1. 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 Kevin Ochsner Social Cognitive Neuroscience Lab Columbia University (Or, what concerns PhD scientists doing fMRI research?)

2. RoadmapRoadmap What we study What we study ‣ kinds of questions we ask ‣ kinds of data we collect Two kinds of incidental findings Two kinds of incidental findings ‣ neural ‣ behavior Policy issues and implications Policy issues and implications What we study What we study ‣ kinds of questions we ask ‣ kinds of data we collect Two kinds of incidental findings Two kinds of incidental findings ‣ neural ‣ behavior Policy issues and implications Policy issues and implications

3. Nonverbal Behavior Attitudes + Intergroup Relations Learning, Memory and Decision- making Emotion + Self - Control

4. NoneNone 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) specific behaviors (computerized tasks) Brain activity or structure (fMRI, MRI or other imaging techniques) imaging techniques) Brain activity or structure (fMRI, MRI or other imaging techniques) imaging techniques) Address questions by linking data collected at multiple levels of analysis..... LevelLevelDataData Infer their operation

5. Example: Performance Level Cognitive Reappraisal Rethink the meaning of an event or action Rethink the meaning of an event or action Cognitive Reappraisal Rethink the meaning of an event or action 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….” InstructionInstruction ReappraisalReappraisal

6. Example: Neural Level

7. Turn on regions involved in higher cognition Amygdala Decreases Prefrontal Increases Turn off regions involved in generating emotion Example: Neural Level

8. 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

9. RoadmapRoadmap What we study What we study ‣ kinds of questions we ask ‣ kinds of data we collect Two kinds of incidental findings Two kinds of incidental findings ‣ neural ‣ behavioral Policy issues and implications Policy issues and implications What we study What we study ‣ kinds of questions we ask ‣ kinds of data we collect Two kinds of incidental findings Two kinds of incidental findings ‣ neural ‣ behavioral Policy issues and implications Policy issues and implications

10. Neural incidental findings IFs found in structural images of the brain 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) IFs found in structural images of the brain 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)

11. How does this play out in actual practice? 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 How does this play out in actual practice? 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 ExampleExample

12. How does this play out in actual practice? 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 How does this play out in actual practice? 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 ExampleExample

13. What this highlights 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 What this highlights 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 ExampleExample

14. Behavioral incidental findings Behavioral IFs from self-reports or observations 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? Behavioral IFs from self-reports or observations 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?

15. How does this play out in actual practice? 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 How does this play out in actual practice? 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 ExampleExample

16. Beck Depression Inventory, BDI (0-9 = none; 9-18 = mild; 19-29 = moderate; 30-63 = severe)

17. ExampleExample ✴ A high score on a depression inventory, and in particular an item indicating suicidal ideation How does this play out in actual practice? 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 How does this play out in actual practice? 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?

18. What this highlights 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 What this highlights 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 ExampleExample

19. RoadmapRoadmap What we study What we study ‣ kinds of questions we ask ‣ kinds of data we collect Two kinds of incidental findings Two kinds of incidental findings ‣ neural ‣ behavioral Policy issues and implications Policy issues and implications What we study What we study ‣ kinds of questions we ask ‣ kinds of data we collect Two kinds of incidental findings Two kinds of incidental findings ‣ neural ‣ behavioral Policy issues and implications Policy issues and implications

20. Concluding thoughts 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 Concluding thoughts 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 PolicyPolicy