Ethical Opinions in Research Ethics Committees: A Narrative Review of Normative Foundations, Deliberative Architecture, and Quality Standards

Research ethics committees occupy a central position in scientific governance, yet the literature reveals a persistent gap in structured, theoretically grounded guidelines for drafting ethical opinions. Opinions are frequently characterised by insufficient substantiation and communicative opacity, eroding researcher trust and institutional legitimacy. This study provides an integrated framework for the production of quality ethical opinions. A narrative review was conducted through searches in PubMed, SCOPUS, and Web of Science, supplemented by normative documents from the WHO, Council for International Organizations of Medical Sciences, and World Medical Association. Opinion quality depends on three interdependent dimensions: normative grounding in foundational principles, deliberative integrity in collective processes, and communicative responsibility in documented reasoning. The most frequent deficiencies concern informed consent and risk-benefit analysis. Structured discretionary judgement proves superior to algorithmic standardisation. This work is original in integrating Habermasian communicative rationality with the Aristotelian concept of phronesis to propose a tripartite framework that transcends compliance-based approaches.