Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica

G, Manuel Oyarzún; C, María Eugenia Pinto; B, Gina G Raineri; Amigo, Hugo; O, Lucía Cifuentes; González, Marı́a Julieta; Horwitz, Nina; F, Claudia Marshall; Orellana, Gricel

doi:10.4067/s0034-98872014000700009

Cited by 7 publications

(5 citation statements)

References 10 publications

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“…Otro elemento agravante de su escasa visibilidad en el país ha sido la adopción de la ley 20.584, pues su artículo 28 expone que "[...] ninguna persona con discapacidad psíquica o intelectual, que no pueda expresar su voluntad, podrá participar en una investigación científica" (Chile, 2012). Este elemento, controversial para los Comités de Ética de investigación nacionales (Oyarzún et al, 2014), ha restringido las posibilidades de generar conocimiento científico vinculado a la salud de una parte importante de este colectivo.…”

Section: Introductionunclassified

“I was raped inside, being in a place where I was supposed to be taken care of”: Experiences of oppression and violence in health contexts towards women with disabilities and approaches from feminist occupational therapy

Yupanqui-Concha,

Arismendi,

Godoy

2022

Cad. Bras. Ter. Ocup.

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Introduction The practices of violence in health contexts constitute one of the multiple manifestations of violence against women with disabilities. In Chile, as in the rest of the world, the development of studies on this violence is still incipient. Objectives To characterize practices of violence against women with disabilities in health contexts, and to characterize experiences of vindication of human rights of this group of women in Chile, from the voices of activists and professional occupational therapists. Method A secondary analysis of qualitative data from a study executed between 2015 and 2020 was conducted. From a qualitative approach and collective case study, a secondary thematic analysis of the data obtained from 8 interviewees was performed. Results From the perspective of the informants, women with disabilities experience structural violence in a systematic and transversal way, which crosses other various forms of violence: physical, psychological, sexual, obstetric, and symbolic-institutional. The experiences of this group in claiming their human rights reflect processes of emancipation, resistance, and construction of practices that transform these violations. Conclusion The practices of violence in health contexts toward women with disabilities in Chile is a situation visualized as manifestations of domination and oppression against them, which perpetuate their social exclusion and inequalities in health. Faced with this situation of social injustice, women activists and professional occupational therapists propose the need to implement strategies for the vindication of human rights, together with practices of collective resistance.

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Section: Introductionunclassified

“I was raped inside, being in a place where I was supposed to be taken care of”: Experiences of oppression and violence in health contexts towards women with disabilities and approaches from feminist occupational therapy

Yupanqui-Concha,

Arismendi,

Godoy

2022

Cad. Bras. Ter. Ocup.

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“…Por lo tanto, el paciente debería otorgar una autorización notarial. Esta situación, podría generar un obstáculo difícil de superar para efectuar investigación médica, que resulta imprescindible para poder conocer la situación clínica y epidemiológica de diversas enfermedades y condiciones patológicas a nivel nacional 6 .…”

Section: Introductionunclassified

“…en relación a lo que se ha planteado en nuestro medio sobre el acceso a la ficha clínica con fines de investigación, se puede considerar la reciente proposición del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina, universidad de Chile 6 . Para autorizar el uso de fichas clínicas en investigación, este comité propone usar procedimientos diferentes según se trate de estudios prospectivos o retrospectivos.…”

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Acceso a la ficha clínica con fines de investigación biomédica

2015

Rev. chil. enferm. respir.

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The clinical information obtained from the clinical records is crucial for doing biomedical research. Up until some years ago a scarce limitation existed in the use of this information for research purposes. This situation has changed in nowadays because of the legal safeguarding of the privacy and confidentiality of personal data. In fact, article 13 of the Law 20.584 "Regulations of the rights and duties of health care users", states that people not related directly with patient care cannot have access to clinical records, with the exception of people with notarial authorization by the patient. Lately the following proposal has been done on this issue: in prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records; in retrospective studies, consent should be obtained from the patient if his/her personal information is going to be used; if the information is nameless, the consent can be disregarded after being reviewed the protocol by a Research Ethics Committee. Ethical requirements of the collections of anonymized data and use of historical records of deceased subjects are also discussed. The role of the Research Ethics Committees as well as the Editorial Boards in observing and respecting the ethical regulations in the approval of research projects and in the acceptance of biomedical research publications has a major importance.

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“…Señor Editor, Luego de promulgada la Ley 20.584, que regula los derechos y deberes de las personas en su atención en salud 1 , la comunidad académica manifestó su preocupación por la prohibición absoluta que imponía el artículo 28 para investigar con personas con discapacidad psíquica o mental que no pueden manifestar su voluntad 2,3 . Dicho artículo señalaba que "Ninguna persona con discapacidad psíquica o intelectual que no pueda expresar su voluntad podrá participar en una investigación científica", ocasionando una disminución significativa de proyectos en el área de salud mental 4 .…”

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Ley de salud mental chilena y su impacto en la investigación biomédica

Lecaros

Salas

2022

Rev. méd. Chile

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Experiencia del Comité de Ética de Investigación en Seres Humanos de la Facultad de Medicina de la Universidad de Chile y los desafíos que impone la nueva legislación chilena en la investigación médica

Abstract: Experience of a research Ethics Committee and the challenges of the new Chilean legislation on research in human beings (Rev Med Chile 2014; 142: 889-895)

Cited by 7 publications

References 10 publications

“I was raped inside, being in a place where I was supposed to be taken care of”: Experiences of oppression and violence in health contexts towards women with disabilities and approaches from feminist occupational therapy

“I was raped inside, being in a place where I was supposed to be taken care of”: Experiences of oppression and violence in health contexts towards women with disabilities and approaches from feminist occupational therapy

Acceso a la ficha clínica con fines de investigación biomédica

Ley de salud mental chilena y su impacto en la investigación biomédica

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