Bunnik Eline M, van Bodegom Lisa, Pinxten Wim, de Beaufort Inez D, Vernooij Meike W
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
Department of Morphology, Hasselt University, Agoralaan Gebouw D, BE 3590, Diepenbeek, Belgium.
BMC Med Ethics. 2017 Feb 6;18(1):10. doi: 10.1186/s12910-017-0168-y.
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.
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).
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.
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.
随着成千上万的健康研究参与者被纳入大大小小的影像学研究中，妥善处理偶然发现所引发的困境至关重要。当前的伦理指南指出，应建立处理偶然发现的途径，但并未具体说明这些途径应是怎样的。基于一项对研究人员实践与观点的访谈研究，我们确定了在影像学研究中建立偶然发现的检测、管理及沟通途径的关键考量因素。
我们对荷兰各地研究机构的研究人员进行了有目的抽样访谈（n = 20）。基于对这些访谈的定性分析以及文献中现有的指南，我们制定了一个原型伦理框架，该框架在与生物伦理学家以及来自英国、德国、瑞典和比利时的大型人群影像学研究代表（n = 14）举行的为期两天的国际专家会议上得到了批判性评估和微调。
荷兰各地处理偶然发现的实践和政策差异很大，从不对研究扫描进行审查且对研究参与者反馈有限，到对扫描进行常规审查并安排临床随访。受访者认为研究人员没有主动寻找偶然发现的义务，但一旦发现，他们有义务对这些发现采取行动。互惠原则在我们的访谈和专家会议中显著体现。
我们提出了一个伦理框架，可指导研究人员和研究伦理委员会设计和/或评估影像学研究中处理偶然发现的适当途径。该框架包括七个步骤：发现的预期、信息提供与知情同意、扫描采集、扫描审查、对检测到的异常进行咨询、发现的沟通以及对研究参与者的进一步临床管理和随访。这些步骤中的每一步都代表着研究人员要做出的关键决策，做出这些决策不仅应参考成本和/或后勤方面的考虑，还应参考研究人员的道德义务和互惠原则。
