List of Ethical Principles for Medical Research Involving Human Subjects

Abstract

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.

Keywords

• protocolo de investigación
• ética de la investigación
• consentimiento informado