TUH Clinical Research, Clinical Audit, Quality Improvement and Service Evaluation - PowerPoint Presentation

1.  TUH Clinical Research, Clinical Audit, Quality Improvement and Service Evaluation – How TUH use your data1. PurposeTallaght University Hospital (TUH) must comply with all applicable data protection, privacy and security laws and regulations when performing clinical research, clinical audit, quality improvement initiatives and service evaluations. We respect your rights to privacy and to the protection of your personal information. The purpose of this privacy notice is to explain how we collect and use personal information for clinical research performed by staff in partnership with staff from our academic partner Trinity College Dublin (TCD), clinical audit performed by our Healthcare Practitioners, and quality improvement and service evaluation both performed by our staff members.2. Clinical researchClinical research is the study of patients, their data (personal information) and sometimes their samples (blood, urine, tissue, hair, etc) in order to generate new knowledge about diseases and conditions affecting patients. The overall aim of clinical research is to improve the quality of our health service and the quality of life of patients by finding new and better ways to detect, prevent, diagnose and treat diseases.There are many different types of clinical research studies taking place in Tallaght University Hospital, some examples are:Clinical Trials – this is a study conducted to test if a new drug is effective at treating a specific disease.Clinical Research Utilising Patient Samples – some studies involve looking at patient samples in conjunction with the medical data associated with the sample. Observational Studies - these studies involve the observation of patients over a period of time and may include the collection of samples.Research Using Patient Medical Records (Retrospective Studies) – these studies involve looking back at patients medical history with the aim of learning more about the disease or condition, an example would be to determine the number of people with a certain disease or the average age of onset of a particular disease.4. When do we process your personal dataFollowing your consent – for clinical trials, clinical research using your samples and observational studies your consent will be sought before proceeding with the research. You will be provided with an information leaflet which will outline the study. If you agree to take part you will give your consent by signing a consent form and agreeing to all aspects of the research on the study consent form .Pre-screening – pre-screening is the process researchers use to identify patients that may be suitable for the research study they wish to undertake. This involves accessing medical records for the purpose of identifying patients but no data is removed/copied/recorded. This is only done by healthcare practitioners, student healthcare practitioners within TUH and hospital employees who normally have access to medical records. You will not be contacted to give your consent for pre-screening, however, should you be deemed suitable you will be contacted in order to provide you with information about the study and if you feel comfortable and happy, to obtain your consent. TUH do not currently allow authorised persons to access charts for pre-screening purposesResearch using patient medical records (Retrospective studies) – is a type of research design in which pre-recorded, patient-centred data collected for the provision of healthcare are used to answer a research question. Consent is not sought for this type of study BUT only when the study meets certain criteria: (i)the data is protected by a unique coding system. This means your name and any other information that could identify you will never be stored with the medical data collected (ii) a data protection impact assessment has concluded that the study is low risk (iii) it is performed by a healthcare practitioner who is an employee of TUH or a student healthcare practitioner (iii) is another employee of TUH who in their normal duties has access to medical records (iv) the data will not be shared unless completely anonymous (v) the published results will not identify any individual and (vi) the Research Ethics Committee must review and approve. If the study does not met this criteria your consent will be sought.6. Legal basis for processing your dataUnder GDPR there must be a legal and valid reason for a person/researcher to process data. There are 2 articles within GDPR that set out the legal basis for processing. The include Article 6 which is the legal basis for processing personal data and Article 9 which includes the legal basis for processing sensitive data. Medical data is sensitive personal data and therefore one legal basis from Article 6 and one legal basis from Article 9 is required. Researchers lawfully process personal data in TUH using Article 6 (1)(e) - processing is necessary for the performance of a task carried out in the public interest./ Article 6 (1)(f) - legitimate interest and Article 9 (2)(j) - processing is necessary for scientific research purposes. This means if you withdraw your consent data collected up to the time of withdrawal will continue to be processed …………..……………………………………………………………….…………. 