A survey in Mexico about ethics dumping in clinical research.

BACKGROUND: The exportation of unethical practices to low- and middle-income countries ("Ethics Dumping") has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. METHOD: We designed an exploratory survey based on a five-point Likert scale, following an established, validated and published methodology. The questionnaire included both open close-ended questions. The aspects covered in the questionnaire were introductory questions on the existence of ethical issues; general perception on ethics dumping in Mexico; lack of voluntariness, undue inducement, and therapeutic misconception as exploitation risks; existence of exploitative practices; norms facilitating ethics dumping; acceptable levels of benefit to Mexico; boundaries of ethics dumping. The survey was administered to a sample of research ethics committee members from public and private Mexican hospitals in 2016. RESULTS: Most of the ethics committee members believed clinical trials are generally ethically sound, though almost a majority think that ethics dumping is a common occurrence and that it is a serious issue. Most agree that ethics dumping needs to be addressed. They also identified other issues such as ethical issues related to patient participation and ethics committees. Further, most committee members agree that undue inducement and therapeutic misconception affect voluntariness, and that both individuals and communities receive appropriate benefits. CONCLUSION: From the perspective of Mexican research ethics committee members, ethics dumping commonly exists in Mexican clinical trials, as well as several related issues such as ethical issues on patient participation and ethics committees, as well as voluntariness issues. Further, most members believed these issues need to be addressed. However, most were also of the opinion that clinical trials are generally ethically compliant. This points to the need for further studies on the reasons for these perspectives.

[Patients' perceptions of and attitudes towards epilepsy surgery: mistaken concepts in Colombia]. / Percepciones y actitudes de los pacientes frente a la cirugia de la epilepsia: conceptos equivocados en Colombia.

INTRODUCTION: Selected patients with drug-resistant focal epilepsy benefit from epilepsy surgery, however significant delays remain. The aim of this study was to assess knowledge and attitudes toward epilepsy surgery among patients with epilepsy and identify barriers that might delay the treatment. PATIENTS AND METHODS: A 10-minute questionnaire was administered to patients with epilepsy in Colombia. Survey assessed the following: knowledge of surgical options, perceptions about the risks of surgery vs. ongoing seizures, disease disability, treatment goals, and demographic and socioeconomic variables. RESULTS: We recruited 88 patients with focal epilepsy. More than half of patients (56%) were not aware that surgery might be an option. Apprehension about epilepsy surgery was evident, 60% of patients perceived epilepsy surgery to be very or moderately dangerous. A large proportion of patients believe death (41%), stroke (47%), vision loss (56%), personality change (56%), paralysis (62%), difficulties in speaking (69%), and memory loss (60%) were frequent side effects. The majority of patients (62%) consider the surgical procedure as the last option of treatment. CONCLUSIONS: There is a negative attitude toward epilepsy surgery based on the patients' misperceptions of suffering neurological deficits during the surgery, reflecting lack of knowledge toward this type of treatment. These perceptions can contribute to delays in surgical care.

TITLE: Percepciones y actitudes de los pacientes frente a la cirugia de la epilepsia: conceptos equivocados en Colombia.Introduccion. Los pacientes con epilepsia focal farmacorresistente se podrian beneficiar de la cirugia de la epilepsia; sin embargo, existen demoras en la realizacion del procedimiento. El objetivo de este estudio fue evaluar el conocimiento y las actitudes de los pacientes hacia la cirugia de epilepsia e identificar barreras que pudieran retrasar el tratamiento. Pacientes y metodos. Se aplico un cuestionario de 10 minutos a pacientes con epilepsia en Colombia. La encuesta evaluo el conocimiento de la opcion quirurgica, las percepciones sobre el riesgo de la cirugia frente al riesgo de crisis no controladas, la discapacidad producida por la enfermedad, las metas del tratamiento y las variables demograficas y socioeconomicas. Resultados. Se seleccionaron 88 pacientes con epilepsia focal. El 56% de los pacientes no sabia que la cirugia podria ser una opcion terapeutica. El 60% considero que la cirugia de la epilepsia es muy o moderadamente peligrosa. Una gran proporcion pensaba que la muerte (41%), el ictus (47%), la perdida visual (56%), los cambios en la personalidad (56%), la paralisis (61%), las dificultades para hablar (69%) y la perdida de la memoria (60%) eran efectos secundarios comunes. La mayoria (62%) consideraba el procedimiento como la ultima opcion de tratamiento. Conclusiones. Existe una actitud negativa por parte de los pacientes frente a la cirugia de la epilepsia fundamentada en la sobreestimacion del riesgo de adquirir deficits neurologicos secundarios al procedimiento, lo que refleja la falta de conocimiento hacia este tratamiento. Estas percepciones erroneas pueden contribuir a demoras en la atencion quirurgica.

A Missing Piece in Clinical Trial Inspections in Latin America: Interviews With Research Subjects in Peru.

Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs. Participants did not object to being interviewed and provided information not obtained during regular inspections. Participants were appreciative of the agency's concern for the integrity of the CT process. Most interviewees did not understand the consent form and were unaware that they were participating in an experiment with unapproved new drugs. Participants' decision to enroll in CT related to undue inducement and therapeutic misconception. Some patients' behaviors, undisclosed to researchers, could have compromised the integrity of the data collected.

Possibilidades de inserção da psicologia no trabalho com os cuidadores de crianças com deficiência / Psychology insertion possibilities in working with caregivers of children with disabilities

Este artigo fala sobre o trabalho realizado com o grupo de cuidadores das pessoas com deficiência beneficiadas com o Programa de Natação Adaptada, oferecido em parceria com o Departamento de Educação Física da Universidade Federal Fluminense entre 2013 e 2015. A partir do que Vinciane Despret (2011) chama de mal-entendido, procuramos pensar a inserção do profissional de psicologia neste espaço. Durante nosso trabalho foi preciso modificar nossa proposta de intervenção algumas vezes, dentre as mudanças, destacamos a proposta de desvincular a figura do cuidador da pessoa que é cuidada. Em seguida, pensamos no trabalho de intervenção em conjunto com a equipe da Educação Física, numa tentativa de ampliar as possibilidades de cuidado. Quando pensamos em cuidado como um processo, como proposto por Annemarie Mol (2008), foi possível aceitar um espaço de intervenção que fugisse do ambiente asséptico normalmente utilizado pela Psicologia. Esta mudança possibilitou o surgimento de afetos e articulações que não eram possíveis anteriormente.

This article is about the work with the caregivers of the people with disability who attend the Adapted Swimming Program, offered in partnership with Federal Fluminense University's Physical Education Department between 2013 and 2015. From what Vinciane Despret calls a misunderstanding, we try to formulate the insertion of the psychology professional in this space. During our work we had to modify our intervention proposition a few times, initially thinking about separating the caregiver's figure from the person who is 'receiving' care. Then, we thought about an intervention made with the P.E. team. When we took care as an ongoing process, as proposed by Annemarie Mol, we could accept an intervention space that escaped the aseptic environment normally used by Psychology. This change allowed the unfold of affections and articulations that were not possible before.

Este artículo habla sobre el trabajo realizado con el grupo de cuidadores de personas con discapacidad beneficiadas con el Programa de Natación Adaptada, que se ofrece en asociación con el Departamento de Educación Física de la Universidad Federal Fluminense entre 2013 y 2015. A partir de lo que Vinciane Despret llama malentendido, procuramos pensar en la inserción del profesional de psicología en este espacio. Durante el trabajo se tuvo que modificar nuestra propuesta de intervención algunas veces, reflejando en primer lugar sobre separar la figura del cuidador a la de la persona que es cuidada. Por último, pensamos en un trabajo de intervención en conjunto con el equipo de Educación Física. Cuando tomamos el cuidado como un proceso, tal como es propuesto por Annemarie Mol, podemos aceptar un espacio de intervención que se aleja del ambiente aséptico normalmente utilizado por la Psicología. Este cambio hizo posible el surgimiento de afecciones y articulaciones que no eran posibles anteriormente.

Miragens perimetrais: sobre o erro como limite / Mirages perimeter: about the error as limit

O erro linguístico tem sido diversamente abordado ao longo das diferentes tradições dos estudos da linguagem. O presente trabalho propõe, a partir da psicanálise, uma discussão a respeito de possíveis considerações e sobre o que o erro viola. Assim, pretendemos vislumbrar onde, na topologia da língua, o erro encontra a sua morada, bem como questionar se, de fato, ele estaria aí em posição de limite...

Perimetrical mirages: on error as a limit. Linguistic error has been approached differently throughout different traditions of language studies. This paper, based on psychoanalytical doctrine, proposes a discussion about some possible considerations and about what error violates. Thus we want to envision where in the topology of language indwells linguistic error, and question whether, in fact, it would be there in some boundary position...

Miragens perimetrais: sobre o erro como limite

O erro linguístico tem sido diversamente abordado ao longo das diferentes tradições dos estudos da linguagem. O presente trabalho propõe, a partir da psicanálise, uma discussão a respeito de possíveis considerações e sobre o que o erro viola. Assim, pretendemos vislumbrar onde, na topologia da língua, o erro encontra a sua morada, bem como questionar se, de fato, ele estaria aí em posição de limite(AU)

Perimetrical mirages: on error as a limit. Linguistic error has been approached differently throughout different traditions of language studies. This paper, based on psychoanalytical doctrine, proposes a discussion about some possible considerations and about what error violates. Thus we want to envision where in the topology of language indwells linguistic error, and question whether, in fact, it would be there in some boundary position(AU)

Factores asociados al empleo de varios antibióticos en pacientes clínicos / Factors related to the use of several antibiotics in clinical patients

