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Canada Research Chair in Neuroethics Professor of Neurology National Core for Neuroethics University of British Columbia Presidential Commission for the Study of Bioethical Issues February 2011. Frontiers in Incidental Findings. Judy Illes, Ph.D. Agenda. Background Current landscape

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Frontiers in incidental findings

Canada Research Chair in Neuroethics

Professor of Neurology

National Core for Neuroethics

University of British Columbia

Presidential Commission for the

Study of Bioethical Issues

February 2011

Frontiers in Incidental Findings

Judy Illes, Ph.D.


Agenda
Agenda

Background

Current landscape

Ongoing discovery

Uncharted territory


Agenda1
Agenda

Background

Current landscape

Ongoing discovery

Uncharted territory


Incidental findings
Incidental Findings

Findings unrelated to the purpose of a research study or clinical examination


Case study in neuroimaging
Case Study in Neuroimaging

MK is a medical student conducting functional MRI research for his PhD on memory. He has been a mentor to the incoming medical student class. Two weeks into the program SH, a new medical student, enthusiastically enrolls in MK’s study. On the anatomy pre-scan, MK notices an anomaly in SH’s prefrontal cortex. There is no institutional protocol in place.

What should he do?


Real people, real problems

• Potentially significant disorders of the CNS

• Psychological and financial cost

• Risk to personal health care security

• Relevance to third parties

• Trust and reciprocity

• Cost to the research enterprise

• Increasing applications of

neuroimaging

• Expanding requirements for

biobanks and data sharing

Fundamental Issues


Agenda2
Agenda

Background

Current landscape

Ongoing discovery

Uncharted territory


Structural anomalies
Structural Anomalies

Meningioma

Cavernous hemangioma

AVM

Mucous plug


Frequency
Frequency

Overall occurrence of anomalies in adults and children:

18%-20% (one in every five people scanned)

vascular and tumours

Clinically significant findings requiring follow-up: 2%-8%


Routine

Urgent

Associations with Age

high

Frequency

low

young

old

Age

Illes et al., Neurology, 2008


Management strategies
Management Strategies

Personnel conducting scans

Neuroradiological review

Illes et al., JMRI, 2004

Racine et al., BMC Ethics, 2010


Subjects expectations
Subjects’ Expectations

Kirschen et al., JMRI, 2006


The Challenge

Illes, Nature Clinical Neurology, 2006; Illes et al., Neurology, 2008


C

Research Study

Incidental finding is detected

All scans

reviewed

Principal investigator or designate

Physician qualified to read scans

D

Incidental finding is evaluated

Principal investigator or designate

No action taken

Incidental finding is communicated

Research subject or surrogate is encouraged to initiate clinical follow-up

A

Research protocol anticipates incidental findings

B

IRB protocol & informed consent articulate plan for managing incidental findings

Subject

option to decline

to be informed

Incidental findings are managed

Incidental findings are not managed

Illes et al., based on Science 2006, Neurology 2008


Agenda3
Agenda

Background

Current landscape

Ongoing discovery

Uncharted territory


Economic analysis

Economic Analysis

Cost implications of managing incidentally found intracranial aneurysms

Mathematical modeling of four strategies for different populations of human subjects

Sadatsafavi et al., Value in Health, 2010


Four different strategies
Four Different Strategies

1. No screening, no further workup

2. MRI read by researcher not trained in clinical neuroimaging

If suspicious: read by specialist

If suspicious: MR Angiography (MRA)

3. MRI read by specialist

If suspicious: MRA

4. Full clinical-grade work-up in all participants



Implications for management
Implications for Management

A shift from researcher-focused to participant-focused decision-making for incidental findings

Initial screening by a non-trained researcher is not

cost-effective for any subgroup

A customized strategy is essential

Optimal strategy is affected by variables at time of screening: age group, gender, family history

Exclusion of certain participant groups may be justified when weighing risk and cost of screening


An emerging approach to the study of genetic variations and functional brain responses

• Brain activation patterns and the course of cognitive decline in people with AD susceptibility genes

• COMT gene polymorphism and prefrontal dopamine regulation with genetic risk of schizophrenia

•  5-HTT serotonin transporter gene and amygdala activation in response to fearful stimuli

Imaging Genetics


Structural functional brain responses

(CT, MRI, DTI)

Neurochemical

(MRS, SPECT, PET)

Functional

(MRI, SPECT, PET)

Neuroimaging

Clinical Features

Genes

Gene expression

Protein

Cells

Systems

Behaviour

Roffman et al., 2005

Disease Differentiation

Incidental Findings

Translation

Stigma

Response Sensitivity

Commercialization

Privacy/

Autonomy

Resources

Science and Society

Imaging

Genetics

Ethical

Considerations

Discriminative Power

Cumulative

Power

Tairyan et al., Neuroscience, 2009


Functional frontier resting state fmri
Functional Frontier: functional brain responsesResting State fMRI

  • The brain is highly active at rest

  • Connectivity analyses suggest distributed, large-scale functional networks

  • Detection of changes in functional connectivity within individuals from a single scan

  • Disruptions of the networks have been observed in Alzheimer’s, schizophrenia and other disorders of the CNS

  • Will task-dependent or task-independent resting state fMRI be the first functional frontier for incidental findings?


Frontier challenges

•  Uncertainty in current understanding of the resting state

• Heritability of networks

•  Anonymization in offline processing

• Implications of findings for perception of self and social categories

Frontier Challenges


Agenda4
Agenda state

Background

Current landscape

Ongoing discovery

Uncharted territory


Uncharted territory
Uncharted Territory state

•  Economic analyses beyond aneurysms

• Incidental findings in children

• Evolving processes for recruitment

and consent

• Responsibilities and policies in the unregulated non-clinical for-profit sector

• Management of incidental findings in cultures in which ownership of health data and consent are shared by communities

• Evidence-based policies in a changing health care climate


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