scholarly journals A Just Standard: The Ethical Management of Incidental Findings in Brain Imaging Research

2021 ◽  
Vol 49 (2) ◽  
pp. 269-281
Author(s):  
Mackenzie Graham ◽  
Nina Hallowell ◽  
Julian Savulescu
Keyword(s):  
Healthy Volunteers ◽  
Brain Imaging ◽  
Clinical Significance ◽  
Incidental Findings ◽  
Ethical Management ◽  
Imaging Research

AbstractNeuroimaging research regularly yields “incidental findings”: observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.

scholarly journals Practical approaches to incidental findings in brain imaging research

Neurology ◽  
2008 ◽  
Vol 70 (5) ◽  
pp. 384-390 ◽  
Author(s):  
J. Illes ◽  
M. P. Kirschen ◽  
E. Edwards ◽  
P. Bandettini ◽  
M. K. Cho ◽  
...  
Keyword(s):  
Brain Imaging ◽  
Incidental Findings ◽  
Imaging Research

scholarly journals ETHICS: Incidental Findings in Brain Imaging Research

Science ◽  
2006 ◽  
Vol 311 (5762) ◽  
pp. 783-784 ◽  
Author(s):  
J. Illes
Keyword(s):  
Brain Imaging ◽  
Incidental Findings ◽  
Imaging Research

FEATURES

2014 ◽  
Vol 18 (06) ◽  
pp. 29-44
Keyword(s):  
Brain Imaging ◽  
Incidental Findings ◽  
Neurological Impairment ◽  
Ethical Responsibility ◽  
Capacity To Consent ◽  
Imaging Research ◽  
The Law ◽  
The Impact

Neuroscience and the Law. Neurological Impairment and the Capacity to Consent to Participate in Research. Ethical Responsibility to Manage Incidental Findings in Brain Imaging Research. The Impact of Discrimination on Research into Depression.

Impact of incidental findings on young adult participants in brain imaging research: an interview study

2022 ◽  
Author(s):  
Anke J. M. Oerlemans ◽  
Daniëlle M. H. Barendregt ◽  
Sabine C. Kooijman ◽  
Eline M. Bunnik
Keyword(s):  
Young Adult ◽  
Brain Imaging ◽  
Incidental Findings ◽  
Interview Study ◽  
Adult Participants ◽  
Imaging Research

scholarly journals Management of incidental findings during imaging research in “healthy” volunteers: current UK practice

2012 ◽  
Vol 85 (1009) ◽  
pp. 11-21 ◽  
Author(s):  
T C Booth ◽  
A D Waldman ◽  
J M Wardlaw ◽  
S A Taylor ◽  
A Jackson
Keyword(s):  
Healthy Volunteers ◽  
Incidental Findings ◽  
Imaging Research

scholarly journals Prevalence, Severity, and Clinical Management of Brain Incidental Findings in Healthy Young Adults: MRi-Share Cross-Sectional Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Aïcha Soumaré ◽  
Naka Beguedou ◽  
Alexandre Laurent ◽  
Bruno Brochet ◽  
Constance Bordes ◽  
...  
Keyword(s):  
Young Adults ◽  
Brain Imaging ◽  
Incidental Findings ◽  
Brain Mri ◽  
Imaging Study ◽  
Final Diagnosis ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Imaging Research ◽  
Medical Referral

Background and Objectives: Young adults represent an increasingly large proportion of healthy volunteers in brain imaging research, but descriptions of incidental findings (IFs) in this age group are scarce. We aimed to assess the prevalence and severity of IFs on brain MRIs of healthy young research participants aged 18–35 years, and to describe the protocol implemented to handle them.Methods: The study population comprised 1,867 participants aged 22.1 ± 2.3 years (72% women) from MRi-Share, the cross-sectional brain MRI substudy of the i-Share student cohort. IFs were flagged during the MRI quality control. We estimated the proportion of participants with IFs [any, requiring medical referral, potentially serious (PSIFs) as defined in the UK biobank]: overall, by type and severity of the final diagnosis, as well as the number of IFs.Results: 78/1,867 participants had at least one IF [4.2%, 95% Confidence Interval (CI) 3.4–5.2%]. IFs requiring medical referral (n = 38) were observed in 36/1,867 participants (1.9%, 1.4–2.7%), and represented 47.5% of the 80 IFs initially flagged. Referred IFs were retrospectively classified as PSIFs in 25/1,867 participants (1.3%, 0.9–2.0%), accounting for 68.4% of anomalies referred (26/38). The most common final diagnosis was cysts or ventricular abnormalities in all participants (9/1,867; 0.5%, 0.2–0.9%) and in those with referred IFs (9/36; 25.0%, 13.6–41.3%), while it was multiple sclerosis or radiologically isolated syndrome in participants with PSIFs (5/19; 26.3%, 11.5–49.1%) who represented 0.1% (0.0–0.4%) and 0.2% (0.03–0.5%) of all participants, respectively. Final diagnoses were considered serious in 11/1,867 participants (0.6%, 0.3–1.1%). Among participants with referred IFs, 13.9% (5/36) required active intervention, while 50.0% (18/36) were put on clinical surveillance.Conclusions: In a large brain imaging study of young healthy adults participating in research we observed a non-negligible frequency of IFs. The etiological pattern differed from what has been described in older adults.

scholarly journals Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?

2008 ◽  
Vol 36 (2) ◽  
pp. 271-279 ◽  
Author(s):  
Franklin G. Miller ◽  
Michelle M. Mello ◽  
Steven Joffe
Keyword(s):  
Brain Imaging ◽  
Incidental Findings ◽  
Human Subjects ◽  
Clinical Care ◽  
Research Participant ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Potential Health ◽  
Imaging Research ◽  
General Topic

A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation?Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that is, “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.

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