Los comités de ética clínica en México: la ambigua frontera entre la ética asistencial y la ética en investigación clínica / Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics

OBJETIVO: Identificar los comités de ética de la práctica clínica en México y establecer las posibles implicaciones derivadas de su composición y funcionamiento. MÉTODOS: Estudio transversal descriptivo realizado entre enero y diciembre de 2005. Se envió por correo electrónico una encuesta a todos los hospitales y unidades de medicina familiar del Instituto Mexicano del Seguro Social (n = 437) y del Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (n = 167) que contaran con más de 10 consultorios, y a los establecimientos asistenciales más importantes de la Secretaría de Salud de México (n = 15). Los elementos analizados fueron: nombre del comité, fecha en la que fue constituido, estado actual de actividad, composición, funciones y facultades. RESULTADOS: Se identificaron 116 comités con muy diversos nombres, de ellos 101 (87,1 por ciento) estaban activos. Estos comités se crearon entre 1985 y 2006, con un pico entre los años 2004 y 2005. De los comités activos, 59 (58,4 por ciento) se encargaban tanto de los problemas/dilemas éticos relacionados con la práctica clínica como de los proyectos de investigación. De los integrantes, 357 (59,0 por ciento) tenían puestos directivos en el establecimiento al que pertenecía el comité del que eran miembros; predominó la profesión médica (71,5 por ciento), seguida de personal de enfermería (11,9 por ciento). De los integrantes de los comités activos, 77,9 por ciento no había recibido entrenamiento en el campo de la ética. CONCLUSIONES: Puede esperarse que surjan conflictos legales, principalmente en los establecimientos cuyos comités se confieren la autoridad de dictaminar el curso apropiado de una acción. Se requiere un plan integral para estandarizar la composición y los procedimientos de los comités de ética clínica en México y mejorar la preparación de sus miembros.

OBJECTIVE: To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. METHODS: A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n = 437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n = 167) and to the Mexican Ministry of Health's most important health care centers (n= 15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. RESULTS: In all, 116 committees were identified, with various names. Of these, 101 (87.1 percent) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4 percent) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0 percent) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5 percent), followed by nursing staff (11.9 percent). Among the members of the active committees, 77.9 percent had not received training in ethics. CONCLUSIONS: Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

Los Comités de de Ética Asistencial y las repercusiones jurídicas de sus informes / Legal repercussions of Clinical Ethics Committees reports

Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.