Abstract / Summary
Public health emergencies heighten the need for reliable evidence while increasing uncertainty, participant vulnerability, health-system strain, and political pressure. This critical narrative review examines how clinical trials can be accelerated while protecting participants’ dignity, rights, safety, and agency. Drawing on empirical literature, international ethical guidance, and Brazilian legal and regulatory sources, we analyse challenges involving scientific validity, consent, inclusion, adaptive designs, oversight, data governance, and equitable access. We propose the DIGNITY conceptual model: Dignity; Inclusive and locally responsive research; Governance, accountability, and transparency; Necessity and scientific validity; Informed and revisable consent; Timely, risk-proportionate oversight; and Yielding fair and accessible benefits. Brazil provides a regulatory case study through Law No. 14,874/2024, Decree No. 12,651/2025, single ethics review, national ethics governance, post-trial obligations, and risk-, complexity-, and reliance-based regulatory pathways. Regulatory agility requires preparedness, scientific prioritization, local responsiveness, and accountable coordination. DIGNITY is proposed as a normative framework for preparedness and ethical deliberation, requiring empirical evaluation. Procedural adaptations are ethically defensible when they preserve scientific validity, meaningful participant protection, independent oversight, and equitable access to benefits.