Informed consent in medical practice and clinical research

Abstract

Introduction. Informed consent is a fundamental pillar in medical practice and clinical research, evolving from a paternalistic model to one that emphasizes patient autonomy and shared decision making. Over time, the importance of ensuring that patients and clinical trial participants fully understand the procedures, risks, and benefits has been recognized as essential to protect their rights and ensure ethical treatment. Objective. The aim of this article is to conduct a review of the literature on informed consent in medical practice and clinical research, identifying advances, challenges, and associated ethical considerations, to provide a comprehensive and up-to-date understanding of its status and application in different contexts. Methodology. he methodology of the review was based on a systematic search for studies in academic databases such as PubMed, Scopus, and Web of Science. Articles addressing informed consent in medical and clinical research contexts, published in the last 10 years, were included. The selected studies were critically appraised to identify biases and extract relevant issues, such as patients' understanding of consent, cultural barriers, and the influence of technological innovations. Results. The results of the review revealed that, despite advances in the conceptualization of informed consent, significant challenges persist in its implementation. These include limited understanding by patients and participants, communication barriers, and cultural differences that complicate the consent process. The need for technological tools and ongoing training for professionals is highlighted, as well as cultural adaptation of the consent process to improve its effectiveness and respect the rights of individuals. Conclusion. Informed consent in medical practice and clinical research is a cornerstone, its importance cannot be underestimated, because as medicine and research continue to evolve, so must the practice of informed consent, adapting to modern technologies, ethical challenges, and the changing needs of patients and participants. General Area of Study: Medicine. Specific Area of Study: Bioethics and Medical Ethics. Type of study: Original articles.