BRC Nucleus PO Box 92
Mapother House
De Crespigney Park
London
SE5 8AF
Tel: 0203 228 8559
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NIHR Biomedical Research Centre
INFORMATION SHEET FOR PARTICIPANTS
REC Protocol Number:CREC/07/08-152
YOU WILL BE GIVEN A COPY OF THIS INFORMATION SHEET
You (and everybody living at your address) have been asked to participate in this original research project organised by King’s College London and funded by the South London and Maudsley NHS Trust and King’s College London National Institute of Health Research Biomedical Research Centre.If you complete the study we will pay you £15.
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 wish to know more.
You should only participate if you want to; choosing not to take part will not disadvantage you in any way. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve.
Physical and mental health in South East London: a cross sectional study
What are the aims of the survey?
- The first aim of the survey is to work out how many people have various mental disorders (e.g. depression, anxiety and other forms of “stress”) in this area. This will enable services to be planned more effectively and to assist and help certain groups if they appear at particular risk.
- The second aim is to work out how frequent some risk factors for various physical illnesses are. These include obesity, hypertension, smoking and alcohol consumption.
- A third aim is to work out the pattern of these disorders, for example if they are more or less common in certain groups, such as ethnic minority groups, or people who are struggling financially.
- A fourth aim of the study is to provide information and data so that the information you provide us can be compared with groups of patients with specific disorders in South East London. This will enable us to work out how important certain risk factors are, such as hypertension, in causing illnesses such as depression.
- Finally, we will ask whether we can take a sample of DNA by collecting saliva so that we can study and control for the effect of genetic variation on the disorders listed in our four aims. Your DNA will be used for this study and we will also ask your permission to use it for future studies. We will provide more information when you have completed the interview. Please note that you can do the interview, and still turn down this request.
We are asking English-speaking people living in households in Lambeth, Lewisham and Southwark, aged 16 years and older to help us by taking part in this study.
What are the benefits for you of taking part?
- As a “thank you” we are paying all those who complete the interview £15.
- There are no other direct benefits, howeverwe believe that by participating and allowing us to conduct this study,you will contribute to the greater good by providing real statistics regarding mental and physical health problems to allow the health service to help people in the community.
What will we ask of you if you take part in the study?
- If you agree to participate you will be asked to complete an interview which will take about 1hour. The interview will include questions regarding a range of stresses and strains, and we are particularly interested in how difficulties in living may impact on your mental and physical health. We will also ask you questions about stressful life events and daily habits such as exercise and diet.
- If you wish you can choose whether you want to take part in another component of this study that involves collection of saliva for genetic analysis. This will be explained to you by the researcher.
- If you report to us that you have been unwell, we may try to gain more information from medical records. We are not allowed to do this unless we have your permission and we will ask you for this. You can decide not to give your permission but still do the main study.
What are the risks?
- There are no major risks involved – all we want to do is ask you a lot of questions about your health and various stresses and strains you might be under. Some of these questions touch on sensitive areas. If you feel uncomfortable with any of the questions you do not have to answer them. If you want to stop the interview you can do so at any time without giving us any reason.
Is Confidentiality guaranteed?
We take confidentiality very seriously. All personal information about you is regarded as strictly confidential. Only the researcher asking these questions and the study leader will be able to trace the information you have given us to your personal details. All the information about you will be coded; you will not be identifiable in any research outcome (e.g. publication). This ensures that suitable standards of security and confidentiality are applied.All information collected will be securely held in King’s College London.
- If you agree to take part in this project you will be asked whether you are happy to be re-contacted about participation in future research projects. In that case your name will be retrieved and you will be re-contacted. This decision will not affect your participation to this current survey.
- Under certain circumstances we may be interested in accessing your medical recordsto check medical information but we can do it only if you allow us to. You can refuse consent and this will not affect your participation in this current survey.
You are free to withdraw from this study within a month after the interview without giving a reason by contacting the researcher whose details are at bottom of this information sheet. Withdrawal will not affect any of the care and treatment you receive from the NHS.
Only in cases where you tell us something which may place you at severe risk (such as suicidal plans) would we consider breaching confidentiality. In those cases you might be contacted by an expert from the study team, or we might contact your GP if we considered your life at risk.
- Who is funding the project?
The study is funded by South London and Maudsley NHS Trust and Institute of Psychiatry National Institute of Health Research Biomedical Research Centre. This is a government funded project.
If this study has harmed you in any way you can contact King's College London using the details above for further advice and information: Maria Verdecchia (tel: 020-78485417, Address: King’s College London, Institute of Psychiatry, Weston Education Centre, 10 Cutcombe Rd, London SE5 9RJ) and you will be offered the King's College London 'No Fault Compensation Scheme'.
Thank you very much for your time and once again please ask for more information on the project if you wish.
Professor Matthew Hotopf
Principal Investigator