El marco normativo de la investigación biomédica en personas con demencia

Abstract

Dementia is one of the major causes of disability and dependency worldwide, with a negative physical, psychological, social, and economic impact. This circumstance has boosted biomedical research in persons with dementia and drawn the interest of other areas, like Law. This significant and controversial activity poses two main problems: the chance and appropriateness of the participation of persons with dementia in biomedical research, and the determination of the criteria and procedures for a sound process of decision-making. These problems have received several answers from the ethical, Soft Law and legal field throughout last years, bringing about an uneven and somehow confusing normative picture. The aim of this paper is to assess this regulation and present an interpretative proposal that supports the inclusion of persons with dementia in biomedical research, describes a decision-making process that improves the competence evaluation assessment, increases their participation, guides research activity, and guarantees the rights of persons with dementia and any other people involved.