- Ethics Commentary
The case scenario reflects the dilemmas frequently faced by researchers who discover incidental findings in the course of their studies. Indeed, the literature suggests that the prevalence of incidental findings in neuroimaging research is common,1 and a recent meta-analysis found that such findings increase significantly with age.2 Thus, given the age of the study population and increased likelihood of co-morbidities, it is puzzling that the research team did not anticipate the possibility of finding an anomaly. Even more puzzling is that the reviewing IRB did not detect this omission and require that the team build a plan into the research protocol for managing incidental findings. Following international recommendations,3 such a plan would have likely included protocols for obtaining consent in dealing with an incidental finding, a procedure for evaluating the clinical relevance of the finding, and arranging for suitable follow-up care if necessary.
Nevertheless, the research team, not having obtained consent to disclose an incidental finding to the participant, or not, must decide whether to break protocol and contact the participant with information that could have serious health implications for his or her health, especially if the observed lesion turns out to be cancer or some other life-threatening neuropathology. Any decision to break the research protocol should be made in consultation with the approving IRB. The principal investigator, Dr. M, who is ultimately responsible for the ethical conduct of this study, has a number of factors to consider when making this decision. First and foremost, Dr. M will need to weigh up the risks and benefits of disclosing the findings to this 72-year-old [End Page 283] research participant who is presumably already experiencing cognitive impairments, if not early stage symptoms of dementia.
Numerous international scholars agree that disclosure of incidental findings should rely on the net beneficence to an individual research participant.4 Specifically, Wolf et al. argue that there should be a strong net benefit for disclosing an incidental finding, such that the information reveals a condition that is likely to be either life-threatening or grave and can be avoided or ameliorated through an intervention. In such instances, the researchers have an ethical obligation to disclose the findings and potentially follow up with clinical care. However, if there is only a net possible benefit, such that the condition is not life-threatening but may be grave or serious and cannot be avoided or ameliorated, then investigators may consider other factors, such as the respect that is owed to research participants and their needs and preferences for information about their health and well-being. Where the condition is not likely to be serious, researchers are not compelled to disclose an incidental finding.
In determining the seriousness of an incidental finding, a specialist with expertise in assessing the clinical significance of MRI scans is needed to examine the participants’ images.5 In this instance, Dr. M has a neurologist on the research team who has detected the lesion but is unable to ascertain its clinical relevance without further investigation. The reasons why follow-up information is required is not detailed in the case scenario, but may have arisen because the scans were taken for research purposes and may not be clinically validated for diagnostic purposes — a possibility given the aims of the study (i.e., to elucidate the transition of minimal cognitive impairment to dementia, not brain tumours). For whatever reason, the detected lesion is only a suspected incidental finding that may or may not be life-threatening or grave. Thus, the net benefit to the participant in disclosing this unclear finding is harder to judge.
Assuming that the lesion is a serious or life-threatening condition, the team may consider whether it can be avoided or ameliorated with an intervention. The cognitively impaired, although still mentally competent, participant is 72 years old and may respond poorly to a neurosurgical intervention if the diagnosis of a tumour or malignancy is confirmed. The physical and emotional distress of such a procedure may exacerbate the existing cognitive impairments, reducing the net benefit ratio of the disclosure. Indeed, the team should consider the impact that the disclosure...