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|Title: ||Ethical framework for the detection, management and communication of incidental findings in imaging studies, building on an interview study of researchers' practices and perspectives|
|Authors: ||Bunnik, Eline M.|
van Bodegom, Lisa
de Beaufort, Inez D
Vernooij, Meike W.
|Issue Date: ||2017|
|Citation: ||BMC medical ethics, 18, p. 1-15 (Art N° 10)|
|Abstract: ||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.
Conclusion: 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.|
|Notes: ||Bunnik, EM (reprint author), Univ Med Ctr Rotterdam, Dept Med Eth & Philosophy Med, Erasmus MC, Wytemaweg 80, NL-3015 CN Rotterdam, Netherlands.
|ISI #: ||000393923800002|
|Type: ||Journal Contribution|
|Validation: ||ecoom, 2018|
|Appears in Collections: ||Research publications|
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|Published version||493.35 kB||Adobe PDF|
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