Bioethics in research on human beings

A theoretical reflection

Abstract

Introduction: Research involving human beings must be governed by the ethical principles of autonomy, beneficence, non-maleficence and justice and the priority function of bioethics in research involving human beings is to protect the participant undergoing a study. Objective: To recover the history of ethics in research involving human beings, presenting the guidelines currently in force and the possible effects that Bill (PL) 7082/2017 could bring if approved. Materials and methods: This is a theoretical-reflective essay based on the analysis of PL 7082/2017 and its repercussions in light of the historical recovery of bioethics and comparison with PL 200/2015, currently in force. Results and Discussion: Research ethics underwent an evolution from the 17th to the 21st century, when the Council of International Organizations of Medical Sciences, in partnership with the World Health Organization, updated the standards in research involving humans, arriving at 2015 with the PL200. PL 7082/2017, which is currently being processed, aims to change some points previously considered fundamental, leaving participants involved in research even more vulnerable. Final considerations: Currently, we still come across true cases of disrespect for ethical precepts, leading to consequences or even death in humans, as in the Tuskegee, Vipeholm cases and the study of proxalutamide in the treatment of Covid-19. The new Law, if approved, puts the built and well-consolidated structure of the CEP/CONEP system at risk, and consequently threatens the protection of the individual and the guarantee of ethics during research.

Keywords: Research ethics, Conflict of Interest, Health Research Policy.