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1.
Fertil Steril ; 115(4): 860-869, 2021 04.
Article in English | MEDLINE | ID: mdl-33832741

ABSTRACT

Human Immunodeficiency Virus is a serious but manageable chronic disease that affects persons of reproductive age, many of whom express a desire for biological parenthood. This document is a revision of the original document of the same name, last published in 2015 (Fertil Steril 2015;104:e1-8).


Subject(s)
Ethics Committees/trends , HIV Infections/epidemiology , HIV Infections/therapy , Infertility/epidemiology , Infertility/therapy , Reproductive Techniques, Assisted/trends , Female , Humans , Male , Risk Factors
2.
Fertil Steril ; 115(4): 874-878, 2021 04.
Article in English | MEDLINE | ID: mdl-33632473

ABSTRACT

This statement explores the ethical considerations surrounding the provision of fertility services to transgender individuals and concludes that the denial of access to fertility services is not justified.


Subject(s)
Ethics Committees , Fertility Preservation/methods , Health Services Accessibility , Infertility/therapy , Transgender Persons , Ethics Committees/trends , Female , Fertility/physiology , Fertility Preservation/trends , Humans , Infertility/diagnosis , Male
3.
Healthc (Amst) ; 8(2): 100425, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32553523

ABSTRACT

Like all facets of healthcare practice, quality improvement (QI) should be conducted in an ethically responsible manner. For methodologically complex QI, accountability and thoughtful ethical monitoring might be particularly important. Yet, access to ethical guidance for QI, as opposed to research, is often limited. Available mechanisms tend to be ill-equipped to accommodate the rapid cycle nature of QI, and monitoring standards for QI are not well defined. Providing appropriate ethical guidance for complex, multi-site QI initiatives can be especially challenging, as the body providing guidance must be familiar with QI methods, recognize the competing interests of stakeholder groups, respond to numerous requests, and understand the initiative's design. This case report describes our solution-an initiative-specific QI Ethics Committee that provided ethical guidance and consultation to a Veterans Administration QI initiative employing local innovations and a centralized evaluation. Enhanced by multiple tables, we discuss structuring and staffing the committee, the committee's role, functions and activities, requests for ethics guidance, and our strategy applying initiative-specific ethical principles to guide recommendations. Supported by feedback obtained from stakeholder interviews, we share key insights regarding the value of: • Clarifying and marketing the committee's role to users. • Reconciling conflicting interests between site-based team members and cross-site evaluators. • Separating ethics guidance from regulatory oversight. • Addressing the ethics of evaluative design. • Adjusting the intensity of the committee's work over time. • Creating tangible products. Our approach shows promise in supporting the ethical practice of methodologically complex QI, especially in institutions that lack applicable ethics monitoring mechanisms. Building on this approach, other complex QI initiatives can develop effective and feasible methods to protect participants from unintentional ethical lapses.


Subject(s)
Ethics Committees/trends , Ethics, Medical , Quality Improvement , Humans , United States , United States Department of Veterans Affairs/organization & administration
5.
Am J Med Genet B Neuropsychiatr Genet ; 180(8): 543-554, 2019 12.
Article in English | MEDLINE | ID: mdl-31124312

ABSTRACT

Psychiatric genetics research is improving our understanding of the biological underpinnings of neurodiversity and mental illness. Using psychiatric genetics in ways that maximize benefits and minimize harms to individuals and society depends largely on how the ethical, legal, and social implications (ELSI) of psychiatric genetics are managed. The International Society of Psychiatric Genetics (ISPG) is the largest international organization dedicated to psychiatric genetics. Given its history, membership, and international reach, we believe the ISPG is well-equipped to contribute to the resolution of these ELSI challenges. As such, we recently created the ISPG Ethics Committee, an interdisciplinary group comprised of psychiatric genetics researchers, clinical geneticists, genetic counselors, mental health professionals, patients, patient advocates, bioethicists, and lawyers. This article highlights key ELSI challenges identified by the ISPG Ethics Committee to be of paramount importance for the ethical translation of psychiatric research into society in three contexts: research settings, clinical settings, and legal proceedings. For each of these arenas, we identify and discuss pressing psychiatric genetics ELSI dilemmas that merit attention and require action. The goal is to increase awareness about psychiatric genetics ELSI issues and encourage dialogue and action among stakeholders.


