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Table 2 The seven steps framework and minimum requirements for pathways for the detection, management and communication of incidental findings in research

From: Ethical framework for the detection, management and communication of incidental findings in imaging studies, building on an interview study of researchers’ practices and perspectives

The seven steps framework

Minimum requirements

1.

Anticipation of incidental findings

Incidental findings should be anticipated.

In large-scale imaging studies, lists should be made of anticipated incidental findings, stipulating their management.

2.

Information provision and informed consent

As part of the informed consent process, research participants should be informed about the possibility that incidental findings may be detected, and about the pathway for handling such findings.

Research participants should be given the opportunity either to opt out of receiving information about incidental findings or to withdraw from the study.

3.

Scan acquisition

Researchers need not acquire any (diagnostic-quality) scans in addition to the scans that are necessary for the research purposes.

Radiographers should be instructed whether and to what extent to review scans for abnormalities during scan acquisition

4.

Review of scans

In studies in which diagnostic-quality images are acquired, some form of routine review of research scans should be arranged.

5.

Consultation on detected abnormalities

Detected abnormalities should be confirmed by experts (i.e. radiologists) before they are reported to the research participants.

Researchers should make prior arrangements with experts.

6.

Communication of the incidental finding

Policies for the communication of the incidental finding to the research participant should align with national regulations and customs.

7.

Further clinical management and follow-up of the research participant

In case of serious incidental findings, researchers should take responsibility for the clinical follow-up of the research participant (i.e. through adequate and timely referral).

Researchers should make prior arrangements with relevant clinicians.