incidental findings in functional imaging: a view from psychology and neuroscience

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