Perez-Rodriguez Marcela, Berea-Baltierra Ricardo, Roy-García Ivonne Analí, Palacios-Cruz Lino, Rivas-Ruiz Rodolfo
Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Centro de Adiestramiento e Investigación Clínica, Ciudad de México, México.
Rev Alerg Mex. 2019 Oct-Dec;66(4):474-482. doi: 10.29262/ram.v66i4.706.
The ethical principles of a research proposal are not contained only in a paragraph or in the informed consent form; actually, they are an essential part of the whole protocol from the beginning to the end. In a complementary manner to the regulatory and educative documents, our objective in this article is to propose a checklist of questions so researches can ensure they have included the necessary information and precautions to meet the ethical considerations that are required for every research with human beings, which shall be called List of Ethical Principles for Medical Research Involving Human Subjects. We propose questions that researchers must ask themselves when they compose the background, justification, objectives, research question, hypothesis, selection criteria, sample size calculation, sampling, research design, statistical analysis plan, ethical aspects, publication plan, and references.
研究提案的伦理原则并非仅包含在某一段落或知情同意书中;实际上,从始至终,它们都是整个方案的重要组成部分。作为对监管和教育文件的补充,本文的目的是提出一份问题清单,以便研究能够确保他们已纳入必要信息和预防措施,以满足每项涉及人类的研究所需的伦理考量,这份清单将被称为《涉及人类受试者的医学研究伦理原则清单》。我们提出了研究人员在撰写背景、理由、目标、研究问题、假设、选择标准、样本量计算、抽样、研究设计、统计分析计划、伦理方面、发表计划和参考文献时必须自问的问题。