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Ethics documentation

Ethics documentation. Adult patient Information form. Guy’s and St Thomas’ NHS Trust Research Ethics Committee. PATIENT INFORMATION SHEET. The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes. Principal Investigator: Professor J A McGrath Other Investigator/s

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Ethics documentation

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  1. Ethics documentation

  2. Adult patient Information form

  3. Guy’s and St Thomas’ NHS Trust Research Ethics Committee PATIENT INFORMATION SHEET The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Principal Investigator: Professor J A McGrath Other Investigator/s enrolling patients: Dr Suzanne Clements Ethics Committee Code No: 06/Q0702/154 Other reference numbers: Study title: THE ROLE OF P63 IN HUMAN SKIN AND IN ECTODERMAL DYSPLASIA SYNDROMES Invitation: You are being invited to take part in a research study. 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? Our research aims to discover the causes of Ectodermal Dysplasia syndromes and the impact these have on the structure and function of skin. Abnormalities in a gene called p63 have recently been linked to several Ectodermal Dysplasia syndromes but there is currently very little scientific information known about it. We will examine genetic material obtained from your blood and skin samples to help us understand the cause of the condition that you have. Why have I been chosen? You have been invited to take part in this research project because you have an Ectodermal Dysplasia syndrome that may be due to a p63 gene abnormality. Do I have to take part? Participation is entirely voluntary. If you do decide to take part, you will be given this information sheet and be asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, 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? If you decide to take part, you will be asked to give two samples: some blood and a piece of skin.

  4. Role of p63 in ED Syndromes Page 2 What do I have to do? If you agree to take part, you will first be asked to donate a blood sample. This involves a small needle prick in your arm. The amount of blood taken will be approximately 2 teaspoonfuls. There may be a slight bruise at the site of the needle puncture but this should clear within a few days. Secondly, you will be asked to donate a skin sample (also known as a biopsy). The site of the biopsy will be discussed with you but is usually from your arm. The area of skin to be sampled will be injected with local anaesthetic. This procedure causes brief stinging. The skin sample taken will be about the size of a 5 pence coin. It is likely that one or two sutures (stitches) will be required. The wound will be dressed and allowed to heal, with the sutures being removed after about 7 days. What is being tested? The blood sample will be used to extract genetic material (called DNA) which is important in finding out why you have an Ectodermal Dysplasia syndrome. The skin sample will be used to extract another form of genetic material (called RNA) so that we can see what p63 does to the rest of the skin genes and proteins. Part of the skin sample will also be grown in the laboratory (known as keratinocyte culture). This will allow us to expand the number of cells available for research and to limit the size of the skin biopsy we take from you. What are the alternatives for treatment? At the moment there are no effective treatments for any of the Ectodermal Dysplasia syndromes. The research project will help us understand the conditions and hopefully in the future will enable us, and others, to develop new treatments. What are the possible disadvantages and risks of taking part? The risks associated with taking a skin biopsy are minimal but you need to be aware of them. Slight bleeding can occur and this is usually easily controlled with firm pressure (fingers) over the wound site. Local skin infection may develop during the week following the biopsy; the features of which are redness, failure of the wound to heal and discharge of pus. If this happens, you may need to have a short course of oral antibiotics. Finally, you will get a small line scar as the biopsy is closed. What are the possible benefits of taking part? It is likely that participation in this research project will not be of immediate benefit to you. However, if new information arises from the study that may be of benefit to you a member of the research team will contact you to discuss it in more detail. The research should be able to help us understand the function of the p63 gene leading to a better comprehension of the Ectodermal Dysplasia syndromes. This will allow us to plan future studies but they will not form part of the current research project. What if new information becomes available? Sometimes during the course of a research project, new information becomes available about the skin cells being studied. If this happens, your research doctor will tell you about it and discuss whether you want to continue with the study. If you decide to withdraw your research doctor will make arrangements for your care to

