Ethical and Legal Framework in Scientific Research From Chile: Functioning of Accredited Scientific Ethics Committees

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Natalia Herrera Medina; Sebastián Rivera Gutiérrez & Omar Espinoza-Navarro


Scientific research in human beings is essential for the development and advancement of health science and for the well-being of society. The need to have explicit ethical principles and a regulatory framework allowed in 2001 the approval of the Standard on the Regulation of Clinical Trials in Human Beings. Law 20,120 (2006), regulates scientific research in human beings and describes central aspects for the development of research, giving legal support to the creation of Scientific Ethics Committees (SEC), collegiate entities whose purpose is to ensure the protection of the vulnerability of rights and freedoms of the participants, being able to approve or reject the protocols of the projects. In Chile by 2021, 62 accredited CECs are registered. The Metropolitan region concentrates 58.2 %, the North zone 11.2 % and in the south of the country 30.6 %, of which only 12.9 % are accredited to evaluate randomized clinical trials (RCTs). The most widely used international ethical criteria are the Helsinki Declaration, ethical guidelines on health, well-being and the rights of patients; The International Council of Medical Sciences (CIOMS) that protects in vulnerability low-resource settings; and the Belmont Report on the protection of research subjects. It is concluded that the national and international ethical guidelines are appropriate legal ethical guidelines and risk-benefit ratio that protect the participants, ensuring respect for the autonomy, justice and fair selection of the participants, through voluntary informed consent. The development of a culture of ethical conduct in research must be based on three general dimensions; the human environment, political environment and mechanisms of civil society.

KEY WORDS: Scientific Ethics Committee, Ethical Guides, Accreditation, Chile.

How to cite this article

HERRERA, M. N.; RIVERA, G. S.; ESPINOZA-NAVARRO, O. Ethical and legal framework in scientific research from Chile: functioning of accredited scientific ethics committees. Int. J. Morphol., 40(4):953-958, 2022.