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Abstract
Objective: To analyze and consolidate the main criteria that define research as clinical, in light of Brazilian national legislation (Resolution CNS nº 466/2012, RDC ANVISA nº 9/2015, Law nº 14.874/2024) and international guidelines (Declaration of Helsinki, ICH-GCP, CIOMS). The study aims to provide a solid and updated theoretical basis for correct characterization, ensuring the ethical, scientific, and regulatory validity of these studies involving human beings.
Methods: A comprehensive literature review was conducted, focusing on the identification and discussion of elements that characterize clinical research. The analysis included current Brazilian legislation and international guidelines on ethics and good clinical practices. Methodological, ethical, regulatory, and institutional aspects that directly influence the classification of a study as clinical were addressed, with special attention to the distinction between research types and scientific study designs.
Results: Clinical research was characterized by the direct involvement of human beings, the application of health interventions (therapeutic, diagnostic, preventive, or rehabilitative), a prospective design, mandatory ethical submission to Research Ethics Committees (CEPs), and registration on national (Plataforma Brasil, ReBEC) and international (ClinicalTrials.gov) platforms. The requirements for traceability, continuous monitoring, mandatory insurance policies, and guaranteed post-study access were highlighted. The discussion emphasized the importance of conceptual clarity to avoid misinterpretations and ensure scientific integrity, differentiating clinical research from other types of investigation (retrospective, population surveys, literature reviews, and studies with stored biological material).
Conclusion: The proper classification of research as clinical is a multifactorial process that transcends the mere presence of human participants or interventions, requiring an integrated understanding of ethical, regulatory, and methodological factors. Such characterization is essential to protect participants, ensure the methodological and ethical robustness of the study, guarantee alignment with national and international legal frameworks, and position Brazil competitively in the global health research scenario.
Keywords: Clinical research, Research ethics, Resolution CNS 466/12, ANVISA, Scientific legislation
References
Brasil. Conselho Nacional de Saúde. Resolução CNS nº 466, de 12 de dezembro de 2012. Diário Oficial da União. 2013 jun 13.
Brasil. Agência Nacional de Vigilância Sanitária (ANVISA). Resolução RDC nº 9, de 20 de fevereiro de 2015. Dispõe sobre o regulamento para a realização de ensaios clínicos com medicamentos. Diário Oficial da União. 2015.
Brasil. Lei nº 14.874, de 17 de maio de 2024. Marco Legal das Pesquisas com Seres Humanos. Diário Oficial da União. 2024.
World Health Organization (WHO). Handbook for Good Clinical Research Practice (GCP). Geneva: WHO; 2020.
World Medical Association (WMA). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–4.
Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans. Geneva: CIOMS/WHO; 2016.
International Council for Harmonisation (ICH). Guideline for Good Clinical Practice E6(R2). ICH Harmonised Tripartite Guideline; 2016.
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009 Jul 21;6(7):e1000097.
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Copyright (c) 2025 Luciano Barreto Silva, Ana Cristina Vilela de almeida, Lucivânia dos Santos Pimentel, Marise Ramos Alves do Nascimento, Isaias Barros Santos, Flávia Luciene de Novaes, Marineuza Gomes Albuquerque
