本文選題：審查指南　切入點(diǎn)：倫理委員會(huì)　出處：《臨床兒科雜志》2017年09期

【摘要】：正兒科臨床研究方案設(shè)計(jì)應(yīng)嚴(yán)格遵循風(fēng)險(xiǎn)、不適和痛苦最小化原則。血樣采集數(shù)量、次數(shù)以及可能的痛苦和傷害是兒科研究者、家長(zhǎng)/監(jiān)護(hù)人、兒童以及倫理委員會(huì)最為關(guān)心的問題之一。目前關(guān)于兒童采血限量的直接證據(jù)很少,國(guó)內(nèi)尚未見相關(guān)指南報(bào)道。作者經(jīng)查詢世界衛(wèi)生組織(WHO)簡(jiǎn)報(bào)、美國(guó)著名兒童醫(yī)院的倫理審查指南以及美國(guó)北岸醫(yī)療集團(tuán)(North ShoreLIJ Health System)人體受試者保護(hù)指南等資料[1-10],
[Abstract]:The risk, discomfort and pain minimization principles should be strictly followed in the design of clinical studies in pediatrics. The number, frequency, and potential pain and injury of blood samples are pediatricians, parents / guardians, Children and one of the issues of greatest concern to the Ethics Committee. At present, there is very little direct evidence on children's blood intake limits, and no relevant guidelines have been reported in the country. The author has consulted the World Health Organization (WHO) briefing. Guidelines for Ethical Review of famous Children's Hospitals in the United States and guidelines for the Protection of Human subjects of North ShoreLIJ Health system [1-10],
【作者單位】： 浙江大學(xué)醫(yī)學(xué)院附屬兒童醫(yī)院;溫州醫(yī)科大學(xué);
【基金】：國(guó)家自然科學(xué)基金(No.81573516,81273607) 國(guó)家科技重大專項(xiàng)(No.2013ZX09303003)
【分類號(hào)】：R72
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本文編號(hào)：1691290