PARTICIPANT INFORMATION

Transcription

1 PARTICIPANT INFORMATION IMPERIAL POPULATION BIORESOURCE TISSUE BANK (PART OF NIHR BIORESOURCE) In the UK around 20 million people are said to be living with a long-term condition such as diabetes or heart disease. Living with a long-term condition has a major impact on a person s quality of life and on their family. The Imperial Population BioResource has been set up to help in the fight against these and other illnesses. We would like to invite you to help us in this fight against ill health by joining the Imperial BioResource, a resource of thousands of volunteers, both with and without health problems, who are willing to be approached to participate in research studies investigating the links between genes, the environment, health and disease. Before you decide, it is important for you to understand why the Imperial BioResource has been set up, its aims and purpose, what research is likely to be done, and what your participation will involve. Please take your time to read the following information carefully and feel free to ask us if there is anything that is not clear, or if you would simply like more information. What is the purpose of the Imperial BioResource? The Imperial BioResource is establishing a panel of thousands of volunteers with and without health problems. These volunteers will be asked to donate a small amount of blood, to complete a lifestyle questionnaire and to consent to be contacted and invited to participate in future medical research studies. A few baseline measurements like BP (blood pressure) and BMI (body mass index) will also be done in the clinic. Information and samples from this BioResource may also be made available to other scientists working in biomedical and healthcare research. By looking more closely at the causes and development of diseases, it may be possible to identify better treatments to help prevent them. It is hoped that the resulting knowledge will help other patients in the future. What are the benefits of joining the Imperial BioResource? The most important health benefits from the BioResource will be realised many years from now, and will largely help future generations. This BioResource is intended to benefit the general population as a whole in the years to come. It will improve our understanding of the genetic and non-genetic factors that affect health. It will also provide a resource for future research that will contribute to public health improvement. Page 1 of 5 Imperial BioResource abbreviated Patient Information Leaflet Version /09/2014

2 What are the risks and disadvantages of joining the Imperial BioResource? Joining the Imperial Bio Resource will involve donating a small sample of your blood. Qualified, experienced nurses or phlebotomists will collect the samples; however, blood sampling can cause some discomfort when the needle is placed in the vein and the blood is drawn. There is also a possibility that a small bruise may develop. Will my taking part be confidential? Yes. All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you that is given to the researchers will have your name, your address and any other personal information removed so that you cannot be recognised from it. What happens at the clinic? When you arrive for your appointment, a member of our team will explain the study protocol to you and will answer any questions or concerns you may have. The research staff will then ask for your consent to take part. The clinical procedure involves the research staff recording various details about you, taking baseline measurements. They will then collect some blood samples from you. At the clinic will also ask you to complete a short health and lifestyle questionnaire. Further relevant information about your health may be obtained from your medical records. In summary this is what happens at the clinic: Personal details (e.g., name, address, GP address); Any current or prior medical conditions, medications and questions about lifestyle; Brief health check, including weight, height, body composition, blood pressure, and pulse rate; Blood sample (three tubes - around 10 teaspoons); A questionnaire about your general health and family history. What will happen to the samples I give? We want to know how genes influence disease. Genes are made out of DNA. We will isolate, analyse and store a sample of your DNA from your donated blood sample. Using the latest state of the art techniques, we will determine your genetic make-up. This may include determining the sequence of all or part of your DNA code. We will also isolate and test other components of your blood such as RNA and proteins. Ribonucleic acid, or RNA, is a molecule essential for the coding, regulation and expression of genes and proteins. What if researchers find new information about my health? When you join the Imperial BioResource we do not screen your enrolment sample or use it to investigate your health. The sample is used to ascertain whether you have the genes of Page 2 of 5 Imperial BioResource abbreviated Patient Information Leaflet Version /09/2014

