Abstract
With the rapid advances in neurosciences in the last three decades, there has been an exponential increase in the use of neuroimaging both in basic sciences and clinical research involving human subjects. During routine neuroimaging, incidental findings that are not part of the protocol or scope of research agenda can occur and they often pose a challenge as to how they should be handled to abide by the medicolegal principles of research ethics. This paper reviews the issue from various ethical (do no harm, general duty to rescue, and mutual benefits and owing) and medicolegal perspectives (legal liability, fiduciary duties, Law of Tort, and Law of Contract) with a suggested protocol of approach.
Highlights
Modern scienti c research o en involves recruitment of human participants, and in the eld of neuroimaging research employing various methods based on nuclear magnetic resonance, it is o en a routine to obtain high-resolution structural scans of the brain and spinal cord as a template for subsequent interpolation of data
Used for magnetic resonance imaging (MRI) and fMRI research and found 13 different strategies with varying attributes in dealing with incidental ndings [10]. ese attributes include participant(s)’ choice to be informed of the nding, participant(s)’ choice to inform their own physician for the ndings, arrangement to inform the participants directly, arrangement to review the scans with a specialist, arrangement to follow up the participants, and so forth. ere was high variability of strategies used amongst different research centres and low consistency within a centre in using a single strategy. e authors opined that such variability cannot be solely ascribed to local Research Ethics Board (REB); rather, it is a combination of different research context and lack of consensus and common standards amongst all Canadian REBs
Another study from Germany looking at routine brain MRI scans from 2536 healthy young male applicants for military showed vascular and cystic abnormalities in 2.2% and intracranial tumours in 0.5% [6]. ese two studies report tumours basing on their radiological appearances and reliable distinction between benign and malignant nature is not possible
Summary
Modern scienti c research o en involves recruitment of human participants, and in the eld of neuroimaging research employing various methods based on nuclear magnetic resonance, it is o en a routine to obtain high-resolution structural scans of the brain and spinal cord as a template for subsequent interpolation of data. During such routine scans, it is not unusual to discover incidental abnormalities which are pure incidental ndings not relevant to the actual research but can be life endangering to the participants if they are not pursued further. A recent survey showed that actual knowledge of the issue and logistics of management differ widely [2]
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