Ireland to prepare new ethics bill for clinical research

8th February 2019 (Last Updated February 11th, 2019 06:22)

The Government of Ireland has approved Minister for Health Simon Harris’ proposals to draft a new bill for national research ethics committees (RECs).

RECs review proposed clinical trials and check if the studies observe both domestic and international ethical guidelines. The committees also monitor the trials and take any necessary follow-up action after the research ends.

The committees can approve or decline research studies or request changes to research protocols on an ethical basis.

The new system is intended to address concerns raised by stakeholders regarding the existing RECs for clinical trials and health research over the last ten years.

According to the Ireland Department of Health, the new method will maximise synergies and value-for-money outcomes, while attracting other markets to carry out health research in the country.

The Department is considering the bill as a priority and plans to work with stakeholders, including the Health Research Board (HRB) and the Health Products Regulatory Authority, to publish it by the end of the year.

Minister Harris said: “RECs are key in ensuring that health research is carried out to the ethical standards expected by society, and we need to support a national system of research ethics committees that is fit for purpose.

“The new National REC system will ensure that there is public confidence in how health research is being conducted, especially in new and emerging areas of research.”

The HRB provided more than €150m in funding over the past decade for clinical research and clinical trials infrastructure, in line with the government’s Innovation 2020 strategy for research and development.

HRB CEO Darrin Morrissey noted: “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.”