Incidental Findings Found in "Healthy" Volunteers During Imaging Performed for Research: Current Legal and Ethical Implications
Keywords
ConsentDisclosure
Harm
Incidental Findings
Informed Consent
Research
Research Subjects
Rights
Reporting
Standards
Volunteers
Truth-telling
Human Experimentation Policy Guidelines / Institutional Review Boards
Informed Consent or Human Experimentation
International and Political Dimensions of Biology and Medicine
Full record
Show full item recordOnline Access
http://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Incidental+findings+found+in+"healthy"+volunteers+during+imaging+performed+for+research:+current+legal+and+ethical+implications.&title=The+British+journal+of+radiology+&volume=83&issue=990&date=2010-06&au=Booth,+T+C;+Jackson,+A;+Wardlaw,+J+M;+Taylor,+S+A;+Waldman,+A+Dhttps://dx.doi.org/10.1259/bjr/15877332
http://hdl.handle.net/10822/1022735
Abstract
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.Date
2016-01-09Identifier
oai:repository.library.georgetown.edu:10822/1022735doi:10.1259/bjr/15877332
The British journal of radiology 2010 Jun; 83(990): 456-65
http://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Incidental+findings+found+in+"healthy"+volunteers+during+imaging+performed+for+research:+current+legal+and+ethical+implications.&title=The+British+journal+of+radiology+&volume=83&issue=990&date=2010-06&au=Booth,+T+C;+Jackson,+A;+Wardlaw,+J+M;+Taylor,+S+A;+Waldman,+A+D
http://dx.doi.org/10.1259/bjr/15877332
http://hdl.handle.net/10822/1022735
DOI
10.1259/bjr/15877332ae974a485f413a2113503eed53cd6c53
10.1259/bjr/15877332