title: Understood consent versus informed consent: a new paradigm for obtaining consent for pediatric research studies.
abstract: All too often the informed consent process is viewed by members of research teams as a challenge of getting a parent or young person's signature on a form. Informed consent is, however, much more than a signed form. Rather, it is a process, often iterative, in which the parent or young person is given sufficient information about a study in order that they can make a truly informed decision about participation. Substantial effort is required in producing appropriately formatted and readable documents using plain language at about Grade 6 or 12-year old reading level. Achieving truly understood consent involves the researcher spending significant one-on-one time with the parent or young person explaining in simple language what is proposed and then using so-called repeat-back techniques to test the understanding of the participants. This is critically important if the research involves randomization to different treatments or use of a placebo arm and, in particular if the research involves more than minimal risk.
authors.affiliation: Royal Children's Hospital , Brisbane, QLD , Australia ; University of Queensland , Brisbane, QLD , Australia ; Queensland Children's Medical Research Institute , Brisbane, QLD , Australia.
authors.forename: Alan F
authors.initials: AF
authors.lastname: Isles
keywords: conflicts of interest; developing countries; informed consent; readability; understood consent