Understood Consent Versus Informed Consent: A New Paradigm for Obtaining Consent for Pediatric Research Studies

Frontiers in Pediatrics

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