The General Data Protection Regulations were introduced in EU member states on May 25th 2018. The intention was that personal data would be regulated in the same way in each jurisdiction, but member states were allowed to apply additional safeguards with respect to personal and health data.
In Ireland, the Health Research Regulations followed GDPR on August 8th, 2018, containing additional governance stipulations, processes and procedures
https://www.hrb.ie/funding/gdpr-guidance-for-researchers/health-research-regulations-2018/ A key element of the HRR is that identifiable personal and health data is only permitted if a patient has given explicit consent or if a consent declaration has been received from the Health Research Consent Declaration Committee. Explicit consent also applies to archival data from former patients, treated before 2018, if the HRCDC does not consider that the proposed research fulfils the criterion of “significant public interest”.
Amendments to the HRR were enacted in 2021
Although designed to protect data subjects, GDPR and HRR have unfortunately had negative effects on Irish health research – see Publications
- Mee B, Kirwan M, Clarke N, et al. What GDPR and the Health Research Regulations (HRRs) mean for Ireland: a research perspective [published online ahead of print, 2020 Jul 29]. Ir J Med Sci. 2020;10.1007/s11845-020-02330-3. doi:10.1007/s11845-020-02330-3
- Kirwan, M., Mee, B., Clarke, N. et al. What GDPR and the Health Research Regulations (HRRs) mean for Ireland: “explicit consent”—a legal analysis. Ir J Med Sci (2020). https://doi.org/10.1007/s11845-020-02331-2
Biobanks can provide researchers with large numbers of high quality samples and data, donated with patient consent, saving a great deal of time, and enabling a project to “start running”. Biobanks are essential in developing and storing COVID-19 vaccines. The UK Biobank, which has samples from half a million people, conducts multiple genome-wide studies in various diseases. Large sample numbers are needed for cancer research because no two cancer cells are identical and cancers have complex genetic mutation profiles. These are being elucidated by next generation sequencing and related techniques which may be used to identify cancer-specific genomic alterations and heterogeneity
K Nones, A-M Patch. The impact of Next Generation Sequencing in Cancer Research.
Cancers 2020, 12(10), 2928; https://doi.org/10.3390/cancers12102928
Biobank Ireland is an active member of the National Biobank Working Group and of the international biobanking organisation ISBER.
St James’s Hospital Cancer Biobank is based in the Department of Histopathology at St. James Hospital. At St James Hospital Cancer Biobank, we promote the collection, storage, and release to academic and industry researchers of cancer tissue and matching normal tissue, using The International Society for Biological and Environmental Repositories (ISBER) best practice procedures. The Sample Application Policy is based on those of international biobanks. Tiered charges apply.
Researchers from Trinity College Dublin are the principal users of the biobank but samples are available to all approved researchers. The biobank has collaborations with Cancer Trials Ireland and Breast Predict, a large collaborative project based in UCD.
A dedicated BIMS has been developed by Biobank Ireland and Modul-bio, a French company with extensive experience in Biobank Information Management Systems. Work on the web portal, to display coded information on FF and FFPE samples and linked data for researchers, has commenced. The BIMS will be used by the other network biobanks. This will enable all researchers to access the database and request samples and data.