Benster R, Pollock A M
University College, London.
Public Health. 1993 Jan;107(1):3-7. doi: 10.1016/s0033-3506(05)80486-x.
A multicentre population research study was undertaken, involving ethical approval from 28 local research ethics committees. The major problems encountered were delays, which fell into three categories: requests to complete separate application forms, delay in processing applications and additional requests for patient and consultant consent. We examine these sources of delay in the context of the recently published DoH guidelines for local research ethics committees. Our findings reveal that there is not only an absence of adequate guidelines for multicentre research studies but that the new guidelines for local research ethics committees fail to distinguish between patient research and the population study.
开展了一项多中心人群研究，获得了28个当地研究伦理委员会的伦理批准。遇到的主要问题是延误，这些延误分为三类：要求填写单独的申请表、申请处理延误以及对患者和会诊医生同意的额外要求。我们根据最近发布的卫生部针对当地研究伦理委员会的指南来审视这些延误的原因。我们的研究结果表明，不仅缺乏针对多中心研究的充分指南，而且针对当地研究伦理委员会的新指南未能区分患者研究和人群研究。
