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神经科学研究中正常志愿者脑部磁共振成像结果的高发生率及生物伦理学问题

The high incidence and bioethics of findings on magnetic resonance brain imaging of normal volunteers for neuroscience research.

作者信息

Hoggard N, Darwent G, Capener D, Wilkinson I D, Griffiths P D

机构信息

University of Sheffield, Sheffield, UK.

出版信息

J Med Ethics. 2009 Mar;35(3):194-9. doi: 10.1136/jme.2008.025502.

DOI:10.1136/jme.2008.025502
PMID:19251973
Abstract

BACKGROUND

We were finding volunteers for functional magnetic resonance imaging studies with abnormalities requiring referral surprisingly frequently. The bioethics surrounding the incidental findings are not straightforward and every imaging institution will encounter this situation in their normal volunteers. Yet the implications for the individuals involved may be profound. Should all participants have review of their imaging by an expert and who should be informed?

METHODS

The normal volunteers that were imaged with magnetic resonance (MR) which were reviewed by a consultant neuroradiologist. All participants completed a volunteer consent form in addition to a standard departmental MR safety screening form. The volunteer screening form requires the general practitioner details to be completed and asks the participant to consider closely the possibility and implications of finding an unexpected but potentially serious abnormality before signing.

RESULTS

525 different individuals were scanned as normal volunteers, the mean age was 35-years and 330 were males. Of these 525, 46 had definite significant abnormalities (8.8%), mean age 50-years.

CONCLUSION

We have found a high rate of incidental abnormalities amongst individuals participating in imaging studies at our institution. It is our current practice to inform the research study participant of the findings, counsel them and inform their primary care physician. We think that it is advisable for researchers utilising MR imaging of the brain to have access to trained neuroradiologists, a protocol in place to deal with this problem and take consent in a way that allows the participant to realise the possibility of an abnormal finding.

摘要

背景

我们发现,在功能磁共振成像研究中,需要转诊的异常情况在志愿者中出现的频率出奇地高。围绕偶然发现的生物伦理问题并不简单直接,每个成像机构在其正常志愿者中都会遇到这种情况。然而,这对相关个人的影响可能是深远的。所有参与者都应该由专家对其影像进行评估吗?应该告知谁?

方法

对接受磁共振成像(MR)检查的正常志愿者的影像由神经放射科顾问进行评估。除了标准的科室MR安全筛查表外,所有参与者都填写了志愿者同意书。志愿者筛查表要求填写全科医生的详细信息,并要求参与者在签字前仔细考虑发现意外但可能严重异常的可能性及影响。

结果

525名不同个体作为正常志愿者接受了扫描,平均年龄为35岁,其中330名为男性。在这525人中,46人有明确的显著异常(8.8%),平均年龄为50岁。

结论

我们发现在本机构参与成像研究的个体中,偶然异常的发生率很高。我们目前的做法是将检查结果告知研究参与者,为他们提供咨询,并通知他们的初级保健医生。我们认为,对于利用脑部MR成像的研究人员来说,最好能有经过培训的神经放射科医生,制定处理这一问题的方案,并以让参与者意识到可能出现异常发现的方式获得同意。

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