Minister for Health secures Government approval to create national research ethics committee
The Government has approved proposals by Minister for Health Simon Harris TD to prepare a General Scheme of a Bill to provide for national research ethics committees.
Speaking today (Thursday), Minister Harris said “Health research is essential to deliver the best care and treatment for our patients, better value for our health spending and more high-quality jobs for our workforce. Supporting health research is a key part of the Sláintecare programme”.
The Minister added: “Research ethics committees (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”.
Innovation 2020, Ireland’s strategy for research and development, science and technology , aims to make Ireland a global leader in research and innovation and the Government is committed to the ongoing development of a quality focussed research-active health system in Ireland. That commitment has already seen major public investment in research infrastructure, personnel, new skills and technology. Over the last decade, there has been more than €150 million Government funding invested in clinical research and clinical trials infrastructure through the Health Research Board (HRB) alone. There has also been significant investment from State bodies, like Science Foundation Ireland, voluntary organisations and the private sector.
The proposed new system will address concerns that have been raised by stakeholders over the last decade about the existing RECs system in Ireland for clinical trials and health research generally. This approach will maximise synergies and value-for-money outcomes and make Ireland a more attractive international location for all health research.
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.”
The HPRA also welcomed the Bill saying “The HPRA supports further development of the National Ethics Committee framework as a key part of the infrastructure required for active health research and clinical trials in Ireland and to align to future changes in the regulatory requirements for European clinical trials.”
The Bill is regarded as a priority and the Department will work closely with stakeholders, including the Health Research Board and the Health Products Regulatory Authority to have a Bill published by the end of the year.
In the context of the preparation of the General Scheme, the Department will engage with a broad range of stakeholders including other Departments, agencies, institutional RECs, researchers, industry and patients to seek their views on specific matters.
Notes to the Editor
RECs review proposed studies with human participants (this includes where the research is about the use of patient data or samples) to ensure that they conform to internationally and locally accepted ethical guidelines, monitor studies once they have begun and, where relevant, take part in follow-up action and surveillance after the end of the research. Committees can approve or refuse to give ethical approval to research studies or require modifications to research protocols.
Review by a research ethics committee is required by international ethical standards governing research involving human participants, as well as by local law in many jurisdictions. Review is also essential if the researchers intend to publish the results of their investigation, as most scientific/medical journals will not publish the results of research that has not received the approval of a research ethics committee.
The main responsibility of a research ethics committee is to protect potential participants in the research, but it must also take into account potential risks and benefits for the community in which the research will be carried out.