Tissue Donation and Genetic Research

What is tissue?

Tissue is any kind of human material including blood, urine, skin, bone marrow, hair and teeth. Tissue can also be the whole or a part of an organ which has been removed during surgery.

Why is tissue needed for research?

Using tissue samples is a very useful way to study disease in humans. Having human tissue to experiment on also reduces the need to use animals for medical research.

How will I donate tissue?

There are several ways this may happen.

• Researchers may study blood or urine samples left over after routine tests or medical treatment.
• Researchers may study organs or parts of organs removed during surgery.
• Researcher may ask you to donate a sample of tissue specifically for a research study.

Why does it matter how tissue is used by researchers?

Protecting tissue samples and donations has become more important in recent years for two main reasons.
Firstly there have been situations in the past where patients or their families have been upset to discover that organs have been kept and possibly used for research without them knowing or giving their consent.
Secondly scientific advances mean that it is now possible to find out a large amount about a person from even the smallest sample of their tissue. This means it is now important that only authorised researchers have access to this information and that they must abide by certain rules.

Consent to use human tissue for research

If researchers want to collect tissue for the sole purpose of carrying out research they need to ask for your consent.

You should also be aware that if you are having routine treatment carried out at the hospital it is normal practice to store any tissue which is left over. One reason for this is to allow doctors to go back to the samples if you have to come into hospital again. However, these samples also provide useful material for researchers to study and you should be told if there is a chance that your tissue may be used in this way. If you don't want this to happen you have a right to ask for your tissue to be destroyed.

Things you need to know before you give consent

• Tissue donations are treated as a gift from you to the researcher: You can't be paid for the donation and the donation doesn't legally belong to you.
• While a researcher does not legally own your tissue donation, they do have the right to use it in the agreed way. The researcher is also responsible for keeping the donated tissue safe.
• Researchers are not allowed to use your tissue donation for financial gain.
• The sample may be kept and used for future research.
• You should be told how long the sample will be kept and who will be responsible for it.
• If your sample has been completely anonymised then it can no longer be identified as belonging to you and therefore you can't choose to withdraw it or have any say in what happens to it in future.
• If your sample can still be linked to you (by your name or NHS number for example), then any future research will need to be looked at and approved by the ethics committee.
• If this future research could affect you in any way then the ethics committee will require that you are contacted again to give consent.

Genetic Research

Genetic research looks at the effect genes have on our health. Genes are made of DNA. The DNA contains coded messages that pass on characteristics from generation to generation.

Characteristics such as eye colour and skin colour are passed from parents to their children and in the same way the chances of developing certain diseases can also be passed on.

Researchers study genes to understand more about why certain peoples develop diseases and other don't and why medicine can work for one person and not for another.

There are two main types of genetic research.

Population studies

This is when researchers take a large number of tissue samples and extract the DNA so that they can learn more about how genes vary within the whole population. Usually in these studies the tissue samples will not be linked to you in any way and so it is not possible to give you any personal results.

Research on specific diseases

In this kind of research you may be asked to take part because you or a member of your family has a particular medical condition. Researchers will be looking for specific genes which may play a part in this disease. In this kind of research DNA from your tissue sample will be linked to other medical details about you, but researchers must be careful to keep this information confidential.

Genetic research into specific disease has to be looked at and approved by an ethics committee, and you should be fully informed about the study and what is involved before you agree to take part. You also have the right to withdraw at any time, as you do for any other research study.

If you are asked to give a sample for research into a specific disease, these are some issues you may want to think about first:

Your family

• Researchers may want to contact other members of your family, how do you feel about involving them?
• How do you think you family would feel about being involved in the research?
• If family members are not related by blood this might become known during the research.

Dealing with results

Researchers may offer to tell you your personal results. Before agreeing to this you may want to discuss some of the following issues:

• What can the results tell you?
• Could the results show that you or your family are at risk of developing a particular disease?
• If you are at risk, is there anything you can do to minimise your chances of developing the disease

Even if your genes show that you have a higher risk of a certain disease it does not follow that you will get the disease. You may decide that it is less worrying not to know the results. Gene research is still in an early stage and so it is also possible that the information you are given is not completely accurate. In this case you could end up worrying about your health for no reason.

Discrimination

You may be asked when you apply for a mortgage or insurance whether you have been involved in any gene studies. Researchers are responsible for making sure that taking part in the study will not lead to discrimination against you. They might for example need to provide a properly phrased covering letter, for insurance purposes.

The following websites have more detailed information about the issues involved in donating tissue for research.

Genetic Interest Group - www.gig.org.uk
Medical Research Council - www.mrc.ac.uk