Subject(s)
Genetic Research/ethics , Genomics/ethics , Mental Disorders/genetics , Ethics Committees/trends , Humans
6.
Fertil Steril ; 110(6): 1022-1028, 2018 11.
Article in English | MEDLINE | ID: mdl-30396539

ABSTRACT

Planned oocyte cryopreservation ("planned OC") is an emerging but ethically permissible procedure that may help women avoid future infertility. Because planned OC is new and evolving, it is essential that women who are considering using it be informed about the uncertainties regarding its efficacy and long-term effects.


Subject(s)
Cryopreservation/trends , Ethics Committees/trends , Fertility Preservation/trends , Oocyte Retrieval/trends , Oocytes/physiology , Cryopreservation/methods , Female , Fertility Preservation/methods , Humans , Infertility, Female/prevention & control , Infertility, Female/therapy , Oocyte Retrieval/methods
7.
An. pediatr. (2003. Ed. impr.) ; 87(3): 175.e1-175.e6, sept. 2017. tab
Article in Spanish | IBECS | ID: ibc-166304

ABSTRACT

Los conflictos que se plantean al negarse el menor de edad o sus representantes a recibir un tratamiento considerado necesario por el pediatra suponen un importante problema ético y conllevan fuerte impacto emocional. Para afrontar el rechazo al tratamiento es necesario explorar y comprender las razones que aducen los implicados, considerar los factores contextuales de cada caso y conocer la conducta a seguir teniendo en cuenta consideraciones bioéticas y el fundamento legal (AU)


The conflicts that arise when minors or their legal representatives refuse to receive medical treatment considered necessary by the paediatrician pose a serious ethical dilemma and also have a considerable emotional impact. In order to adequately tackle this rejection of medical treatment, there is to identify and attempt to understand the arguments of the people involved, to consider the context in each individual case and be conversant with the procedure to follow in life-threatening scenarios, taking into account bioethical considerations and the legal framework (AU)


Subject(s)
Humans , Child , Treatment Refusal/ethics , Third-Party Consent/ethics , Informed Consent By Minors/ethics , Ethics Committees/trends , Decision Making/ethics , Bioethical Issues , Brief, Resolved, Unexplained Event
8.
Rev. derecho genoma hum ; (46): 37-42, ene.-jun. 2017.
Article in Spanish | IBECS | ID: ibc-176402

ABSTRACT

El presente artículo recoge literalmente el voto particular que emitió el Profesor Carlos María Romeo Casabona al Informe del Comité de Bioética de España sobre "Aspectos éticos y jurídicos de la maternidad subrogada"


This article literally reflects the private vote that Professor Carlos María Romeo Casabona gave to the Report of the Bioethics Committee of Spainon "Aspectos éticos y jurídicos de la maternidad subrogada"


Subject(s)
Humans , Female , Pregnancy , Surrogate Mothers/legislation & jurisprudence , Birth Registration/legislation & jurisprudence , Principle-Based Ethics , Bioethical Issues , Ethics Committees/trends , Spain , Social Values , Women's Rights/ethics , Child Advocacy/ethics
10.
Cuad. bioét ; 27(91): 293-298, sept.-dic. 2016.
Article in Spanish | IBECS | ID: ibc-159467

ABSTRACT

Existe hoy en día una tendencia generalizada a considerar la ética ambiental y la bioética como casos específicos relativos a una supuesta especie de "ética aplicada". La aplicación puede entenderse en dos sentidos diferentes: un sentido concreto, como en las aplicaciones técnicas, y un significado psicológico, como cuando nos aplicamos mentalmente en hacer bien una tarea. La ética se ha pensado siempre como un conocimiento práctico, en un sentido "práxico" y no en uno "poiético". La ética tiene que ver con "fines", no con "medios"; en este sentido la ética es "inútil". Dado que la ética tiene que ver con el sentido último de las cosas, las opciones éticas dan sentido a todas las actividades prácticas. En ese sentido la ética, en lugar de ser inútil, debe considerarse como "supra-útil" (Maritain). Hoy en día la política tiende a instrumentalizar la ética para objetivos políticos. La consecuencia ha sido la reconceptualización de una ética específica como ética aplicada. La ética ambiental y la bioética son sometidas a la política, siguiendo la lógica de aplicaciones técnicas. La ética ambiental y la bioética, consideradas como éticas aplicadas están en riesgo de convertirse no sólo en inútiles, sino también en algo que, en tanto que éticas, carece de sentido


