Patients' refusal to consent to storage and use of samples in Swedish biobanks: cross sectional study
Patients' refusal to consent to storage and use of samples in Swedish biobanks: cross sectional study
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DOI：
10.1136/bmj.a345
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发表时间：
2008-07-26
影响因子：
--
通讯作者：
Helgesson, Gert
中科院分区：
文献类型：
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作者：
Johnsson, Linus;Hansson, Mats G.;Helgesson, Gert
目的估计有多少人反对在瑞典卫生保健中收集的生物样本的储存及其在研究中的使用，以及有多少人撤回先前的同意。2005-6.每年从21个县中的20个县获得140万份生物库样本的拒绝同意的人口数据。结果690例中约1例患者拒绝同意储存或使用其样本;约1/1600例患者通过填写异议表确认其决定。6200名患者中约有1人希望限制其使用，而不是销毁样本。那些谁以前同意，约1/19 000撤回他们的consent.Conclusions拒绝同意在瑞典的生物库研究是罕见的，和个人的利益和研究利益不需要在矛盾。瑞典医疗保健组织目前有义务获得同意或拒绝使用每份样本的每一种可能性，并将同意研究作为默认立场。一个假定同意的系统，直接选择退出;将符合人们的态度，在他们的行动中表达，对生物库研究。
Objectives To estimate how many people object to storage of biological samples collected in health care in Sweden and to their use in research and how many withdraw previous consent.Design Cross sectional study of register data.Setting Biobanks used in Swedish health care, 2005-6.Population Data on refusal to consent were obtained for 1.4 million biobank samples per year from 20 of 21 counties.Main outcome measures Rates of preliminary refusal to consent, confirmed refusal, and withdrawal of consent.Results Patients refused consent to either storage or use of their samples in about 1 in 690 cases; about 1 in 1600 confirmed their decision by completing a dissent form. Rather than having the samples destroyed, about 1 in 6200 patients wanted to restrict their use. Of those who had previously consented, about 1 in 19 000 withdrew their consent.Conclusions Refusal to consent to biobank research in Sweden is rare, and the interests of individuals and research interests need not be at odds. The Swedish healthcare organisation is currently obliged to obtain either consent or refusal to each potential use of each sample taken, and tack of consent to research is used as the default position. A system of presumed consent with straightforward opt out;would correspond with people's attitudes, as expressed in their actions, towards biobank research.