Avoiding rejections by European ethics committees.
The Competent Authority has been notified. The clinical investigator is anxious to begin. Just when the process of conducting a clinical investigation is proceeding as planned, the ethics committee issues an unfavourable opinion. This article discusses the actions that should be taken to avoid this occurrence and how to meet other requirements related to ethics committees.
Donawa
Maria
M
Donawa & Associates Ltd, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D003187:Compliance; D030881:Disclosure / Q000331:legislation & jurisprudence / Q000592:standards*; D004282:Documentation; D004864:Equipment and Supplies / Q000592:standards*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards*; D005062:European Union; D012941:Social Responsibility