There is actually a pervasive tendency to consider environmental ethics and bioethics as specific cases pertaining to a supposed kind of "applied ethics". Application can be understood in two different meanings: a concrete sense, as in technical applications, and a psychological meaning, as when we mentally apply ourselves to a task. Ethics has been always thought as a practical knowledge, in a "praxical" sense and not in a "poietic" one. Ethics has to do with "ends" not with "means"; in this sense ethics is "useless". Since ethics has to do with the ultimate meaning of things, ethical choices give meaning to all practical activities. In that sense ethics instead of being useless must be considered as "over useful2 (Maritain). Nowadays politics tend to instrumentalize ethics in order to political objectives. The consequence has been the reconceptualization of specific ethics as applied ethics. Environmental ethics and bioethics are then submitted to politics following the logic of technical applications. Environmental ethics and bioethics considered as applied ethics are at risk to becoming not only useless, but also meaningless


Subject(s)
Conservation of Natural Resources , Environmental Health/ethics , Bioethics/trends , Principle-Based Ethics , Ethics Committees/trends , Ethics, Research
11.
Cuad. bioét ; 26(87): 291-301, mayo-ago. 2015. tab, graf
Article in Spanish | IBECS | ID: ibc-144149

ABSTRACT

El siguiente proyecto se basa en el diseño para la creación de un comité de ética médica asistencial a nivel hospitalario. Se elaboró en el Hospital San Miguel Arcángel, Distrito de San Miguelito, Provincia de Panamá, durante el año 2013. Dado que la creación de proyectos sociales requiere parámetros unificados a nivel internacional, se toma como formato las guías de creación y funcionamiento de los comités de bioética de la Unesco, adaptadas al contexto socioeconómico, político y cultural del Distrito de San Miguelito, Provincia de Panamá. Además de adaptarlo al aspecto socio-ecológico donde se realiza el proyecto de investigación, se abarca el aspecto teórico desde la bioética ontológica personalista, donde el eje fundamental es la dignidad de la persona humana. Se elaboró un estudio de percepción del personal médico y de enfermería, sobre el manejo de los dilemas éticos más frecuentes en el Hospital San Miguel Arcángel. El instrumento de medición utilizado fue una encuesta de percepción previamente validada a través de una prueba piloto. La confiabilidad se midió con el coeficiente alfa de Cronbach y la validez se obtuvo del contenido. Se obtiene resultados estadísticos satisfactorios que comprueban las hipótesis de trabajo sobre el reconocimiento de la importancia de la autonomía, confidencialidad, protección a la población vulnerada, bienestar laboral del personal de salud e integración de la bioética en la agenda institucional. Sin embargo, hubo aspectos particulares que indican algunas dudas en cuanto al manejo de algunas realidades que se presentan en el contexto de la atención sanitaria


The next project was based on the design on the creation of a medical ethical Committee at a hospital. It was developed at the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama, in 2013. Insomuch as the creation of social projects requires unified international parameters, format is taken from the Unesco’s guides for the establishing and working of bioethics committees; adapted to the socio-economic, political and cultural context of the San Miguelito District, Panama Province. Furthermore to adapting to socioecological aspect where the research project is carried out, the theoretical aspect includes from the ontological personalistic bioethics, where the cornerstone is the dignity of the human person. A study of perceptions of medical staff and nursing was developed on the management of the most common ethical dilemmas in the Hospital San Miguel Arcángel. The instrument used was a previously validated perception survey through a pilot test. Reliability was measured using Cronbach’s alpha coefficient, and validity was obtained from the content. Satisfactory statistical results, that verify the working hypotheses on the recognition of the importance of autonomy, confidentiality, protection of vulnerable population, occupational health staff welfare and integration of bioethics at the institutional agenda, were obtained. However, there were particular aspects that indicate some doubt as to the management of some realities that are presented in the context of health care


