Minister for Health publishes new Bill to reform the Research Ethics landscape
Minister for Health Simon Harris TD has today published the General Scheme of the National Research Ethics Committees Bill confirming plans to develop a streamlined, regulated and fit-for-purpose model for the ethical review of health research projects.
The Bill will modernise the current system, will support more consistent and more efficient decisions for research studies and will mean better results for patients.
Speaking today, Minister Harris said: “The Government is committed to supporting health research development in Ireland as it means better care and outcomes for patients, recruitment and retention of a high-calibre and innovative health workforce, better returns on healthcare expenditure and achievement of broader government goals in terms of employment and economic gain.
This Bill is essential to achieving those goals”.The reform will see the establishment of a number of National Research Ethics Committees, starting with one in the area of clinical trials of medicinal products, and these single-opinion national committees will be supported by dedicated and professional staff in a National Office for Research Ethics Committees (to be hosted by the Health Research Board).
The Minister added “Ireland currently punches below its weight in the area of clinical trials and therefore reform is particularly pressing in this area. The reform proposed will ensure that patients in Ireland have the best chance possible to participate in trials and avail of cutting edge and innovative therapies.”Ireland is likely to hold a unique place in the European clinical trial arena as the only mature English-speaking country in Europe post-Brexit, so urgent reform is critical to ensure that Ireland is viewed globally as an attractive location to progress cutting-edge trials, and health research generally.
Welcoming the Minister’s initiative, the CEO of the Health Research Board, Darrin Morrissey, said “The establishment of a single, cohesive national Research Ethics Committee structure in Ireland is long overdue. It will help grow health research and clinical trial activity that will benefit people’s health and patient care, as well as underpinning health innovation and economic growth in Ireland.”
Grainne Power, Director of Human Products Authorisation and Registration at the Health Products Regulatory Authority (HPRA), said that “The HPRA welcomes the arrival of another important milestone in the development of the National Ethics Committee framework as a key part of the infrastructure required for active health research and clinical trials in Ireland”.
Read the General Scheme of the Bill.
Read the Regulatory Impact Assessment of the Bill.