Clinical Trials

Clinical trials and studies are conducted in order to ascertain the safety and/or efficacy of thera­peutic interventions, and to generate evidence on the benefits and harms of these.Approval must be obtained from an ethics research committee before any clinical trials can be carried out. Ethics research committees are composed of lay and health care professionals who review the trial protocol, the suitability of the investigator(s), facilities, and the methods and materials to be used in obtaining and documenting informed consent of the trial sub­jects. These committees may also interview the principal investigator(s) as part of the review and approval process.

In the context of medicinal product trials being conducted at multiple sites, under the clinical trials legislation a sponsor need only seek ethical approval from one of the twelve recognised ethics committees regulated by the Minister for Health. However, this is not the case for multi-centre trials which do not involve investigational medicinal products (e.g. translational or radiotherapy trials) where approval of the relevant ethics committees is required for each centre. The Department of Health has committed to establish a national ethics committee to speed up and streamline the process for these trials, but this has not yet happened. Click here to read the expert statement.