Universal ethical principles and their application in clinical drug trials

https://doi.org/10.18294/sc.2015.415

Published 4 March 2015 Open Access


Médico Neurólogo. Especialista Consultor, Hospital Privado de Comunidad, Mar del Plata, Buenos Aires, Argentina




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Keywords:

Research, Human Rights, Scientific Misconduct, Bioethics, Ethics Committes


Abstract


Since 1931, and especially since the Nuremberg Code of 1947, an increasing number of declarations, regulations, norms, guidelines, laws, resolutions, and rules intended to create conditions for better protection of subjects participating in research studies have been published, although some have meant setbacks in the human rights of vulnerable populations. As such, violations of the dignity of experimental subjects in clinical trials continue. What researchers investigate and how the research is done, the quality and transparency of the data, and the analysis and the publication of results (of both raw and processed data) respond to the financial interests of the pharmaceutical companies, coming into permanent tension with bioethical principles and the needs of society. The active participation of civil society is necessary to make it so that pharmaceutical research, results and applications subordinate economic benefits to the protection of human rights.