El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países (...) del norte y del sur.a Los participantes en el GFBR provenientes de Latinoamérica incluyeron a eticistas, investigadores, miembros de comités de ética y representantes de autoridades sanitarias provenientes de Argentina, Brasil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Panamá, Perú, Nicaragua y la República Dominicana. Una legítima preocupación por la protección de las mujeres embarazadas y sus embriones o fetos ha llevado a la mayoría de los países de la Región de las Américas a limitar la realización de estudios con mujeres embarazadas exclusivamente a aquellos estudios específicos sobre el embarazo, y a requerir la exclusión sistemática de las mujeres embarazadas o de las mujeres que quedan embarazadas en el curso del estudio. Ciertamente, a lo largo de la historia de la ética de la investigación, se ha creído erróneamente que proteger a una población es sinónimo de excluirla de los estudios. Se sabe ahora que proceder así implica exponer a riesgos mucho mayores a la población que se busca proteger. El embarazo implica cambios fisiológicos sustantivos e impacta profundamente la manera como el cuerpo metaboliza los medicamentos. Sin embargo, por evitar hacer investigación con mujeres embarazadas, no se ha producido la evidencia científica necesaria para tomar decisiones sobre tratamientos e intervenciones preventivas con dosis eficaces y seguras para ellas y sus embriones o fetos. A manera de ilustración, en el 2001 había en los Estados Unidos apenas más de una docena de medicamentos aprobados para uso en el embarazo (1) y en el 2011 la Food and Drug Administration (FDA) aprobó por primera vez en 15 años un medicamento para su uso en el embarazo (2). Como consecuencia de no haber producido la evidencia necesaria, se pone en riesgo la salud de las mujeres embarazadas cada vez que se les da atención médica. Las mujeres embarazadas se enferman y las mujeres enfermas se embarazan, y no se sabe si los medicamentos que se les da son eficaces o siquiera seguros para ellas y sus embriones o fetos. (shrink)

Organ transplantation is a lifesaving procedure for end-organ damage and remains up to today as the most cost-effective alternative to treat these conditions. However, the main limitation to performing organ transplants is the availability of donor organs suitable for transplantation. To increase the donor pool, expanding organ donation from the conventional neurologic determination of death (NDD) to include circulatory determination of death (DCD) has been a well-established method of increasing donors in other countries. In this article, we discuss the clinical (...) and ethical considerations for introducing DCD in Chile. The concepts we have used could very well be translatable to other similar countries which have not implemented this donation system yet. The most relevant issue to date is that DCD needs to alter the care of dying patients to obtain quality donor organs. In some countries, including Chile, there are some cultural barriers regarding withdrawal-of-care. These barriers include confusing withdrawal of care with acceleration of death, which leads to many practitioners refusing to remove artificial life support, and in turn only minimize ventilatory support or switch to a T-tube (without extubation). This cultural barrier could be overcome with careful consideration of the opinions of healthcare workers, family members, community and policy-based stakeholders. We also identified ethical issues related to informed consent of both donor and recipients, among other relevant ethical considerations. In conclusion, DCD donation in Chile can increase organ donation numbers in one of Latin America's countries with the lowest effective donor rate. However, this opportunity must be taken with caution to avoid the opposite effect if this policy is not well implemented, respecting the sound ethical principles mentioned in this paper. (shrink)

Organ transplantation is a lifesaving procedure for end-organ damage and remains up to today as the most cost-effective alternative to treat these conditions. However, the main limitation to performing organ transplants is the availability of donor organs suitable for transplantation. To increase the donor pool, expanding organ donation from the conventional neurologic determination of death (NDD) to include circulatory determination of death (DCD) has been a well-established method of increasing donors in other countries. In this article, we discuss the clinical (...) and ethical considerations for introducing DCD in Chile. The concepts we have used could very well be translatable to other similar countries which have not implemented this donation system yet. The most relevant issue to date is that DCD needs to alter the care of dying patients to obtain quality donor organs. In some countries, including Chile, there are some cultural barriers regarding withdrawal-of-care. These barriers include confusing withdrawal of care with acceleration of death, which leads to many practitioners refusing to remove artificial life support, and in turn only minimize ventilatory support or switch to a T-tube (without extubation). This cultural barrier could be overcome with careful consideration of the opinions of healthcare workers, family members, community and policy-based stakeholders. We also identified ethical issues related to informed consent of both donor and recipients, among other relevant ethical considerations. In conclusion, DCD donation in Chile can increase organ donation numbers in one of Latin America's countries with the lowest effective donor rate. However, this opportunity must be taken with caution to avoid the opposite effect if this policy is not well implemented, respecting the sound ethical principles mentioned in this paper. (shrink)

Organ transplantation is a lifesaving procedure for end-organ damage and remains up to today as the most cost-effective alternative to treat these conditions. However, the main limitation to performing organ transplants is the availability of donor organs suitable for transplantation. To increase the donor pool, expanding organ donation from the conventional neurologic determination of death (NDD) to include circulatory determination of death (DCD) has been a well-established method of increasing donors in other countries. In this article, we discuss the clinical (...) and ethical considerations for introducing DCD in Chile. The concepts we have used could very well be translatable to other similar countries which have not implemented this donation system yet. The most relevant issue to date is that DCD needs to alter the care of dying patients to obtain quality donor organs. In some countries, including Chile, there are some cultural barriers regarding withdrawal-of-care. These barriers include confusing withdrawal of care with acceleration of death, which leads to many practitioners refusing to remove artificial life support, and in turn only minimize ventilatory support or switch to a T-tube (without extubation). This cultural barrier could be overcome with careful consideration of the opinions of healthcare workers, family members, community and policy-based stakeholders. We also identified ethical issues related to informed consent of both donor and recipients, among other relevant ethical considerations. In conclusion, DCD donation in Chile can increase organ donation numbers in one of Latin America's countries with the lowest effective donor rate. However, this opportunity must be taken with caution to avoid the opposite effect if this policy is not well implemented, respecting the sound ethical principles mentioned in this paper. (shrink)

Organ transplantation is a lifesaving procedure for end-organ damage and remains up to today as the most cost-effective alternative to treat these conditions. However, the main limitation to performing organ transplants is the availability of donor organs suitable for transplantation. To increase the donor pool, expanding organ donation from the conventional neurologic determination of death (NDD) to include circulatory determination of death (DCD) has been a well-established method of increasing donors in other countries. In this article, we discuss the clinical (...) and ethical considerations for introducing DCD in Chile. The concepts we have used could very well be translatable to other similar countries which have not implemented this donation system yet. The most relevant issue to date is that DCD needs to alter the care of dying patients to obtain quality donor organs. In some countries, including Chile, there are some cultural barriers regarding withdrawal-of-care. These barriers include confusing withdrawal of care with acceleration of death, which leads to many practitioners refusing to remove artificial life support, and in turn only minimize ventilatory support or switch to a T-tube (without extubation). This cultural barrier could be overcome with careful consideration of the opinions of healthcare workers, family members, community and policy-based stakeholders. We also identified ethical issues related to informed consent of both donor and recipients, among other relevant ethical considerations. In conclusion, DCD donation in Chile can increase organ donation numbers in one of Latin America's countries with the lowest effective donor rate. However, this opportunity must be taken with caution to avoid the opposite effect if this policy is not well implemented, respecting the sound ethical principles mentioned in this paper. (shrink)