Incidental Findings in Functional Imaging:
A View from Psychology and Neuroscience
(Or, what concerns PhD scientists doing fMRI
research?)
Kevin Ochsner
Social Cognitive Neuroscience Lab
Columbia University
Roadmap
• What we study
‣ kinds of questions we ask
‣ kinds of data we collect
• Two kinds of incidental findings
‣ neural
‣ behavior
• Policy issues and implications
Learning, Memory
and Decisionmaking
Attitudes +
Intergroup
Relations
Nonverbal
Behavior
Emotion +
Self - Control
Address questions by linking data
collected at multiple levels of analysis.....
Level
Data
Person level descriptors
age, race, beliefs,
moods, personality, or
other individual
differences
(questionnaires)
Social/Cognitive/Affective Performance
specific behaviors
(computerized
tasks)
Psychological Processes
Infer their
None
operation
Neural Systems
Brain activity or structure
(fMRI, MRI or other
imaging techniques)
Example: Performance Level
Cognitive Reappraisal
• Rethink the meaning of an event or action
Instruction
Think about image in way that
makes you feel less negative….
Reappraisal
“He’s just tired/annoyed, is
hearty, will be right as rain….”
Example: Neural Level
Example: Neural Level
Turn on regions
involved in higher
cognition
Turn off regions
involved in generating
emotion
Prefrontal Increases
Amygdala Decreases
Example: Psychological
Level
Turn on regions
involved in higher
cognition
Reappraisal involves
specific linguistic,
memory and inhibitory
processes
Turn off regions
involved in generating
emotion
Reappraisal modulates
specific affectgenerating processes
Prefrontal Increases
Amygdala Decreases
Roadmap
• What we study
‣ kinds of questions we ask
‣ kinds of data we collect
• Two kinds of incidental findings
‣ neural
‣ behavioral
• Policy issues and implications
Neural incidental findings
• IFs found in structural images of the brain
‣
‣
‣
during recruitment/screening
 participants may indicate they, “want a diagnosis”
 researcher/consent indicates that scans are not
medically diagnostic and researchers are not
clinicians
during data collection and analysis
 participants may ask if scans look normal/OK
 may request and/or typically be given brain picture
 how/who identifies potential IFs?
 strong preference for mandatory reads by M.D.
post-discovery
 when found, PhDs are neither qualified to - nor
comfortable with - communicating IFs to participants
 strong preference for policies allowing/requiring
communication via M.D. (e.g. neuroradiologist)
Example
• How does this play out in actual practice?
‣
‣
Highlight anticipated vs. unanticipated issues that arise
Case study from CU MRI Center:
1. ~2 weeks after data collection, PI notices potential IF
2. PI’s protocol stipulated that reads not mandatory
3. If technician/researcher notes potential IF, a radiologist
would read scan & contact participant as needed
4. Contacts Center, which has changed directorship
5. The stipulated M.D. no longer associated with center
6. Told by interim director that reporting process being
revised
7. ~2 weeks later told to contact participant
8. Because participant did not give phone #, PI emailed to
arrange phone conversation
Example
• How does this play out in actual practice?
‣ Cont’d......
9. Participant responds, but does not give phone number
10. 2 days later PI informs IRB, who stipulates PI has
violated protocol and should wait til IRB reviews matter
11. 2 days later IRB indicates that PI should have an M.D.
contact the participant, in accord with protocol
12. PI seeks Center’s assistance in securing new M.D.,
which takes ~3 weeks (summer! busy doctors!)
13. Participant responds to PI’s emails indicating he/she has
moved across the country
14. Same day M.D. contacts participant who follows up with
personal physician
Example
• What this highlights
‣
‣
‣
‣
Anticipated: Plan was in place for dealing with IFs
Unanticipated: Change in Center directorship/policy;
confusion about reading scan and contacting participant
Differences in philosophy
 Prior director was PhD who had relationship with
radiologist to read scans & make contact
 New/Interim director followed M.D. model of PI’s making
contact directly
Do differently?
 Contact IRB before making contact with participant
 Need for PIs, imaging centers and IRBs to have general
plans in place for unanticipated circumstances
 Minimize problems with standardized, blanket policies
Behavioral incidental findings
• Behavioral IFs from self-reports or
observations
‣ Important to consider because many, if not all, of our type
‣
‣
‣
of studies collect both behavioral and neural data that
could be sources of potential IFs
Behavioral IF typically include responses/actions
indicating serious psychological or physical distress or
potential for harm/self-harm
When anticipated: protocols can require concurrent
screening of responses and offer referrals to appropriate
evaluation/counseling
When unanticipated: what should a PI and IRB do when
a finding arises and the protocol did not include an
appropriate action plan?
Example
• How does this play out in actual practice?
‣
‣
Highlight anticipated vs. unanticipated issues that arise
Case study from CU MRI Center:
1. A few weeks after data collection, PI’s research team
notices what they believe could be a potential behavioral
IF
Beck Depression Inventory, BDI
(0-9 = none; 9-18 = mild; 19-29 = moderate; 30-63 = severe)
Example
• How does this play out in actual practice?
‣
‣
Highlight anticipated vs. unanticipated issues that arise
Case study from CU MRI Center:
1. A few weeks after data collection, PI’s research team
notices what they believe could be a potential behavioral
IF
 A high score on a depression inventory, and in
particular an item indicating suicidal ideation
2. PI’s protocol does not stipulate any policy for dealing
with behavioral IFs
 What should PI do?
Example
• What this highlights
‣ Importance of considering IF policies for behavioral - not
just neural – data – esp. when many labs collect both
types of data simultaneously
 Not always appreciated (my lab, e.g., has plans in
place for some but not all protocols)
 Many measures are collected, and IFs on each one
are hard to quantify, so policy harder to set
Roadmap
• What we study
‣ kinds of questions we ask
‣ kinds of data we collect
• Two kinds of incidental findings
‣ neural
‣ behavioral
• Policy issues and implications
Policy
• Concluding thoughts
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‣
‣
‣
‣
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General policies are useful for reducing confusion in the
face of both anticipate and unanticipated events
Should indicate whether scans are read, by whom, and
how communication to participants takes place
Communication btw. PIs, IRBs and imaging centers is
essential
Standing operating committees with M.D.s and Ph.D.s to
set std policy/protocol, esp. for new events as they arise
May be worthwhile to consider policies on specific types of
behavioral IFS as well
Can be valuable to ask basic scientists for their input
 Helps identify new issues
 Bears on how scientists understand how to
implement protocols