Students: Please sit with your project group in the first set of rows. Auditors: Please sit in the back.

1. Students: Please sit with your project group in the first set of rows. Auditors: Please sit in the back. FMRI – Week 12 – Ethics Scott Huettel, Duke University

2. FMRI : Ethics FMRI Undergraduate Course (PSY 181F) FMRI Graduate Course (NBIO 381, PSY 362) Dr. Scott Huettel, Course Director FMRI – Week 12 – Ethics Scott Huettel, Duke University

3. Topics in Ethics • Presenting fMRI to the media • Incidental findings • Privacy: HIPAA • Safety issues • Testing of subject groups • Reverse Inference • Future Applications • Lie Detection • Traits (good and bad) FMRI – Week 12 – Ethics Scott Huettel, Duke University

4. Exercise 1: FMRI and the Media In the (real) news article provided, identify as many statements as you can that are incorrect or misleading (based on what you’ve learned in class). Underline the problematic statements – and be prepared to defend your reasoning. FMRI – Week 12 – Ethics Scott Huettel, Duke University

5. FMRI – Week 12 – Ethics Scott Huettel, Duke University

6. FMRI – Week 12 – Ethics Scott Huettel, Duke University

7. Incidental Finding A neural abnormality discovered in a volunteer research subject who does not otherwise present with symptoms. ~1% of all subjects. Lesion Arteriovenous Malformation Subarachnoid Cyst Images: www.popovic.com.au, medpix.com FMRI – Week 12 – Ethics Scott Huettel, Duke University

8. Exercise 2: Incidental Findings How should we (fMRI scientists) deal with incidental discoveries in healthy research subjects? In your group, write down some rules that you think researchers should follow. That is, what should our policy be? FMRI – Week 12 – Ethics Scott Huettel, Duke University

9. Scenarios for Incidental Findings #1. You are an institutional board member at Duke. You can guide policy for all fMRI research being done here. Should you insist that all fMRI scans be read by a board-certified neuroradiologist, to minimize the chances of missing an incidental finding? #1a. … Most fMRI sessions collect only one type of anatomical image, typically T1, and thus cannot easily detect many problems (e.g., fluid). Should you insist that all fMRI scans include multiple, clinical quality anatomical images – so that the neuroradiologist has the best quality images? FMRI – Week 12 – Ethics Scott Huettel, Duke University

10. Scenarios for Incidental Findings #2. You are a graduate student in a fMRI laboratory who is analyzing data for her project. You notice that one of your subject’s brains looks a little odd. What should you do? #2a. You are a graduate student in a fMRI laboratory who is analyzing data for her project. You fail to notice that one of your subject’s brains looks a little odd. The subject turns out to have a malignant tumor. Are you (or Duke!) liable for not catching it? FMRI – Week 12 – Ethics Scott Huettel, Duke University

11. Scenarios for Incidental Findings #4. You are a researcher who identifies an incidental finding in one of your subjects. After consultation with a neuroradiologist, the abnormality is determined to be benign. What, if anything, do you tell that subject? #4a. … suppose that, in the scenario above, the scans were inconclusive. What should you do? #5. … suppose that the inconclusive but suggestive scan is not noticed until more than a year later, when you are finishing the study for publication. What should you do? FMRI – Week 12 – Ethics Scott Huettel, Duke University

12. PUBLIC LAW 104-191 AUG. 21, 1996 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 Public Law 104-191104th Congress An Act To amend the Internal Revenue Code of 1986 to improve portability and continuity of health insurance coverage in the group and individual markets, to combat waste, fraud, and abuse in health insurance and health care delivery, to promote the use of medical savings accounts, to improve access to long-term care services and coverage, to simplify the administration of health insurance, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, FMRI – Week 12 – Ethics Scott Huettel, Duke University

13. FMRI – Week 12 – Ethics Scott Huettel, Duke University

14. What is Private Health Information?(for a research study) • Name of participant • Insurance, medical records • Medical history, current conditions • Group assignments (e.g., Alzheimer’s) • Brain data? FMRI – Week 12 – Ethics Scott Huettel, Duke University

