PAEDIATRIC NORTH STAR
TITLE OF PROJECT: UK NorthStar Clinical Network for Neuromuscular Disease Management Database
R&D ref: 18NM10 (12DN14)
GENERAL DATA PROTECTION REGULATION
Thank you for your interest in the UK NorthStar Clinical Network. In this document we would like to explain why we collect identifiable personal information of children with Duchenne Muscular Dystrophy (DMD) and how this information will be used. This document also provides details on who you should contact to understand more about how the information that is collected from you or your child is managed.
The UK NorthStar Clinical Network has been set up to record and evaluate information surrounding the diagnosis, disease progression and response to treatment in children with DMD. The aim of this database is to facilitate an understanding of the clinical course and improve clinical care service in DMD. The principal investigators responsible for this network are Professor. Francesco Muntoni (Professor of Paediatric Neurology, Director of the Dubowitz Neuromuscular Centre, Great Ormond Street Hospital) and Dr Adnan Manzur (Consultant Paediatric Neurologist, Dubowitz Neuromuscular Centre, Great Ormond Street Hospital).
Great Ormond Street Hospital is the sponsor for this study based in the United Kingdom. We will be using information from your medical record in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Personal data will be stored for the duration of the study and for 15 years after data collection has ceased. This is will be required to link the patient to the database should clinically relevant data become apparent. The participant / parents / guardians / personal consultee will then be informed about the findings by the participant's clinician.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by contacting the Information Governance team at the Great Ormond Street Hospital for Children at Your.Data@gosh.nhs.uk.
Great Ormond Street Hospital may use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Great Ormond Street Hospital and regulatory organisations may look at your medical and research records to check the accuracy of the research study.
Great Ormond Street Hospital will collect information about you for this research study from your hospital notes. This information will include your name/ NHS number/ date of birth/ gender / age at the time of diagnosis / ethnicity / specific neurological problems / frequency of seizures (if applicable) / EEG and MRI findings / dietary history (where applicable) / medications including any vitamin supplement and any anticonvulsants / any relevant clinical, genetic or biochemical history and health information, which is regarded as a special category of information. Great Ormond Street Hospital will pass these details to the research team based at UCL Great Ormond Street Institute of Child Health along with information collected from your medical records. The research team will use this information to understand more about the condition and help establish a clinical and research network to improve standards of care in DMD, regionally and nationally.
This information will be put onto a secure computer database to store the information with strict arrangements as to who can access this data. Each individual participating in this study will be allocated a unique identifier. Only a limited number of designated individuals will have access to this information and will be able to de-anonymise the data. Members of the extended research team will not have access to patient names or other identifiable information, nor will this information be shared with external collaborators.
The doctors and health care professionals looking after the affected children will have access to their case notes. The researchers, sponsors, regulatory authorities & R&D audit will have access to the results generated by this study. . Only selected people who analyse the information will be able to identify you. They will not however be able to find out your contact details.
The only people in Great Ormond Street Hospital who will have access to information that identifies you will be people who need to contact you if something is found that may be relevant to your clinical care or audit the data collection process.
Anonymised data generated from the information recorded in the database may be shared with other researchers around the world without divulging identifiable details. The recipients of data must agree not to make any attempt to identify the participant.. The recipients must also agree that any accessed data will be held securely and only used for research, and will only be made available to third party researchers under a Data Access Agreement.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. With respect to the UK NorthStar Clinical Network, anonymised data may be shared with third parties such as other similar national or international database networks evaluating DMD, pharmaceutical and healthcare research companies; with the future aim to establish optimal standards of care, develop and monitor new treatments for DMD.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
If you wish to raise a complaint on how we have handled your personal data, you can contact the Information Governance team at the contact detail given above/ PALS (pals@gosh.nhs.uk) who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
R&D ref: 18NM10 (12DN14)
GENERAL DATA PROTECTION REGULATION
Thank you for your interest in the UK NorthStar Clinical Network. In this document we would like to explain why we collect identifiable personal information of children with Duchenne Muscular Dystrophy (DMD) and how this information will be used. This document also provides details on who you should contact to understand more about how the information that is collected from you or your child is managed.
The UK NorthStar Clinical Network has been set up to record and evaluate information surrounding the diagnosis, disease progression and response to treatment in children with DMD. The aim of this database is to facilitate an understanding of the clinical course and improve clinical care service in DMD. The principal investigators responsible for this network are Professor. Francesco Muntoni (Professor of Paediatric Neurology, Director of the Dubowitz Neuromuscular Centre, Great Ormond Street Hospital) and Dr Adnan Manzur (Consultant Paediatric Neurologist, Dubowitz Neuromuscular Centre, Great Ormond Street Hospital).
Great Ormond Street Hospital is the sponsor for this study based in the United Kingdom. We will be using information from your medical record in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Personal data will be stored for the duration of the study and for 15 years after data collection has ceased. This is will be required to link the patient to the database should clinically relevant data become apparent. The participant / parents / guardians / personal consultee will then be informed about the findings by the participant's clinician.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by contacting the Information Governance team at the Great Ormond Street Hospital for Children at Your.Data@gosh.nhs.uk.
Great Ormond Street Hospital may use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Great Ormond Street Hospital and regulatory organisations may look at your medical and research records to check the accuracy of the research study.
Great Ormond Street Hospital will collect information about you for this research study from your hospital notes. This information will include your name/ NHS number/ date of birth/ gender / age at the time of diagnosis / ethnicity / specific neurological problems / frequency of seizures (if applicable) / EEG and MRI findings / dietary history (where applicable) / medications including any vitamin supplement and any anticonvulsants / any relevant clinical, genetic or biochemical history and health information, which is regarded as a special category of information. Great Ormond Street Hospital will pass these details to the research team based at UCL Great Ormond Street Institute of Child Health along with information collected from your medical records. The research team will use this information to understand more about the condition and help establish a clinical and research network to improve standards of care in DMD, regionally and nationally.
This information will be put onto a secure computer database to store the information with strict arrangements as to who can access this data. Each individual participating in this study will be allocated a unique identifier. Only a limited number of designated individuals will have access to this information and will be able to de-anonymise the data. Members of the extended research team will not have access to patient names or other identifiable information, nor will this information be shared with external collaborators.
The doctors and health care professionals looking after the affected children will have access to their case notes. The researchers, sponsors, regulatory authorities & R&D audit will have access to the results generated by this study. . Only selected people who analyse the information will be able to identify you. They will not however be able to find out your contact details.
The only people in Great Ormond Street Hospital who will have access to information that identifies you will be people who need to contact you if something is found that may be relevant to your clinical care or audit the data collection process.
Anonymised data generated from the information recorded in the database may be shared with other researchers around the world without divulging identifiable details. The recipients of data must agree not to make any attempt to identify the participant.. The recipients must also agree that any accessed data will be held securely and only used for research, and will only be made available to third party researchers under a Data Access Agreement.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. With respect to the UK NorthStar Clinical Network, anonymised data may be shared with third parties such as other similar national or international database networks evaluating DMD, pharmaceutical and healthcare research companies; with the future aim to establish optimal standards of care, develop and monitor new treatments for DMD.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
If you wish to raise a complaint on how we have handled your personal data, you can contact the Information Governance team at the contact detail given above/ PALS (pals@gosh.nhs.uk) who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
