Learn more about samples
Frequently Asked Questions about giving samples
Basic information about sample collection for research can be found in the introduction section. For some people this will be enough – others may want to know a little more. This resource is a launch-pad for them.
Q1: Who has assessed the proposal to collect my sample?
The responsibility for reviewing most proposals to collect samples from patients in the NHS lies with the national Research Ethics Service run by the Health Research Authority.
Researchers complete an on-line application form where they set out why they want to collect samples, how they will do it and what the samples will be used for. They also submit copies of the patient information leaflet and consent form that they plan to use.
Applications are considered by a Research Ethics Committee (REC) including independent experts and members of the general public.
The collection of samples from NHS patients cannot start until the research team have REC approval and the go-ahead from the relevant hospital or GP clinic.
Q2: Why do I have to sign a consent form?
Although it isn’t a legal requirement to sign a consent form to donate samples for research in most cases you will be asked to do this- as a record that you have understood what is involved and agree to the sample being collected and used in the way described in a patient information leaflet you will be given to read.
You should be given time to read both the information leaflet and consent form carefully and there should be the opportunity to ask questions. This can pose practical problems in busy clinics and on a hospital ward.
You may be anxious about your treatment and there may not be time for you to think everything through. If this is the case either say no- this will not affect your treatment- or ask to take the information away to read later.
In some cases the information will be available for you to go back and review later on-line. Remember, you can withdraw your consent if you change your mind.
Q3: What is a biobank?
A biobank is a collection of samples used for research.
In some cases the collection is available for researchers to use outside of the institution where the biobank was set up. For example, the UKBiobank obtained samples from half a million volunteers aged between 40 and 69 and has now supported over 300 projects from around the world since the collection was completed in 2010.
In the UK research biobanks must hold a licence from the Human Tissue Authority to ensure that they have valid consent in place for the collection of samples and that storage facilities are of a good standard.
The use of samples is overseen by the Health Research Authority, as described above. A biobank may apply to have Research Ethics Committee (REC) approval for their collection, allowing them to distribute samples without additional external review, as long as they keep within the scope approved by the REC and submit an annual report which describes how the quality of each application to use samples was assessed. The HRA has published a list of REC approved biobanks.
For a short video about a typical biobank please click here.
Q4: What about my data?
Retention of records which provide your identity is very strictly controlled through the Data Protection Act (more details are given on the website of the Information Commissioners’s Office). In addition researchers must comply with the Caldicott Guidelines which restrict information on a strict “need to-know” basis.
In almost all cases there is no need for the researcher to know your name or where you live. These details may be retained by someone independent of the researcher so that additional information can be provided at a future date by, for example, looking at your medical records. This arrangement is called linked anonymisation .
Linked anonymisation is also essential if you want you sample to be destroyed if you decide to withdraw your consent.
Q5: What happens if the researcher finds out something which could affect my health or that of my family?
It is very difficult to know how to deal with this in the best way and no solution is perfect!
One compromise is to
- tell you roughly how likely it is that the research will throw up something unexpected. If, for example, the research involves your normal DNA then incidental findings (as they are called) are more likely to occur than in studies where DNA is not studied
- inform you that if something is found your GP or hospital doctor will be told so that they can decide whether the risk is sufficient to warrent asking you to repeat the test (this will need to happen in any event as the test will need to be done in a hospital laboratory). Before this happens you may be offered expert genetic councilling so that you can understand the implications for your family.
However, some biobanks will decide that they will not return findings to donors or the doctors looking after them as they take the view that the results are not sufficiently reliable to guide treatment and may cause unnecessary anxiety.
Q6: What is my sample going to be used for?
I have concentrated on biobanks- collections of samples made available for several different projects, but samples may also be requested for specific research projects and as part of drug trials. Information regarding your donation should be available when you are asked for your consent.
Samples are essential for the study of most forms of disease. For example, in order to understand how dementia arises researchers need to look at normal and diseased brain under the microscope and to undertake laboratory tests, including the analysis of DNA (the genetic code) and proteins (the building blocks of the cell).
The Medical Research Council have funded a network of Brain Banks throughout the UK to collect brain tissue after death. To find out more visit their website
Children’s Cancer and Leukaemia
Thankfully cancer is rare in children. In addition, due to research over the last 30-40 years, most children can now be cured. This wouldn’t have been possible without access to samples of cancer cells for research which has helped to guide treatment.
Biobanks of children’s cancer samples have been established to gather enough samples to make meaningful research possible. In the UK the Children’s Cancer and Leukaemia Group Tissue Bank and the Bloodwise Cell Bank have been providing samples for research for many years, enabling research teams to understand how cancer and leukaemia (a cancer of the blood cells) arises in children.
An example is the pioneering work of Professor Christine Harrison in understanding how particular changes in the chromosomes of a leukaemia cell can predict how a child will respond to treatment.
The 100,000 genomes project was set up in 2012 to discover the causes of a wide range of rare genetic diseases (and several forms of cancer). The aim is to read the entire genetic code from 70,000 patients or their relatives in order to detect which genes are involved in producing rare inherited diseases. This will lead to more accurate diagnosis and possibly, in time, to new forms of treatment.
Understanding health: the UK Biobank
The UK Biobank was set up in order to understand how we stay healthy. Blood, urine and saliva samples were collected from 500,000 people aged between 40-69 years between 2006 and 2010 and have been used for a wide range of studies aimed at improving the prevention, diagnosis and treatment of a wide range of illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia.