Consideraciones Éticas en la Investigación Psiquiátrica: Estudios en Pacientes con Esquizofrenia Institucionalizados en EE.UU (1940-1975) y su Influencia en la Regulación Bioética

Luis Guillermo Herrera Jiménez
Departamento de Farmacia, Universidad de Costa Rica, San José, Costa Rica.

Luis Andrés Núñez Alpízar
Departamento de Farmacia, Universidad de Costa Rica, San José, Costa Rica.

Fabricio López Ortega
Departamento de Farmacia, Universidad de Costa Rica, San José, Costa Rica.

Freddy Arias Mora
Departamento de Farmacia, Universidad de Costa Rica, San José, Costa Rica.

Resumen

Este trabajo analiza la investigación biomédica realizada entre 1940 y 1975 en pacientes con esquizofrenia institucionalizados en hospitales psiquiátricos de Estados Unidos, partiendo de la hipótesis de que la ausencia de protocolos éticos estandarizados permitió su utilización sistemática en estudios experimentales, lo que finalmente condujo a la creación de mecanismos regulatorios como las Institutional Review Boards (IRB). Se discute cómo el contexto histórico de la psiquiatría asilar, la percepción de los pacientes como “material clínico disponible” y la falta de derechos civiles facilitaron la realización de experimentos farmacológicos e intervenciones invasivas (como la administración de neurolépticos, LSD, lobotomía y terapia electroconvulsiva) frecuentemente sin consentimiento informado ni supervisión ética externa. La revisión de literatura y fuentes históricas evidencia que, aunque estos estudios contribuyeron al desarrollo de la psicofarmacología y la transformación de la psiquiatría moderna, lo hicieron a costa de graves violaciones a los derechos humanos y la dignidad de los pacientes. Como resultado, las denuncias y cuestionamientos éticos derivados de estas prácticas impulsaron la creación de marcos regulatorios y la implementación obligatoria de las IRB, estableciendo la necesidad de supervisión ética, consentimiento informado genuino y protección de poblaciones vulnerables en la investigación biomédica contemporánea.

Palabras claves

Ética en investigación, esquizofrenia, consentimiento informado, psiquiatría institucional, Institutional Review Boards.

Abstract

This paper analyzes biomedical research conducted between 1940 and 1975 on institutionalized patients with schizophrenia in United States psychiatric hospitals, based on the hypothesis that the absence of standardized ethical protocols enabled their systematic use in experimental studies, ultimately leading to the creation of regulatory mechanisms such as Institutional Review Boards (IRBs). The discussion addresses how the historical context of asylum psychiatry, the perception of patients as “available clinical material,” and the lack of civil rights facilitated pharmacological experiments and invasive interventions (including the administration of neuroleptics, LSD, lobotomy, and electroconvulsive therapy) often without informed consent or external ethical oversight. A review of the literature and historical sources shows that, although these studies contributed to the development of psychopharmacology and the transformation of modern psychiatry, they did so at the cost of serious violations of patients’ human rights and dignity. As a result, the ethical controversies and denunciations arising from these practices prompted the creation of regulatory frameworks and the mandatory implementation of IRBs, establishing the need for ethical oversight, genuine informed consent, and protection of vulnerable populations in contemporary biomedical research.

Keywords

Research ethics, schizophrenia, informed consent, institutional psychiatry, Institutional Review Boards.

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