Participant Information Leaflet (Healthy / Control Volunteers)

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1 Tuberculosis Risk Factors Study Participant Information Leaflet (Healthy / Control Volunteers) Introduction Please read this information leaflet about the study before you decide whether or not to take part. This leaflet will tell you: Why the study is being done. What you need to do if you decide to take part. What is the Study about? This study aims to get more information about why some people are more likely to get tuberculosis (TB) than others. We are investigating two things that might affect the risk of a person getting TB: The effect of vitamin D The effect of variations in genes that control the immune system (the body s defence system against infection) Why have I been chosen and do I have to take part? You are 1of around 300 people who have been invited to act as a control that is, somebody who does not have TB. We are comparing results from controls like yourself to those of patients who have been diagnosed with TB of the lung in the North West of England from and whose diagnosis was notified between the years Do I have to take part? We are inviting you to take part in this study, but it is up to you to decide whether or not you want to take part. If you decide not to take part your health care will not be affected in any way. Page 1 of 6

2 Vitamin D Vitamin D helps keep our bones and teeth healthy. It also helps keep our immune system working properly this is how it might affect the risk of getting TB disease. We get most of our Vitamin D from sunlight and some from our diet. Three things can affect the amount of vitamin D that the human body can use: The amount of sunlight that a person is exposed to The kind of things that a person eats and drinks The genes that control the way that the body can use vitamin D This study will look at the effect of all of these on the risk of getting TB. Variations in genes that control the immune system Genes are a set of instructions that tell the body what sort of proteins to make. Genes are made from a chemical called DNA (deoxyribonucleic acid). Most of the DNA in our genes is the same as everybody else s but there are small differences (variations). These variations mean that we look different from anybody else (except if we have an identical twin). These variations might also affect our risk of getting some diseases like TB. The body fights TB with the cells and the chemicals of the immune system. The immune system might work differently in different people and this might affect the risk of getting TB. One possible reason for this is variations in genes that control parts of the immune system that are involved in the body s defence against TB. This study will aim to find out if there are differences in these genes between people who have had TB and those who have not. What sort of Study is this? This study is called a case-control study. It will compare people who have had TB (cases) with those that are not known to have had the disease (controls). Page 2 of 6

3 A case is someone who: Has been diagnosed with TB of the lungs that is confirmed on laboratory testing AND Has been reported to the to the Health Protection Agency s North West enhanced tuberculosis surveillance scheme during AND Has been recorded as being of Black African, South Asian or White ethnicity AND Is resident in the North West region of England at the time of the study. A control is someone who does not have (or is not known to have had) TB and who lives in North West England at the time of the study. Controls will be selected so that overall the cases and controls are, as much as possible, similar with regard to sex and ethnic group. The following will not be able to take part in the study: Aged 16 years or under Known to be unable to consent In prison at the time of the study. It will compare the factors affecting vitamin D levels and the presence of genetic variations in cases and controls. You are being invited to join the study as a control. Who is organising this Study? The study is being organised by the University of Manchester and the Health Protection Agency in the North West. How did we get your details? We contacted you using the details provided by you for the Salford Citizen Scientist Project. What happens next if I agree to take part in this Study? If you do agree to take part, you will be asked to: Page 3 of 6

4 1. Fill in a consent form. This is to show that you agree to take part in the study. 2. Fill in a questionnaire about your exposure to ultraviolet rays (sunlight or tanning booths) and any vitamin D supplements in your diet. 3. Provide a saliva (spit) sample so we can test for the presence of genetic variation. What will happen to your saliva sample? This will be tested for genetic variations. Because this study is trying to develop new knowledge the results will not be helpful to you in making decisions about your healthcare in the immediate future. The sample will be stored and may be used in future studies, if you agree. What kind of information will be collected about me? We will collect information like your name, age, ethnic group, post code, and any relevant medical history. We will also ask about your exposure to sunlight and about your diet. How will this information be kept confidential? The law called the Data Protection Act (1998) tells us how to keep the Study information secure. We will store the information that you give us on a secure electronic database. Only authorised members of the study team using special passwords will have access to your data. We will not give your details to anyone else. When we publish the results of the study we will group together all the information that we have collected from everyone taking part in the study and your name and identity will be kept anonymous. What are the benefits in taking part in this Study? Page 4 of 6

5 This study will help to provide more information about the kind of things that may affect the risk of getting TB. Once there is enough information from other studies on this subject it might help to develop betters ways of preventing or treating TB. The results of this study on its own will not be able to give you information that will affect your personal healthcare. Are there any risks in taking part in this Study? No. There are no risks in taking part in this study. Will I need to tell my insurance company if I have these genetic tests? No. There is no need for you to tell your insurance company about these tests. Will anybody else be able to use my DNA? We will not make your genetic material available to any third party or any public authority (such as the police) unless legally compelled to do so. What if I have a question or there is a problem? If you are not sure about any aspect of this study you should ask to speak to Dr M Petrovic who will try to answer your questions. What happens when the Study finishes? The results will be published as reports in medical journals and presented at conferences. Your name and any other information that can identify you will not be used. If you would like us to send you a summary of the results, please tick the box on the consent form. This will be available during After this study has finished, we may wish to undertake more research and it would be very helpful to be able to use the samples Page 5 of 6

6 that you have provided. In the consent form we are asking your permission to do this. Who has checked the Study? Before a study like this goes ahead it has to be checked by an NHS Ethics Committee. This study has been checked and approved by the North West 5 Research Ethics Committee. Contact Details During office hours: Dr M Petrovic, tel no Out of office hours: Please leave a message on the telephone number above More information You can get information about TB at: You can get more information about vitamin D at: minerals/vitamind/ You can get more information about genes and genetics in general at: ages/what-is-it.aspx and at: If you decide to take part in the Study, please keep this information sheet and a signed copy of the consent form. Thank you for taking the time to read this information sheet. Page 6 of 6

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