Abstract

This study analyzes the evolution of the Declaration of Helsinki in relation to the external regulation of medical research and transparency in clinical trials, highlighting its impact on contemporary biomedical ethics. Its objective was to evaluate the perceptions of healthcare and bioethics professionals on these as pects, considering the educational, professional, and geographic context. A quantitative, cross-section al, and correlational design was adopted, with a purposive sample of bioethics and healthcare specialists from diverse regions, ensuring cultural, demographic, and socioeconomic representativeness. The results indicated a broad consensus on the need for external regulation and the publication of negative results in clinical studies, although differences persist in the interpretation of participant well-being and in the appli cation of ethical principles depending on the regulatory context of each country. The study contributes to the field of knowledge by demonstrating how professional and regulatory factors influence the perception of ethics in research, although it has limitations regarding the inclusion of patient and policymaker per spectives. As future lines of research, we suggest analyzing civil society's perception of ethics in medical research, comparing the implementation of the Declaration of Helsinki in different health systems, and eval uating the impact of new technologies, such as artificial intelligence, on the ethics of biomedical research.

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