7. Your rightsYou have certain legal rights concerning your information and the manner in which we process it. This includes:8. Who is the data controller?The data controller of your medical records is TUH. However when third parties are involved in the research and sometimes they decide why and how your data is being collected they are the controller of the coded study data. This arises in a clinical trial for a new medicine. The pharmaceutical company becomes the controller of the data collected which relates to the trial. In these circumstances only coded data is sent to the third party, no identifiable data is shared with the third party. It is members of the medical team and researchers under TUH supervision who access your data and collect the relevant data for the third party. You coded medical data may also be shared with researchers in other countries within the EU and outside the EU. TUH will only send non-identifiable data to which you have consented to be shared and TUH will ensure a contract is in place with the third parties inside and outside the EU in order to ensure your data is protected to the same level as in Ireland.5. How TUH researchers protect your dataAll patient data collected for clinical research is protected by a process know as pseudonymisation or coding. Your identifiable data, such as your name, medical record number, address, telephone number, full date of birth are kept separate to your medical data. Your identifiable data is given a code and your medical data is given the same code. Your identifiable data and medical data are stored separately in pass-word protected, files on secure computer networks. Therefore your identifiable data can only be linked back to medical data by the researchers.Additionally, TUH researchers minimise the amount of data they collect to only that which is 100% necessary to achieve the objectives of the research study. Therefore in cases where your name, address, telephone number, etc are not required they are not collected.9. Retention periodResearchers may retain your data for a period of time, as determined by TUH, TCD, legislation or by scientific journals. All completed research must be shared with the wider scientific community in order to progress science and medicine beyond the research group. To do this researchers publish their research in scientific journals. Data published in journals will never identify you. Data may also be irrevocably anonymised (all identifiable information is deleted and there is no way to ever link the medical data to you) and retained indefinitely. If the researchers intend to do this you will be informed and you will give your consent except for retrospective studies.Contact detailsPlease contact our Research Ethics Manager:If you have any queries in relation to data protection or other issues around the security of your personal information used for clinical research, clinical audit, quality improvement or service evaluation.For more information about the steps we are taking to protect your information.For more information about your rights, including the circumstances in which you can exercise them and how to exercise them.If you wish to make a complaint on how we have handled your personal information for clinical research, clinical audit, quality improvement or service evaluation, you can contact our Research Ethics Manager who will investigate the matter. We hope that we can address any concerns you may have. The Research Ethics Manager can be contacted by email ResearchEthics@tuh.ie or telephone 01-414 2199to get access to your personal information;to request us to correct inaccurate information, or update incomplete information;to request that we restrict the processing of your information in certain circumstances;to request the deletion of personal information excluding medical recordsto receive the personal information you provided to us in a portable format;to object to us processing your personal information in certain circumstances; to lodge a complaint with the data protection commissioner.The right to withdraw your consent3. The personal data processed for researchTo enable us to perform clinical research, we collect and process various categories of personal information. Information we collect may include:Personal details about you, such as date of birth, medical record numberNotes and reports about your health needsResults of investigations, such as x-rays and laboratory testsRelevant information from other health and social care professionals, your carers or relativesSamples (Blood, urine, hair, tissue samples, stored samples)10. Clinical AuditClinical audit is the systematic review and evaluation of current practice against standards with a view to improving clinical care for patients. Clinical audit is performed to ensure TUH are meeting certain standards and providing patients with the best care possible. Your consent is not required for clinical audit.11. Quality ImprovementQuality improvement is the process of improving the way care is delivered to TUH patients. Improving quality is about making healthcare safe, effective, patient-centred, timely, efficient and equitable. In order to achieve improvements processes are defined, measured, analysed, with improvements implemented and then controlled. Your consent is not required for quality improvement.12. Service EvaluationService evaluation is an internal evaluation of a service provided to a patients in order to identify issues or good practices and implement appropriate changes if necessary. The purpose is to assess how functional TUH services are for patients and adjust these service to meet the needs of patients when required. Your consent is not required for service evalutaion.