As part of your clinical care, you may need a biopsy or surgery to diagnose your condition. Often there are cells or tissue left over which are either stored in the hospital where they were obtained or discarded. We would like to invite you to donate some of this for medical research related to rare cancers. We would also like to ask your permission to use some details about you and your medical condition in research projects. We will not pass on any information which could reveal your identity to the researchers.

We do not undertake research ourselves but make samples from donors such as yourself available for research to be undertaken by groups based in universities or companies.

The information from these samples and clinical data could help improve the diagnosis and treatment of other patients with rare cancer in the future.
This leaflet explains why the research is being done and what it may involve. Please take time to read it carefully and discuss it with anybody you wish. If there is anything that is not clear, please ask us using the contact details at the end of this leaflet.

A ‘biopsy’ is a small piece of tissue removed for examination.

Cells are the basic units from which our bodies are made. Most cells in our body are organised into tissue. In tissue, a mixture of cell types work together to carry out a particular job for your body.

Human cells and tissue are essential for many types of medical research. Scientists use them to:

• learn how diseases such as rare cancers start and progress.
• develop new tests for diseases.
• see the effects of new drugs before clinical trials begin with volunteer patients.

Research may lead to new tests, better treatments for diseases and ways of detecting diseases earlier; it may take place in the UK, or overseas in international partnerships.

The laboratory analysis of clinical samples may involve a wide range of methods including measuring cell growth or studying the molecules which make up cells such as proteins, fat or DNA.

You may need a biopsy or surgery and/or a blood sample to diagnose or treat your condition. This means removing pieces of tumour tissue or taking a blood sample for clinical testing. These tests can determine any further treatment you may need.

After the sample has been examined by a specialist doctor, called a pathologist, there may be some left over. If there is, we would like your permission to allow us to use it immediately for research or store it in our BioResource for use later. In addition, there may be samples stored in your hospital’s pathology department which would be of value for research. We would like to ask your permission to access these as well. They will only be released if the pathologist is satisfied that they will not be needed in the future to help with your treatment.

A ‘pathologist’ is a doctor who is trained to examine specimens taken as part of your treatment

A ‘BioResource’ is a place where cells and tissues can be kept safely and made available to researchers

We will need to use information from you to successfully operate the BioResource for the benefit of research. This information will include:

• Your name
• Your date of birth
• Your contact details
• the first part of your postcode
• A copy of your histology report

Only people who work for RareCan operating its BioResource and who need to know who you are will be able to see your name or contact details. For anyone else, your data will have a code number instead. We will keep all information about you safe.

A ‘histology report’ summarises what is seen under the microscope and is the basis for your diagnosis.

You can withdraw your consent for your samples to be used in the BioResource at any time, without giving a reason. If you wish we will also delete any identifiable data that we hold, apart from a record of your decision to withdraw your consent. Your other rights under the current data protection laws are set out in our privacy policy.

Researchers who use your anonymised samples or data for research will need to manage their records in specific ways for the research to be reliable. This means that they won’t be able to let you see or change the research data they hold about you.

You can find out more about how information is used in medical research in the leaflet provided by the Health Research Authority, which accompanies this document.

If anything is unclear or you would like more details please contact us on info@rarecan.com. If you provide contact details we would be happy to phone you back if you wish.

Research using your cells and tissues may involve discovering how the genes in human cells can affect how they become diseased. However, many different research studies are needed, on samples from many individuals, before we understand the importance of any single change. Because of this, we will not pass on to you or your doctors the results of genetic research done using your cells or tissue.

Your ‘genes’ make up your body’s ‘instruction manual’. They contain almost all the information needed to make you, run you and repair you. You have copies of all your genes in almost every cell in your body. You inherited these from your parents.

Genes are made up of a chemical code called DNA. There are 3 billion ‘letters’ of code in every cell and these can be ‘read’ to produce your unique DNA sequence.

Anyone wishing to use the tissue or cells for research will have to provide evidence that their research meets all current legal and ethical requirements. Researchers will need to have approval of their research by a Research Ethics Committee or by the independent Access Committee organised by Rarecan. (Details of the membership of the committee are available here.) The role of these committees is to represent patients’ interests in research studies and to ensure that proposed uses of tissue in research are appropriate.

