Child's objection to non-beneficial research: capacity and distress based models.
A child's objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child's objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child's assent in research. In the second part we distinguish and analyze two models of a child's objection to research: the capacity-based model and the distress-based model. In the last part we present arguments for a broader and unified understanding of a child's objection within regulations and practices. This will strengthen children's rights and facilitate the entire process of assessment of research protocols.
Department of Philosophy and Bioethics, Faculty of Health Science, Jagiellonian University, Medical College, Michałowskiego 12, 31-126, Krakow, Poland. waligora.marcin@gmail.com.
Marcin
http://orcid.org/0000-0002-1553-1416
M
Waligora
Department of Ethics, Institute of Philosophy, University of Warsaw, Krakowskie Przedmieście 3, 00-927, Warsaw, Poland.
Joanna
J
Różyńska
Department of Philosophy and Bioethics, Faculty of Health Science, Jagiellonian University, Medical College, Michałowskiego 12, 31-126, Krakow, Poland.
Jan
J
Piasecki
D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D003657:Decision Making; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D016743:Mental Competency; D010372:Pediatrics / Q000941:ethics; D035842:Research Subjects / Q000523:psychology*
Assent; Children; Dissent; Incompetent subjects; Non-beneficial research; Pediatrics; Proxy consent; Vulnerable subjects