Subject(s)
Female , Humans , Male , Ethics Committees/classification , Ethics Committees/ethics , Ethics Committees/organization & administration , Bioethics/education , Bioethics/trends , Ethics Committees/statistics & numerical data , Ethics Committees/trends
12.
Indian J Med Ethics ; 11(3): 181-5, 2014.
Article in English | MEDLINE | ID: mdl-25160969

ABSTRACT

This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using "research ethics committees" (MeSH] and "India" (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14). The authors identified many challenges related to the lack of oversight by regulatory bodies (n=14) as well as issues pertaining to the ethical training of IEC members and investigators (n=13). It is evident from the multitude of papers on the issue that the challenges related to the constitution and functioning of IECs must be given the attention they deserve to ensure that research participants in India are better protected.


Subject(s)
Ethics Committees , Ethics, Research/education , Ethics Committees/legislation & jurisprudence , Ethics Committees/organization & administration , Ethics Committees/standards , Ethics Committees/trends , Ethics Committees, Research/organization & administration , Humans , India , Research Personnel/education , Research Personnel/ethics
14.
Theor Med Bioeth ; 34(6): 461-77, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24234589

ABSTRACT

Bioethicists working on national ethics commissions frequently think of themselves as advisors to the government, but distance themselves from any claims to actual authority. Governments however may find it beneficial to appear to defer to the authority of these commissions when designing laws and policies, and might appoint such commissions for exactly this reason. Where does the authority for setting laws and policies come from? This question is best answered from within a normative political philosophy. This paper explains the locus of moral authority as understood within one family of normative political theories--liberal political theories--and argues that most major "liberal" commentators have understood both the source and scope of ethics commissions' authority in a manner at odds with liberalism, rightly interpreted. The author argues that reexamining the implications of liberalism for bioethics commissions would mean changing what are considered valid criticisms of such commissions and also changing the content of national bioethics commission mandates. The author concludes that bioethicists who participate in such commissions ought to carefully examine their own views about the normative limits of governmental authority because such limits have important implications for the contribution that bioethicists can legitimately make to government commissions.


Subject(s)
Advisory Committees , Ethicists , Ethics Committees , Government Regulation , Morals , Policy Making , Politics , Advisory Committees/standards , Advisory Committees/statistics & numerical data , Advisory Committees/trends , Ethics Committees/standards , Ethics Committees/statistics & numerical data , Ethics Committees/trends , Humans , Philosophy , Public Policy , Social Responsibility
15.
Rev. Círc. Argent. Odontol ; 69(215): 6-12, dic. 2012.
Article in Spanish | BINACIS | ID: bin-128543

ABSTRACT

Las discusiones que se dieron a comienzos del siglo pasado entre científicos y humanistas para determinar las reglas entre la ciencia y la vida, donde las investigaciones se realizan por el amor a la ciencia y a los conocimientos, dejaron consecuencias en el sector social, al no asumir el compromiso de ver que "aquello que es técnicamente posible resulta éticamente correcto. Hechos que marcan en la historia de la humanidad la génesis de los Comités de Etica, con la necesidad de una reflexión sobre la condición humana del paciente. Hay que diferenciar entre los Comités de Etica en investigación de los comités de etica asistenciales o clínicos, en el momento de su creación. En la actualidad, los estados presentan regulaciones específicas, nacionales y locales, para garantizar el derecho a la salud, los derechos de los pacientes y las normas para el mejor desarrollo de las prestaciones. El grave problema son los países en desarrollo, por carecer de legislación suficiente; la bioética será la herramienta principal ante las realidades que convergen en principios clásicos y universales como son: respeto a la vida, respeto a la salud y la justicia. En el presente artículo, aunque Argentina carece de legislaciones nacionales en Bioética, se presentan referencias importantes relacionadas expresamente a la investigación e importancia de los Comités de Etica.(AU)


