O consentimento livre e esclarecido na jurisprudência dos tribunais brasileiros

Informed consent corresponds to the concretion of the respect for patient's autonomy in medical care practice, representing a deep change of paradigm to the doctor-patient relationship. Bioethics and American courts had concurred for its birth and development. However, the way informed consent has been delineated by the courts has restricted it to the fulfillment of the legal duties to obtain patient's consent and to disclose information. Moreover, the popularization of consent forms containing standardized information for the purpose of evidence of the fulfillment of such duties has moved informed consent away from its original foundation. In Brazil, informed consent was first developed by Bioethics and only recently the legal approach has started to emerge. Regarding its approach by the Brazilian courts, it was verified in a study of case law that informed consent is a reality in such courts, basically due to the questioning on the doctor's duty to disclose information. Such questioning is based on the application of the Consumer's Statute to the doctor-patient relationship. Thus, Consumer's Statute aspects - such as the use of an objective standard of information and the focus in the protection of the consumer - have delineate the understanding of the Brazilian courts on informed consent in medical care practice. The acceptance and even the requirement of the standardized forms utilization were mentioned in many of the obtained decisions. Therefore, there are indications, that the judicial approach of informed consent in Brazil is following the path trod by the American case law.O consentimento livre e esclarecido corresponde à concretização do respeito à autonomia do paciente na prática de assistência médica, representando profunda mudança de paradigma para a relação médico-paciente. A bioética e os tribunais estadunidenses concorreram para o seu nascimento e desenvolvimento. Entretanto, a maneira como os tribunais delinearam o tema acabou por reduzi-lo ao cumprimento dos deveres de obter o consentimento do paciente e de informá-lo. Além disso, a popularização dos formulários com informações padronizadas para fins de prova documental distanciou o tema de seu originário fundamento. No Brasil, o consentimento livre e esclarecido foi primeiramente desenvolvido pela Bioética e, apenas recentemente, passou a se esboçar a abordagem jurídica do tema. No que se refere a sua abordagem pelos tribunais brasileiros, verificou-se em levantamento jurisprudencial que a temática do consentimento livre e esclarecido faz-se presente nos tribunais fundamentalmente em função do questionamento sobre o dever de informar do médico. Tal questionamento, por sua vez, mostra-se impulsionado pela aplicação do Código de Defesa do Consumidor à relação médico-paciente. Assim, são aspectos da legislação consumerista, como a utilização de um padrão objetivo de informação, que vão delinear a abordagem dos tribunais brasileiros sobre o consentimento livre e esclarecido na prática de assistência médica. A aceitação e até mesmo a exigência da utilização de formulários padronizados foram verificadas em diversas decisões obtidas. Há indícios, portanto, de que a abordagem judicial do consentimento livre e esclarecido no Brasil está seguindo o caminho trilhado pela jurisprudência estadunidense

O consentimento livre e esclarecido na jurisprudência dos tribunais brasileiros

O consentimento livre e esclarecido corresponde à concretização do respeito à autonomia do paciente na prática de assistência médica, representando profunda mudança de paradigma para a relação médico-paciente. A bioética e os tribunais Estadunidenses concorreram para o seu nascimento e desenvolvimento. Entretanto, a maneira como os tribunais delinearam o tema acabou por reduzi-lo ao cumprimento dos deveres de obter o consentimento do paciente e de informá-lo. Além disso, a popularização dos formulários com informações padronizadas para fins de prova documental distanciou o tema de seu originário fundamento. No Brasil, o consentimento livre e esclarecido foi primeiramente desenvolvido pela Bioética e, apenas recentemente, passou a se esboçar a abordagem jurídica do tema. No que se refere a sua abordagem pelos tribunais brasileiros, verificou-se em levantamento jurisprudencial que a temática do consentimento livre e esclarecido faz-se presente nos tribunais fundamentalmente em função do questionamento sobre o dever de informar do médico. Tal questionamento, por sua vez, mostra-se impulsionado pela aplicação do Código de Defesa do Consumidor à relação médico-paciente. Assim, são aspectos da legislação consumerista, como a utilização de um padrão objetivo de informação, que vão delinear a abordagem dos tribunais brasileiros sobre o consentimento livre e esclarecido na prática de assistência médica. A aceitação e até mesmo a exigência da utilização de formulários padronizados foram verificadas em diversas decisões obtidas. Há indícios, portanto, de que a abordagem judicial do consentimento livre e esclarecido no Brasil está seguindo o caminho trilhado pela jurisprudência estadunidense

Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación

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

Les droits disciplinaires des fonctions publiques : « unification », « harmonisation » ou « distanciation ». A propos de la loi du 26 avril 2016 relative à la déontologie et aux droits et obligations des fonctionnaires

The production of tt‾ , W+bb‾ and W+cc‾ is studied in the forward region of proton–proton collisions collected at a centre-of-mass energy of 8 TeV by the LHCb experiment, corresponding to an integrated luminosity of 1.98±0.02 fb−1 . The W bosons are reconstructed in the decays W→ℓν , where ℓ denotes muon or electron, while the b and c quarks are reconstructed as jets. All measured cross-sections are in agreement with next-to-leading-order Standard Model predictions.The production of $t\overline{t}$, $W+b\overline{b}$ and $W+c\overline{c}$ is studied in the forward region of proton-proton collisions collected at a centre-of-mass energy of 8 TeV by the LHCb experiment, corresponding to an integrated luminosity of 1.98 $\pm$ 0.02 \mbox{fb}^{-1}. The $W$ bosons are reconstructed in the decays $W\rightarrow\ell\nu$, where $\ell$ denotes muon or electron, while the $b$ and $c$ quarks are reconstructed as jets. All measured cross-sections are in agreement with next-to-leading-order Standard Model predictions

Measurement of the J/ψ pair production cross-section in pp collisions at s=13 \sqrt{s}=13 TeV

The production cross-section of J/ψ pairs is measured using a data sample of pp collisions collected by the LHCb experiment at a centre-of-mass energy of $\sqrt{s}=13$ TeV, corresponding to an integrated luminosity of 279 ±11 pb$^{−1}$. The measurement is performed for J/ψ mesons with a transverse momentum of less than 10 GeV/c in the rapidity range 2.0 < y < 4.5. The production cross-section is measured to be 15.2 ± 1.0 ± 0.9 nb. The first uncertainty is statistical, and the second is systematic. The differential cross-sections as functions of several kinematic variables of the J/ψ pair are measured and compared to theoretical predictions.The production cross-section of $J/\psi$ pairs is measured using a data sample of $pp$ collisions collected by the LHCb experiment at a centre-of-mass energy of $\sqrt{s} = 13 \,{\mathrm{TeV}}$, corresponding to an integrated luminosity of $279 \pm 11 \,{\mathrm{pb^{-1}}}$. The measurement is performed for $J/\psi$ mesons with a transverse momentum of less than $10 \,{\mathrm{GeV}}/c$ in the rapidity range $2.0<y<4.5$. The production cross-section is measured to be $15.2 \pm 1.0 \pm 0.9 \,{\mathrm{nb}}$. The first uncertainty is statistical, and the second is systematic. The differential cross-sections as functions of several kinematic variables of the $J/\psi$ pair are measured and compared to theoretical predictions

Measurement of forward W→eνW\to e\nu production in pppp collisions at s=8 \sqrt{s}=8\,TeV

