The debate over research on stored biological samples -: What do sources think?
The debate over research on stored biological samples -: What do sources think?
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DOI：
10.1001/archinte.162.13.1457
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发表时间：
2002-07-08
影响因子：
--
通讯作者：
Emanuel, E
中科院分区：
文献类型：
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作者：
Wendler, D;Emanuel, E
背景：关于对储存的生物样本进行研究的知情同意的辩论具有巨大的科学意义。不幸的是，没有关于何时应该征得个人同意进行此类研究的个人态度的数据。方法：通过对504名居住在美国的个人进行电话调查来收集数据。研究了两个队列：(1)参与临床研究并提供生物样本的个人和(2)随机选择的医疗保险接受者，结果：在受访者中，65.8%的人要求对临床派生的个人识别样本进行研究；27.3%的人要求对临床派生样本的研究进行匿名。对于研究衍生的样本，如果样本保留个人识别码，29.0%的受访者会要求他们同意；如果样本在进行研究之前被匿名，12.1%的受访者会要求同意。此外，88.8%的人希望被告知临床意义不确定的结果，91.9%的人不会对未来对不同疾病的研究施加更大的保障。结论：目前关于使用储存的生物样本进行研究的做法和政策建议可能在几个方面与来源的偏好不一致。特别是，似乎大多数来源都想控制他们的样本是否用于研究目的，与将要研究的特定疾病无关，并希望收到临床意义不确定的结果。将需要进行后续研究，以评估当前数据的概括性。
Background: The debate over informed consent for research on stored biological samples has enormous scientific implications. Unfortunately, there are no data on individuals' attitudes regarding when their consent should be obtained for such research.Methods: Data were gathered using a telephone survey of 504 individuals living in the United States. Two cohorts were studied: (1) individuals who had participated in clinical research and contributed biological samples and (2) randomly selected Medicare recipients,Results: Of the respondents, 65.8% would require their consent for research on clinically derived, personally identified samples; 27.3% would require it for research on clinically derived samples that are "anonymized." For research-derived samples, 29.0% of the respondents would require their consent if the samples retain personal identifiers; 12.1% would require it if the samples are anonymized before the research is conducted. Also, 88.8% would want to be informed of results of uncertain clinical significance, and 91.9% would not impose greater safeguards on future research on a different disease.Conclusions: Current practice and policy recommendations regarding research using stored biological samples may be inconsistent with sources' preferences in several respects. In particular, it appears that most sources want to control whether their samples are used for research purposes, are not concerned with the particular disease that will be studied, and want to receive results of uncertain clinical significance. Follow-up research will be needed to assess the generalizability of the current data.