Subject(s)
Humans , Bioethics , Ethics Committees/trends , Ethics Committees/history , Legislation, Dental/standards , Dental Research , Argentina , Morals , Patient Rights
16.
Rev. Círc. Argent. Odontol ; 69(215): 6-12, dic. 2012.
Article in Spanish | LILACS | ID: lil-689034

ABSTRACT

Las discusiones que se dieron a comienzos del siglo pasado entre científicos y humanistas para determinar las reglas entre la ciencia y la vida, donde las investigaciones se realizan por el amor a la ciencia y a los conocimientos, dejaron consecuencias en el sector social, al no asumir el compromiso de ver que "aquello que es técnicamente posible resulta éticamente correcto. Hechos que marcan en la historia de la humanidad la génesis de los Comités de Etica, con la necesidad de una reflexión sobre la condición humana del paciente. Hay que diferenciar entre los Comités de Etica en investigación de los comités de etica asistenciales o clínicos, en el momento de su creación. En la actualidad, los estados presentan regulaciones específicas, nacionales y locales, para garantizar el derecho a la salud, los derechos de los pacientes y las normas para el mejor desarrollo de las prestaciones. El grave problema son los países en desarrollo, por carecer de legislación suficiente; la bioética será la herramienta principal ante las realidades que convergen en principios clásicos y universales como son: respeto a la vida, respeto a la salud y la justicia. En el presente artículo, aunque Argentina carece de legislaciones nacionales en Bioética, se presentan referencias importantes relacionadas expresamente a la investigación e importancia de los Comités de Etica.


Subject(s)
Humans , Bioethics/trends , Ethics Committees/history , Ethics Committees/trends , Argentina , Dental Research , Legislation, Dental/standards , Morals , Patient Rights
17.
Rev. esp. salud pública ; 86(1): 5-19, ene.-mar. 2012. tab
Article in Spanish | IBECS | ID: ibc-99784

ABSTRACT

La experiencia holandesa en relación con la legalización y la práctica de la eutanasia es más conocida en España que la experiencia belga. Sin embargo, el proceso histórico de debate social en Bélgica en torno a la eutanasia tiene una riqueza en matices que debería ser conocida por los profesionales sanitarios, bioeticistas, políticos y juristas. El presente trabajo se inaugura con un análisis sobre las similitudes y diferencias que existen entre España y Bélgica, lo que permite encuadrar el desarrollo posterior. Después se describe la historia del proceso de debate realizado en Bélgica que tiene su punto álgido en la aprobación de la ley de eutanasia en el año 2002. En el apartado siguiente se analiza de forma detallada el contenido de esta disposición legislativa, señalando los aspectos más relevantes. A continuación se exponen algunos datos epidemiológicos sobre la práctica de la eutanasia en Bélgica y se finaliza con un relato sobre la manera en que diversos grupos de población han afrontado el tema de la eutanasia. En este último apartado el trabajo se detiene en las posiciones de dos grupos especialmente relevantes: los especialistas en Cuidados Paliativos y la Iglesia Católica. Se finaliza con una exposición de los motivos por los que resulta conveniente incorporar la perspectiva y experiencia belga en futuros debates sobre la posible legalización de la eutanasia en España(AU)


The experience of the Netherlands in relation with the legalization and practice of euthanasia is better known in Spain than the Belgian experience in this matter. But the historical process of social debate in Belgium has many specific details which should be known by Spanish healthcare professionals, bioethicists, politicians and lawyers. This paper begins with a comparative analysis of both countries: Spain and Belgium and follows with a description of the milestones of the historical process of debating and, finally, passing the Belgian Law on Euthanasia in 2002. The next chapter consists of a description of themain contents of this important Law. The paper continues then with an approach to the epidemiology of the practice of euthanasia in Belgium and finishes with a description of the different positions of the actors of the process. Two positions are described more in depth: the opinion of the specialists in palliative care, and the opinion of the Catholic Church. The paper ends underlining the reason for the incorporation of the Belgian experience on euthanasia to the debate about the possibility of legalizing euthanasia in Spain(AU)


