Frontiers in Pediatrics | |
Understood Consent Versus Informed Consent: A New Paradigm for Obtaining Consent for Pediatric Research Studies | |
Alan F. Isles1  | |
关键词: informed consent; understood consent; readability; conflicts of interest; developing countries; | |
DOI : 10.3389/fped.2013.00038 | |
学科分类:儿科学 | |
来源: Frontiers | |
【 摘 要 】
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.
【 授权许可】
CC BY
【 预 览 】
Files | Size | Format | View |
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RO201904026678557ZK.pdf | 416KB | download |