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. |