The General Data Protection Regulation (GDPR) is a European Union wide regulation protecting citizens' personal data from improper use across the spectrum of recording, processing, usage and storage, to include data for health research. To this end, it is a welcome regulation, providing harmonisation across EU member states and protecting the fundamental rights and freedoms of our populations. GDPR came into effect in May 2018, having provided all data controllers with a two-year lead-in phase to review processes and procedures of data protection.
The GDPR is not the first time that principles and requirements were set out for data protection in Ireland. There has been data protection legislation since 1988. In the previous legislation, informed consent was a key requirement for the processing of data for research purposes whereas in GDPR it is called explicit consent - the only difference in interpretation being that GDPR stresses that explicit consent must be clear and unambiguous and that a researcher must be able to provide evidence of the consent secured should they be asked to present it.
While both the GDPR and Ireland's subsequent Data Protection Act 2018 mentioned health research, both had a broader remit and specific regulations were required to provide clarity for health researchers. The Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 sought to provide safeguards for Article 9(2) of GDPR, providing certainty to the health research community with regard to processing of special categories of personal data and the necessity of obtaining explicit consent from individuals for their inclusion in health research. As such, the Health Research Regulations (HRR) provide a framework for current practices in this country that are standard, or at least are expected to be standard, and as such should not be onerous on the research community.
However, in highlighting that explicit consent should continue to be sought and secured for the purposes of processing personal data for health research purposes, the Department was very aware that there are situations which arise where securing consent is either impossible or impracticable for various reasons. Therefore, the HRR importantly contains an innovation in Irish law (the establishment of the Health Research Consent Declaration Committee- HRCDC) to directly address these situations where consent for a health research project is of significant public importance but where it is not possible to obtain consent. This is a major development that will certainly benefit those carrying out important health research who could not secure explicit consent, and it will provide them with a mechanism to put forward their proposal and to secure a lawful decision from the Committee.
Far from seeking to make Ireland a restrictive place to do research, the Minister and the Department of Health have repeatedly publicly stated the importance of health research to better patient care and treatment, the development of innovative and life-saving therapies and at a wider economic level to bringing in foreign investment and creating high skilled jobs. Ireland has a vibrant and growing research community, supported by significant investment by the Department of Health, and there are high levels of public support for, and trust in, health research conducted in Ireland. The purpose of the HRR is namely to promote the conduct of health research in Ireland aligned with best international practice, while at the same time maintaining and promoting public confidence in health research.
The long-term success of health research in any democratic society requires public confidence. Without that confidence, the necessary support for health research, especially in evolving and complex areas such as genomics or artificial intelligence, will not be forthcoming. Above all, the purpose of the HRR is, therefore, to promote the long-term success of health research in Ireland by ensuring that individual patients and the public generally can have confidence in how their sensitive health information is being used.