%A Isles,Alan %D 2013 %J Frontiers in Pediatrics %C %F %G English %K Informed Consent,understood consent,readability,conflicts of interest,Teach back methodology %Q %R 10.3389/fped.2013.00038 %W %L %M %P %7 %8 2013-November-21 %9 Perspective %+ Prof Alan Isles,Royal Children's Hospital,Respiratory Medicine,Herston Road,Herston,Brisbane,4075,Queensland,Australia,IslesA@health.qld.gov.au %+ Prof Alan Isles,University of Queensland,Brisbane,Australia,IslesA@health.qld.gov.au %+ Prof Alan Isles,Queensland Children's Medical Research Institute,Royal Children's Hospital,Herston Rd,Herston,Brisbane,Australia,IslesA@health.qld.gov.au %# %! Improving informed conset processes in pediatric research %* %< %T Understood Consent Versus Informed Consent: A New Paradigm for Obtaining Consent for Pediatric Research Studies %U https://www.frontiersin.org/articles/10.3389/fped.2013.00038 %V 1 %0 JOURNAL ARTICLE %@ 2296-2360 %X 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.