CFRI Re-Consent Programme

The Cystic Fibrosis Registry of Ireland (CFRI) are currently undertaking a programme of re-consenting all participants in the national registry. By collecting and analysing information on all people with CF in Ireland, the CFRI aim to better understand their health and wellbeing, and the treatments they receive. The introduction of the General Data Protection Regulation (GDPR) in 2018 gave us all more control over how our personal data is stored and used. As a result, CFRI need to ask you to re-confirm your consent for them to collect this information. The new consent forms are fully GDPR compliant and have passed a review process with the ethics committee of each CF Centre. CFRI are inviting all individuals attending CF centres in Ireland to join the CF Registry of Ireland, regardless of whether or not you have previously given your consent. Their hope is to include every individual with CF in Ireland in the CFRI. A patient registry is a secure, centralised database, containing health data on people with a specific diagnosis or condition. The CFRI have collected and recorded information on the health status of people with CF who agree to participate in the registry since 2002. Approved researchers use the registry to study cystic fibrosis treatments and outcomes.

How is information collected?

Your consent authorises the CFRI to access your (or your child’s) medical records, collect and record your medical information. The CF team(s) or approved CFRI staff take the relevant medical information from paper-based and electronic hospital(s) records, and information on healthcare services used from the Health Service Executive (HSE).

What is collected?

Information on your diagnosis, CF genetics, weights, heights, lung function measurements, test results, health complications, medicines and treatments, hospitalisations and use of healthcare services are collected by our team, as well as information about how the condition and treatments have impacted you.

How is the information protected?

CFRI fully comply with the General Data Protection Regulation (GDPR) (2018) and the Data Protection Act 2018 in processing participant data. These regulations safeguard individuals’ fundamental right to data privacy. Password protection and encryption of computer files and data, training of staff in data protection and regular review of data protection procedures are just some of the ways CFRI protect your (your child’s) information.

Is the information confidential?

Yes. Ensuring personal information is private and confidential is extremely important to the CFRI. Participants are allocated a unique record number upon registration with the CFRI. Information that could directly identify an individual, such as name and date of birth, is hidden in the registry record. Only certain people can identify participants personally: approved CFRI staff and authorised contractors, and your consultant doctor and CF team. Participants will never be identified by name in published research and annual data reports.

What is involved in joining?

You will receive a new consent form (and assent form if under 18) and a copy of the CFRI patient information booklet. Ideally, participants will sign the consent form in clinic, and the form is co-signed by their consultant or other designated member of the CF team. Under the current COVID-19 restrictions, and with many CF centres using online or virtual clinics, this may not always be possible. CFRI have received ethical approval to utilise postal re-consent in some centres. In these cases, the consent forms will be co-signed once they have been received by the registry in the self-addressed Freepost envelopes. For individuals under the age of 18, parental consent is required for participation. Parents will receive a parent/ guardian information booklet. Young people aged 13-17 are asked to sign an Assent form by CFRI. Assent is a term used to express willingness to participate in research by persons who are too young to give informed consent, but who are old enough to understand the proposed research in general. Thank You to the Irish CF community for your continued support of the CF Registry of Ireland. Further information is available from www.cfri.ie, by contacting us at info@cfri.ie, or from your CF team.