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DECLARACION DE HELSINKI PDF

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La publicación de una nueva versión de la Declaración de Helsinki es una // yazik.info+html. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June and amended by the: 29th WMA General Assembly, Tokyo, Japan, October Qué Hacemos / Ética Médica / Declaración de Helsinki / DoH-Jun DoH- Jun Copiar PDF World Medical Assembly, Helsinki, Finland, June


Declaracion De Helsinki Pdf

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Declaración de Helsinki ha sido objeto de varias enmiendas y aclaraciones, la última en Japón enquedando así la versión que actualmente se utiliza. Download PDF Declaración de Helsinki: reflexiones y propuestas para su renovación. Declaration of Helsinki: reflections and proposals for its renovation. Declaración de Helsinki. LA /documentos/ceica/declaracion-helsinki- yazik.info; yazik.info

Un participante amenazado, de forma implicita o explicita, de sufrir consecuencias indeseables si no accede a ciertas exigencias, consentira colaborar bajo una decision coaccionada. Si la informacion que se brinda es tergiversada, sesgada o parcializada de manera intencional, de inmediato debe anularse el consentimiento.

La devolu. El manejo de la fragilidad. Es la retroalimentacion que el investigado tal vez espera sobre los avances del proyecto de investigaciOn en lo que concierne a su colaboraciOn. Esta forma de intercambiar la informaciOn plantea una cierta equidad entre los interesados durante el PCI.

Estas problematicas son mas relevantes en investigaciones de tipo social, en las cuales, frecuentemente, se privilegian las bondades metodologicas y poco se hace o reflexiona por las afecciones en los participantes o bien, en el propio investigador. En el formato del CI, que es una hoja informativa que tiene el objetivo de servir como soporte de la descripcion oral, deben aparecer minimamente los siguientes datos: 17 Dar al posible participante la oportunidad de hacer preguntas.

Excluir el engano injustificado o la intimidacion.

Procurar el consentimiento despues de que el participante tenga conocimiento de todo lo referente a su colaboracion, y haya tenido la oportunidad de considerarla. Proporcionarle formalmente una hoja informativa como soporte de la descripcion oral, conocida como Formato de CI, que el investigador y el participante firmaran, si las condiciones del estudio lo permiten.

Incluir en el Formato de CI los datos del investigador nombre, telefono, etc. Es decir, no es lo mismo el consentimiento informado de las investigaciones socialesls que de los estudios biornedicos.

Recommendations of the Declaration of Helsinki

Ahora sabemos que un consentimiento que se considera aceptable no solo tiene que ser libre e informado, sino que tambien tiene que cuidar cada elemento constitutivo y el contexto en el que este se dara.

De no ser asi, pueden surgir algunos inconvenientes como: causar depresiOn, angustia o miedo en el participante, abandono de la atencion, cuando es una intervencion terapeutica, o la negation del participante por cuestiones econamicas.

Hasta aqui hemos revisado que es el proceso del consentimiento informado y cuales son sus elementos eticos que lo componen. Sin embargo, una pregunta que siempre surge es para que sirve el formato del consentimiento informado, mas ally de su cumplimiento etico, en ocasiones, este ha servido como un documento legal, sin serlo, que ha protegido los intereses del investigador.

Alrededor de este imperative etico, se han creado una serie de mitos sobre la utilidad del formato del CI Cuadro 1.

Cuadro 1 Mitos y realidades de la firma del participante en el formate del CI. La interaction entre el partidpante y el equipo de investigation antes, durante y despues de la colaboraciOn es lo mas importante del PCI.

La proteccien no es legal.

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Al participante lo protege porque ahi se enuncian sus derechos. Convierte el formato en un contrato que no puede disolverse. El participante es libre de cambiar de opini6n, decidir ya no participar despues de haber firmado o dejar de colaborar en cualquier momenta, sin repercusiOn alguna.