A measurement of the cross-section for $W \to e\nu$ production in $pp$ collisions is presented using data corresponding to an integrated luminosity of $2\,$fb$^{-1}$ collected by the LHCb experiment at a centre-of-mass energy of $\sqrt{s}=8\,$TeV. The electrons are required to have more than $20\,$GeV of transverse momentum and to lie between 2.00 and 4.25 in pseudorapidity. The inclusive $W$ production cross-sections, where the $W$ decays to $e\nu$, are measured to be \begin{align*} \begin{split} \sigma_{W^{+} \to e^{+}\nu_{e}}&=1124.4\pm 2.1\pm 21.5\pm 11.2\pm 13.0\,\mathrm{pb},\\ \sigma_{W^{-} \to e^{-}\bar{\nu}_{e}}&=\,\,\,809.0\pm 1.9\pm 18.1\pm\,\,\,7.0\pm \phantom{0}9.4\,\mathrm{pb}, \end{split} \end{align*} where the first uncertainties are statistical, the second are systematic, the third are due to the knowledge of the LHC beam energy and the fourth are due to the luminosity determination. Differential cross-sections as a function of the electron pseudorapidity are measured. The $W^{+}/W^{-}$ cross-section ratio and production charge asymmetry are also reported. Results are compared with theoretical predictions at next-to-next-to-leading order in perturbative quantum chromodynamics. Finally, in a precise test of lepton universality, the ratio of $W$ boson branching fractions is determined to be \begin{align*} \begin{split} \mathcal{B}(W \to e\nu)/\mathcal{B}(W \to \mu\nu)=1.020\pm 0.002\pm 0.019, \end{split} \end{align*} where the first uncertainty is statistical and the second is systematic.A measurement of the cross-section for $W \to e\nu$ production in $pp$ collisions is presented using data corresponding to an integrated luminosity of $2\,$fb$^{-1}$ collected by the LHCb experiment at a centre-of-mass energy of $\sqrt{s}=8\,$TeV. The electrons are required to have more than $20\,$GeV of transverse momentum and to lie between 2.00 and 4.25 in pseudorapidity. The inclusive $W$ production cross-sections, where the $W$ decays to $e\nu$, are measured to be \begin{equation*} \sigma_{W^{+} \to e^{+}\nu_{e}}=1124.4\pm 2.1\pm 21.5\pm 11.2\pm 13.0\,\mathrm{pb}, \end{equation*} \begin{equation*} \sigma_{W^{-} \to e^{-}\bar{\nu}_{e}}=\,\,\,809.0\pm 1.9\pm 18.1\pm\,\,\,7.0\pm \phantom{0}9.4\,\mathrm{pb}, \end{equation*} where the first uncertainties are statistical, the second are systematic, the third are due to the knowledge of the LHC beam energy and the fourth are due to the luminosity determination. Differential cross-sections as a function of the electron pseudorapidity are measured. The $W^{+}/W^{-}$ cross-section ratio and production charge asymmetry are also reported. Results are compared with theoretical predictions at next-to-next-to-leading order in perturbative quantum chromodynamics. Finally, in a precise test of lepton universality, the ratio of $W$ boson branching fractions is determined to be \begin{equation*} \mathcal{B}(W \to e\nu)/\mathcal{B}(W \to \mu\nu)=1.020\pm 0.002\pm 0.019, \end{equation*} where the first uncertainty is statistical and the second is systematic.A measurement of the cross-section for W → eν production in pp collisions is presented using data corresponding to an integrated luminosity of 2 fb$^{−1}$ collected by the LHCb experiment at a centre-of-mass energy of $\sqrt{s}=8$ TeV. The electrons are required to have more than 20 GeV of transverse momentum and to lie between 2.00 and 4.25 in pseudorapidity. The inclusive W production cross-sections, where the W decays to eν, are measured to be ${\sigma}_{W^{+}\to {e}^{+}{\nu}_e}=1124.4\pm 2.1\pm 21.5\pm 11.2\pm 13.0\kern0.5em \mathrm{p}\mathrm{b},$ ${\sigma}_{W^{-}\to {e}^{-}{\overline{\nu}}_e}=809.0\pm 1.9\pm 18.1\pm \kern0.5em 7.0\pm \kern0.5em 9.4\,\mathrm{p}\mathrm{b},$ where the first uncertainties are statistical, the second are systematic, the third are due to the knowledge of the LHC beam energy and the fourth are due to the luminosity determination

Measurement of the B0s→μ+μ− Branching Fraction and Effective Lifetime and Search for B0→μ+μ− Decays

A search for the rare decays Bs0→μ+μ- and B0→μ+μ- is performed at the LHCb experiment using data collected in pp collisions corresponding to a total integrated luminosity of 4.4  fb-1. An excess of Bs0→μ+μ- decays is observed with a significance of 7.8 standard deviations, representing the first observation of this decay in a single experiment. The branching fraction is measured to be B(Bs0→μ+μ-)=(3.0±0.6-0.2+0.3)×10-9, where the first uncertainty is statistical and the second systematic. The first measurement of the Bs0→μ+μ- effective lifetime, τ(Bs0→μ+μ-)=2.04±0.44±0.05  ps, is reported. No significant excess of B0→μ+μ- decays is found, and a 95% confidence level upper limit, B(B0→μ+μ-)<3.4×10-10, is determined. All results are in agreement with the standard model expectations.A search for the rare decays $B^0_s\to\mu^+\mu^-$ and $B^0\to\mu^+\mu^-$ is performed at the LHCb experiment using data collected in $pp$ collisions corresponding to a total integrated luminosity of 4.4 fb$^{-1}$. An excess of $B^0_s\to\mu^+\mu^-$ decays is observed with a significance of 7.8 standard deviations, representing the first observation of this decay in a single experiment. The branching fraction is measured to be ${\cal B}(B^0_s\to\mu^+\mu^-)=\left(3.0\pm 0.6^{+0.3}_{-0.2}\right)\times 10^{-9}$, where the first uncertainty is statistical and the second systematic. The first measurement of the $B^0_s\to\mu^+\mu^-$ effective lifetime, $\tau(B^0_s\to\mu^+\mu^-)=2.04\pm 0.44\pm 0.05$ ps, is reported. No significant excess of $B^0\to\mu^+\mu^-$ decays is found and a 95 % confidence level upper limit, ${\cal B}(B^0\to\mu^+\mu^-)<3.4\times 10^{-10}$, is determined. All results are in agreement with the Standard Model expectations

