Princípios da Pesquisa Clínica

Abstract

Objective: The present study aims to analyze and systematize the main criteria that define a research as clinical, in the light of Brazilian national legislation (CNS Resolution No. 466/2012, ANVISA RDC No. 9/2015 and Law No. 14,874/2024) and widely recognized international guidelines, such as the Declaration of Helsinki, the Good Clinical Practices of the ICH-GCP and the recommendations of the CIOMS. It seeks to offer an updated theoretical basis that allows the correct characterization of this type of investigation, ensuring ethical, scientific and regulatory validity in studies carried out on human beings. Methodology: A comprehensive literature review was carried out, aimed at identifying and analyzing the elements that make up clinical research. The investigation included the current national legislation and international guidelines for ethics and good practices, focusing on the methodological, ethical and regulatory aspects that determine the classification of a study as clinical. The importance of distinguishing between different research modalities and scientific designs was also highlighted. Results: The clinical research was characterized by the direct inclusion of human participants, by the application of health interventions (therapeutic, diagnostic, preventive or rehabilitative) and by the prospective nature of its designs. Submission to Research Ethics Committees (RECs), registration on national and international platforms, traceability and continuous monitoring, contracting insurance, and guaranteed access to post-study benefits were essential requirements. It was observed that conceptual clarity is essential to avoid misclassifications and preserve scientific integrity, differentiating clinical research from other types of investigation, such as retrospective studies, literature reviews, and research with previously stored biological material. Conclusion: The correct classification of an investigation as clinical research is a multifactorial process that requires an integrated understanding of ethical, methodological and regulatory aspects. This characterization is essential to ensure the protection of the participants, the scientific robustness of the study, and the alignment with national and international regulatory frameworks, contributing to the strengthening of health research in Brazil.