  5. Role of p63 in ED Syndromes Page 3 continue. If you decide to continue in the study you will be asked to sign an updated consent form. Also, on receiving new information your research doctor might consider it to be in your best interests to withdraw from the study. He/she will explain the reasons and arrange for your care to continue. What happens when the research study stops? When the research is completed, information resulting from the study will be given to you. Completion of this research project will not affect the clinical care you receive. We plan to store your skin tissue and extracted genetic material on a long-term basis in the Genetic Skin Disease Group laboratory for possible future research into the Ectodermal Dysplasia syndromes and/or skin development. Your personal details will be kept confidential at all times and will not be released to anyone involved in any future research studies. However, future research may involve collaboration and exchange of samples (including yours) with other researchers and other laboratories which may be in other countries. Your samples will be anonymous and will not be used for any other purposes unless further ethical approval is sought. This is based on the framework advised by The Human Tissue Act 2004. You should be aware that in the unlikely event that your genetic material was to become of commercial value in the future, you would not be able to claim financial reimbursement. What if something goes wrong? If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds for legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms will be available to you. Will my taking part in this study be kept confidential? All information which is collected about you during the course of the research will be kept strictly confidential. However, your GP will receive a letter informing him/her of your participation in this project; this letter will also contain contact numbers for the investigators. What will happen to the results of the research study? The results will be published in a scientific/medical journal, as well as being presented at national and international scientific/medical meetings. However, any written or illustrative material will not identify you in any report/presentation. Who is organising and funding the research? This research project has been funded by two European Union grants. “Epistem” is an integrated European Union project whose main goal is to study the role of p63 in Ectodermal Dysplasia syndromes. “Geneskin” is a European information and training network for genetic skin diseases. These two grants will fund the salary of one clinical research fellow and the cost of laboratory reagents necessary for the work.

  6. Role of p63 in ED Syndromes Page 4 Who has reviewed the study? This research project has been reviewed by the St Thomas’ Hospital Research Ethics Committee and the Guys and St Thomas’ NHS Research and Development department. Contact for further information Professor John McGrath or Dr Suzanne Clements Genetic Skin Disease Group St John’s Institute of Dermatology St Thomas’ Hospital Lambeth Palace Road London SE1 7EH Tel: 020-71886409 E-mail: john.mcgrath@kcl.ac.uk Patient information sheet v3: 13th November 2006 You will be given a copy of the information sheet and a signed consent form to keep. Thank you for taking part in this study.

  7. Adult patient consent form

  8. Version 3 (13/11/06) COREC Number: 06/Q0702/154 Study Number: Patient Identification Number for this study: CONSENT FORM Title of project: The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Name of Researcher: Statement of patient Please initial box 1. I confirm that I have read and understand the information sheet dated ……………… for the above study and have had the opportunity to ask questions 2. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason and without my medical care or legal rights being affected 3. I understand that sections of any of my medical notes may be looked at by responsible individuals or regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records 4. I consent to my DNA sample (extracted from my blood sample) and skin biopsy sample being kept for possible future research into the Ectodermal Dysplasia syndromes and/or skin development. These samples will be anonymised and kept in either the Genetic Skin Disease Group laboratory or a known laboratory in another country. 5. I understand that I am donating my blood sample and skin sample for this research project and that these samples no longer belong to me once they are taken for this research. I am aware that in the unlikely event that my genetic material was to become of commercial value in the future, I would not be able to claim financial reimbursement. 6. I agree to take part in the above study Signature Name of Patient Date Name of Person taking consent (if different from researcher) Date Signature Researcher Date Signature 1 for patient; 1 for researcher; 1 to be kept with hospital notes

  9. Information form for Parent of child for biopsy

  10. Guy’s and St Thomas’ NHS Trust Research Ethics Committee PARENT INFORMATION SHEET The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Principal Investigator: Professor J A McGrath Other Investigator/s enrolling patients: Dr Suzanne Clements Ethics Committee Code No: 06/Q0702/154 Other reference numbers: Study title: THE ROLE OF p63 IN HUMAN SKIN AND IN ECTODERMAL DYSPLASIA SYNDROMES Invitation: Your child is being invited to take part in a research study. Before you and your child decide it is important 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. Thank you for reading this. What is the purpose of the study? Our research aims to discover the causes of Ectodermal Dysplasia syndromes and the impact these have on the structure and function of skin. Abnormalities in a gene called p63 have recently been linked to several Ectodermal Dysplasia syndromes but there is currently very little scientific information known about it. We will examine genetic material obtained from your child’s blood and skin samples to help us understand the cause of the condition that he/she has. Why has your child been chosen? Your child has been invited to take part in this research project because he/she has an Ectodermal Dysplasia syndrome. Does he/she have to take part? Participation is entirely voluntary. If you and your child do agree to take part, you will be given this information sheet and be asked to sign a consent form. Your child is still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care your child receives. What will happen to your child if he/she takes part? Participation in the project involves your child donating two samples: some blood and a piece of skin.

