Perceptions of using biological materials in research

在过去几年中，提出了一些建议，说明应向正在考虑就与人类生物标本有关的研究和储存提供同意的受试者提供哪些信息。这主要是基于对哪些信息应该对受试者重要的理论评估。然而，关于这些建议是如何执行的，或者这些建议是否满足了受试者的信息需求，数据有限。在过去的一年里，我们进行了两项实证研究。 我们回顾了美国国立卫生研究院临床中心使用的258份同意书中对遗传学研究的描述。在54%的同意书中，遗传学/二次研究是研究的主要目的，而在46%的同意书中，它是研究的次要目的。只有67%的人提到是否会提供结果，只有62%的人讨论了任何基因特有的风险。少数同意书(20%)允许受试者从最多五种情况中选择如何将其样本用于二级研究，包括：允许或拒绝任何类型的二级研究(16%)、关于无关疾病的二级研究(7%)、关于可识别的样本(4%)、由其他研究人员(1%)、或者只有在再次联系受试者以获得额外同意之后(10%)。这些备选方案并不是相互排斥的；找到了五个备选方案类别的九种不同组合。这些特征表明，研究人员和/或IRBs没有以一致的方式接近使用生物样本进行基因研究的同意书。 我们刚刚完成了对美国5个医疗中心的1200名患者的调查，使用30分钟的电话采访来评估他们对遗传学研究的态度，并正在分析数据。

Over the last few years there have been a number of recommendations about what information should be given to subjects who are considering providing consent for the research related to and storage of human biological specimens. This is based primarily on theoretical assessments of what information should be important to subjects. However there are only limited data on how these recommendations are implemented or whether these recommendations address the informational needs of subjects. During the last year we conducted two empirical studies. We reviewed the description of genetics research in 258 consent forms used at the NIH Clinical Center. Genetics/secondary research was a major purpose of the study in 54% of these consent forms, while it was a minor purpose of the study in 46% of consent forms. Only 67% mentioned whether or not results would be provided and only 62% discussed any genetic specific risks. A minority of consent forms (20%) allow subjects to choose from up to five circumstances for how their samples could be used in secondary research including: the opportunity to permit or refuse secondary research of any kind (16%), on unrelated diseases (7%), on identifiable samples (4%), by other researchers (1%), or only after subjects were re-contacted for additional consent (10%). These options were not mutually exclusive; nine different combinations of the five option categories were found. These characteristics suggest that investigators and/or IRBs are not approaching consent forms for genetic research using biological samples in a consistent manner. We have just completed a survey of 1200 patients at 5 medical centers in the US using 30-minute telephone interviews to assess their attitudes towards genetics research and are in the process of analyzing the data.