Document Detail


Incidental findings found in "healthy" volunteers during imaging performed for research: current legal and ethical implications.
MedLine Citation:
PMID:  20335427     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Incidental findings found in "healthy" volunteers during research imaging are common and have important implications for study design and performance, particularly in the areas of informed consent, subjects' rights, clinical image analysis and disclosure. In this study, we aimed to determine current practice and regulations concerning information that should be given to research subjects when obtaining consent, reporting of research images, who should be informed about any incidental findings and the method of disclosure. We reviewed all UK, European and international humanitarian, legal and ethical agencies' guidance. We found that the guidance on what constitutes incidental pathology, how to recognise it and what to do about it is inconsistent between agencies, difficult to find and less complete in the UK than elsewhere. Where given, guidance states that volunteers should be informed during the consent process about how research images will be managed, whether a mechanism exists for identifying incidental findings, arrangements for their disclosure, the potential benefit or harm and therapeutic options. The effects of incidentally discovered pathology on the individual can be complex and far-reaching. Radiologist involvement in analysis of research images varies widely; many incidental findings might therefore go unrecognised. In conclusion, guidance on the management of research imaging is inconsistent, limited and does not address the interests of volunteers. Improved standards to guide management of research images and incidental findings are urgently required.
Authors:
T C Booth; A Jackson; J M Wardlaw; S A Taylor; A D Waldman
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2010-03-24
Journal Detail:
Title:  The British journal of radiology     Volume:  83     ISSN:  1748-880X     ISO Abbreviation:  Br J Radiol     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-27     Completed Date:  2010-08-02     Revised Date:  2013-03-27    
Medline Journal Info:
Nlm Unique ID:  0373125     Medline TA:  Br J Radiol     Country:  England    
Other Details:
Languages:  eng     Pagination:  456-65     Citation Subset:  AIM; IM    
Affiliation:
Royal Free Hospital NHS Trust, Department of Radiology, Pond Street, London, UK. tombooth@doctors.org.uk
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MeSH Terms
Descriptor/Qualifier:
Biomedical Research* / ethics,  legislation & jurisprudence
Conflict of Interest
Diagnostic Imaging / ethics*
Europe
Great Britain
Humans
Incidental Findings*
Practice Guidelines as Topic*
Research Subjects / legislation & jurisprudence*
Truth Disclosure / ethics
United States
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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