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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21NS077050-02
Application #
8473293
Study Section
Special Emphasis Panel (SEIR)
Program Officer
Odenkirchen, Joanne
Project Start
2012-06-01
Project End
2014-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
2
Fiscal Year
2013
Total Cost
$231,518
Indirect Cost
$29,306
Name
University of New Mexico Health Sciences Center
Department
Neurology
Type
Schools of Medicine
DUNS #
829868723
City
Albuquerque
State
NM
Country
United States
Zip Code
87131