Measurements of prompt charm production cross-sections in pp collisions at s=5 \sqrt{s}=5 TeV

Production cross-sections of prompt charm mesons are measured using data from $pp$ collisions at the LHC at a centre-of-mass energy of $5\,$TeV. The data sample corresponds to an integrated luminosity of $8.60\pm0.33\,$pb$^{-1}$ collected by the LHCb experiment. The production cross-sections of $D^0$, $D^+$, $D_s^+$, and $D^{*+}$ mesons are measured in bins of charm meson transverse momentum, $p_{\text{T}}$, and rapidity, $y$. They cover the rapidity range $2.0 < y < 4.5$ and transverse momentum ranges $0 < p_{\text{T}} < 10\, \text{GeV}/c$ for $D^0$ and $D^+$ and $1 < p_{\text{T}} < 10\, \text{GeV}/c$ for $D_s^+$ and $D^{*+}$ mesons. The inclusive cross-sections for the four mesons, including charge-conjugate states, within the range of $1 < p_{\text{T}} < 8\, \text{GeV}/c$ are determined to be \begin{equation*} \sigma(pp\rightarrow D^0 X) = 1190 \pm 3 \pm 64\,\mu\text{b} \end{equation*} \begin{equation*} \sigma(pp\rightarrow D^+ X) = 456 \pm 3 \pm 34\,\mu\text{b} \end{equation*} \begin{equation*} \sigma(pp\rightarrow D_s^+ X) = 195 \pm 4 \pm 19\,\mu\text{b} \end{equation*} \begin{equation*} \sigma(pp\rightarrow D^{*+} X)= 467 \pm 6 \pm 40\,\mu\text{b} \end{equation*} where the uncertainties are statistical and systematic, respectively.Production cross-sections of prompt charm mesons are measured using data from pp collisions at the LHC at a centre-of-mass energy of 5 TeV. The data sample corresponds to an integrated luminosity of 8.60 ± 0.33 pb$^{−1}$ collected by the LHCb experiment. The production cross-sections of D$^{0}$, D$^{+}$, D$_{s}^{+}$ , and D$^{∗+}$ mesons are measured in bins of charm meson transverse momentum, p$_{T}$, and rapidity, y. They cover the rapidity range 2.0 < y < 4.5 and transverse momentum ranges 0 < p$_{T}$ < 10 GeV/c for D$^{0}$ and D$^{+}$ and 1 < p$_{T}$ < 10 GeV/c for D$_{s}^{+}$ and D$^{∗+}$ mesons. The inclusive cross-sections for the four mesons, including charge-conjugate states, within the range of 1 < p$_{T}$ < 8 GeV/c are determined to be $\begin{array}{l}\sigma \left( pp\to {D}^0X\right)=1004\pm 3\pm 54\mu \mathrm{b},\\ {}\sigma \left( pp\to {D}^{+}X\right)=402\pm 2\pm 30\mu \mathrm{b},\\ {}\sigma \left( pp\to {D}_s^{+}X\right)=170\pm 4\pm 16\mu \mathrm{b},\\ {}\sigma \left( pp\to {D}^{\ast +}X\right)=421\pm 5\pm 36\mu \mathrm{b},\end{array}$ where the uncertainties are statistical and systematic, respectively.Production cross-sections of prompt charm mesons are measured using data from $pp$ collisions at the LHC at a centre-of-mass energy of $5\,$TeV. The data sample corresponds to an integrated luminosity of $8.60\pm0.33\,$pb$^{-1}$ collected by the LHCb experiment. The production cross-sections of $D^0$, $D^+$, $D_s^+$, and $D^{*+}$ mesons are measured in bins of charm meson transverse momentum, $p_{\text{T}}$, and rapidity, $y$. They cover the rapidity range $2.0<y<4.5$ and transverse momentum ranges $0 < p_{\text{T}} < 10\, \text{GeV}/c$ for $D^0$ and $D^+$ and $1 < p_{\text{T}} < 10\, \text{GeV}/c$ for $D_s^+$ and $D^{*+}$ mesons. The inclusive cross-sections for the four mesons, including charge-conjugate states, within the range of $1 < p_{\text{T}} < 8\, \text{GeV}/c$ are determined to be \sigma(pp\rightarrow D^0 X) = 1004 \pm 3 \pm 54\,\mu\text{b} \sigma(pp\rightarrow D^+ X) = 402 \pm 2 \pm 30\,\mu\text{b} \sigma(pp\rightarrow D_s^+ X) = 170 \pm 4 \pm 16\,\mu\text{b} \sigma(pp\rightarrow D^{*+} X)= 421 \pm 5 \pm 36\,\mu\text{b} where the uncertainties are statistical and systematic, respectively

