Imaging plays an essential role in medical research. Unexpected or incidental abnormal findings arising in the course of imaging research are common; around 3 to 12% in brain imaging and up to 30% in body imaging. Such unexpected findings can have profound implications for a patient’s future health, and as currently there are no agreed protocols in place, these findings may go unrecognised or unreported.
The Royal College of Radiologists (RCR) and Scottish Imaging Network: A Platform for Scientific Excellence (SINAPSE) lead a UK-wide initiative, supported by the Wellcome Trust, which has resulted in the publication of a report, Management of Incidental Findings Detected During Research Imaging. The report, produced following a meeting at the Wellcome Trust in July 2010, summarises current opinions and concerns regarding the practical aspects of managing incidental findings among those involved in research using imaging. The meeting participants, representing many UK researchers, ethicists, patient groups, professional, regulatory and funding bodies, and interested parties from other European countries, find the present situation unsatisfactory on many counts; in particular, practice varies across the UK, so that there is little evidence on which to base ethical practice. The report recommends:
- raising awareness of the issues among imaging researchers;
- disseminating information on incidence and common types of incidental findings
- assisting prospective researchers seeking guidance from ethics committees and central ethics agencies, on how to handle research studies using imaging;
- issuing guidance for funders of research imaging studies, to ensure measures are in place to manage incidental findings;
- training imaging researchers to recognise common abnormalities and artefacts;
- transparency of study information sheets and consent procedures, to increase understanding of the risk of, and procedures for, managing incidental findings;
- that information be made available on aspects of incidental findings for which there is currently no evidence base.
Professor Mary Evans, Chair of the RCR’s Clinical Radiology Patients’ Liaison Group, said, “In recent years, imaging research has resulted in great benefits for patients in the treatment of a wide range of diseases. The difficulties of deciding what to do about incidental findings during that research have, for some researchers, created a dilemma in how to act in the best interests of research volunteers without detriment to all. This report has done the groundwork, enabling both non imaging trained researchers and research radiologists to work with the lay public towards a more ethical and consistent position which does not compromise the results of their research”.