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Informed consent: Navigating the bioethical complexities of clinical research
Ravindra Waykar1, Yogesh A Kulkarni2
1Caspersen School of Graduate Studies, Drew University, 36 Madison Ave, Madison, NJ 07940, United States.
None:
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.
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