For an overview of human subject protections in Ireland, see the EFGCP Report.
See this summary on Clinical Trials Involving Medical Products.
Governing Agencies and Ethics Review Structure
- European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004)
- European Communities (Clinical Trials on Medicinal Products for Human Use) Amendment 2004 (S.I. No. 190 of 2004)
- Data Protection Act (1988), as Amended (2003)
- Operational Procedures for Research Ethics Committees: Guidance 2004
- Health Service Executive National Consent Policy
- Human Biological Material: Recommendations for Collection, Use, and Storage in Research (2005)
- Guidelines for Pharmacogenetic Research (2006)
- Clinical Trials in Ireland Regulatory Framework
Points to Consider – Investigators
- The investigator is required to apply for an ethics committee opinion in writing, to a competent ethics committee recognized by the Ethics Committees Supervisory Board.
Local Research Institutions