Risk evaluation and ethical review of investigator-initiated trials
JIANG Xue-wei
CAO Jiang
LIANG Bei-bei
CAI Yun
WANG Jin
WANG Rui
BAI Nan
Abstract：There exist defects in the supervision and conduction of investigator-initiated clinical trials,because they are mainly reviewed and approved by ethics committees/institutional review boards (EC/IRB).And the mission of EC/IRB is to evaluate risk and protect participants.Subjects who attend clinical studies will suffer potential psychological harm,privacy/legal harm,financial harm and health/physical harm.The risks are classed into four grades,which are not more than minimum risk,minor increase over minimal risk,moderate risk and high risk.The ethics committees should have a risk-based review when reviewing investigator-initiated trials,consider the possible risks brought by the research contents and interventions,and comprehensively evaluate the research risks from the perspectives such as investigators' qualification,subject selection,foundation laid by previous work,interventions and emergency plans.This article explored how ethics committees perform risk-based review on investigator-initiated trials including off-label use drug research,clinical research in special populations,clinical application of new medical technologies and clinical research of no less than the minimum risk.
Keywords：investigator-initiated trialsbiomedical researchrisk evaluationethical review
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2714-2718 )