Unexpected Findings in Research Do You Want to Know?
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1 Unexpected Findings in Research Do You Want to Know? Judy Illes, Ph.D. Canada Research Chair in Neuroethics Professor of Neurology National Core for Neuroethics University of British Columbia Dementia Forum 2013 Bridging Research, Practice and Care Saturday, January 26, 2013
2 Acknowledgements Distinguished collaborators colleagues, advisors, and supporters of the National Core for Neuroethics Knowledge Development Fund
3 Our Path Today Some context and background What we know What we do not know Take-away messages
4 Context Unexpected (incidental) findings Findings of potential medical significance that are unrelated to the purpose of a research study or clinical examination. Our focus today: mostly imaging, genetics
5 Magnetic Resonance Imaging Structural Functional arterial HbO 2 Hb venous Perform a Task Neuronal Activity Blood Flow Activation Map
6 Magnetic Resonance Imaging Structural Functional arterial HbO 2 Hb venous Perform a Task Neuronal Activity Blood Flow Activation Map
7 Structural Anomalies Cavernous hemangioma AVM Meningioma Mucous plug
8 Case Study (This is a true story) MK is an MD/PhD student conducting research on working memory. He has been a mentor to the incoming medical student class. Two weeks into the program, SH enthusiastically enrolls in MK s study that involves functional MRI. On one of SH s scans, MK notices an anomaly in her prefrontal cortex. There is no institutional protocol in place. What should he do?
9 Some Considerations and Variations SH is 23 years old (true) SH is 17 years old (hypothetical) SH is 82 years old and presumably healthy (hypothetical) SH is 82 years old and has been diagnosed with mild dementia (hypothetical) SH is 82 years old and has an advanced dementia (hypothetical)
10 Our Path Today Some context and background What we know What we do not know Take-away messages
11 What Do We Know (and What s All the Fuss About)? Real people, real problem in the protection of human subjects in research
12 Frequency Overall occurrence of anomalies in adults and children: - 18%-20% (one in every five people scanned) Clinically significant findings requiring followup: 2%-8% - vascular and tumours
13 Associations with Age high Routine Urgent Frequency low young Age old Illes et al., Neurology, 2008
14 Participant Expectations Significance of Finding Would Want to be Informed Would Seek Evaluation Benign 91% 77% Malignant, but curable 100% 97% Malignant and not curable 96% 99% Life-threatening medical emergency 100% 98% Kirschen et al., JMRI, 2006
15 Research Strategies Vary Widely Personnel conducting scans Neuroradiological review Illes et al., JMRI, 2004 Racine et al., BMC Ethics, 2010
16 Research Guidance Varies Widely
17 Fundamental Issues for Participants On the upside: Serendipitous discovery of a potentially significant disorder of the central nervous system Relevance to third parties Trust and reciprocity
18
19 Fundamental Issues for Participants On the downside: Anxiety-provoking false positive Costs and morbidity of follow up tests Implications for insurance and employment Blurring of research and clinical medicine Cost to the research enterprise
20 Challenges for Researchers Illes, Nature Clinical Neurology, 2006; Illes et al., Neurology, 2008
21 Harmonized Guidance
22 Our Path Today Some context and background What we know What we do not know Take-away messages
23 Cost Simulating four strategies for different populations of participants using aneurysms as a model. Sadatsafavi et al., Value in Health, 2010
24 Best Economic Strategy per Subgroup Age Gender Family History No screening M M - >60 M - Screening by researcher Screening by specialist F F - >60 F M M + >60 M + Full, clinical grade screening F F + >60 F +
25 Respecting the Rights of Youth
26 Magnetic Resonance Imaging Structural Functional arterial HbO 2 Hb venous Perform a Task Neuronal Activity Blood Flow Activation Map
27 Predicting Minds Alzheimer s Disease (fmri) Frontotemporal Dementia (SPECT) Greicius et al., PNAS, 2004 Honig et al., Sci. Aging Knowl. Environ., 2003
28 Combined Technologies Powerful, combined approach to the study of functional genetic variations and brain responses in neurologic and psychiatric disorders
29 Imaging Genetics Genetic risk of Alzheimer Disease Associations of brain activation patterns and the course of cognitive decline in patients with susceptibility genes for Alzheimer Disease
30 Respecting Cross Cultural Views
31 Incidental Findings in Shared Data
32 Our Path Today Some context and background What we know What we do not know Take-away messages
33 We Return to the Case SH is 23 years old (true) SH is 17 years old (hypothetical) SH is 82 years old and presumably healthy (hypothetical) SH is 82 years old and has been diagnosed with mild dementia (hypothetical) SH is 82 years old and has an advanced dementia (hypothetical) The participant is you
34 Scientists, physicians and ethics scholars seeking standards of practice and a common voice and language Neuroscience Knowledge Values Engaged world press dedicated to ethical science journalism and journalistic accuracy Critical voice of patients, caregivers, research sponsors, policy-makers and the public in matters of neuroscience discovery
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