Your data in the trial
Key points
- All trial data is protected in accordance with the Data Protection Act (2018) and UK General Data Protection Regulation.
- Everyone involved in the trial who has access to your data must follow applicable laws and trial rules about keeping your data safe.
- Your identity will always be confidential if any trial results are published.
Giving consent
At your first appointment, you filled in a consent form to confirm that you wish to take part in the trial. In this form, you agreed to give blood samples, fill in surveys about your health, and allow the NHS to share information about your health.
Before attending your appointment, you received a copy of the Participant Information Sheet (available in English, Bengali, Gujarati, Punjabi and Urdu). This sheet provides detailed information about study activities, benefits and risks.
What data the trial collects about you
The trial collects the following personal data about you, as outlined in your consent form.
Contact details
The trial collects your contact details (such as your name, date of birth and address) and your NHS number, to use where needed for running the trial.
Health data you share
At each trial appointment, you were asked to fill in a short survey about your health. In these surveys, you shared information about yourself (such as your age and sex), your health behaviours (for example, whether you smoke or drink) and your medical history. This information was collected at each of your trial appointments over 2 years.
Health data the NHS shares
The NHS shares limited information about your health that is relevant to the trial, such as your use of health services, whether you have had a cancer diagnosis, and the types of diagnostic tests and cancer treatments you may have received.
This data is from records held in national databases. This data is provided by national organisations like the National Disease Registration Service (NDRS) and the Office for National Statistics (ONS). For more details about disease registration, including your rights to opt out, please visit the NDRS website.
Information about your health will be collected for up to 10 years from when you joined the trial.
How your data is stored and protected
Your data is securely stored in trial databases. These databases are managed by the trial team at GRAIL Bio UK Ltd. (GRAIL) and Queen Mary University of London (QMUL).
Your data will be stored by these organisations for up to 10 years after the trial finishes. The trial will finish about 18 months after the last participant attends their last (24 month) appointment.
Some of your health data will be sent to GRAIL, Inc. in the United States (US), where some of GRAIL’s researchers and databases are. Only pseudonymised health data will be sent to the US. This means that any information that could identify you, such as your name, date of birth, and NHS number will be removed and replaced with a code number. Pseudonymised health data will be kept for up to 20 years after the trial finishes.
All trial data is protected in accordance with the Data Protection Act (2018) and UK General Data Protection Regulation. Together, GRAIL and QMUL are the Data Controllers for trial data. This means that they can make decisions about how this data can be used. You can read more about how trial data can be used by reading our privacy notice.
Who can access your data
Your data is accessed by GRAIL and QMUL staff involved in the trial, for the purposes of the trial and only where necessary for carrying out their parts of the trial. Your data is also accessed by staff at King’s College London (King’s) involved with the trial, on behalf of QMUL.
GRAIL, QMUL and King’s staff will only access data for the purposes of the trial and only where necessary for carrying out their parts of the trial. Only the members of the trial team who need to see your data have access to it.
The trial uses the services of third-party organisations in the UK and outside the UK for activities such as letter mailing and call centre services. These organisations may need to access some of your data to perform these services. Other third-party organisations that are not involved in the trial will not have access to your data.
Some of your health data is sent to GRAIL, Inc. in the US, as pseudonymised data, where it may be accessed by GRAIL researchers.
Everyone involved in the trial who has access to your data, including people in the US, must follow applicable laws and trial rules about keeping your data safe.
How your data is used
Your data can only be used in relation to the trial or for other research in the future that you have agreed to (see below).
Your data might be used to:
- Contact you about the trial to arrange appointments, provide trial updates, ask you about your health or your contact details, or, if you are one of the small number of participants in the test group who has a cancer signal detected, contact you to tell you the test result.
- Access information about your health from records held in national databases.
- Work out the results of the trial and write up reports that might be shared publicly. Any public reports will be written in a way so that no one can work out that you took part in the trial.
- Support licensing work, study monitoring, auditing, safety reporting and quality assurance, by officials such as trial monitors and auditors, regulatory bodies and members of the trial team.
Your choice
You can stop being part of the trial at any time, and you do not have to give a reason why. However, information about you that has already been collected will be kept.
If you choose to stop taking part in the trial, the trial team would like to continue collecting information about your health from the NHS, as outlined in your consent form.
If you would like to stop this data collection, or if you want to leave the trial, please contact the trial team.
Your data needs to be managed in specific ways for the research to be reliable. This means that you will not be able to see or change the data the trial holds about you.
You have been asked to give permission for the trial team to share and receive information about your health with the health professionals who are involved in your care. This could include your GP. If the Galleri test finds a cancer signal in your blood, your GP will be told about this.
Your blood sample and future research
At your first trial appointment, you were asked if your blood samples could be stored and tested at a later date to help with future research.
Future research may include work to further improve the Galleri® test, and to develop and improve other tests and see how well they work.
Future research using your samples will not involve two types of specific genetic analysis. These are called whole genome sequencing and exome sequencing. These genetic analyses can say a lot about your risk of developing particular health problems, or about your ancestry or ethnicity. Even if you give permission for your samples to be used in future research, these particular types of genetic analysis will not be done on them.
Allowing your samples to be used for future research could help detect cancer in people in the
future.
You will not receive any updates about your samples being used in future research, not even after the trial is finished. You will not benefit financially if a product or test is successful because you have
been involved in the trial.
Your samples will not be used for any other purpose and will not be shared with any other organisation. You cannot be identified from any of the information used in future research.
Samples from the control group might be sent to the US if they are used for future research.
You can change your mind about your samples being stored for future research, and you do not have to give a reason why. If you do not want your samples to be stored for future research, please contact the trial team. Your stored samples will then be destroyed.