| 关于加强临床试验招募广告伦理审查的探讨 |
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| 引用本文： | 林颖,周谏开. 关于加强临床试验招募广告伦理审查的探讨[J]. 中国处方药, 2014, 0(9): 1-3 |
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| 作者姓名： | 林颖 周谏开 |
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| 作者单位： | 中山大学附属第一医院药学部,广州510080 |
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| 摘 要： | 招募受试者的广告须经伦理委员会审查和批准之后方可使用。其形式和招募的途径多样化。国内的招募广告伦理审查主要存在以下问题：相应的伦理审查法律法规不完善;临床试验相关人员重视度不够;招募广告自身的缺陷等。审查招募广告的要点包括发放媒介及其主要内容。针对招募广告伦理审查存在的问题,建议通过完善法律和各项规章制度、提高审查招募广告的意识和加强监督管理,以提高招募广告伦理审查水平,更好地保障受试者安全和权益。
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| 关 键 词： | 临床试验 招募广告 伦理审查 伦理委员会 受试者 |
The preliminary exploration and reflection on strengthening the ethics rview of advertising for clinical trial |
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| LIN Ying,ZHOU Jian-kai. The preliminary exploration and reflection on strengthening the ethics rview of advertising for clinical trial[J]. China Prescription Drug, 2014, 0(9): 1-3 |
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| Authors: | LIN Ying ZHOU Jian-kai |
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| Affiliation: | ( the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China.) |
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| Abstract: | Advertisement of recruiting subjects must be reviewed and approved by IEC before it can be used. The forms and recruiting ways are diversified. The main problem of the ethic review of advertising is as follows： the laws and regulations of ethics review are not perfect, the relevant personnel of clinical pay insufficient attention to the review of advertising and its own deficiencies. The points of review recruitment advertisement is its mass media for handing out and main contents. In view of the existing problems, suggestions are given to improve the review level of advertising and protect the rights and interests of subjects by improving the rules and regulations of the review of advertisement, enhancing the awareness of reviewing advertising and strengthening the supervision and management. |
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| Keywords: | Clinical trial Recruitment advertising Ethic review IEC Subjects |
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