Subject(s)
Humans , Male , Female , Euthanasia/ethics , Euthanasia/legislation & jurisprudence , Suicide, Assisted/legislation & jurisprudence , Bioethics/trends , Ethics, Medical , Palliative Care/methods , Palliative Care , Ethics Committees/legislation & jurisprudence , Ethics Committees/trends , Ethics Committees , Netherlands/epidemiology , Suicide, Assisted/ethics , Suicide, Assisted/trends , Palliative Care/ethics , Palliative Care/legislation & jurisprudence , Ethics Committees/ethics , Ethics Committees/organization & administration
18.
Index enferm ; 20(4): 262-266, oct.-dic. 2011. ilus
Article in Spanish | IBECS | ID: ibc-102965

ABSTRACT

Objetivo principal: analizar los elementos de sustentación de discursos ético-profesionales, a partir de un caso ejemplar de proceso ético juzgado. Metodología: Estudio cualitativo con diseño exploratorio-descriptivo y documental, teniendo como fuente procesos éticos tramitados y archivados en el Consejo Regional de Enfermería/SC (Brasil), en el período de 1999 a 2007. Resultados principales: el caso ejemplar seleccionado (responsabilidad ético-profesional) es representativo de discursos profesionales presentes en procesos éticos, en sus elementos de sustentación (enunciados, reglas y prácticas), y describe las referencias usadas por los profesionales para justificar sus deliberaciones morales, o dar legitimidad a los discursos accionados en estos juicios. Conclusión principal: los elementos de sustentación de los discursos, articulados en un modelo empírico analítico, son interesantes por dar visibilidad a los diseños de procesos de deliberación moral y, también, por suministrar un diseño general de los procesos éticos en su capacidad de "hablar para" y "hablar de la" Enfermería (AU)


Main goal: analyzing the supporting elements of ethical - professional discourses, from an exemplary case of a judged ethical process. Methodology: Qualitative study with documentary, descriptive and exploratory design, having as a source the ethical procedures conducted and filed at the Regional Council of Nursing / SC (Brazil), between 1999 and 2007. Main results: the exemplary case selected (ethical - professional responsibility) is representative from professional discourses that are present in ethical processes, in their supporting elements (statements, rules and practices) and describes references used by practitioners to justify their moral decisions or give legitimacy to the speeches triggered in those judgments. Main conclusion: discourses' supporting elements, articulated in the analytical -empirical model, are interesting for giving visibility to the intricacies of moral deliberation processes, and also, for providing a general design of ethical processes in their ability to "talk to" and "talk about" nursing (AU)


Subject(s)
Humans , Ethics, Nursing , Nursing Process/ethics , Bioethical Issues , Ethics Committees/trends , Nursing Care/ethics
19.
Radiología (Madr., Ed. impr.) ; 53(5): 399-405, sept.-oct. 2011.
Article in Spanish | IBECS | ID: ibc-91182

ABSTRACT

La labor de un revisor es fundamental en el proceso editorial de una revista científica. La calidad de sus revisiones determina la calidad de la revista. Por lo tanto, es muy importante que el revisor interiorice esta misión y contribuya al desarrollo de la ciencia y el de la propia revista. Por otro lado, el enfoque de una revisión dependerá mucho del tipo de revista para la que se revisa. En este artículo se expone qué espera R adiología , revista científica de la Sociedad Española de Radiología Médica, de sus revisores y sus revisiones de los artículos originales. Con ello se pretende establecer unas normas básicas que sirvan de punto de partida para el desarrollo posterior de unas normas de revisión más elaboradas para Radiología (AU)


The reviewer's job is fundamental to the editorial process in a scientific journal. The quality of the review will determine the quality of the journal. Therefore, it is very important for the reviewers to make this mission their own and to contribute to the development of science and of the journal. On the other hand, the focus of a review will depend largely on the type of journal for which one is reviewing. In this article, we explain what the journal R adiología , the scientific journal of the Spanish Society of Medical Radiology, expects of its reviewers and their reviews of original articles. We aim to establish some basic rules to lay the groundwork for the development of more detailed guidelines for reviewing articles for the journal Radiología (AU)


