Double standard in clinical research

Nilceu José Oliveira
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Abstract

In the development of clinical research, the social conditions of the societies involved must be taken into account, such as vulnerability and social vulnerability. The contexts of conflicts of interest, whether economic or academic, must also be considered. Another highlight is related to the so-called moral imperialism, a condition in which societies impose their moral standards on others, not considering cultural differences, geographical conditions and social development. Thus, the “double ethical standard” in research imposes a form of imperialism of principles, values, moral relativism and na exclusively economic vision above all. The principles of ethics in biomedical research promulgated by international consensus statements are not sufficient to protect the most vulnerable societies, especially the poorest countries. The ethical principles that govern clinical research need to be translated into procedures and practices that take into account the different cultural aspects and socioeconomic resources of societies. Research participants cannot just bear the risks and not reap the benefits. There are arguments that propose the double standard as a violation of human rights, especially for not taking into account the principles of the Universal Declaration of Bioethics and Human Rights of UNESCO, approved by consensus by the countries in 2005. The existence of a “strong” system ethical evaluation of research projects, with social participation, especially in local ethics committees in the most vulnerable societies, is a minimum condition for the protection of people and societies.
临床研究双重标准
在开展临床研究时,必须考虑到所涉及的社会的社会条件,如脆弱性、社会脆弱性等。还必须考虑利益冲突的背景,无论是经济上的还是学术上的。另一个重点与所谓的道德帝国主义有关,在这种情况下,社会不考虑文化差异、地理条件和社会发展,将其道德标准强加于他人。因此,研究中的“双重伦理标准”首先强加了一种原则、价值、道德相对主义和唯一的经济视野的帝国主义形式。国际共识声明所颁布的生物医学研究伦理原则不足以保护最脆弱的社会,特别是最贫穷的国家。指导临床研究的伦理原则需要转化为考虑到不同文化方面和社会经济资源的程序和实践。研究参与者不能只承担风险而不从中获益。有观点认为,这种双重标准是对人权的侵犯,特别是没有考虑到2005年各国一致通过的联合国教科文组织《世界生物伦理与人权宣言》的原则。在社会参与下,特别是在最脆弱社会的地方伦理委员会中,对研究项目进行“强有力”的伦理评价制度是保护人民和社会的最低条件。
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