Donating tissue or cell samples for research

Why Your Help is Important

We are asking whether you would like to take part in research by donating your samples. These are usually remaining samples from tests or treatment that you no longer need for your care. We may also ask you for a small extra blood sample.

You do not have to donate. If you say no, the care you receive from the NHS will not change.

Your samples can help researchers learn more about illness, improve laboratory tests, develop new tests, and train doctors and laboratory scientists. This may help patients now and in the future.

What this leaflet explains

• what tissue and cell samples are
• what happens to samples taken during your care
• how to decide whether to donate remaining samples for research, quality checks, and teaching
• what basic clinical information may be used with your samples
• how your privacy is protected

What are tissue and cell samples?

A tissue is a group of cells from the body. Tissue and cell samples can include blood, urine, saliva, a small piece of tissue taken in a biopsy, or tissue removed during an operation.

A biopsy is a test where a small piece of tissue is taken so it can be looked at more closely.

Samples are usually taken as part of your normal care to help diagnose or treat your condition.

About CUH and the tissue bank

Cambridge University Hospitals NHS Foundation Trust is also called CUH. Addenbrooke's Hospital is part of CUH.

CUH carries out research into why diseases happen and how they can be treated. Some research studies use samples taken only for that study after a person has agreed to take part.

Other research can use remaining samples that were first taken for your care. The CUH Human Research Tissue Bank collects and stores these samples so they can be used for approved research in the future.

How are samples used for diagnosis?

Laboratory staff may test liquid samples, such as blood, urine, or saliva, to look at cells or chemicals in the sample.

Solid tissue may be frozen or put in a preserving liquid called formalin. It may then be covered with hot wax, which cools and becomes hard to make a tissue block.

Very thin slices can be cut from the block and put on glass slides. A pathologist, who is a doctor or scientist trained to examine samples, looks at the slides under a microscope and sends a report to your doctor. Other tests may also be done on the tissue.

What happens after diagnosis?

Samples are first used for the tests needed for your care. Some liquid samples, such as blood, urine, and saliva, are usually kept for only a few weeks and then destroyed safely.

Solid tissue samples are usually stored by the CUH Histopathology department for at least 10 years in case more tests are needed for your care. Histopathology is the department that examines tissue to help diagnose disease.

Any tissue or cell sample that is not needed for your care may be called a remaining sample or surplus tissue. With your permission, these remaining samples can be donated to the CUH Human Research Tissue Bank.

What would my samples be used for?

With your permission, remaining samples can be used for research, for checking the quality of laboratory tests, and for teaching doctors and laboratory scientists.

Research using samples may help researchers understand diseases, develop new tests, and improve treatments for patients.

Your samples will not be released for animal research under the CUH consent form. This consent is for the research, quality checks, and teaching described in this leaflet.

How can I donate samples?

During your care at Addenbrooke's, staff may discuss whether you would like to donate remaining tissue or cell samples. If you agree, you will be asked to sign a consent form that records your decision.

You may also be asked to give a small extra blood sample. This is 10 ml, about two teaspoons. It is usually taken from a vein in your arm, like a routine blood test, while you are already attending for your care or when blood is already being taken. It may briefly hurt or leave a small bruise.

You may be asked about donation once, or at more than one appointment, depending on your care. For example, if you have a separate procedure or hospital visit in the future, staff may discuss donation with you again. Staff should explain what is being requested each time. You can say no to donation or to an extra blood sample.

If you are interested in donating samples for research, you can ask your nurse or doctor about the CUH Human Research Tissue Bank.

What basic clinical information would be used?

We will also ask if we can use basic clinical information from your electronic hospital record for research.

This may include your diagnosis, your age when the sample was taken, your sex recorded in your hospital record, the operation linked to the sample, and where in the body the sample came from.

Will information about me be kept confidential?

Yes. Researchers will not be given information that directly identifies you, such as your name, NHS number, hospital number, address, or contact details.

Samples and information released for research are de-identified. This means researchers will not know who you are.

The link between you and your sample is held securely by authorised CUH staff so the tissue bank can manage records, trace samples, and act if you change your mind.

How long are samples stored, and where?

Remaining tissue and extra blood samples may be used for research soon after they are taken. They may also be stored for many years before use.

If they are stored for research, they are stored in the CUH Human Research Tissue Bank. The tissue bank is licensed by the Human Tissue Authority with licence number 12315.

Material needed for your care remains available for your care. Only material not needed for your care is made available for approved research.

Who checks how samples are used?

The CUH Human Research Tissue Bank is licensed by the Human Tissue Authority and is regulated.

Research using human tissue must be reviewed and approved by the Health Research Authority, a Research Ethics Committee, or both. This helps make sure samples are used properly and for a worthwhile purpose.

Research projects must also follow an approved study protocol.

Will I know what research is being done?

Medical science changes quickly, so we cannot tell you about research projects that may use your sample.

You can find general information about current research at CUH here. https://www.cuh.nhs.uk/our-research/

Could genetic research be done?

Yes. Genes are instructions inside cells. Changes in genes can play a part in many diseases. For example, a tumour may grow because a gene change happens in a small part of the body.

Genetic tests done for your own diagnosis or treatment are separate from research. Future research may look at genes in de-identified samples, but researchers will not know who you are. Research findings will not be given back to you or used to guide your care.

Could my samples be used by other organisations?

Yes. Research is often carried out with other hospitals, universities, or sometimes commercial companies, in the UK or abroad.

This means your de-identified sample could be sent to another organisation for an approved research project. The organisation receiving it will not know your personal details.

Can I change my mind?

Yes. You can change your mind at any time. If you no longer want your samples or information to be used for research please contact the Patient Advice and Liaison Service (PALS) using the details below.

We will not send any remaining samples or information for new research after you withdraw. Any samples still held by the tissue bank will be destroyed safely.

We may not be able to get back samples or information that have already been used, sent to approved researchers, or de-identified in a way that can no longer be linked back to you.

Further information and contact details

CUH Human Research Tissue Bank: https://www.cuh.nhs.uk/our-services/human-research-tissue-bank/

CUH PALS page: www.cuh.nhs.uk/contact-us/let-us-know-your-views/get-advice-or-raise-a-concern-the-patient-advice-and-liaison-service/

PALS phone: 01223 216756

PALS can answer questions, help resolve concerns, and support you if you want to withdraw consent or make a complaint.