Informed consent: Navigating the bioethical complexities of clinical research

Abstract

Informed consent (IC) has traditionally been regarded as the fundamental principle of ethical clinical research involving human subjects. This article explores the limitations of the IC, assesses the need for a comprehensive ethical framework and proposes a roadmap for developing a framework that holistically safeguards participants' rights, safety and well-being. The evolving nature of medical technology and complex decision-making situations necessitate a more comprehensive approach to research ethics. This review emphasizes the need for a procedural plan to structure moral deliberations and address potential conflicts between ethical values. By integrating ethical values and benchmarks, a systematic and consistent approach is required to uphold ethical integrity in clinical research beyond the limitations of informed consent.