Literature DB >> 27312969

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

Scott B Reeder1, Vera Kimbrell2, Titti Owman3, Michael Steckner4, Fernando Calamante5.   

Abstract

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.
© 2016 International Society for Magnetic Resonance in Medicine.

Entities:  

Keywords:  consent; magnetic resonance imaging; nonclinical; nonresearch; regulatory

Mesh:

Year:  2016        PMID: 27312969      PMCID: PMC5164877          DOI: 10.1002/jmri.25333

Source DB:  PubMed          Journal:  J Magn Reson Imaging        ISSN: 1053-1807            Impact factor:   4.813


  6 in total

1.  Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent.

Authors:  Alexander Radbruch; Lukas D Weberling; Pascal J Kieslich; Oliver Eidel; Sina Burth; Philipp Kickingereder; Sabine Heiland; Wolfgang Wick; Heinz-Peter Schlemmer; Martin Bendszus
Journal:  Radiology       Date:  2015-04-06       Impact factor: 11.105

2.  Progressive increase of T1 signal intensity of the dentate nucleus on unenhanced magnetic resonance images is associated with cumulative doses of intravenously administered gadodiamide in patients with normal renal function, suggesting dechelation.

Authors:  Yuri Errante; Vincenzo Cirimele; Carlo Augusto Mallio; Vincenzo Di Lazzaro; Bruno Beomonte Zobel; Carlo Cosimo Quattrocchi
Journal:  Invest Radiol       Date:  2014-10       Impact factor: 6.016

3.  Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging.

Authors:  Robert J McDonald; Jennifer S McDonald; David F Kallmes; Mark E Jentoft; David L Murray; Kent R Thielen; Eric E Williamson; Laurence J Eckel
Journal:  Radiology       Date:  2015-03-05       Impact factor: 11.105

4.  High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material.

Authors:  Tomonori Kanda; Kazunari Ishii; Hiroki Kawaguchi; Kazuhiro Kitajima; Daisuke Takenaka
Journal:  Radiology       Date:  2013-12-07       Impact factor: 11.105

5.  Acting on incidental findings in research imaging.

Authors:  J M Wardlaw; H Davies; T C Booth; G Laurie; A Compston; C Freeman; M O Leach; A D Waldman; D J Lomas; K Kessler; F Crabbe; A Jackson
Journal:  BMJ       Date:  2015-11-10

6.  An implementation framework for the feedback of individual research results and incidental findings in research.

Authors:  Adrian Thorogood; Yann Joly; Bartha Maria Knoppers; Tommy Nilsson; Peter Metrakos; Anthoula Lazaris; Ayat Salman
Journal:  BMC Med Ethics       Date:  2014-12-23       Impact factor: 2.652

  6 in total

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