The Declaration of Helsinki and the Evolution of Ethics in Medical Research

Abstract

This study analyzes the evolution of the Declaration of Helsinki about 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 regarding these aspects, taking into account their educational, professional, and geographic contexts. A quantitative, cross-sectional, and correlational design was employed, utilizing a purposive sample of bioethics and healthcare specialists from diverse regions to ensure 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. However, differences persist in interpreting participant well-being and applying 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. However, it has limitations regarding the inclusion of patient and policymaker perspectives. 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 evaluating the impact of new technologies, such as artificial intelligence, on the ethics of biomedical research.