Subject(s)
Humans , Male , Female , Peer Review/methods , Peer Review/trends , Ethical Review/standards , Periodicals as Topic/ethics , Peer Review/ethics , Peer Review/legislation & jurisprudence , Peer Review/standards , Ethical Review/legislation & jurisprudence , Ethics Committees/standards , Ethics Committees/trends , Ethics Committees , Systems for Evaluation of Publications , Scientific and Technical Publications , Publications for Science Diffusion
20.
Pers. bioet ; 14(2): 176-186, jul.-dic. 2010.
Article in Spanish | LILACS | ID: lil-609989

ABSTRACT

Describir problemas que enfrentan los Comités de Ética en Investigación (CEI) en la Ciudad de México. Método. Estudio cualitativo con muestreo intencional, grupos de discusión y teoría fundamentada con CEI de sector público y privado en instituciones de salud de la Ciudad de México. Resultados. Se detectaron importantes diferencias entre los CEI públicos y privados. Principalmente en carga de trabajo y prioridades de investigación. Los protocolos aprobados por CEI públicos son asumidos por la institución como un todo. Enfrentan cada caso como equipo de salud. Los CEI privados dirigen la responsabilidad de los protocolos al investigador principal que es quien la asume individualmente. Los CEI privados tienen una agenda centrada en los reportes de efectos adversos y la legalidad del proceso, mientras que los públicos en general se abocan además a la relevancia de la investigación para los pacientes. Ambos reciben pago por la revisión. Ambos coinciden en priorizar la ética de los protocolos en beneficio del paciente. Ambos están al tanto de que la industria farmacéutica les marca sus prioridades de investigación. Los CEI públicos abarcan principalmente investigación epidemiológica. Los CEI privados, esencialmente terapéutica.


Describe the problems facing research ethics committees (RECs) in Mexico City. Methodo. A qualitative study with purposive sampling, discussion groups and grounded theory focused on public and private sector RECs in health institutions in Mexico City. Results. Significant differences were detected between public and private RECs, mainly with respect to their workload and research priorities. The protocols approved by public RECs are assumed by the institution as whole. They address each case as health team. In contrast, the private RECs place accountability for the protocols on the chief researcher, who assumes that responsibility individually. The private RECs have an agenda focused on reports of adverse effects and the legality of the process, while the public RECs also generally afford consideration to the relevance of research for patients. Both are paid for the review. Both agree on prioritizing the ethics of protocols for the benefit of the patient. Both are aware the pharmaceutical industry has its research priorities. The public RECs deal mainly with epidemiological research, while the private RECs are concerned essentially with therapeutic research.


Objetivo. Descrever os problemas enfrentados pelos Comitês de Ética em Pesquisa (CEI) na Cidade do México. Metodo. Estudo qualitativo com amostragem intencional, grupos focais e teoria fundamentada, realizado nos CEI dos setores público e privado em instituições de saúde na Cidade do México. Resultados. Foram detectadas diferenças significativas entre os CEIs públicos e os privados. Principalmente nas prioridades de trabalho e pesquisa. A instituição se encarrega dos protocolos aprovados pelos CEIs públicos como um todo. Cada caso é estudado como equipe de saúde. Os CEIs privados delegam a responsabilidade dos protocolos ao investigador principal, que os assume individualmente. Estes CEIs têm uma agenda baseada nos relatórios de efeitos adversos e da legalidade do processo, enquanto os públicos procuram, ademais, a relevância da pesquisa para os pacientes. Ambos recebem pagos pela revisão. Ambos concordam em priorizar a ética dos protocolos em benefício do paciente. Ambos estão conscientes de que a indústria farmacêutica determina as suas prioridades de pesquisa. Os CEIs públicos dedicam-se à investigação epidemiológica; os privados, à terapêutica.


Subject(s)
Ethics , Ethics Committees , Ethics, Medical , Ethics Committees/ethics , Ethics Committees/organization & administration , Ethics Committees/trends
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