diagnosis, treatment, or care must always come first, and the scientific part of your donation will only happen if it is safe to do so.

That depends on whether something is found which might have a direct impact on you or not. Scientists are not allowed to perform diagnostic tests deliberately, but it doesn't mean to say they won't find out something unexpected and urgently important.

We call these “incidental findings of clinical significance” (or “incidental findings” for short). If scientists do uncover incidental findings, we expect them to notify us immediately. We will then contact your most relevant clinician, who will consider:

• How reliable the scientific results are
• How relevant they are, not only to your current health, but to your future health
• Whether you might wish to be told about them or not
• Whether proper diagnostic tests are needed and available
• What support you might need to help you and your family deal with the new information.

This is important, because:

• No-one wants to worry you unnecessarily with clinically unimportant or poor-quality results
• Some donors don't wish to know about things like increased risk of a cancer, while others change their mind about it, and still others always want to know
• Not every hospital can offer all available diagnostic tests and support, so you may need to be referred to another hospital as part of your clinical care.

We ask you not to contact scientists about their results. Scientists are forbidden from trying to re-identify donors, and it would also be very unethical for them to try to answer specific clinical questions using only their scientific knowledge.

However, scientists are required to let us give out a “lay summary” (a brief description of the research without all the jargon), along with the title of their project, the name of the lead scientist, and the organisation they work for.

You may contact us at any time to find out lay summaries and what has happened to your samples. If you contact us, we will first ask you a few simple questions to prove that you are who you claim to be. This is not just because it's part of the process for tracking consent and samples, but because we must also take precautions against accidentally re-identifying someone to those who have no legal right to know.

Your DNA will only be analysed if the scientists have stated that they need to do so as part of their scientific investigations. Often, scientists will only look at DNA sequences ("genes") directly involved in your disease to see what is going wrong. Sometimes, however, they may look more widely to see whether other genes are involved, such as those used when the cells of your body signal to each other.

Occasionally, scientists may also ask to look at your “whole genome” – the entire DNA sequence of a cell. Scientists will only be allowed to do this if it benefits the scientific question being asked about your particular condition, disease, or illness.

Scientists will never be permitted to try to re-identify you by your DNA, or to perform deliberate diagnostic tests on your DNA. It is unethical for tests like paternity or infection status to be run deliberately for the purpose of generating results useful outside of scientific research, so we will not allow it.

No. Your samples can't be sold, because that is prohibited by law. The HBRC is expected to recover some of its running costs, because the HBRC is operated by the University of Birmingham (a publicly-funded university with charity status) – but it would be illegal for us to sell the actual samples.

We do distribute samples to pharmaceutical and other commercial companies for scientific research, but they are forbidden from selling those samples onwards. Collaborations with pharmaceutical and commercial companies are vital for the discovery and pre-trial development of suitable drugs.

For example, it is often the case that discoveries made in a university laboratory can only be turned into real patient treatments if commercial companies support the cost. In 2020, such costs were estimated to be around $1 billion per drug – more than a year's budget for running a whole university.

Yes. Your participation in the biobank will be recorded in your medical notes. In identifiable form, it will only be viewed by those legally entitled to see those medical notes. This is not only a requirement of our ethical approval, but it is a matter of common law and the Data Protection Act 2018 ("UK GDPR"). The Human Tissue Act 2004 also requires that confidentiality be maintained.

We will not give scientists identifiable information, such as your name, address, or phone number. We will also take precautions to ensure that they can't re-identify you from the combination of publicly-available data and any data they have requested from us.

We take this so seriously that every research group has to sign an agreement which prohibits them trying to re-identify you. We also remind them of this prohibition every time they receive material from us.

Generally, that depends on the science. We will only collect data which is available in your medical record, and which is relevant to the science being performed, or which is useful to help scientists decide whether a sample is useful to them. That said, we are required by the Human Tissue Act 2004 to record and keep a small amount of data for the purposes of traceability.

When dealing with scientists, we will always refer to samples and data by a “pseudonym” – a unique code which allows us to track every sample and every donor, and to link samples with donors without mentioning identifiable data.

Our pseudonyms are numbers generated by one of our secure databases, with each number following on from the last. The order of numbers is determined simply by the order in which we recorded our receipt of the sample or consent. To all intents and purposes, therefore, we believe it impossible for anyone outside the biobank to re-identify someone purely by their sample-number or their donor-number.

The HBRC is a “generic” biobank. That means we exist to support as much scientific research as we can, using samples and data from as broad a population as the NHS supports.

However, there are some types of research which the law prohibits us from performing, and there are others which we have chosen not to allow (so they are specifically excluded by our approved protocol).

We cannot support:

• Transplant or therapeutic research which aims to put your samples, or material made from them, back into a human (even you)
• Reproductive research, including reproductive cloning and abortion research
• Research that is not related to healthcare, such as the testing of cosmetics/other consumer products or market research

Sometimes scientists may declare their intention to use samples from us in animals. This is increasingly rare, and we will only permit it if:

• There is no alternative, and the University is satisfied of their claim via a separate formal process, and
• You have positively consented for use of your samples in animals

Yes. You can object to use of your samples in animal experiments by not consenting to it ("not opting in"). We take our promise to you so seriously that:

• We record every sample from someone who objects to animal experiments with an (anonymous) “no animals” tag
• We explicitly state to scientists on our sample-release form exactly which samples they must never use in animal experiments

Consent will last until the date of your death, unless you choose to withdraw it sooner. One consent form can last your whole life, if you wish. We have chosen this way of obtaining consent because most donors do not want to be asked the same thing repeatedly. We also understand that many things might be occupying your mind during your clinical consultation, so we don't want to add to any stress.

That's not to say that we won't remind you about your consent – in fact, we expect clinicians and consenters to remind you whenever they see you and we have asked for more samples.

If you’re approached, it's perfectly alright to say “not this time”, and it won't affect your treatment or care. If you're being reminded about a previous consent, we will not regard “not this time” as consent withdrawal – just as “no sampling this time”.

Yes. You can withdraw your consent at any time you like. This is your legal and ethical right.

You can withdraw a minute after you gave consent, a few months after you gave it, or years after you gave it – even a century after you gave it!

Please note that the person who gave consent is the only person who can withdraw it. Again, this is a legal and ethical right.

Withdrawal of consent means that you no longer agree to us storing or using your samples – so we will dispose of anything unused through the usual hospital routes (the same routes that would have been used, if you hadn't given consent in the first place).