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Rev Alerg Mex. 2019 Jan-Mar;66(1):115-122. doi: 10.29262/ram.v66i1.594.

Research protocol VIII. The ethics of research on human subjects.

[Article in Spanish; Abstract available in Spanish from the publisher]

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Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Unidad de Investigación en Análisis y Síntesis de la evidencia, Ciudad de México, México.


in English, Spanish

Research on human subjects cannot occur if it does not comply with these ethical principles: autonomy, beneficence and justice. The historical antecedents that emphasized the need to have documents to guide the researchers' behavior point to regrettable events for humanity. Even though the first recommendations were published more than 50 years ago in the Declaration of Helsinki, it is possible to find examples of investigations that have been conducted without complying with the aforementioned ethical principles. Approval by an ethics committee is required by law for all the research projects that involve human subjects. At present, virtually all scientific journals require the proof of approval and they assess whether the risks which participants were subjected to in the studies were necessary, and they also assess whether the benefits that were obtained from the research justify its conduction. Meeting the criteria that are required in order to conduct a study in an ethical manner should not be seen as an imposition; but as a moral commitment that has been established between the researcher and the participants of the study.


Ethical principles; Ethics in research; Informed consent


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