What will happen to the study results?
The results will not be known until some time after the last participant has entered the study (about 1 year after study end). You can decide if you would like to receive the study results. The results will be reported in medical journals and presented at meetings but your identity will not be disclosed.
Who is organising and reviewing the study?
This study has been reviewed by an independent Research Ethics Committee, who protect your safety, rights, wellbeing and dignity. The study is also reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA). They are the UK’s regulator of medicines and are responsible for ensuring the safety, quality and effectiveness of the medicine. North Bristol NHS Trust is the sponsor and has overall responsibility for the study. The study is being coordinated by the Bristol Trials Centre (BTC), University of Bristol. This study is funded by the National Institute for Health Research – Health Technology Assessment Programme (NIHR132968).
How will my data be used?
North Bristol NHS Trust is the sponsor for this study based in the United Kingdom and the study coordination team is based at the University of Bristol. Together we will use information from you and your medical records in order to undertake this study and will act as the joint data controllers for this study. This means that we are responsible for looking after your information and using it properly. Your local hospital will process your personal data on behalf of the data controllers, in their role as data processors.
Your data will be stored and used in compliance with the relevant, current data protection laws; Data Protection Act 2018 and General Data Protection Regulation (GDPR) 2018.
Your local hospital site will collect this information in accordance with our instructions.
This information will include your:
- NHS number
- Name
- Contact details
- Date of birth
- Email address
- Sex
- Ethnicity
- Smoking history
- Medical history
Your Study ID (assigned to you when you join the study), Date of Birth, NHS number, postcode and sex will be sent to NHS Digital to obtain data. We will be gathering data that covers your time in the study (day of enrolment until Day 90). We may also look at data recorded prior to your admission. NHS Digital sends us back information from the Hospital Episode Statistics dataset which provides information about participants who have been in hospital and the treatment they have received. We will be looking at information on whether there have been any episodes of stroke, cardiovascular events or any other life-threatening events since your time in the study. NHS Digital will also send us data from the Civil Registries about recorded civil deaths. The data from NHS Digital will help us answer the study question as we will be able to compare the frequency of events in both groups. This information will be reviewed in a report by statisticians and committees that are unbiased to the study. The reports will be provided in tables without any personal identifiers, which means you will not be able to be identified.
If you choose to consent online, we will need your email address to send you a link to the consent form. Your email address along with your name and unique study number will be stored in our electronic consent system for this purpose. Your email address will also be used if you have agreed to complete the questionnaire or have signed up to receive study newsletters or be informed of the study results.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number (or study ID) instead.
We will keep all information about you safe and secure.
This information will be used to allow us to keep in touch with you during the study, to make sure that relevant information about the study is recorded for your care and to oversee the quality of the study; and we will collect information about your health, to allow us to compare the two groups.
If you agree, your information may be stored securely for potential use for future research and training purposes.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. Paper copies will be stored in a secure location during the conduct of the study and for 10 years after the end of the study.
Your medical records and study files may be inspected by individuals from the regulatory authorities, the Sponsor organisation or the local NHS Trust, as required to ensure the study is being conducted to all legal and policy standards and to check the data collected is of high quality.
With your consent, your GP will also be informed that you are taking part in the study. Your GP may be asked to provide information from your records which is required for the research.
What are my choices about how my information will be used?
You can stop being part of the study at any time but please be aware that we will keep information about you that we already have. To safeguard your rights, we will use the minimum personally-identifiable information possible. 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 choose to stop taking part in the study, we would like to continue collecting information about your health from your medical records. If you do not want this to happen, tell us and we will stop.
If you agree to take part in this study, you will have the option for your data to be saved for potential use for future research being run in this organisation and in other organisations. This data will be stored in a University of Bristol secure repository under controlled access and made available only to researchers who meet the criteria for access to confidential data. You can still be involved in the study if you do not want your data to be saved for future research.
Where can I find out how my information will be used?
You can find out more about how we use your information
- at www.hra.nhs.uk/information-about-patients/
- by asking one of the research team
- by sending an email to aspect-trial@bristol.ac.uk,
- by reading ASPECT’s privacy notice
- by contacting Helen Williamson (Head of Information Governance) at helen.e.williamson@nbt.nhs.uk or 0117 41 44767.
You can find out more about NHS digital at https://digital.nhs.uk/about-nhs-digital.