GDPR: an impediment to research?

Background: The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland's Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland's clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.