title: Non-beneficial pediatric research: individual and social interests.
abstract: Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects.
authors: Department of Philosophy and Bioethics, Faculty of Health Sciences, Jagiellonian University, Medical College, Michalowskiego 12, 31-126, Kraków, Poland, jan.piasecki@uj.edu.pl.
authors: Jan
authors: J
authors: Piasecki
authors: Marcin
authors: M
authors: Waligora
authors: Vilius
authors: V
authors: Dranseika
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002648:Child; D026689:Ethical Analysis; D006801:Humans; D010372:Pediatrics / Q000941:ethics*; D035842:Research Subjects; D018570:Risk Assessment