Ethical framework for the detection, management and communication of incidental findings in imaging studies, building on an interview study of researchers' practices and perspectives.
BACKGROUND
As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers' practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of incidental findings in imaging research.


METHODS
We conducted an interview study with a purposive sample of researchers (n = 20) at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium (n = 14).


RESULTS
Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting.


CONCLUSIONS
We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers' moral obligations and the principle of reciprocity.
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands. e.bunnik@erasmusmc.nl.
Eline M
EM
Bunnik
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
Lisa
L
van Bodegom
Department of Morphology, Hasselt University, Agoralaan Gebouw D, BE 3590, Diepenbeek, Belgium.
Wim
W
Pinxten
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
Inez D
ID
de Beaufort
Department of Epidemiology, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.|Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
Meike W
MW
Vernooij
D035843:Biomedical Research / Q000941:ethics*; D003952:Diagnostic Imaging; D030881:Disclosure / Q000941:ethics*; D032984:Ethics, Research; D005060:Europe; D006801:Humans; D033162:Incidental Findings; D028681:Moral Obligations; D012108:Research Personnel / Q000941:ethics*
Ethical framework; Imaging studies; Incidental findings; Interview study; Population imaging; Principle of reciprocity; Research ethics