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巴拉圭研究伦理委员会的认证:一项伦理要求。

Accreditation of research ethics committees in Paraguay: An ethical imperative.

作者信息

García Cristina Raquel Caballero, Bianchini Alahí Dana

机构信息

Ministerio de Salud Pública y Bienestar Social del Paraguay. Directora Nacional, Dirección Nacional Estratégica de Recursos Humanos en Salud, Ministerio de Salud Pública y Bienestar Social. PhD. en Ciencias en Salud Pública.

Instituto de Investigaciones Jurídicas "Ambrosio L. Gioja", Facultad de Derecho, Universidad de Buenos Aires (UBA); Programa de Bioética de FLACSO Argentina. Doctoranda en Filosofía. Universidad de Buenos Aires.

出版信息

Rev Bioet Derecho Perspect Bioet. 2023 Jul;58:109-127. doi: 10.1344/rbd2023.58.39928. Epub 2023 Jun 15.

Abstract

In the last decade, Paraguay has made progress in the development of health-related research involving human subjects. This entails the obligation of the State to ensure that research is conducted ethically: protecting the dignity, rights and welfare of the participants, scientific integrity and adherence to international ethical guidelines. Research Ethics Committees are the main instance or resource to guarantee the aforementioned obligation. In view of the above and the context lacking adequate regulation in which research is currently carried out in the country, this article will defend the ethical imperative of establishing an accreditation system for research ethics committees. To this end, its necessity will be presented and justified and some objections related to the ethical imperative defended will be answered, such as the per se value of the accreditation of research ethics committees in the protection of participants, the investment of time and bureaucracy involved in the accreditation processes and the incipient regulatory framework for research on human beings in Paraguay. Finally, it will be proposed to strengthen the governance of research ethics in the country, as the main means to establish, implement and supervise an accreditation system for research ethics committees.

摘要

在过去十年中,巴拉圭在涉及人类受试者的健康相关研究发展方面取得了进展。这使国家有义务确保研究在伦理上得以进行:保护参与者的尊严、权利和福利、科学诚信并遵守国际伦理准则。研究伦理委员会是保障上述义务的主要机构或资源。鉴于上述情况以及该国目前开展研究缺乏适当监管的背景,本文将捍卫为研究伦理委员会建立认证体系的伦理必要性。为此,将阐述并论证其必要性,并回应与所捍卫的伦理必要性相关的一些反对意见,例如研究伦理委员会认证本身在保护参与者方面的价值、认证过程中涉及的时间投入和官僚作风以及巴拉圭人类研究的初始监管框架。最后,将提议加强该国研究伦理的治理,作为建立、实施和监督研究伦理委员会认证体系的主要手段。

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