Navigating the ethical and regulatory landscape in surgical research: The Irish surgical research collaborative's...

The ethical and regulatory framework governing surgical research in Ireland is complex and often perceived as a barrier to study initiation. Compliance with ethical standards and data protection legislation is essential to ensure participant safety, research integrity, and public trust.

To provide a structured, evidence-informed overview of the ethical and governance requirements for conducting surgical research in Ireland, with practical guidance for investigators navigating the ethical and regulatory framework.

This article is a narrative educational review intended to describe the current ethical and governance framework for surgical research in Ireland and to provide practical, investigator-focused guidance. It does not seek to evaluate outcomes or endorse specific institutional processes. This review synthesises national and European regulatory frameworks, including guidance from the Health Service Executive (HSE), National Office for Research Ethics Committees (NREC), and the European Union Clinical Trials Regulation (EU No. 536/2014). Practical insights were derived from the operational experience of the Irish Surgical Research Collaborative (ISRC).

The review delineates the distinctions between audit, quality improvement, and research, clarifying when REC approval is required. It outlines the procedural steps for REC submission, including mandatory documentation such as research protocols, patient information leaflets, patient consent forms, and Data Protection Impact Assessments (DPIAs). The importance of compliance with the General Data Protection Regulation (GDPR) (EU 2016/679) and International Council for Harmonisation Good Clinical Practice (ICH-GCP) certification is emphasised. Meaningful Patient and Public Involvement (PPI) is identified as a key determinant of study relevance, ethical robustness, and transparency.

This ISRC and NSRSC guide provides a practical framework to support investigators in delivering high-quality, compliant, and patient-centred research within the Irish healthcare system.