Objetivo: identificar factores asociados con el empleo de varios antibióticos en pacientes clínicos.Métodos: se realizó un estudio de casos y controles en pacientes con infección, egresados de los servicios clínicos en el Hospital Docente Clínicoquirúrgico Joaquín Albarrán entre mayo de 2008 y diciembre de 2011. Se consideró caso al paciente que utilizó tres o más antibióticos. Se obtuvo la siguiente información: edad, sexo, antecedentes patológicos personales, tiempo de inicio de los síntomas sugestivos de un proceso infeccioso, uso previo de antibióticos, signos vitales y estado de conciencia al ingreso, resultados de estudios hematológicos y de química sanguínea, estudios radiográficos de tórax, diagnóstico de infección nosocomial y uso inadecuado de antimicrobianos. Se compararon las frecuencias mediante las pruebas de homogeneidad y prueba exacta de Fisher, pruebas t y de Wilcoxon. Se empleó la regresión logística para la identificación de los factores de riesgo.Resultados: Se estudiaron 92 casos y 184 controles. El riesgo de empleo de varios antibióticos se incrementó 2,68 veces por cada grado centígrado que se encontró elevada la temperatura del paciente (OR= 2,68; IC 95 por ciento 1,21-5,94), 7 veces si existió alteración del nivel de conciencia (OR= 7,32; IC 95 porciento 1,88-28,55), 3,88 veces si se diagnosticó infección nosocomial y 9,98 veces si se consideró inadecuado el uso de antimicrobianos.Conclusiones: Los factores de riesgo para el uso de varios antibióticos identificados pueden contribuir a elaborar estrategias de control de la calidad de prescripción de antimicrobianos

La falacia terapéutica / A falácia terapêutica / The therapeutic misconception

La falacia terapéutica tiene servido para negar la legítima esperanza de pacientes ?sujetos de investigación? que se incorporan a estudios clínicos Fase III para obtener beneficios clínicos directos. Esta ?falacia? busca ratificar los esfuerzos de investigadores en negar la diferencia entre estudios terapéuticos que benefician directamente los afectados e estudios no terapéuticos, que incorporan sujetos a investigaciones totalmente aisladas de sus necesidades. En países con populaciones pobres, precaria educación y acceso a servicios médicos, se intentan reclutar participantes ofreciendo terapias no disponibles localmente; obvio abuso das legítimas esperanzas de estos pacientes de acceder a estas indispensables terapias que les son prometidas al interior de las investigaciones. Así, la falacia terapéutica torna-se un modo de justificar a negativa de ofrecer beneficios médicos a los reclutados constituyendo sesgo de trasgresión ética, especialmente nos países en los cuales el participante no tienen expectativa de tratamiento. Esta justificada expectativa de los reclutados que ingresan en estudios clínicos aleatorios es argumento adicional contra el uso de placebo.

A falácia terapêutica tem servido para negar a legítima esperança de pacientes ?sujeitos da pesquisa? que se incorporam a estudos clínicos Fase III para obter benefícios clínicos diretos. Esta ?falácia? busca ratificar os esforços de pesquisadores em negar a diferença entre estudos terapêuticos que beneficiam diretamente os afetados e estudos não terapêuticos, que incorporam sujeitos a pesquisas totalmente distanciadas de suas necessidades. Em países com populações pobres, precária educação e acesso a serviços médicos, se tentam recrutar participantes oferecendo terapias não disponíveis localmente; óbvio abuso das legítimas esperanças destes pacientes terem acesso às indispensáveis terapias, prometidas pelas pesquisas. Assim, a falácia terapêutica torna-se um modo de justificar a negativa de oferecer benefícios médicos aos recrutados constituindo viés de transgressão ética, especialmente nos países nos quais o participante não tem expectativa de tratamento. Esta justificada expectativa daqueles que ingressam em estudos clínicos randomizados constitui argumento adicional contra o uso de placebo.

The therapeutic misconception has been described as the ?research subjects? unwarranted expectations of obtaining medical benefits by participating in clinical trials. Thus, researchers have found a new conceptual instrument to deny that research ought to be of benefit to subjects involved, once again disregarding the difference between therapeutic and non therapeutic clinical trials. This paper argues that patients involved in research are justified and in fact entitled to expect therapeutic benefits from their participation in research protocols, because the sick should only be recruited for such therapeutic trials as designed to improve their medical condition, and ought never to be involved in non therapeutic research and the risks involved. Insisting that therapeutic expectations research subjects constitute a misguided and erroneous attitude, is an unethical bias when applied to countries with precarious medical services. Subjects with unmet medical needs will willingly participate in research that might be the only way of obtaining badly required medication, an expectation that is obviously understandable and in no way fallacious. These justified expectations will be thwarted in those who randomly fall into the control group, thus delivering an additional argument against the use of placebos.