Research with stored biological samples - What do research participants want?
Research with stored biological samples - What do research participants want?
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DOI：
10.1001/archinte.165.6.652
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发表时间：
2005-03-28
影响因子：
--
通讯作者：
Wendler, D
中科院分区：
文献类型：
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作者：
Chen, DT;Rosenstein, DL;Wendler, D
背景：关于使用储存的生物样本进行研究所需的同意类型存在广泛的分歧。许多人认为，为了尊重个人，未来的每一次使用都需要征得同意。其他人担心这种方法可能会阻碍重要的研究。Magnuson临床中心，美国国立卫生研究院，2000年1月1日至2002年5月31日之间，为未来的研究与参与者的生物样本提供选择。研究参与者是健康的志愿者，受影响的个人的家庭成员，并与广泛的医疗条件的个人参加临床研究studies，并没有直接的医疗benefit.Results的前景：总体而言，87.1%的研究参与者给予的选择，选择授权任何医疗条件的未来研究。超过85%的人允许他们储存的生物样本在未来进行无限制的研究，无论性别、年龄、地理位置，也无论个人是否受到正在研究的疾病的影响，还是健康的志愿者。只有6.7%的人选择拒绝所有未来的研究。虽然非洲裔美国人不太可能允许未来的研究，75.0%的非洲裔美国人仍然授权无限的未来研究与他们的samples.Conclusions：大多数研究参与者授权无限的未来研究使用他们的生物样本时，有机会这样做。这些发现表明，为研究参与者提供一个简单的二元选择来授权或拒绝所有未来的研究可能会允许个人控制他们的样本的使用，简化同意书，并允许重要的研究进行。
Background: There is widespread disagreement about the type of consent needed for research with stored biological samples. Many believe consent for each future use is required to respect individuals. Others worry this approach may block important research.Methods: We analyzed 1670 consent forms signed by research participants at the Warren G. Magnuson Clinical Center, National Institutes of Health, between January 1, 2000, and May 31, 2002, that offer options for future research with participants' biological samples. The research participants were healthy volunteers, family members of affected individuals, and individuals with a broad range of medical conditions enrolled in clinical research studies with and without the prospect of direct medical benefit.Results: Overall, 87.1% of research participants given the option chose to authorize future research on any medical condition. More than 85% permitted unlimited future research with their stored biological samples regardless of sex, age, geographic location, or whether the individual was affected by the disease being studied or a healthy volunteer. Only 6.7% of those given the option to refuse all future research did so. Although African Americans were less likely to permit future research, 75.0% of African Americans still authorized unlimited future research with their samples.Conclusions: Most research participants authorize the unlimited future research use of their biological samples when given the opportunity to do so. These findings suggest that providing research participants with a simple binary choice to authorize or refuse all future research might allow individuals to control use of their samples, simplify consent forms, and allow important research to proceed.