For Patients

What is a biobank?

A biobank is a place (typically a freezer) where blood or cancer tissue, donated by patients, is stored until the samples are used by researchers in approved research projects.

How does a tissue sample help in the fight against cancer?

The pathological diagnosis of cancer type is based on microscopic appearance, and patients whose cancer type, extent of spread and aggressiveness are similar receive the same post-operative treatment. However, we now know that two patient’s cancers may look the same, but their cancer genes and proteins may be different, causing a difference in response to treatment and prognosis.

This is where biobanking comes in. In frozen tissue samples the cancer cells’ genes (and the proteins they code for) are preserved. Researchers can therefore examine the tissue to learn more about how individual cancers grow and spread. Cancer cells have internal signaling pathways, and, at intervals along the pathways, protein stations, a bit like DART stations. Just as each train responds to signals between stations, the cell responds to signals to divide and produce more cancer cells, or to die or carry out other functions. If we can identify the protein stations in a particular cancer, we might be able to develop a new drug to block the signal to one or more stations, thus stopping cancer growth. Herceptin is an example of a new drug that blocks the growth of aggressive breast cancer in this way, and has improved the prognosis for many thousands of women.

What do researchers do with the samples?

Researchers may use tissue to investigate, for example, how and why cancers grow and spread, or to better understand why some cancers occur spontaneously while others occur in families e.g breast cancer. Cancer tissue (and blood) are essential for this research, and this is why tissue samples donated by cancer patients are so critical. Validating and translating basic research findings is leading to new tests and treatments for established cancers. However, the ultimate goal is to discover novel biomarkers or components of tissue which will identify people at risk of developing cancer, so they can be monitored more carefully. In the years to come, biobanked samples may eventually help prevent the development and growth of cancer.

 

Patient Confidentiality

Why is access to Patient records so important?

Basic information in the database will help researchers select their study group, e.g. men with colon cancer under 45 years of age. However, detailed information from Patients’ charts may help explain the research findings, and might indicate why a particular group of patients is likely to have a better prognosis.

Will all Patient data be confidential?

Yes. All information will be confidential and secure. Each sample is labelled with a code and anonymised. The biobank database links the sample code to a particular Patient but this information is not made available to researchers. Databases will comply with the Data Protection Act. If at a later stage researchers require additional information, e.g. the type of treatment the Patient received, doctors and nurses collaborating in the research project can make this information available to them. Patients are made aware that their samples will not be sold for commercial gain, and that results of research may not be of direct benefit to themselves. Samples are freely given as donations to the biobank in the patient’s own hospital, which is guardian of the samples, but research may be carried out elsewhere. Donors have the right to have their samples withdrawn from a research project at any time. Patients have the expectation that their samples will be used, and researchers are obliged to make the best possible use of patient donors’ samples.

 

What is the ethical and legal situation regarding use of human tissue?

Hospital Research and Ethics Committees require patient consent for biobanking, and separately approve specific project applications by researchers. More than 95% of patients give consent for biobanking and 95% of those do not wish to be asked to give consent for a second research project using leftover research samples (Mee B, prospective study, 2009). FFPE samples from archived diagnostic pathology specimens can be used for an individual research project following application to the REC to waive patient consent. However, European Union legislation (proposed but not yet enacted in 2015) might in future require researchers to obtain patient consent for each research project. All research projects involving tissue samples must have scientific approval before samples and data will be released from the network hospitals.

The Irish Council for Bioethics reported recommendations on the use of human tissue for research in 2005, but human tissue legislation, as adopted by other countries, is still awaited in Ireland. The UK, including Northern Ireland, is regulated by the Human Tissue Authority.

 

Do Patients have to take part?

No. Patients are perfectly entitled to refuse and this will not affect the standard of care they receive. The great majority of patients agree to take part, because of the chance that they may be able to help others with their disease.

What will happen to Patients who decide to take part?

Patients will be asked to sign a consent form to allow tissue samples from their operation specimen (or blood samples) to be stored and used in future cancer research. When Patients enter the hospital, they are informed about the biobank, provided with an Information Sheet and asked if they would be comfortable donating some surplus tissue to the biobank. If the Patient agrees, he/she signs a Biobank Consent Form (Consent Form), following discussion with a nurse or doctor. No additional procedure is needed other than completing the consent form. At all points, the Patient’s diagnosis has priority over research. Even with consent, we opt not to biobank samples from 15-20% of patients, when, for example, the cancer is very small. Patients are also asked to consent that doctors and nurses in the research team can review their medical charts (for family history, blood results, pathology, radiology, treatment and follow-up).

 

The Patient Consent Form, Patient Information Leaflet and Sample Access Policy (see For Researchers) were developed by Biobank Ireland in consultation with hospital medical staff, and sanctioned by patient advocate groups, the Assistant Data Protection Commissioner, and the Director of the National Cancer Registry.

A medical lawyer also examined the documents. All documents have been approved by the Research and Ethics Committees of 3 hospitals (St James’s, Cork and Galway University Hospitals). Text in the consent documents was made user-friendly with help from The National Adult Literacy Agency (NALA).

Download the Patient Consent form here.

What do patient advocates and patient advocate groups do?

Patient advocates are people with personal experience of a condition, who:

  • campaign for access to the best available diagnosis, treatment and care
  • work to make good quality information available to the public, patients and their families
  • press for ongoing research into the causes and treatment of the condition

Advocacy has been defined as ‘The act of pleading or arguing in favour of something, such as a cause, idea, or policy’. A quote on breast cancer advocacy:

‘Every woman has a voice. Every woman’s voice tells a highly personal story, which, when blended with the voices of a thousand other women, becomes a rising wave of similar hopes and dreams, fears and concerns. In the field of breast cancer, this rising tide of women’s voices speaking out as sufferers, supporters and campaigners is a powerful force for progress in combating the disease, and it was to give a platform to those voices and harness the power that EUROPA DONNA was launched’. Cancer Futures Vol 1 (2-3), March 2002

From http://www.europadonnaireland.ie/