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Information Sheet (Ver. 1.5, October 2009)

A UK control population.

You are being invited to take part in a research study because you have responded to one of our advertisements asking for volunteers. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

What is the purpose of the study?

The major aim of this project is to collect blood samples from a number of people (100-150) from throughout your locality as part of a larger, UK-wide study. These blood samples will be used as a source of DNA and RNA (the translation of DNA that the body uses to make proteins) for genetic studies. We may also eventually make cell lines from the blood cells. These cell lines can be frozen and then grown up at a later date to be used as a continuing source of DNA. This is particularly useful when the DNA/RNA that was initially made from the blood sample has been used up. The cell lines will also allow us to investigate the proteins themselves that are coded for by the genes.

The idea behind the project is to look at genetic variation within and between different populations from throughout the UK. Genetic variation contributes to inherited differences in susceptibility to many common diseases such as cancer and heart disease. The genetic basis of this can be investigated by looking at differences in the frequency of certain DNA/RNA variations, also called "markers", in individuals with a specific disease compared to the controls in whom the disease is not known to occur. A marker that is at a higher frequency amongst patients than among controls can be used to identify inherited components of the disease. A recent development is that it will soon be possible to sequence all the DNA from a volunteer and this will be the best way to investigate all DNA markers in a sample. Your DNA/RNA sample will form part of the UK control population, aimed at obtaining a large control population, ultimately more than 3,500 people, from throughout the UK. These samples will be used for future studies on the inherited basis of common diseases and normal traits. The understanding that should come from such studies is aimed at better approaches to prevention and treatment of the diseases and this study will continue indefinitely. As the samples are anonymised, it should not be possible to link the genetic data to you directly as an individual.

As part of this study, we are especially interested in the inherited variation of facial features, including the ears. This will require that 3D photographs are taken of volunteers so that distributions of particular features can be objectively defined and associated with specific genetic markers. These are very likely to be geographically informative and will help define variation throughout the UK. We will also measure some other normal phenotypes such as height, hair and skin colour, and features of the hand based on a single photograph, such as finger size and hairiness. There will also be a questionnaire, which we will fill in, asking about some additional normal traits such as ability to curl the tongue, colour blindness, left versus right handedness and sleep patterns, and this will be accompanied by a few simple tests for phenotypes such as taste, smell, colour perception and absolute pitch. There is a general interest in the specific genetic differences that underlie such variation in normal traits. Worldwide variation has already been studied to some extent for some of these traits, but their detailed distribution in the UK, which may be expected to vary from one part of the country to another, has not so far been studied. No published data will allow any possibility of individual identification of any of our volunteers. Access to all the data that enables any individual identification will be strictly limited to researchers working directly on the project with us, and all electronic transmission of the data will be encrypted.

A second aim to this project will be to use the genetic data generated by the study to investigate historical patterns of movement within the UK. To help with this, it is proposed to look at the geographic distribution of surnames and compare those patterns with the genetic variation seen throughout the different regions of the UK. If you consent to your surname being used, it will be used only by this study and only then if it occurs a number of times amongst the samples we collect. In this way it should not be possible to link the genetic data directly to you as an individual. Many investigators around the world will have the opportunity to study both the data and the samples for a wide range of genetic variation. They will NOT have access to your surname.

Why have I been chosen?

You have been invited to participate in this study because you have responded to one of our advertisements asking for volunteers whose parents and grandparents were born in the locality. This is to collect samples from families who have lived in the same locality for several generations. We are hoping to collect samples from 100-150 individuals from each locality.

Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are nevertheless still free to withdraw without giving a reason at any time up to the point where we have taken the blood sample and you have left the premises. Once you have left, the blood sample will be given an anonymous identity and it will not be possible to trace it back to you, which is why we cannot subsequently withdraw your sample from the project. A decision to withdraw at any time up to this point, or a decision not to take part, will not affect the standard of care you receive.

What will happen to me if I take part?

This study will need a small quantity of your blood (about 20ml - less than a standard measure), or only a cheek swab if you have previously donated a blood sample. The blood sample, or cheek swab, will be taken when you turn up to the place where we have arranged to see you. The blood sample will be processed by us and DNA/RNA from it will be used for an indefinite amount of time. The cheek swab will be used only to provide a small additional amount of DNA. Once you have given us some blood or provided a cheek swab, and we have taken photographs and collected other information, you will not be required for any more visits. If you need it, we will pay your travel expenses for the visit.

What do I have to do?

There is nothing that you should or should not do as a result of taking part in this study, although we would recommend that you refrain from donating blood for a week afterwards. If you do donate blood, let them know which arm we took the sample from.

What are the possible disadvantages and risks of taking part?

In the very unlikely event of any injury occurring during taking part in this study, there are no special compensation arrangements.

As technology advances, there may be new ways of linking information back to you that we cannot foresee now. Also, we cannot always foresee the results of research, so new risks may come up in the future that we cannot predict now.

What are the possible benefits of taking part?

There are no intended clinical benefits for any person taking part in this project. There is also the possibility that researchers in companies may study the data and the samples. If any commercially valuable products result from these studies, donors will not receive any of the profits.

Will my taking part in this study be kept confidential?

All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you that leaves the laboratory will have your name removed so that you cannot be recognised from it. All samples will be anonymised and will not be linked to you in any way.

What will happen to the results of the research study?

As the study samples are anonymised, any individual results from this study cannot therefore be made known to you and cannot be linked to you. General results from this study will be published in the usual medical and scientific journals and may be released as press statements and through the media, at the time they are published. Data, including complete genome sequences, will be made available to researchers via open access (public) databases available on the internet. There is a possibility that the data in the databases will be used to study questions related not only to health and disease but also of various non-medical traits, and that both individual and group comparisons will be made. Surnames and photographs will NOT be made publicly available.

If you wish, we will be happy to send you details of the overall results from the study as and when they are obtained and keep you informed of the progress of the project.

Who is organising and funding the research?

The funding for this project comes from the Wellcome Trust and will be organised by the Cancer and Immunogenetics Laboratory, CRUK. The work will take place at the Department of Clinical Pharmacology, University of Oxford at the Old Road Campus Research Building, which is where the samples will be stored. Samples will be collected by collaborators throughout the UK.

Who has reviewed the study?

The study has been reviewed by Leeds (West) Research Ethics Committee (05/Q1205/35).

Contact for Further Information

If you have any questions about the research, please contact the Research Nursing Sister and event coordinator, Tammy Day on:

01865 863 819 or

07914 264 794 or:

tammy.day@clinpharm.ox.ac.uk

You will be given a copy of the information sheet and a signed consent form to keep.


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