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IRB ; 38(6): 1-9, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-30088377

RESUMEN

Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of whether, to satisfy the ethical and legal norms of consent for research, participants in pediatric studies who attain the age of majority after their parents or guardians enrolled them in a study should be "recontacted" to obtain their consent to remain in the study. Using three different contexts (longitudinal studies, clinical trials, and newborn screening), we argue that distinctions should be made between the risks and benefits involved in recontacting for consent before determining the potential duties of researchers. An obligation to recontact should always be balanced with the feasibility and cost of such efforts in each particular research context and with consideration for the existence or lack of an ongoing relationship with the participant.


Asunto(s)
Deber de Recontacto/ética , Consentimiento Informado/ética , Pediatría/ética , Sujetos de Investigación , Factores de Edad , Ensayos Clínicos como Asunto/ética , Comités de Ética en Investigación/ética , Comités de Ética en Investigación/organización & administración , Humanos , Recién Nacido , Estudios Longitudinales , Tamizaje Neonatal/ética
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