The approved BALLOON Participant Information Sheet and consent form describe the use of research information for participating families. When those documents are added, they will take precedence if there is any inconsistency with this summary.
Who is responsible for personal information?
Cardiff University leads BALLOON and is expected to act as a data controller for research information processed by the University. The precise controller and joint-controller arrangements must be checked against the current protocol, contracts and Participant Information Sheet before this notice is approved.
Cardiff University is registered with the Information Commissioner’s Office as a data controller for research purposes, registration number Z6549747.
Information collected through this website
You can read the public website without providing your name or contact details. The current demonstration does not include an enquiry form, account or participant portal. Standard technical information may nevertheless be processed by the hosting service to deliver and secure the website, such as IP address, browser type, requested page, date and time, and security logs.
Opening an email link launches your own email service. Any information you send by email will be processed to respond to your enquiry. Do not use the central study email for urgent clinical advice.
Information collected for the BALLOON trial
For enrolled babies and their parents or carers, the research team may process identifiers, contact information, health information, treatment and follow-up information, questionnaire responses, recordings from study tools, and biological-sample information. The definitive categories, sources, recipients and retention period will be stated in the approved Participant Information Sheet and consent form.
Research information may be obtained from families, participating hospitals, healthcare records and other sources authorised by the approved trial documents. Only information necessary to deliver the trial, monitor safety and answer the research questions should be collected.
Lawful basis
Cardiff University conducts research as a public research institution. Its general research-participant notice states that personal data are normally processed because this is necessary for a task carried out in the public interest or under official authority, and special-category health information is processed for scientific research subject to safeguards. The data-protection lawful basis is separate from ethical consent and the common-law duty of confidentiality.
Access, sharing and security
Access should be limited to authorised members of the trial team and organisations responsible for trial delivery, oversight, audit or regulation. Information used for analysis and publication should be coded or anonymised wherever possible. BALLOON will not publish information that identifies a participating baby or family.
Retention and withdrawal
The retention period and what happens following withdrawal must be taken from the approved BALLOON documents. In regulated research, information already collected may need to be retained to preserve the reliability of the research and meet legal or safety obligations. This will be explained in the Participant Information Sheet.
Your rights and concerns
Data-protection rights can include access, rectification, restriction, objection and, in some circumstances, erasure or portability. Some rights may be limited where necessary to maintain reliable scientific research. For trial-specific questions, contact the research nurse at your baby’s local hospital or BALLOON@cardiff.ac.uk.
For independent data-protection advice, contact the Cardiff University Data Protection Officer at inforequest@cardiff.ac.uk, or write to Data Protection Officer, Compliance and Risk, University Secretary’s Office, Cardiff University, 42 Park Place, Cathays, Cardiff CF10 3BB. You may also complain to the Information Commissioner’s Office.