What happens to the information collected?
Any information which is collected about participants during the course of the study will be kept strictly confidential.
Guys and St Thomas NHS Foundation Trust is the sponsor for this study, based in the United Kingdom. We will be using information from you and / or your medical records 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. Guy’s and St Thomas’ will keep identifiable information about you for 5 years after the study has finished.
The lawful basis for processing Data for this study under the UK General Data Protection Regulation (GDPR) where processing is necessary for the performance of a task carried out in the public interest. All your data will be stored in accordance with the GDPR, the Data Protection Act 1998 and the International Conference on Harmonization for Good Clinical Practice. Once you provide consent, your data will be held on a secure confidential database for the purpose of this study, to which only the Chief Investigator and approved delegated members of the study team will have access (by your hospital study team and Guy’s and St Thomas’ NHS Foundation Trust). This information will be entered into the database by your hospital study team following your study visits. Your details on this database will be anonymised. Information will be sent using a secure network, and the data will be stored on a secure server.
The data from this study may be used in other research studies. In such a case, all personal identifiers will be removed and it will not be possible to identify any individual.
You can find out how we use your information at Research and development – Data and research | Guy’s and St Thomas’ NHS Foundation Trust (guysandstthomas.nhs.uk).
Organisations that are data processers for this study are listed below.
- The Intensive Care National Audit and Research Centre (ICNARC) is a data processor acting under the instructions of Guy’s and St Thomas’s NHS Foundation Trust. ICNARC’s role is to process the data according to the agreed protocol and statistical analysis plan.Information collected is stored on ICNARC’s secure servers which are owned by an authorised contractor called Exponential-e (https://www.exponential-e.com/). ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data.ICNARC also contract Babble Cloud who provide external desktop and network managed services, including end user and infrastructure support. Employees at Babble Cloud will not access the data, however, they do have remote access to ICNARC servers
- Kings Clinical Trial Unit (CTU) host the secure database the data is stored in.
What information will be collected?
Your hospital study team will collect information from you and your medical records for this research study in accordance with our instructions. It will use your name, date of birth, hospital number, NHS number (or CHI – Community Health Index number if you are treated in Scotland) CMP unit 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 your hospital study team and regulatory organisations may look at your medical and research records to check the accuracy of the research study. The research team will pass these details to Guy’s and St Thomas’ along with the information collected from you and/or your medical records. The only people at Guy’s and St Thomas’ who will have access to information that identifies you will be people who need it for data linkage, follow up or to audit the data collection process. With your consent, we will also inform your GP about your participation in the trial. We will also seek your consent to share your identifiable details, such as name, date of birth, NHS or CHI number with national providers (such as NHS digital) of healthcare data for the purpose of linking to information held about any hospital admissions you have had. Your hospital study team will keep identifiable information about you from this study for five years after the study has finished, in the line with regulatory requirements. In the event that the results of this study are published, confidentiality will be maintained.
Rights over information
Your rights to access, change or move your information are limited, as we need to manage your information in specific way 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. If you no longer wish that we process your data for this study you can contact Professor Manu Shankar-Hari manu.shankar-hari@ed.ac.uk or your local hospital study team.
You can find out more on how to contact Guy’s and St Thomas’ in regards to your data here: Your health records – Managing your data | Guy’s and St Thomas’ NHS Foundation Trust (guysandstthomas.nhs.uk)
Make a complaint about how your data is handled
If you wish to make a complaint about how your data is handled, you can contact the Information Commissioner’s Office here: https://ico.org.uk/
The ICO is the UK’s independent authority set up to uphold information rights in the public interest, promoting openness by public bodies and data privacy for individuals.
Contact Us
If you have any further questions, please contact us via R&Dcomms@gstt.nhs.uk