All investigators supported by the NCRC must ensure that the necessary ethical, legal, and regulatory requirements are met before undertaking their research. Further to this, evidence that all the required licences and approvals have been obtained by the Principal Investigator, and their research team where appropriate, must be submitted to the NCRC prior to the commencement of the research.
Regardless of where it takes place, research funded through the NCRC adheres to the highest ethical standards. Ethical approval is required for all research supported by the NCRC that involves human participants, human material (including tissue), or animals, and written evidence of this approval must be submitted to the NCRC prior to the commencement of the research.
The Health Products Regulatory Authority (HPRA) is responsible for regulating, amongst other things, clinical trials, and the use of animals for research. If research supported by the NCRC includes a study that requires HPRA approval, then a copy of the approval must be provided to the NCRC prior to the commencement of the study.
All investigators supported by the NCRC are required to follow Good Research Practice as outlined in the:
The General Data Protection Regulation (EU) 2016/679 came into effect on 25th May 2018; in Ireland the national law, giving further effect to the GDPR, is the Data Protections Act 2018. The Regulation itself further strengthens the regulatory framework for the collection, use, and storage of all personal data of living individuals and also provides some new rights to individuals in relation to the use of their data. In addition to GDPR, in Ireland, the Health Research Regulations 2018 (“the Regulations”) came into effect on 8th August 2018.
All data generated in the course of NCRC supported research must be treated in accordance with GDPR, the Data Protections Act 2018, and the Health Research Regulations 2018.