  11. Role of p63 in ED syndromes Page 2 What does he/she have to do? If your child agrees to participate, he/she will first be asked to donate a blood sample. This involves a small needle prick in his/her arm. The amount of blood taken will be approximately 2 teaspoonfuls. There may be a slight bruise at the site of the needle puncture but this should clear within a few days. Secondly, your child will be asked to donate a skin sample (also known as a biopsy). The site of the biopsy will be discussed with you but is usually from the arm. The area of skin to be sampled will be injected with local anaesthetic. This procedure causes brief stinging. The skin sample taken will be about the size of a 5 pence coin. It is likely that one or two sutures (stitches) will be required. The wound will be dressed and allowed to heal, with the sutures being removed after about 7 days. What is being tested? The blood sample will be used to extract genetic material (called DNA) which is important in finding out why your child has an Ectodermal Dysplasia syndrome. The skin sample will be used to extract another form of genetic material (called RNA) so that we can see what abnormal p63 does to the rest of the skin genes and proteins. Part of the skin sample will also be grown in the laboratory (known as keratinocyte culture). This will allow us to expand the number of cells available for research and to limit the size of the skin biopsy we take from your child. What are the alternatives for treatment? At the moment there are no effective treatments for any of the Ectodermal Dysplasia syndromes. The research project will help us understand the conditions and hopefully in the future will enable us, and others, to develop new treatments. What are the possible disadvantages and risks of taking part? The risks associated with taking a skin biopsy are minimal but as a parent, you need to be aware of them. Slight bleeding can occur and this is usually easily controlled with firm pressure (fingers) over the wound site. Local skin infection may develop during the week following the biopsy; the features of which are redness, failure of the wound to heal and discharge of pus. If this happens, your child may need to have a short course of oral antibiotics. Finally, your child will get a small line scar as the biopsy is closed. What are the possible benefits of taking part? It is likely that participation in this research project will not be of immediate benefit to your child. However, if new information arises from the study that may be of benefit to your child, a member of the research team will contact you to discuss it in more detail. The research should be able to help us understand the function of the p63 gene leading to a better comprehension of the Ectodermal Dysplasia syndromes. This will allow us to plan future studies but they will not form part of the current research project. What if new information becomes available? Sometimes during the course of a research project, new information becomes available about the skin cells being studied. If this happens, your research doctor will tell you and your child about it and discuss whether you want to continue with the study. If you and your child decide to withdraw your research doctor will make arrangements for your child`s care to continue. If you and your child decide to

  12. Role of p63 in ED syndromes Page 3 continue in the study you will be asked to sign an updated consent form. Also, on receiving new information your research doctor might consider it to be in your best interests to withdraw your child from the study. He/she will explain the reasons and arrange for your child`s care to continue. What happens when the research study stops? When the research is completed, information resulting from the study will be given to you and your child. Completion of this research project will not affect the clinical care your child receives. We plan to store your child’s skin tissue and extracted genetic material on a long-term basis in the Genetic Skin Disease Group laboratory for possible future research into the Ectodermal Dysplasia syndromes and/or skin development. His/her personal details will be kept confidential at all times and will not be released to anyone involved in any future research studies. However, future research may involve collaboration and exchange of samples (including your child’s) with other researchers and other laboratories which may be in other countries. Your child’s samples will be anonymous and will not be used for any other purposes unless further ethical approval is sought. This is based on the framework advised by The Human Tissue Act 2004. You should be aware that in the unlikely event that your child’s genetic material was to become of commercial value in the future, your child would not be able to claim financial reimbursement. What if something goes wrong? If your child is harmed by taking part in this research project, there are no special compensation arrangements. If your child is harmed due to someone’s negligence, then he/she may have grounds for legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you and your child have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms will be available to you. Will my child taking part in this study be kept confidential? All information which is collected about your child during the course of the research will be kept strictly confidential. However, your GP will receive a letter informing him/her of your child’s participation in this project; this letter will also contain contact numbers for the investigators. What will happen to the results of the research study? The results will be published in a scientific/medical journal, as well as being presented at national and international scientific/medical meetings. However, any written or illustrative material will not identify your child in any report/presentation. Who is organising and funding the research? This research project has been funded by two European Union grants. “Epistem” is an integrated European Union project whose main goal is to study the role of p63 in Ectodermal Dysplasia syndromes. “Geneskin” is a European information and training network for genetic skin diseases. These two grants will fund the salary of one clinical research fellow and the cost of laboratory reagents necessary for the work.

  13. Role of p63 in ED syndromes Page 4 Who has reviewed the study? This research project has been reviewed by the St Thomas’ Hospital Research Ethics Committee and the Guys and St Thomas’ NHS Research and Development department. Contact for further information Professor John McGrath or Dr Suzanne Clements Genetic Skin Disease Group St John’s Institute of Dermatology St Thomas’ Hospital Lambeth Palace Road London SE1 7EH Tel: 020-71886409 E-mail: john.mcgrath@kcl.ac.uk Parent information sheet v3: 13th November 2006 You will be given a copy of the information sheet and a signed consent form to keep. Thank you for taking part in this study.