Open in a separate window Hay que recordar que el formate de CI visto como un recurso legal de proteccien de los investigadores, se origina en el area medico.

El formato del CI siempre va a salvaguardar los derechos del investigado, pero desde un marco total-mente etico y no juridico. No hay que olvidar que este documento es solo la formalization escrita de la obtencion del CI, y que es en el proceso donde se iran cumpliendo los compromises y responsabilidades pactadas eticamente por los dos agentes morales investigador-investigado.

Aunque reconocemos que el consentimiento informado tambien debe elaborarse dentro de un contexto legal. Por lo tanto, el proceso de consentimiento informado no solo debe ser abordado desde el marco etico, sino tambien en el marco legal. MARCO ETICO De acuerdo con la definition de Consejo de Organizaciones Internacionales de la Ciencias Medicas 13 el fundamento principal del proceso del CI es la protecciOn de la libertad de election del individuo y respeto de su autonomia, y como garantia adicional debe estar complementado por la evaluation etica independiente de las propuestas de investigacion.

Lo anterior se enfatiza mas y de manera particular en las personas que tienen dificultad para dar su consentimiento, incluyendo ninos pequelios, adultos con trastornos mentales o conductuales severos y personas que no se encuentran familiarizadas con los conceptos y tecnologia usada en los proyectos.

Tambien sugiere tener en consideration el contexto de desarrollo de grupos culturales diversos al del investigador, sus tradiciones en cuanto a comunicacion y decisiones y respetar estos procedimientos. Aclara que en ningtin caso la autorizaciOn de los consejos de ancianos o jefes de etnias o similares puede reemplazar a la autorizacion y consentimien-to individual. El consentimiento informado podria omitirse en algunos tipos de estudios, cuando este no comprometa los objetivos de la investigaciOn, especificamente cuando en investigaciones de tipo social y psicologica no se explicitan los propositos del estudio para que el participante no modifique su conducta o bien, al conocer estos no se le provoque una preocupacion innecesaria.

En estos casos, el investigador ofrecera las garantias para mantener la confidencialidad y la proteccion del investigado, asi coma de comunicarle los objetivos y pedir el consentimiento de inclusion de su informaci6n, una vez finalizada su participaciOn, o desde el inicio se puede pedir el consentimiento por apoderado el apoderado tendra que ser una persona seleccionada por el sujeto, un familiar o un amigo, que verdade-ramente represente los intereses del sujeto, o bien ser asignado por un juez , lo que implica que una persona de confianza del sujeto potencial, sera quien dard un consentimiento sustituto, es decir, sera quien decidird la participacion o no del sujeto, de acuerdo con los intereses de este.

Critics claimed that the Zidovudine trials in developing countries were in breach of this because Zidovudine was now the best proven treatment and the placebo group should have been given it.

These included the claims that the continuing trials in developing countries were unethical, and pointing out a fundamental discrepancy in decisions to change the study design in Thailand but not Africa. The issue of the use of placebo in turn raised questions about the standard of care in developing counties and whether, as Marcia Angell wrote "Human subjects in any part of the world should be protected by an irreducible set of ethical standards" The American Medical Association put forward a proposed revision in November that year, [22] [23] and a proposed revision Others saw it as an example of Angell's 'Ethical Imperialism', an imposition of US needs on the developing world, [33] and resisted any but the most minor changes, or even a partitioned document with firm principles and commentaries, as used by CIOMS.

The idea of ethical imperialism was brought into high attention with HIV testing, as it was strongly debated from because of its centrality to the issue of regimens to prevent its vertical transmission.

Nevertheless, what had started as a controversy over a specific series of trials and their designs in Sub-Saharan Africa, now had potential implications for all research. These implications further came into public view since the Helsinki declaration had stated, "In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement, it offers hope of saving life, reestablishing health or alleviating suffering.

The justification for this was partly to take account of expanded scope of biomedical research since The Introduction establishes the rights of subjects and describes the inherent tension between the need for research to improve the common good, and the rights of the individual. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards.

