The expanding use of brain imaging methods like MRI in clinical research has created new ethical, medical-legal, and economic challenges for investigators. For example, incidental findings (IF) are often identified, but there are no clear guidelines on how to deal with this information. Across research institutions policies on the review and report of IF in research studies varies greatly, even though most research subjects expect that they will be informed about any abnormalities. For example, some institutions mandate review of all MRI scans by a radiologist, whereas others require no formal review, and other institutions place the burden back on the core investigators who are expected to consult a radiologist if something unusual is noted. We propose a study that utilizes the rich subject pool at The Mind Research Network to evaluate the effect of a mandated universal radiologic review system on research subjects, investigators and IRB members, and to develop validated survey instruments that can be used to extend this work to a multisite definitive study. The current proposal includes both a retrospective survey, followed by a longitudinal prospective evaluation that will provide new and critical information regarding the effect of mandated radiologic reviews on key stakeholders. This investigation will validate survey tools and generate important preliminary data that will be used in a follow up multisite study designed to produce evidence- based ethical guidelines for researchers dealing with incidental findings.
The expanding use of brain imaging methods like MRI in clinical research has created new ethical, medical-legal, and economic challenges for investigators. We propose a study that utilizes the rich subject pool at The Mind Research Network to evaluate the effect of a mandated universal radiologic review system on research subjects, investigators and IRB members. An important outcome of this investigation will be validated survey tools to be used in a follow up multisite study that will provide empiric data to be used in formulating national recommendations for an ethical and reasonable approach to incidental findings in neuroimaging research.
| Shoemaker, Jody M; Cole, Caitlin; Petree, Linda E et al. (2016) Evolution of universal review and disclosure of MRI reports to research participants. Brain Behav 6:e00428 |
| Rancher, Caitlin E; Shoemaker, Jody M; Petree, Linda E et al. (2016) Disclosing neuroimaging incidental findings: a qualitative thematic analysis of health literacy challenges. BMC Med Ethics 17:58 |
| Phillips, John P; Cole, Caitlin; Gluck, John P et al. (2015) Stakeholder Opinions And Ethical Perspectives Support Complete Disclosure Of Incidental Findings In MRI Research. Ethics Behav 25:332-350 |
