Ethical Overview of Placebo Control in Psychiatric Research - Concepts and Challenges.
Psychiatr Danub
; 27(2): 118-25, 2015 Jun.
Article
en En
| MEDLINE
| ID: mdl-26057306
ABSTRACT
Permissibility of placebo controls in psychiatric research is raising everlasting controversies. The main ethical issue remains whether, when, under what conditions, and to what extent is it justifiable to disregard subject's present (best) interest for the presumably "greater" ones. In relation to this main ethical concern, two distinct arguments arose proponents of placebo controls trials (placebo ortxodoxy) and proponents of active controls trials (active-control orthodoxy). More recently, in new ethical guidelines, Declaration of Helsinki and International Ethical Guidelines for Biomedical Research Involving Human Subjects, a "middle way" approach was formulated, acceptable to both sides of the argument, saying placebo controls can be justified under certain conditions when and only when, they firstly present undisputed methodological reasoning, and secondly, fulfill certain ethical considerations - mainly regarding the permissibility of accompanied risks. These ethical evaluations are inevitably contextual and evoke the need for the principle of proportionality. In scope of recent findings of substantial and progressively increasing placebo response in psychiatric research, contextual factors are identified and both theoretical and practical challenges are discussed.
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Base de datos:
MEDLINE
Asunto principal:
Placebos
/
Psiquiatría
/
Guías de Práctica Clínica como Asunto
/
Ensayos Clínicos Controlados como Asunto
/
Investigación Biomédica
/
Declaración de Helsinki
Tipo de estudio:
Clinical_trials
/
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
Psychiatr Danub
Asunto de la revista:
PSIQUIATRIA
Año:
2015
Tipo del documento:
Article