T. C. Booth, A. Jackson, J. M. Wardlaw, S. A. Taylor, A. D. Waldman



Publication year



British Journal of Radiology

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Author Address

Booth, TC Royal Free Hosp NHS Trust, Dept Radiol, Pond St, London NW3 2QG, England Royal Free Hosp NHS Trust, Dept Radiol, London NW3 2QG, England Univ Manchester, Wolfson Mol Imaging Ctr, Manchester, Lancs, England Univ Edinburgh, Western Gen Hosp, SFC Brain Imaging Res Ctr, SINAPSE Collaborat,Div Clin Neurosci, Edinburgh, Midlothian, Scotland Univ London, Dept Med Imaging, London, England Imperial Coll Healthcare NHS Trust, Dept Imaging, London, England Univ London Imperial Coll Sci Technol & Med, London, England

Full version

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.