Information For Patients

Our registries collect information that is routinely recorded when you visit your doctor. They are defined as observational studies, so there is no treatment or procedures involved that you would not be receiving as per your usual treatment.

These kinds of data collected include your diagnosis, genetics, weights, heights and other kinds of demographic data, test results, health complications, medicines and treatments, hospitalisations, healthcare services use, and information about how the condition and treatments have an impact on you. Your quality of life is generally collected by a patient survey. 

Patients are recruited by consultants and their teams at hospitals around Ireland and Internationally.

This can happen in one of the following ways:

1. At a clinic visit if diagnosed with the condition of interest to the registry the patient and/or parent/guardian will be asked whether they would be willing to participate in the study. A Patient Information Sheet and instructions on how to proceed if they are interested in taking part or finding out more about the study will be given to the patient and/or parent/guardian. Where the patient and/or parent/legal guardian feel that they have had adequate time to consider, enough information regarding the study and are happy to proceed, then consent can be sought.
2. Over an online video conference or phone call if the individual is unable to visit the study site but has expressed an interest in enrolling in the study. In this case, over video conference or call, the registry will be explained by the lead of the registry team at that clinical centre. The consent/assent forms and information booklets will have been posted out to the individual in advance of the call, at their request. The individual’s postal address and email address will be recorded in the study centre’s patient file, and not on the NISR Solutions CLG registry. Consent will be collected via online video conference or phone call but all of the registry data will be collected in person at clinic visit

Informed consent is a process initiated prior to an individual agreeing to participate in a study and continues throughout the individual’s participation. It is the freely given permission of a participant for their data to be collected and used for the purpose of the registry. 

Informed consent is essential for all patients participating in the study. In obtaining and documenting informed consent, the investigators comply with applicable regulatory requirements, adhere to Good Clinical Practice (GCP) and to the ethical principles that have their origin in the Declaration of Helsinki.

When informed consent is taken correctly it means you have all the information you need to make the best decision for you. 

To begin you and your child will be provided with information sheets on what the study is, you will be given time to review this information and ask any questions you may have. If you are both happy to participate, as the child’s legal gardian, you will be asked to sign a consent form. If it is appropriate for your child, they will also be asked to sign an assent form.  

From that point on your child’s care will continue as planned by their clinician. There are no extra tests or treatments for your child to undergo if they are a participant in an observational registry.  Their data will simply be collected and entered in the registry by their clinical team. 

If at any point you or your child wishes to withdraw from the registry please contact the clinical team. 

All NISR registries comply with the General Data Protection Regulation (GDPR) (2018) and the Data Protection Act 2018 in processing participant data. These regulations safeguard individuals fundamental rights 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 some of the ways we protect your or child’s information.

The GDPR is all about the protection of personal data. The definition of personal data in Chapter 1 Article 4 is any information relating to an identified or identifiable natural person (data subject); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as name, identification number, location data, on-line identifier, or one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.

All NISR registries are secure web-accessible electronic platforms that support highly secure data entry as well as reporting, sharing and anonymization of the registry dataset for the purposes of patient benefitting research. 

While the data is being collected your doctor and their team will know your name. Then user specific permissions only allows access to specific predefined data, so other users of the registry do not see your name or identifying data. 

A Scientific Research Committee, made up from the disease conditions specific medical care teams, is responsible for the release of any data for research from a registry. They screen and decide if the registry data will be released for research. If they approve the research then NISR package the data for use. 

Names, addresses and other information that could be used to identify participants are kept strictly confidential and are not available to those analysing the data. 

All data is stored and processed in a European Tier 3 data centre that complies with ISO27001 security accreditation.

All data from the primary server is copied to the secondary server every night. Backups are tested regularly to check the quality of restoration. All backups are protected from unauthorised access, theft and tampering with IP address restriction, restricted user access and password authentication.