All the information we collect about you for the study will be anonymous. The researchers at King’s College London will only receive anonymous data to answer the study questions; your data will have a code number instead of you name and the study team will not be able to identify you from the data they receive. The code number will be used to link all the information together to answer the study questions.
The Confidentiality Advisory Group (CAG) is an independent body which provides expert advice on using confidential patient information. The Health Research Authority (HRA) advised by CAG, have given us their support to identify and collect data from women who are eligible for the study.
If you received your kit in the post, we were able to identify you via the NHS England national cervical screening database and invite you to take part in the study. To do this, NHS staff (who are considered part of your direct care team) transferred your name, NHS number, address (including postcode) and your GP practice to a mailing company (3rd party), who organised the mailing of the YouScreen kit. The mailing company is bound by contractual agreements to ensure your information is kept confidential and secure.
By returning your sample, you consent for the study team to collect information about you during the study from the lab. This will include your self-sample result and any subsequent cervical screening results. The lab will also provide us with information from hospital records if you attend your local hospital for further cervical screening tests and treatment. By returning your sample, you are also consenting for us to ask the national cancer registry for any diagnostic information for women who return a self-sample at 3 and 6 years after the end of the study.
This consent does not cover other data collection during the study, for example from your GP practice records and the national cervical screening database. HRA has given us support to collect information from your GP practice records and from the national cervical screening database for all women who are eligible for the study to answer the study questions. This information will be collected for the whole study period, for up to 18 months after the start of the study. We will collect information about all eligible women, including those who do not return the kit. This makes our research useful and will provide information about how self-sampling could be used in the future. The information we collect will include your age, ethnic group, general area location, and details about your previous and future cervical screening. We will only collect information relevant to cervical screening and the study (e.g. the results of any cervical screening tests you have had in the past or might have in the future). We will not link your name or identifiable details to this information.
If you do not want your anonymous information data to be shared with us, you can opt-out by contacting your GP practice.
If you give us permission to keep your leftover sample, we will work with our research partners (based in the UK) to carry out additional research which could help improve cervical screening in the future. To do this, we will share anonymous data about you with them to help them with this research.
The information we collect will be used to do the research or to check your records to make sure that the research is being done properly. We will keep all information about you safe and secure.
At the end of the study, we will keep some of the data for up to 20 years in case we need to check it or use it for future research. We will make sure no-one can work out who you are from the reports we write.