The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine [19] [38] was removed to emphasise the more general application of ethical principles, but the application of the principles to healthy volunteers is spelt out in Articles , and they are referred to in Article 8 'those who will not benefit personally from the research' as being especially vulnerable.

The scope of ethical review was increased to include human tissue and data Article 1 , the necessity to challenge accepted care was added Article 6 , as well as establishing the primacy of the ethical requirements over laws and regulations Article 9.

Amongst the many changes was an increased emphasis on the need to benefit the communities in which research is undertaken, and to draw attention to the ethical problems of experimenting on those who would not benefit from the research, such as developing countries in which innovative medications would not be available.

Article 19 first introduces the concept of social justice, and extends the scope from individuals to the community as a whole by stating that 'research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research'. This new role for the Declaration has been both denounced [18] and praised, [39] Macklin R. Future challenges for the Declaration of Helsinki: Maintaining credibility in the face of ethical controversies.

Additional Principles[ edit ] The most controversial revisions [39] Articles 29, 30 were placed in this new category.

These predictably were those that like the fourth revision were related to the ongoing debate in international health research. The discussions [36] indicate that there was felt a need to send a strong signal that exploitation of poor populations as a means to an end, by research from which they would not benefit, was unacceptable.

In this sense the Declaration endorsed ethical universalism. Article 29 restates the use of placebo where 'no proven' intervention exists. Surprisingly, although the wording was virtually unchanged, this created far more protest in this revision. The implication being that placebos are not permitted where proven interventions are available.

The placebo question was already an active debate prior to the fourth revision but had intensified, while at the same time the placebo question was still causing controversy in the international setting. This revision implies that in choosing a study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries. The wording of the fourth and fifth revisions reflect the position taken by Rothman and Michel [41] and Freedman et al.

The opposing view, as expressed by Levine [19] and by Temple and Ellenberg [43] is referred to as 'placebo orthodoxy', insisting that placebo controls are more scientifically efficient and are justifiable where the risk of harm is low. This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. The utilitarian argument [44] held that the disadvantage to a few such as denial of potentially beneficial interventions was justifiable for the advantage of many future patients.

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These arguments are intimately tied to the concept of distributive justice , the equitable distribution of the burdens of research. Arguments over this have dealt with whether subjects derive benefit from the trial and are no worse off at the end than the status quo prior to the trial, or of not participating, versus the harm of being denied access to that which they have contributed to. There are also operational issues that are unclear.

Aftermath[ edit ] Given the lack of consensus on many issues prior to the fifth revision it is no surprise that the debates continued unabated.

As Macklin [39] points out, both sides may be right, since justice "is not an unambiguous concept". Clarifications of Articles 29, 30 — [ edit ] Eventually Notes of Clarification footnotes to articles 29 and 30 were added in and respectively, predominantly under pressure from the US CMAJ , Blackmer The clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. As WMA states in the note, there appeared to be 'diverse interpretations and possibly confusion'.

It then outlined circumstances in which a placebo might be 'ethically acceptable', namely 'compelling Effectively this shifted the WMA position to what has been considered a 'middle ground'. For this reason the footnote indicates that the wording must be interpreted in the light of all the other principles of the Declaration.

Article 30 was debated further at the meeting, with another proposed clarification [50] but did not result in any convergence of thought, and so decisions were postponed for another year, [53] [54] but again a commitment was made to protecting the vulnerable.

A new working group examined article 30, and recommended not amending it in January Despite these changes, as Macklin predicted, consensus was no closer and the Declaration was considered by some to be out of touch with contemporary thinking, [57] and even the question of the future of the Declaration became a matter for conjecture.Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Prior to the Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a].

Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.

Future[ edit ] The controversies and national divisions over the text have continued. Los articulos de la ley tienen la funciOn de facilitar el cumplimiento de la Ley que especifica. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.