15. Image from Chris Rorden (USC) FMRI – Week 12 – Ethics Scott Huettel, Duke University

16. What about fMRI data? Should this be protected (anonymized) information? FMRI – Week 12 – Ethics Scott Huettel, Duke University

17. Should there be special requirements for scanning…? • Elderly adults who might be likely to have abnormalities? • Children? • Duke students? • Pregnant women? FMRI – Week 12 – Ethics Scott Huettel, Duke University

18. Pregnancy Testing • Epidemiological studies in humans • Is there any evidence that pregnant women exposed to MRI are at higher risk for…? • Mechanistic studies in animals • Does exposure to MRI (at any point in pregnancy) generate problems, when tested under controlled laboratory conditions? Credits: Gregory McCarthy and other BIAC personnel FMRI – Week 12 – Ethics Scott Huettel, Duke University

19. Human Epidemiology • Epidemiological evidence with MRI workers: miscarriages and fertility (Kanal et al., 1993) • Subjects: 1,915 female MRI technicians (not restricted in work). • Tested: Chronic, long term exposure to static and gradient magnetic fields. • Results: No significant effects of working with MR on rates of miscarriage, stillbirth, spontaneous abortion, ectopic pregnancy, premature delivery, infertility, or low birth weight. Studies of children who were scanned as fetuses for medical reasons have found no reliable, significant effects. FMRI – Week 12 – Ethics Scott Huettel, Duke University

20. Rodent Studies • Some studies report effects, others using similar protocols do not. • Key challenge for these studies: controlling for non-MR-related stressors FMRI – Week 12 – Ethics Scott Huettel, Duke University

21. Pregnancy Testing: Trading off Known and Unknown Risks • Blood pregnancy test: most accurate, but requires needle puncture • Small risks of infections, fainting, etc. • Urine pregnancy test: less accurate, potentially subject to errors • No pregnancy test: risk of running a pregnant individual FMRI – Week 12 – Ethics Scott Huettel, Duke University

22. “Pregnant? Metal in your body?” FMRI – Week 12 – Ethics Scott Huettel, Duke University

23. Reverse Inference “… the use of neuroimaging data… to infer the engagement of particular cognitive functions based on activation in particular brain regions.” From Poldrack (2006) FMRI – Week 12 – Ethics Scott Huettel, Duke University

24. Our ability to do reverse inference depends on two factors: 1) the validity of our cognitive task, and 2) the selectivity of our brain region. From Poldrack (2006) FMRI – Week 12 – Ethics Scott Huettel, Duke University

25. Your Brain on Politics, revisited This morning’s New York Times Op Ed page presents us with dazzling pictures, from the lab of Marco Iacoboni, of the brains of swing voters as they react to photos and videos of the leading presidential candidates. … Mitt Romney evokes anxiety – this is deduced from amygdala activation. John Edwards’ detractors feel disgust toward him – this is apparent in the insula of these subjects. First, some criticisms that I don’t think this work necessarily deserves, starting with the old “you can process brain imaging data to make it show anything” criticism… So why do I doubt the conclusions reported in today’s Op Ed piece? The problems I see have less to do with brain imaging per se than with the human tendency to make up “just so” stories and then believe them. … The Edwards insula activation might indicate disgust, but it might also indicate thoughts of pain or other bodily sensations or a sense of unfairness, to mention just a few of the mental states associated with insula activation. … The Romney amygdala activation might indicate anxiety, or any of a number of other feelings that are associated with the amygdala – anger, happiness, even sexual excitement. FMRI – Week 12 – Ethics Scott Huettel, Duke University

26. Exercise 3: Applications What if we could use fMRI to reliably distinguish lies from true statements? What impact would (should?) this have on our legal system? FMRI – Week 12 – Ethics Scott Huettel, Duke University

27. FMRI – Week 12 – Ethics Scott Huettel, Duke University

28. Predictive accuracy, based on GLM, of about 80% FMRI – Week 12 – Ethics Scott Huettel, Duke University

29. FMRI – Week 12 – Ethics Scott Huettel, Duke University

30. FMRI – Week 12 – Ethics Scott Huettel, Duke University