incidental findings in functional imaging: a view from psychology and neuroscience incidental...
Post on 21-Dec-2015
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Incidental Findings in Functional Imaging:
A View from Psychology and Neuroscience
Kevin Ochsner
Social Cognitive Neuroscience Lab
Columbia University
(Or, what concerns PhD scientists doing fMRI research?)
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
Nonverbal Behavior
Attitudes + Intergroup Relations
Learning, Memory and Decision-
making
Emotion +Self - Control
None
Social/Cognitive/Affective Performance
Psychological Processes
Neural Systems
Person level descriptors
age, race, beliefs, moods, personality, or other individual
differences (questionnaires)
specific behaviors
(computerized tasks)
Brain activity or structure
(fMRI, MRI or other imaging techniques)
Address questions by linking data collected at multiple levels of
analysis.....Level Data
Infer their operation
Example: Performance Level
Cognitive Reappraisal
• Rethink the meaning of an event or action
Think about image in way that makes you feel less
negative….
“He’s just tired/annoyed, is hearty, will be right as
rain….”
Instruction
Reappraisal
Example: Neural Level
Turn on regions involved in higher
cognition
Amygdala Decreases
Prefrontal Increases
Turn off regions involved in generating
emotion
Example: Neural Level
Turn on regions involved in higher
cognition
Turn off regions involved in generating
emotion
Reappraisal involves specific linguistic,
memory and inhibitory processes
Reappraisal modulates specific affect-generating
processes
Example: Psychological Level
Amygdala Decreases
Prefrontal Increases
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)
• 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
Example
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?
• 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
Example
Beck Depression Inventory, BDI(0-9 = none; 9-18 = mild; 19-29 = moderate; 30-63 = severe)
Example
✴ A high score on a depression inventory, and in particular an item indicating suicidal ideation
• 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
2. PI’s protocol does not stipulate any policy for dealing with behavioral IFs✴ What should PI do?
• 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
Example
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
• Concluding thoughts‣ 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
Policy