List of Ethical Principles for Medical Research Involving Human Subjects

Revista Alergia México

Marcela Perez-Rodriguez¹  Ivonne Analí Roy-García¹  Rodolfo Rivas-Ruiz¹  Ricardo Berea-Baltierra²  Lino Palacios-Cruz³ 

[1] Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Centro de Adiestramiento e Investigación Clínica, Ciudad de México;Instituto Mexicano del Seguro Social, Hospital de Oncología, Departamento de Medicina Interna, Ciudad de México;Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente Muñiz, Subdirección de Investigaciones Clínicas, Ciudad de México;

关键词: protocolo de investigación;    ética de la investigación;    consentimiento informado;   

DOI  :  10.29262/ram.v66i4.706

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown