儿科临床研究知情同意书完整性调查分析

Investigation and analysis of the integrity of informed consent form for minors in the clinical trial

目的调查儿科临床研究知情同意书的完整性。方法制定知情同意审查要素表,对我院伦理委员会在2012年至2015年受理的43个临床试验项目的知情同意书进行整理分析,统计各要素的缺失情况,并调阅各项目的初始审查伦理意见书,分析伦理审查关注点。结果 2014,2015年的知情同意书完整性>60%的比率分别为87.50%,100.00%,与2012-2013年的54.54%比较,差异均有统计学意义(P<0.05),但2014年与2015年的知情同意书完整性比较差异无统计学意义(P>0.05)。监护人版的知情同意书中,药物类的完整性在80%以上的占57.69%,器械类与体外诊断试剂均没有完整性在80%以上的项目,差异有统计学意义(P<0.01);未成年人版知情同意书全部来自于药物类,完整性均在60%以上,在80%以上的占45.45%。国外申办方(主要是欧美地区的公司)的优良率在100.00%,而国内的优良率仅为33.33%,差异有统计学意义(P<0.01)。知情同意书主要缺失的要素与会议审查关注点基本相符,缺少儿童适用的知情同意书及儿童应签署知情同意的年龄。结论提高知情同意书的质量,设计未成年人受试者及监护人适用的知情同意书,才能更好地保护受试者权益,从而促进儿科临床研究的发展。

Objective To study the integrity of informed consent form（ ICF） for the minors. Methods The ICFs of 43 clinical trials conducted in our hospital during 2012 to 2015 were collected to study the missing rate of elements according to the elements list of ICF arranged by our hospital medical ethics committee. Initial review notification letters were consulted to analyze the concerns of ethical review. Results The ratios of ICF integrity（ 〉60%） were 54. 54%,87. 50% and 100. 00%respectively in 2012- 2013,2014 and 2015. Compared with the integrity in 2012- 2013,there were significantly different（ P〈0. 05）. There was no statistically significant difference between the integrity in 2014 and2015（ P〈0. 05）. In ICFs of legal guardian,there was statistically significant difference among drug,medical instrument and in vitro diagnostic regen clinical trial（ P〈0. 01）. The ratio of ICF integrity（ 〉80%） was57. 69% in drug clinical trial,and there were none in medical instrument and in vitro diagnostic regen clinical trial. The integrity of all the ICFs of the minors,which were all from drug clinical trial,were over 60%,and the ratio of the integrity（ 〉80%） was 45. 45%. The excellent and goodrate of foreign sponsors＇ ICFs integrity was 100%,and that of the domestic sponsors＇ was only 33. 33%. There was statistically significant difference between them（ P〈0. 01）. The major missing elements were consistent with the concerns of ethical review： the lack of special ICFs for the minors to read and the age group to obtain informed consent.Conclusion To improve the quality of ICFs and design the suitable ones for the minors will be good for protecting the rights and interests of subjects and promoting the development of clinical trial of minors.