Confidentiality

Upon completion of the consent form, all participants will be assigned a unique participant ID and all the personal information (called “personal data”) you will be asked (gender, age, diagnosis), will be kept strictly confidential. All of participants’ information will be stored on password-protected cloud storage, which will only be accessible to the study team. Any information will be labelled with a code instead of your name. This ID code will allow data to be linked but will not allow for identification of participants’ name.

Everyone involved in this study will keep their data safe and secure. We will also follow all privacy rules. Participants will be allocated a unique study number, and this will be used to identify any transcripts, to protect their confidentiality in any future data releases. If participants agree, we will save the fully anonymized transcripts in our data repository after this study has finished for use in future studies. Participants will not be identifiable.

We will maintain the link between participants’ personal details and the study ID number only for as long as is required by regulatory authorities if they need to review the study, after which we will destroy any records with participants’ personal details in them. Where external platforms such as Microsoft Forms are used, all data stored within them will be non-identifiable as far as possible. When Informed Consent is recorded on Qualtrics (the platform we will use to collect the consent form and deliver the intervention), this will necessarily contain some of participants’ identifiable data that only the main research team will have access to – this will be treated with full confidentiality. All consent forms will be stored electronically in a separate encrypted folder to the transcriptions and notes. 

The study database is hosted in a secure server by RHUL IT services, which is regularly patched and imaged daily to the University central backup service. Protocols for establishing, implementing, maintaining and improving information security management are maintained by the RHUL IT services. Data will be submitted directly from local research teams to the online study database. The local research team will maintain a screening log to link the study ID to patient contact information at the site.

When the results of the study are reported, data will be fully anonymised and individuals will not be identifiable. The research team will maintain the link between participants’ personal details and their unique ID number for up to 3 months to allow the study to be reviewed, after which we will destroy all records containing participants’ personal information. This excludes consent forms – these will be held securely at Royal Holloway, University of London, for 10 years after the end of the study in a designated password protected folders.