First Line Contact Details: Dr Sadhbh O’Neill, Saidhbh.ONeill@tuh.ie
- The General Data Protection Regulation (GDPR) was signed into law on the on the 28th May 2018 for all of Europe (https://gdpr-info.eu/)
- Irelands Interpretation of GDPR Ireland, namely the Data Protection Act of 2018 (http://www.irishstatutebook.ie/eli/2018/act/7/enacted/en/html) was implemented in Ireland on the 8th August 2018.
- The Department of Health (DoH) in Consultation with the Data Protection Commission (DPC) (https://www.dataprotection.ie/) published the Health
- Research Regulations 2018 (http://www.irishstatutebook.ie/eli/2018/si/314/made/en/pdf), which is Irelands Interpretation of GDPR/Data Protection Act 2018 for Health Research.
- Therefore all Health Research taking place in Ireland is subject to the GDPR, the Data Protection Act and the Health Research Regulation
BUT
- What does this mean for Health Research in Ireland?
GDPR, the Data Protection Act of 2018 and the Health Regulations (HRR) required consent to be sought for all research taking place. However in January 2021 amendments to the HRR were enacted by the DoH and the DPC. These amendments concerned a number of areas but of particular interest to researchers are the amendments to:
- Retrospective Chart Reviews - Consent is no longer required for this type of study BUT only when the study meets certain criteria: (i) the data is protected by a unique coding system (ii)a data protection risk assessment has concluded that the study is low risk (iii) it is performed by a healthcare practitioner who is an employee of TUH or a student healthcare practitioner (iii) is another employee of TUH who in their normal duties has access to medical records (iv) the data will not be shared unless completely anonymous (v) the published results will not identify any individual and (vi) the Research Ethics Committee must review and approve.
- Pre-screening – pre-screening is the process researchers use to identify patients that may be suitable for the research study they wish to undertake. This involves accessing medical records for the purpose of identifying patients but no data is removed/copied/recorded. This is only done by healthcare practitioners, student healthcare practitioners within TUH and hospital employees who normally have access to medical records. Patients will not be contacted to give consent for pre-screening, however, should they be deemed suitable they will be contacted in order to provide them with information about the study and, if they feel comfortable and happy, to obtain their consent.
- Health Research Consent Declaration Committee
- Research involving patients who lack capacity to provide their own informed consent for their participation in research require a consent declaration by the Health Research Consent Declaration Committee (HRCDC)
- The data controller must apply to the HRCDC for a consent declaration
- The HRCDC is a separate committee to the Ethics committee. Their role is to review applications regarding the processing of a patient's data without seeking consent from the patient
I. Personal data (i.e. name. address, MRN, email address, DOB, etc)
II. Personal sensitive data (i.e. patients medical data)
- The HRCDC committee make a decision as to whether there is significant public interest in the study and this public interest outweighs an individual's rights to give their consent for their data to be processed
- The HRCDC will require assent to be sought from the patients next-of-kin.
- More information and the HRCDC application form can be found at the following link HRCDC
- Please refer to GDPR Article 6 for the options under personal data and GDPR Article 9 for options under sensitive personal data
- Consent for Health Research must be dual consent, (i) consent for participating in research and (ii) consent for processing a patients data. The DoH have published their guidance for seeking explicit consent from patients
Link to privacy notice
Clinical Research at Tallaght University Hospital - Information for Patients
