Foster C, Holley S
Centre of Medical Law and Ethics, King's College London.
J R Coll Physicians Lond. 1998 May-Jun;32(3):242-5.
To generate baseline data about the experiences of researchers applying to five or more local research ethics committees (LRECs) for ethical review. The new multi-centre review system will be compared with these data.
Ninety-seven researchers, whose status as multicentre researchers was unclear, were identified from various sources in the South Thames Region. They were each sent a questionnaire asking for their views on the substance of ethical review and their experiences of the process of ethical review.
Of the completed questionnaires, 24 fitted the multicentre criteria of applying to five or more LRECs. Responses showed dissatisfaction with LRECs' treatment of the scientific aspects of research, but satisfaction with aspects relating to consent and protection of patients' welfare. Respondents experienced great difficulty in the administration of the process of ethical review.
The need for a new system of ethical review for multi-centre research is beyond doubt. It remains to be seen whether it will be an improvement.
获取关于向五个或更多地方研究伦理委员会（LREC）申请伦理审查的研究人员经历的基线数据。新的多中心审查系统将与这些数据进行比较。
从南泰晤士地区的不同来源识别出97名研究人员，其作为多中心研究人员的身份不明确。向他们每人发送一份问卷，询问他们对伦理审查实质内容的看法以及伦理审查过程的经历。
在完成的问卷中，24份符合向五个或更多LREC申请的多中心标准。答复显示对LREC对研究科学方面的处理不满意，但对与同意和保护患者福利相关的方面满意。受访者在伦理审查过程的管理中遇到很大困难。
多中心研究新的伦理审查系统的必要性毋庸置疑。它是否会有所改进还有待观察。
