ETHICAL CONSIDERATIONS IN OBTAINING INFORMED CONSENT FOR RESEARCH PARTICIPATION: A REVIEW

Abstract

Informed consent is widely regarded as a foundational ethical requirement in research involving human participants; however, contemporary research practices increasingly expose the limitations of viewing consent as a static, procedural obligation. This paper critically examines informed consent as a dynamic, relational, and context-dependent ethical process shaped by power relations, institutional governance, and participant vulnerability. Drawing on international ethical frameworks and regulatory standards, the analysis demonstrates that meaningful consent extends beyond disclosure and documentation to encompass comprehension, voluntariness, and sustained participant engagement across all research phases. Particular attention is given to systemic challenges, including excessively complex consent materials, unequal researcher–participant relationships, culturally and linguistically mediated misunderstandings, and the ethical tensions surrounding incentives and compensation. The paper further interrogates consent practices involving vulnerable populations, such as children, individuals with diminished capacity, pregnant persons, prisoners, and marginalized communities, arguing that heightened protections must not devolve into paternalistic exclusion from research participation. Emerging issues surrounding broad consent, secondary data use, biobanking, and digital data infrastructures reveal how traditional consent models struggle to accommodate evolving research ecosystems. This analysis advances the argument that ethical informed consent requires a shift from compliance-driven formalism toward reflexive, participant-centred ethical practice. By reconceptualising consent as an ongoing moral negotiation rather than a one-time legal safeguard, the paper underscores the necessity of integrating ethical reflexivity, cultural sensitivity, and accountability into research design and governance. Ultimately, strengthening informed consent practices is essential not only for protecting participant autonomy and dignity, but also for sustaining public trust and the epistemic legitimacy of human subjects research.