Your data in the trial
At your first appointment, you completed a consent form to confirm that you wish to take part in the trial. Before attending your appointment, you received a copy of the Participant Information Sheet (available in English, Bengali, Gujarati, Punjabi and Urdu).
How your data will be used in the trial
Your personal information and health information will be added to GRAIL Bio UK Ltd. (GRAIL) and King’s College London’s (King’s) trial database.
All of your trial data will be protected in accordance with the Data Protection Act (2018) and UK General Data Protection Regulation. Together, GRAIL and King’s will be the Data Controllers for your information. This means that they will make decisions about how your data can be used. You can read more about how your data will be used by reading the privacy notice and the participant information sheet.
Who will be able to view your data
Only members of the trial team who need to see your personal information will have access to it for the purposes of the trial.
Your personal data will be accessed by GRAIL and King’s staff involved in your participation and approved third parties for the purposes of the trial and only where necessary for carrying out their parts of the trial. It will be stored by these organisations for up to 10 years after the trial finishes.
Some of your health information will be sent to GRAIL, LLC in the United States (US), but it will be pseudonymised data. 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 data will be kept for up to 20 years after the trial finishes.
Once the trial has finished, some of the data will be kept so the research team can check the results. Reports will be written in a way so that no one can work out that you took part in the trial. Researchers at GRAIL, LLC in the US who process or store your information for the purposes of this trial must follow the trial rules about keeping your information safe.
Accessing your personal information
The research team will need to use information about you, your healthcare records and information held about you by the NHS and other public bodies for this research project. This information may be collected directly from you, for example by asking you to fill out a survey. Information may also be obtained from medical records that your GP or the NHS holds. The information collected during the trial may include your name, date of birth, NHS number, your address, your medical records and your survey responses.
How your information will be used
Your information will only be used in relation to you taking part in the trial or further research to which you have agreed. This may include the use of information for:
Contacting you about the trial to arrange appointments, provide trial updates, and ask you about your health or your contact details. The trial may use the services of third-party organisations in the UK and outside the UK for the purposes of processing and providing services like letter mailing and call centre services. These organisations may need to access some of your personal information to perform these services.
Licensing work, study monitoring, auditing, safety reporting and quality assurance by designated individuals such as trial monitors, auditors, regulatory bodies and members of the research team.
Accessing your health information from GPs, hospitals, and nationally held datasets in the UK. This may include information about you collected and managed by the NHS, the National Disease Registration Service (NDRS), and the Office of National Statistics (ONS). To do this, GRAIL and King’s will securely send your name, NHS number, date of birth and postcode to these bodies who will send back information held about you as it relates to your health and use of health services. We may do this for up to 10 years following your participation in the trial. You are free to withdraw at any time from this data transfer.
Receiving your updated contact details from NHS Digital or GP should your details change.
For more information about cancer registration, including your rights to opt out, please visit the NRDS website.
You can stop being part of the trial at any time, for any reason, but information about you that has already been collected will be kept. If you choose to stop taking part in the trial, the research team would like to continue collecting information about your health from central NHS records, and your hospital and GP. If you do not want this to happen, please contact the trial team and tell them you want this to stop. Your records need to be managed in specific ways for the research to be reliable. This means that we will not be able to let you see or change the data we hold about you.
You will be asked to give permission for the research team to share and receive health information about you with the health professionals who are involved in your care. This could include your GP. If the Galleri test finds the cancer signal in your blood, your GP will be told about this.
Your blood sample and future research
Everyone will be asked if their samples can be used for research to further improve the Galleri® test, and to develop and improve other tests and see how well they work. Your sample will not be used for any other purpose and will not be shared with any other organisation. You will not receive any updates about your sample being used in future research, not even after the trial is finished. You also will not receive any benefits if your sample helps lead to a commercialised test.
Future research using your sample will not be allowed to involve two types of specific genetic analysis. These are called whole genome sequencing or 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 sample to be used in future research, this particular type of genetic analysis will not be done on it.