Critical review of informed consent and autonomy in the context of biomedical research in developing countries

Lecture at the VIII Annual Symposium on Biomedicine, Ethics and Society. June 12-13, 2006, Sandhamn (Sweden). Centre for Bioethics at Karolinska Institutet & Uppsala university, in collaboration with the Nordic Committee on Bioethics.The emphasis put on informed consent reveals how autonomy has increasingly been considered the most important ethical principle at the possible expense of other values and principles. The symposium Rethinking Informed Consent: The limits of autonomy invited scientists and scholars from both philosophy and clinical/research settings to address these issues in order to identify the limits of informed consent in protecting the diversity of interests of patients and research subjects. More specifically, the symposium aimed to critically examine the ‘standard view’ of informed consent in health care and biomedical research, in terms of both its philosophical underpinnings and the practical difficulties encountered in applying it in real-life situations, and to develop well-argued positions on alternative forms of information and consent procedures, or alternatives to informed consent, for situations where the standard form seems less than adequate. This contribution focuses on critical review of informed consent and autonomy in the context of biomedical research in developing countries, considering the vulnerability of patients as an important determinant of biomedical research.Esta contribución se centra en el análisis de las dificultades asociadas con la investigación biomédica en países en desarrollo, donde aspectos básicos de los protocolos de investigación resultan muy condicionados por el contexto de vulnerabilidad generalizada del que proceden los pacientes y sujetos. En particular, la exigencia de respeto a la autonomía individual se ve sometida a múltiples tensiones derivadas tanto de la situación de vulnerabilidad de la población en aspectos objetivos (nivel de vida, educación, etc.) como del marco de referencia cultural con el que afrontan procesos cotidianos en su comunidad relacionados con la salud.With financial support from the Vårdal Foundation for Health Care and Allergy Research and Riksbankens Jubileumsfond (the Bank of Sweden Tercentenary Foundation). Läkartidningen (the Journal of the Swedish Medical Association) contributed with advertisement. The VIII Annual Symposium on Biomedicine, Ethics and Society was held on June 12-13 2006 in Sandhamn, Sweden. http://www.crb.uu.se/symposia/2006