  14. Consent form for parent of child undergoing biopsy

  15. Version 3 (13/11/06) COREC Number: 06/Q0702/154 Study Number: Patient Identification Number for this study: CONSENT FORM Title of project: The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Name of Researcher: Statement of parent Please initial box 1. I confirm that I have read and understand the information sheet dated ……………… for the above study and have had the opportunity to ask questions 2. I understand that my child’s participation is voluntary and that he/she is free to withdraw at any time without giving any reason and without his/her medical care or legal rights being affected 3. I understand that sections of any of my child`s medical notes may be looked at by responsible individuals or regulatory authorities where it is relevant to his/her taking part in research. I give permission for these individuals to have access to my child`s records 4. I consent to my child’s DNA sample (extracted from his/her blood sample) and his/her skin biopsy sample being kept for possible future research into the Ectodermal Dysplasia syndromes and/or skin development. His/her samples will be anonymised and kept in either the Genetic Skin Disease Group laboratory or a known laboratory in another country. 5. I understand that my child is donating his/her blood sample and skin sample for this research project and that these samples no longer belong to my child once they are taken for this research. I am aware that in the unlikely event that my child’s genetic material was to become of commercial value in the future, neither I nor my child would be able to claim financial reimbursement. 6. I agree on behalf of my child to take part in the above study Signature Name of Parent Date Name of Person taking consent (if different from researcher) Date Signature Researcher Signature Date 1 for patient; 1 for researcher; 1 to be kept with hospital notes

  16. Young person consent form

  17. Version 1 (13/11/06) COREC Number: 06/Q0702/154 Study Number: Patient Identification Number for this study: CONSENT FORM FOR YOUNG PEOPLE Title of project: The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Name of Researcher: Please tick the box √ 1. I read the information sheet and understand about the research. I was able to ask questions about the research. 2. I know that joining in is my choice. I don’t have to join in if I don’t want to. I can stop at any time. I don’t have to give a reason. Stopping won’t change the care I get from St Thomas Hospital for my ectodermal dysplasia. 3. I know that information from my blood and skin samples will be shared with other people but my name and things that might help people recognise me won’t be used. 4. I know that my skin biopsy sample will be kept in a laboratory (in the UK or another country) for possible future research into the Ectodermal Dysplasia syndromes and skin development. 5. I understand that I am donating my blood sample and skin sample for this research project and that these samples no longer belong to me once they are taken for this research project. 6. I agree to join in with the research project Date Signature Name of Patient Researcher Date Signature 1 for patient; 1 for researcher; 1 to be kept with hospital notes Consent form for Young People

  18. Young person assent form

  19. Version 1 (13/11/06) COREC Number: 06/Q0702/154 Study Number: Patient Identification Number for this study: ASSENT FORM FOR YOUNG PEOPLE Title of project: The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Name of Researcher: (To be completed with the researcher or parent) Circle your answer Did you read about the research? Or did someone read it for you? Yes/No Did somebody explain the research to you? Yes/No Do you understand what the research is about? Yes/No Yes/No Did you ask all the questions you wanted to? Were all your questions answered? Did you understand the answers? Yes/No Do you know that it’s OK to stop joining in at any time? Yes/No Are you happy to join in? Yes/No If you circled ‘no’ to any of these don’t write your name. If you don’t want to join in don’t write your name. If you do want to join in, please write your name and today’s date Your name Date Your parent or guardian must write their name here too if they are happy for you to do the project Print Name Sign Date The doctor who explained the research to you needs to sign too: Print Name Signature Date Assent form for Young People

  20. Information form for children aged 4-7 years

  21. Version 1 (21/11/06) The Role of p63 in Human Skin and in Ectodermal Dysplasia Syndromes Information Sheet for Young People (4-7 yrs) Hello! Welcome to St Thomas’ Hospital My name is Suzanne and I am a skin doctor. I want to find out more about how your skin works. Your skin covers your whole body. It helps to look after everything in your body. This is a picture of what your skin looks like under the surface!

  22. Do you want to join in my work to find out more about your skin? It is up to you. If you do not want to that is ok. No one will be cross with you. What do you do if you join in? A special cream is put onto your hand to make sure the blood test I do won’t hurt you. The special cream is put onto your skin to make sure the skin test I do won’t hurt you. I will take a very small piece of your skin - only the size of a 5p coin. You will have 1-2 stitches which come out after about 10 days. When the stitches come out it will not hurt you. I will talk to your mum and dad. They will be with you all the time. Please ask me if you do not know something. I will be happy to tell you what you want to know. Thank you for reading this!

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