El protocolo de investigación VIII. La ética de la investigación en seres humanos.

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 rec...

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Published in:Revista Alergia de Mexico Vol. 66; no. 1; pp. 115 - 123
Main Authors: Miranda-Novales, María Guadalupe, Villasís-Keever, Miguel Ángel
Format: Article
Published: Coleg. Mexicano de Inmunologia Clinica y Alergia A.C.; Soc. Lat. de Alergia, Asma e Inmunologia ene-mar2019
Online Access:View this record in EBSCOhost
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          Miranda-Novales, María Guadalupe
          Villasís-Keever, Miguel Ángel
        affil: Instituto Mexicano del Seguro Social, Coordinación de Investigación en Salud, Unidad de Investigación en Análisis y Síntesis de la evidencia, Ciudad de México, México
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        Ethical principles
        Ethics in research
        Informed consent
        Ética en investigación
        Consentimiento informado
        Principios éticos
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        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.
        La investigación en seres humanos no puede llevarse a cabo sin cumplir con los principios éticos de autonomía, beneficencia y justicia. Los antecedentes históricos que destacaron la necesidad de contar con documentos para guiar la conducta de los investigadores señalan hechos lamentables para la humanidad. Aun cuando desde hace más de 50 años se publicaron las primeras recomendaciones en la Declaración de Helsinki, se pueden encontrar ejemplos de investigaciones que se han llevado a cabo sin respetar dichos principios. La aprobación por un comité de ética es un requisito de ley para todas las investigaciones en seres humanos. En la actualidad, prácticamente todas las revistas científicas solicitan el comprobante de la aprobación y evalúan si los riesgos a los que se sometieron los participantes de los estudios eran necesarios y los beneficios obtenidos de la investigación justificaron su realización. Cumplir con los requisitos que se solicitan para conducir éticamente un estudio no debe considerarse como una imposición, sino como un compromiso moral que se establece entre el investigador y los participantes del estudio.
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    language: Spanish
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