3 interest for studies we are supporting. If during the initial screening that we offer as part of joining the BioResource we encounter anything unusual, we will contact you and suggest you visit your GP. We will never give you any diagnostic information. Most research studies that you might be invited to participate in do not offer feedback on your health. However, if you are invited to take part in a study that does involve tests that could provide indicators of your health you will be informed of this prior to participation. How will my data and sample information be stored? Data information storage The information on data and samples will be stored in a secure database at Imperial College London. In order to keep your information confidential, numerous safeguards are in place. In particular, we will: Remove personal identifiers such as your name or date of birth from your samples and records; Assign codes to your samples and records; Keep your personal details separate from your data and samples; Hold information in secure databases, which can only be accessed by the authorised staff and by approved researchers (who will only have access to coded information) Use stringent security measures to prevent unauthorized use, including: strict access controls, computer security and data encryption techniques, confidentiality agreements and staff training; Have a decoding step that will allow us to re-link your personal details with your samples and information, should you want to withdraw from the study or in order to make sure the database records are correct. Sample storage Blood samples will be stored at a biorepository in Hammersmith campus of Imperial College London OR in UK Biocentre in Manchester in the long term. These are both secure facilities, meeting international security and safety standards for laboratories. The same coding and security measures that are in place for your data will also apply to your samples. Who can access my data and samples? The samples and data may be used by researchers based in academic institutions, the NHS or commercial companies. A Tissue Management Committee will review all applications on the basis of scientific merits before releasing any sample or data. The Tissue management Committee includes members of the public amongst its members. All samples or data given to third party will always be anonymised and no one will be able to identify you. Page 3 of 5 Imperial BioResource abbreviated Patient Information Leaflet Version /09/2014

4 What happens if an invention is made using my sample? If an invention results from the research undertaken with your sample (for example, if we or another research group develop a new blood test or better medicines for prevention or treatment) you will not receive any compensation or payment. Imperial College London may work in partnership with the private sector (e.g. the pharmaceutical or biotech industry) to develop any invention for the benefit of patients. Part of the profits earned from inventions will come back to Imperial College London. How often will I be contacted? We closely monitor the number of times you are approached and invited to studies. The maximum number of invitations to studies will be 4 each year. How do you follow up my health records? We follow up your health records on databases authorised by the NHS to hold these data. Our main sources are the cancer and mortality registers in England & Wales, and Scotland. We also intend to obtain information on Hospital Episodes (HES) and GP records. We may apply to use other NHS databases as they become available, but any such application will be subject to approval by the relevant NHS committees. What if I no longer want to be a member of the Imperial BioResource? If you decide not to take part, it will not affect the standard of care that you receive in any way. You will be free to withdraw at any time and without having to give a reason. You can withdraw by to [p.downey@imperial.ac.uk] or by writing to the Imperial Research Hub. You will then be sent a withdrawal form to complete and sign. This will be overseen by the BioResource research team and you will receive a letter to confirm your withdrawal. If you withdraw from the study, your samples and the data derived from your sample and other personal information will be no longer used. Only your signed consent form and withdrawal form will be kept as a record of your wishes. Such a withdrawal will prevent information about you from contributing to further research and analyses, but it will not be possible to remove your data from analyses that have already been done. Who funds and sponsors the Imperial BioResource? The Imperial BioResource is currently funded by the National Institute for Health Research (NIHR) and jointly sponsored by Imperial College London and Imperial College Healthcare Trust. This study has been reviewed and approved and approved by NRES Committee North West Haydock. How do I join? If you decide to take part, you can contact our recruitment team on or by [ p.downey@imperial.ac.uk ] and book an appointment for your initial visit at our clinic in Charing Cross Hospital London. You will receive an appointment pack by post or that will confirm your time and venue along with any other instructions required. Page 4 of 5 Imperial BioResource abbreviated Patient Information Leaflet Version /09/2014

5 Further information If you need more information about the Imperial BioResource, please ask the person, who gave you this form, or write to: BioResource Manager Imperial Research Hub Charing Cross Hospital Ground Floor, Dinning Block Fulham Palace Road Hammersmith London, W6 8RF Phone: Website: Thank you very much for taking the time to read this information Page 5 of 5 Imperial BioResource abbreviated Patient Information Leaflet Version /09/2014