Introduction: The Beaumont Hospital Ethics (Medical Research) Committee

The Beaumont Hospital Ethics (Medical Research) Committee reviews applications to undertake research in Beaumont Hospital. Its remit is to protect the safety and welfare of research participants, and primarily to weigh the risks and benefits for research participants of individual research projects.

In March 2005, the committee was recognised by the Department of Health to review applications for clinical trials of medicinal products (clinical drugs trials) for the whole of Ireland. There are currently 12 ethics committees in Ireland which have been recognised in this way by the Department of Health.

An Ethics Committee and the Health Products Regulatory Authority must both approve a clinical drugs trial for it to proceed in Ireland. In addition, the drugs trial must have a European Clinical Trial number, called a EudraCT number, and adequate insurance must be in place in case of an injury occurring to a trial participant. Many clinical drugs trials are funded by pharmaceutical companies, and these companies (or indeed any external sponsor) are required to sign an indemnity form, and a clinical trial agreement, which are both legal contracts, with the hospital.

The legislation on the clinical trials of medicines (clinical drugs trials) is very specific and sets out how many members the committee is allowed to have, and what proportion of these must be lay members. The maximum number of members is 21, one third of which must be lay members. The committee's current membership list can be viewed here.

The most recent legislation came into force in Ireland in May 2004. This was the date a statutory instrument called S.I. 190 of 2004 passed the parent EU Regulation into Irish law. There was a transition period of two years during which the previous Irish Clinical Trials legislation operated in tandem with S.I. 190 of 2004. This transition period ended in May 2006, and S.I. 190 now governs clinical drugs trials in Ireland. (S.I. 190 of 2004 has been amended by S.I. 878 of 2004, S.I. 374 of 2006 and S.I. 1 of 2009)

S.I 190 sets out how many members must be at a meeting in order to have a quorum. It also sets out specific timelines within which an Ethics Committee must make a decision in relation to a clinical trial of a medicine (clinical drugs trial), and in relation to amendments to a clinical drugs trial.

The Committee however views many other types of research other than clinical drugs trials. For example, it reviews clinical investigations of medical devices, e.g. stents and pacemakers. There are statutory instruments in place also in relation to medical devices, which the committee must comply with. Unlike drugs trials however, the committee's opinion in relation to a medical device investigation is an opinion for Beaumont Hospital only. The device legislation does not allow an ethics committee to give a central opinion for Ireland. (This is subject to change however as the situation in Ireland in regard to all research will change considerably after the implementation of the proposed Health Information and Patient Safety Bill.) Unlike drugs trials also, not all clinical investigations of medical devices require approval from the Health Products Regulatory Authority.

There are many other types of research ongoing in the hospital. Many consultants, non-consultant hospital doctors, physiotherapists, nurses, speech and language therapists, neurophysiologists and specialists in many other disciplines apply to do research in the hospital. All this research comes to the Beaumont Hospital Ethics (Medical Research) Committee for review. The vast majority of research in the hospital falls into this category of research other than clinical trials of medicines, and there is no specific legislation governing the committee's role in this area. There does exist however more general pieces of legislation which the committee must remain cognisant of e.g. the Data Protection legislation, the Freedom of Information legislation, and the common law on consent for medical treatment and research. In addition, there are relevant publications from the Irish Council for Bioethics (available from the Department of Health) and relevant policies from the Health Services Executive to consider, and many professional organisations have guidelines e.g. Nursing and Midwifery Board of Ireland and the Irish Medical Council.

There are of course many international guidelines on medical research going back many decades which the committee must ensure that it is at all times compliant with, e.g. The World Medical Association Declaration of Helsinki (most recently updated in 2013).