We supply samples to:

• Researchers in publicly funded hospitals, medical schools and universities in the UK and abroad
• Scientists from drug companies and biotechnology companies in the UK and abroad

Studies using human tissue in animals are essential for some medical research into rare cancers. These are kept to a minimum. In the UK, animal research is strictly regulated by law to ensure that animals are only used when there is no alternative and to protect their welfare. For example, cancer cells may be transplanted into a mouse in order to test a new treatment without risking harm to patients. Experiments can only be performed if they have been licensed by the Home Office. (Details of the regulations can be found at https://www.gov.uk/guidance/research-and-testing-using-animals)

When we ask for your consent to use your cells or tissue for research, you will be able to indicate if you don’t want your samples to be used in this way and we will ensure your wishes are respected. We will only provide samples for use in medical research using animals to groups based in the UK who provide evidence of Home Office approval.

Rarecan Limited funds and acts as the Sponsor for the RareCan BioResource. RareCan Limited is a for profit company limited by shares registered in England, company number 12844377, registered address: 8 Park Avenue, Hexham, Northumberland, United Kingdom, NE46 3EN. RareCan is funded by investors, who include the founders, and several professional investors. RareCan may raise further funding from investors in future to support the sustainability of the RareCan BioResource. More information about RareCan’s investment strategy can be found on the website (www.rarecan.com).

RareCan will charge researchers a fee when they obtain material from the BioResource, to cover the costs of collection, processing, storage, transportation, and documentation. This money will be reinvested in RareCan but may also be used to pay dividends to investors and incentivise staff, both of whom are critical to enabling us to deliver our vision.

Your cells or tissue offered for research represent a gift and we will not give you any payment for allowing them to be used for research.

If researchers develop a new drug, treatment or test, a pharmaceutical company, biotech company, university or other researcher may then make a profit. It will not be possible for you to make a claim for a share of these profits if you donated tissue to the BioResource.

No, your individual data are confidential and are protected by law. The results of all types of research are published in scientific and medical journals. However, it is not possible to identify individual people in these publications. As a result, it will be impossible for insurance companies to access your data.

We will provide details of the research projects which have made use of the samples you have donated through your Rarecan account. Although it will not be possible for us to give details of the results obtained for an individual donor we will provide an outline of the results obtained for the whole study- when these become available.

Ethical approval of the RareCan Bioresource has been given by the London-Fulham Research Ethics Committee.

If you need more information before you decide whether to take part please contact us by e-mail on info@rarecan.com, or via our website and we will be happy to phone you to discuss any questions you may have.

If you would like to consent to donate your samples for research, please complete the online consent form (available at the bottom of this page). If you prefer we can provide a paper copy instead. Please be careful about which options you choose so that all can be done in accordance with your wishes. Once we have received this, we will contact the hospital where samples are due to be taken or, if the sample has already been obtained, where it is stored, to arrange collection and transfer either directly to a research team or to our storage facility.

If you would like your samples to be used in research but would prefer this to be done by a bioresource run by a charity or other non-commercial organisation, please contact us and we will try to find an alternative for you.

If you do not want your tissue to be used for medical research, there is no need to do anything further.

You have the right to withdraw your consent for donation at any time after you have signed the consent form, without giving a reason. Your specimen will then be discarded in a lawful manner and a letter of confirmation will be sent to you. If you withdraw consent after the samples have been taken, it is possible that some research may have already taken place. It will not be possible to delete the information obtained by this research once this has occurred, but any remaining tissue will be destroyed. If you want to withdraw your consent please email info@rarecan.com. Please give your name. A simple statement, such as “I want to withdraw my consent for Rarecan to use my samples”, will be sufficient for us to start this process.

For more information about the research we undertake please visit this page.

Details about the laws governing the use of cells and tissues in research may be found at https://www.hta.gov.uk/faqs/donating-your-tissue-research-faqs

For information on how the Health Research Authority protects and promotes the interests of patients and the public in health and social care research visit https://www.hra.nhs.uk/about-us/

For information regarding the regulation of use of data visit https://ico.org.uk/your-data-matters/

Please address any complaints to info@rarecan.com in the first instance. If you have concerns about your data or wish to exercise your rights under the Data Protection Act please contact DPO@rarecan.com. If you are not satisfied with our response you can contact the Information Commissioner’s Office (ICO)

The ICO’s address
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Helpline number: 0303 123 1113