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Consideraciones éticas en intervenciones comunitarias: la pertinencia del consentimiento informado

  • Autores: Rosa María Aguilera Guzmán, Liliana Mondragón Barrios, María Elena Medina-Mora Icaza
  • Localización: Salud mental, ISSN 0185-3325, Vol. 31, Nº. 2, 2008, págs. 129-138
  • Idioma: español
  • Títulos paralelos:
    • Ethical considerations in community interventions: the pertinence of informed consent
  • Enlaces
  • Resumen
    • español

      A pesar de que la bioética surge en la década de 1970, bajo el imperativo del discurso biomédico, su desarrollo como disciplina que reflexiona sobre el comportamiento humano en torno a la salud ha permitido la reunión de varios saberes, entre ellos, la aportación de las ciencias sociales en dicho campo. De esta forma, la bioética se ocupa de los dilemas que pueden presentarse en los estudios sociales sobre salud (adicciones, violencia, migraciones), incluso en aquellos que, por cuestiones de interés común, son de tipo binacional o multicéntrico.

      Los objetivos de este artículo son sistematizar y exponer algunas implicaciones de la pertinencia y adecuación del consentimiento informado (CI) en un estudio binacional México–Estados Unidos sobre salud mental y migración. Además, se aportan elementos de análisis para la detección de dilemas éticos en estas intervenciones comunitarias en salud mental en México. De esta forma, se intenta responder a las siguientes preguntas:

      En el contexto de una investigación binacional, ¿cómo encarar el principio de autonomía y la noción de "voluntariedad", insertos en el requerimiento de un consentimiento informado, en intervenciones de salud mental pública en comunidades rurales mexicanas? ¿Es posible respetar la manera en que los participantes del país anfitrión toman decisiones y cubrir, al mismo tiempo, las exigencias del comité de ética del país patrocinador? Para allegarse los elementos de análisis, se expone someramente la conceptualización de los vocablos ética y bioética, y se abordan algunos postulados planteados tanto de la bioética norteamericana como de la europea, además de aproximarnos a otras posturas bioéticas.

      Por otro lado, se revisan los principales aportes de los diversos códigos, declaraciones e informes internacionales, incluidas las recomendaciones de la Comisión Nacional de Bioética de México, que norman el proceso del consentimiento informado (CI) en investigación social. El CI es un "proceso social que, a través de un intercambio activo y respetuoso, brinda información sobre la investigación en forma comprensible para el sujeto, permite cerciorarse de que la entienda y tenga opción de preguntar y recibir respuestas a sus dudas, brinde oportunidad para negarse a participar o manifestar voluntad de colaborar y pueda expresarla oralmente o firmar un formulario, sin haber sido sometido a coerción, intimidación ni a influencias o incentivos indebidos".

      En este sentido, el proceso de consentimiento informado (PCI) protege la libertad de elección del individuo y el respeto de su autonomía. Por ello, también se debe considerar el contexto de desarrollo de grupos culturales diversos al del investigador, sus tradiciones en cuanto a comunicación y decisión, y se deben respetar estos procedimientos.

      En la investigación social, como en ninguna otra, la puesta en práctica de la normatividad del PCI es muy variada, debido a que se trabaja con sectores dispuestos a participar (prostitutas, usuarios de drogas, primo–delincuentes, etc.) a condición de no firmar ningún consentimiento escrito, lo que otorga prioridad a la calidad de la relación establecida y no sólo al formato.

      Este documento expone la reflexión sobre algunos dilemas éticos que se presentaron durante una investigación social cuyo objetivo fue identificar los malestares emocionales asociados a la migración internacional México–EUA y la utilización de servicios de salud mental. Específicamente, el análisis ético se centra en la información recabada en el trabajo de campo por medio de la técnica observación participante, en una comunidad rural en el estado de Michoacán.

    • English

      Ethics, understood as the study of moral norms in terms of its assumptions, origins, and changes over time, systematizes similarities and differences between various moral codes. It therefore serves as a meeting point between different perspectives, through dialogue, a fundamental characteristic of this discipline. One of its derivations, as applied ethics, is bioethics, defined by Van Rensselaer Potter as "New knowledge that provides knowledge on how to use knowledge for the good of society".

