Survey and Suggestion for Ethical Review of Paediatric Clinical Trials / 中国医学伦理学

ABSTRACT

This article surveyed the protocols and informed consent forms of 15 paediatric clinical trials which had been reviewed by the hospital′s institutional research board from 2008 to 2013 .This survey reevaluated and made suggestions on the protocols and informed consent forms, focusing on the risk level, protocol design back-ground, risk minimization measures, the required elements as well as the language expressions of informed consent forms and finding out the shortage of informed consent and give appropriate advices.