The length of consent documents in oncological trials is doubled in twenty years
The length of consent documents in oncological trials is doubled in twenty years
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DOI：
10.1093/annonc/mdn623
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发表时间：
2009-02-01
影响因子：
50.5
通讯作者：
Loge, J. H.
中科院分区：
文献类型：
--
作者：
Berger, O.;Gronberg, B. H.;Loge, J. H.
背景：该研究的目的是调查肿瘤学试验的知情同意文件(ICD)的长度是否从1987年到2007年增加，并分析ICD的内容。设计：总共分析了1987年至2007年挪威中部地区医学和卫生研究伦理区域委员会(REC)批准的87份ICD。根据ICDS的国际和区域经济共同体指南，编制了17项基本内容(基本医疗和伦理方面)和30项正式内容(司法方面、融资、保险和数据存储)的清单。结果：ICD的平均长度从1987-1990年的338(276-464)字增加到2005-2007年的1087(399-2345)字。在同一时期，部件的数量从9个增加到25个。基本部分从1987-1989年的7个稳步增加到2005-2007年的14个，而与手续有关的部分从2个大幅增加到11个。结论：文件的复杂性，特别是关于手续的更多信息，是ICDS长度增加的原因。这种发展越来越需要有能力的读者，并可能禁止真正知情的同意。
Background: The aim of the study was to investigate whether the length of informed consent documents (ICDs) for oncological trials have increased from 1987 to 2007 and analyze the content of the ICDs.Design: In total, 87 ICDs from oncological trials approved by the Regional Committee for Medical and Health Research Ethics (REC) in the central region of Norway from 1987 to 2007 were analyzed. A list of 17 basic (fundamental medical and ethical aspects) and 30 formal (juridical aspects, financing, insurance and storage of data) content components was constructed based upon international and REC guidelines for ICDs. The number of words and presence of components were registered for all ICDs.Results: The mean length of the ICDs increased from 338 (range 276-464) words in 1987-1990 to 1087 words (range 399-2345) in 2005-2007. The number of components increased from nine to 25 during the same period. Basic components increased steadily from seven in 1987-1989 to 14 in 2005-2007 while the components concerning formalities increased substantially from two to 11.Conclusions: The increased length of the ICDs is explained by an increased complexity of the documents and especially more information about formalities. This development increasingly demands competent readers and might prohibit truly informed consents.