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General Publications and Guidelines

Health Research Board Discussion Document on Data ProtectionLink to HRB website
Data Protection Commissioner's Guide on Research in the Health SectorLink to Commissioner's website
Irish Council for Bioethics Guidelines on Research Ethics CommitteesLink to Council website
Irish Council for Bioethics Guidelines on Human Biological MaterialLink to Council website
Council of Europe Oviedo ConventionLink to Council website
Sample Size Calculation by Dr. Ronan Conroy (RCSI)
Universal Declaration on bioethics and human rightsLink to UNESCO website
World Medical Association Declaration of HelsinkiLink to WMA website

Legislation: Clinical Trials of Medicinal Products

S.I. 190 of 2004 for Clinical Trials of Medicinal Products for Human UseLink to DOHC website
S.I. 878 of 2004 (Amendment to S.I. 190 of 2004)Link to DOHC website
S.I. 374 of 2006 (Amendment to S.I. 190 of 2004)Link to DOHC website
S.I. 1 of 2009 (Amendment to S.I. 190 of 2004)Link to DOHC website

Legislation: Clinical Investigations of Medical Devices

S.I. 252 of 1994 for General Medical DevicesLink to statute books
S.I. 253 of 1994 for Active Implantable Medical DevicesLink to statute books
S.I. 304 of 2001 for In-Vitro Diagnostic Medical DevicesLink to statue books


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