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人体非临床、非研究性MRI的记录与知情同意指南。

Guidelines for documentation and consent for nonclinical, nonresearch MRI in human subjects.

作者信息

Reeder Scott B, Kimbrell Vera, Owman Titti, Steckner Michael, Calamante Fernando

机构信息

Departments of Radiology, Medical Physics, Biomedical Engineering, Medicine, and Emergency Medicine, University of Wisconsin, Madison, Wisconsin, USA.

Brigham and Women's Hospital, Boston, Massachusetts, USA.

出版信息

J Magn Reson Imaging. 2017 Jan;45(1):36-41. doi: 10.1002/jmri.25333. Epub 2016 Jun 17.

DOI:10.1002/jmri.25333
PMID:27312969
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5164877/
Abstract

UNLABELLED

Magnetic resonance imaging (MRI) of human subjects is widely performed for clinical and research purposes. Clinical MRI requires a physician order, while research MRI typically requires an approved protocol from a local Institutional Review Board, as well as informed consent. However, there are several circumstances in which it is appropriate to perform MRI in human subjects, that constitute neither clinical nor research activities. Examples include clinical protocol development, training and teaching, and quality assurance testing. We refer to such activities as nonclinical, nonresearch MRI. The purpose of this document is to provide principles and guidelines for appropriate and safe use of MRI in human subjects for nonclinical, nonresearch purposes.

LEVEL OF EVIDENCE

1 J. Magn. Reson. Imaging 2017;45:36-41.

摘要

未标注

对人类受试者进行磁共振成像(MRI)广泛应用于临床和研究目的。临床MRI需要医生的医嘱,而研究性MRI通常需要当地机构审查委员会批准的方案以及知情同意书。然而,在几种情况下对人类受试者进行MRI检查是合适的,这些情况既不构成临床活动也不构成研究活动。例子包括临床方案制定、培训和教学以及质量保证测试。我们将此类活动称为非临床、非研究性MRI。本文档的目的是为在非临床、非研究目的下对人类受试者安全、适当地使用MRI提供原则和指南。

证据水平

1 J. Magn. Reson. Imaging 2017;45:36 - 41。

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本文引用的文献

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Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent.钆在齿状核和苍白球中的蓄积取决于造影剂的类别。
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