Informed consent in medical care practice: a study of the Brazilian Courts case law

O consentimento livre e esclarecido corresponde à concretização do respeito à autonomia do paciente na prática de assistência médica, representando uma profunda mudança de .paradigma para a relação médico-paciente, tradicionalmente pautada no paternalismo médico. A bicética e os tribunais estadunidenses concorreram para o seu nascimento e desenvolvimento. Entretanto, a maneira como os tribunais delinearam o tema acabou por reduzi-lo ao cumprimento dos deveres legais de obter o consentimento do paciente e de informá-lo. Além ·disso, a popularização dos formulários contendo informações padronizadas e a assinatura do paciente para fins de comprovação do cumprimento de tais deveres distanciou o tema de seu originário fundamento do respeito à autonomia individual. No Brasil, o consentimento livre e esclarecido foi primeiramente desenvolvido pela bicética e, apenas recentemente, passou a se esboçar a abordagem jurídica do tema. Buscando identificar o entendimento dos tribunais brasileiros sobre o consentimento livre e esclarecido na prática de assistência médica, procedeu-se a estudo qualitativo das decisões judiciais proferidas em sede de ações relacionadas à responsabilidade civil médica, no período compreendido entre os anos de 2000 e 2005. Os dados foram coletados a partir dos sítios eletrônicos dos tribunais estaduais de São Paulo, Rio de Janeiro, Minas Gerais e Rio Grande do Sul (considerados os maiores estados brasileiros em termos de produto interno bruto), bem como dos competentes tribunais superiores (Supremo Tribunal Federal e Superior Tribunal de Justiça). Verificou-se que a temática do consentimento livre e esclarecido já se faz presente nos tribunais estaduais pesquisados, bem como no Superior Tribunal de Justiça, fundamentalmente em função do questionamento sobre o dever de informar do médico. Tal questionamento, por sua vez, mostra-se impulsionado pela aplicação do Código de Defesa do Consumidor à relação médico-paciente. Dessa forma, são aspectos da legislação consumerista, tais como a utilização de um padrão objetivo de informação e o foco na proteção do consumidor, que vão delinear a abordagem dos tribunais brasileiros sobre o consentimento livre e esclarecido na prática de assistência médica. A aceitação e até mesmo a exigência da utilização de formulários padronizados foram verificadas em diversas decisões obtidas. Há indícios, assim, de que a abordagem judicial do consentimento livre e esclarecido no Brasil está seguindo o caminho trilhado pela jurisprudência estadunidense.lnformed consent corresponds to the concretion of the respect for patients autonomy in medical care practice, representing a deep change of paradigm to the doctor-patient relationship, traditionally based on medical paternalism. Bioethics and American courts had concurred for its birth and development. However, the way the courts have delineated informed consent restricted it to the fullfilment of the legal duties to obtain the patients consent and to disclose information. Moreover, the popularization of consent forms containing standardized information and the signature of the patient for the porpouse of evidence of the fulfilment of such duties, has moved informed consent away from its original foundation of respect for individual autonomy. In Brazil, informed consent was first developed by bioethics and, only recently, the legal approach has started to emerge. To identify the Brazilian courts\' understanding of informed consent in medical care practice, it was proceeded a qualitative study of the decisions pronounced in legal actions related to the medical civil liability between 2000 and 2005. The data was collected from websites of the courts of the Brazilian states of São Paulo, Rio de Janeiro, Minas Gerais and Rio Grande do Sul (considered the biggest Brazilian states in terms of gross domestic product), as well as of the competent superior courts (Supreme Federal Court and High Court of Justice). lt was verified that informed consent is already a reality in the searched state courts, as well as in the High Court of Justice, basically in function of the questioning on the doctor\'s duty to disclose information. Such questioning is based on the application of the Consumers Statute to the doctor-patient relationship. Thus, Consumer Statute aspects, such as the use of an objective standard of information and the focus in the protection of the consumer, delineate the understanding of the Brazilian courts on informed consent in medical care practice. The acceptance and even the requirement of the standardized forms · utilization were mentioned in many of the obtained decisions. There are indications, therefore, that the judicial approach of informed consent in Brazil is following the path trod by the American case law