Clinical Trials With Mentally Disabled Subjects: Ethical Issues in National and International Documents
La Clinica terapeutica 2010; 161(4): 365-73
This article summarises the key ethical considerations involved in performing clinical trials involving persons who cannot conscious, free and informed consensus. Criteria are considered, which are drawn from ethical codes, declarations, treaties, conventions, regulations and other documents and published by national, international, and supranational institutions and authorities. The article focuses on the evolution of attitudes regarding the evolution of participation of incapacitate people in clinical research--from their almost complete exclusion in the mid-twentieth century, partly because of serious historical violations of human rights, to a gradually acceptance that these "vulnerable" people could be involved in trials, provided that certain conditions were met. In particular, the problem of including incapacitated people in clinical trials during emergencies is also addressed.
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