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. 2008 Mar;13(3):181-4.
doi: 10.1093/pch/13.3.181.

The ethics of using innovative therapies in the care of children

Ayman Al Eyadhy  1 , Saleem Razack
Affiliations

The ethics of using innovative therapies in the care of children

Ayman Al Eyadhy et al. Paediatr Child Health. 2008 Mar.

Abstract
in English, French

An innovative therapy is a newly introduced or modified therapy with unproven effect or side effect, and is undertaken in the best interest of the patient. The ethical use of innovative therapies has been controversial. In paediatrics, the conflict between withholding potential rescue therapy and protecting a vulnerable population's rights and welfare must be considered. Therefore, it is necessary to ensure that this innovation is conducted within an ethical framework that recognizes that the therapy is not standard. This should integrate the patient's autonomy, the role of the institution, professional consensus and innovation evaluation. Innovative therapy represents a justifiable departure from inferior conventional therapy in the absence of an accepted standard therapy. Innovation shares with research its experimental nature, but differs from research in its goal and context that exempts innovative therapy from direct governance by research ethics board. Innovative therapy is part of the continuum of hypothesis generation in the advancement of medical knowledge, and its evaluation is a transforming point for clinical research.

Une thérapie novatrice est une thérapie qui vient d’être adoptée ou qui a été modifiée, qui est entreprise dans l’intérêt supérieur du patient et dont les résultats ou les effets secondaires ne sont pas démontrés. L’utilisation éthique des thérapies novatrices est controversée. En pédiatrie, il faut tenir compte du conflit entre le non-recours à une thérapie de rattrapage potentielle et la protection des droits et du bien-être d’une population vulnérable. Par conséquent, il faut s’assurer d’utiliser cette innovation dans un contexte éthique qui tient compte du caractère non standard de la thérapie. Dans le cadre de cette démarche, il faut intégrer l’autonomie du patient, le rôle de l’établissement, le consensus professionnel et l’évaluation de l’innovation. La thérapie novatrice représente une dérogation justifiable à une thérapie classique inférieure en l’absence d’une thérapie standard. À l’instar de la recherche, l’innovation est de nature expérimentale, mais ses objectifs et ses contextes diffèrent, car les recherches novatrices ne sont pas régies directement par un comité d’éthique de la recherche. La thérapie novatrice fait partie du continuum de formulation d’hypothèses pour faire progresser les connaissances en médecine, et son évaluation est un point de transformation de la recherche clinique.

Keywords: Child health; Ethics; Innovation; Review; Therapy.

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Figures

Figure 1
Figure 1
Interaction among innovative therapy, clinical research, patient’s autonomy, professional consensus and the role of institutional standardization to form an ethical framework
See this image and copyright information in PMC

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