      Although bioethics emerged in the 1970s under the imperative of medical discourse, its development as a discipline reflecting human behavior surrounding health has permitted the combination of various types of knowledge, including the contribution of social sciences in this field. Thus bioethics deals with the dilemmas that may arise in social studies on health (such as addictions, violence and migrations).

      The aims of this manuscript are to systematize and explain some of the implications of the pertinence and adaptation of informed consent (IC) in a bi–national Mexico–United States study on mental health and migration. It also provides elements of analysis for the detection of ethical dilemmas in these community interventions in mental health in Mexico. It therefore attempts to answer the following questions:

      Within the context of bi–national research, how does one deal with the principle of autonomy and the notion of "voluntariness" included in the requirement of informed consent, in public mental health interventions in Mexican rural communities? Is it possible to respect the way participants in the host country make decisions while at the same time, meeting the demands of the ethics committee of the sponsor country? In order to arrive at the elements of analysis, the authors briefly explain the conceptualization of the terms ethics and bioethics, and explore some of the postulates put forward in both North American (principalism and casuism) and European bioethics (communitarianism), in addition to approaching other bioethical positions (ethics of responsibility and protection), by highlighting certain cultural elements that particularize the world views that give rise to the aforementioned ethical approaches.

      At the same time, the authors review the principal contributions of the various international codes, declarations and reports, including recommendations by the National Commission of Bioethics of Mexico that regulate the process of Informed Consent (IC) in Social Research. IC is a social process which, through active, respectful exchange provides information on research in a comprehensible way for the subject, in such a way that he is aware of the risks, benefits, consequences or problems that may occur during research. The researcher must ensure that the participant has properly understood all the information related to the project, has the opportunity to ask and be given answers to his doubts and is aware of his right to dissent (not adjust to someone's feeling or opinion) or express his will to collaborate by consenting (to allow or agree to something being done) without having been subjected to coercion, intimidation or undue influences of incentives. The process of informed consent (IC) is essentially verbal, and without underestimating this fact, given the importance of the decision about to be taken, as happens when one agrees to take part in a research project, it is sometimes necessary to leave a written record of this.

      In this respect, the process of informed consent consists of three elements: information, understanding and voluntariness. In itself, it involves the protection of the individual's freedom of choice and respect for his autonomy. One should therefore consider the context of development of different cultural groups from that of the researcher and his traditions regarding communication and decision and these procedures must be respected.

      The study also includes aspects that have rarely been discussed in the process of informed consent (PIC) such as the need to clarify the type of relationship and exercise of power that may occur between the researcher and the person being researched, the lack of questioning about whether the commitment acquired by the researcher to respect the participants' autonomy during the PIC helps or prevents people from regarding themselves as rights–holders. Finally, the study highlights the fact that, although social research is considered of "minimum risk", the information provided in the PIC may cause emotional distress classified as "psychological risks" such as stress anxiety, fear or lack of tranquility.

      In social research, as in no other, the implementation of PIC normative approach is extremely varied, due to the fact that one works with sectors prepared to participate (prostitutes, drug users, first–time offenders, etc.) on the condition that they will not sign any informed consent, thereby giving priority to the quality of the relationship established, rather than the format.

      This manuscript explains the reflection on certain ethical dilemmas that arose during a social research project, the aim of which was to identify the emotional distress associated with Mexico–United States international migration and the use of mental health services. The ethical analysis specifically focuses on the information obtained during the field work through the participatory observation technique, in a rural community in the state of Michoacan.

      The main conflictive situations experienced due to the notion of voluntariness and the principle of autonomy underpinning PIC include:

      • The fact that for some residents, discussing certain issues related to public mental health such as alcohol and drug consumption may be interpreted as "disloyalty" to their community and constitutes sufficient grounds for not participating.

      • Understanding that some researchers suffer the consequences of their colleagues' mistakes, as borne out by another of the arguments given for not participating: " We are fed up of fly–by–night researchers, who just come in, obtain their data and are never seen in the community again". It is also worth reflecting on whether this argument reflects a questioning of the researcher's authority and/or a loss of faith in social progress through science, but how can one speak of social progress with the residents of communities that lack drainage and electricity?


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