Michael R. Hadskis Assistant Professor, Dalhousie Law School IWK Kermesse Scholar, Health Law Institute Co-investigator,

1. Michael R. Hadskis Assistant Professor, Dalhousie Law School IWK Kermesse Scholar, Health Law Institute Co-investigator, CIHR Neuroethics NET Ethics of Neuroimaging Research Involving Children

2. Sponsor and NET Investigator Affiliations

3. Introduction • “Neuroimaging pediatric patients is accompanied by all the ethical dilemmas associated with neuroimaging in adults, magnified exponentially.” [Hinton, 2002]

4. Introduction • MRI research involving children, with and without neurological disorders, presents difficult issues: • Consent • Balancing harms and benefits • Privacy and confidentiality • Unanticipated (incidental) findings • Interpreting scan data • Allocation of public resources

5. Introduction • Neuroethics New Emerging Team (NET) Grant - “Neuroimaging Ethics: From Theory to Practice” • Institute of Neurosciences, Mental Health and Addiction (INMHA), CIHR

6. Introduction • Talk outline: • Consent challenges • Informed consent (risk disclosure) • Capacity to consent • Unanticipated findings • My thesis

7. Consent Challenges • To be legally and ethically valid, consent to participate in research must be voluntarilygiven by persons competent to make such decisions, after they have been properly informed of all relevant information

8. Consent Challenges: Consent Must be Informed • Legal standards for informed consent in the research context: • Research with no intended benefits for the participants: • “…full and frank disclosure” of all information “which a reasonable person might be expected to consider” Halushka v. University of Saskatchewan • Disclosure of all risks, even those that are rare and remote Weiss v. Soloman • Research with intended benefits for participants – law is unclear

9. Consent Challenges: Consent Must be Informed • Ethical standards for informed consent in the research context: “…full and frank disclosure of all relevant information” Tri-Council Policy Statement (TCPS)

10. Consent Challenges: Consent Must be Informed • MRI research disclosure obligations include (among others): • Nature and purpose of MRI study • Benefits, if any, of participating in MRI study • Risks of participating in MRI study

11. Informing About Physical Risks • Disclosure of physical risks related to: • Metal projectiles • Embedded metallic objects • Interference with implanted electronic/magnetic devices • Physiological responses to magnetic fields • Acoustic noise • Sedation/anesthesia • Contrast agents • Additional diagnostic interventions (re: unanticipated findings)

12. Informing About Psychological Risks • Psychological harms arising from situational characteristics (e.g., noise and small bore size) • Populations at greater risk of psychological harm (e.g., some children and some persons with mental disorders) • Distress/anxiety related to unanticipated findings

13. Template Text for Potential Harms Section of Consent Forms • Template for the disclosure of MRI research risks in consent forms: www.neuroethics.ca • Comments on template would be greatly appreciated: michael.hadskis@dal.ca

14. Consent Challenges: Consent Must be Given by Competent Persons • Competency assessment: • Test – Ability to understand the information presented and to appreciate the potential consequences of the decision to participate (“mature minor”) • Provincial variation regarding law on competence • Functional assessment (not global or static) • Who will do the assessment and how will it be done?

15. Consequences of Finding a Child Incompetent • If the child is incompetent, according to the TCPS: • Voluntary and informed consent must be sought from child’s parent/guardian (“best interests”) • The research question can only be addressed using the target population • The research cannot expose child to more than “minimal risks” without the potential for direct benefits for him/her, but note: • Eve v. E. • Civil Code of Quebec, Article 21 • Child’s assent may be required

16. Unanticipated Findings • Unanticipated findings in MRI research are not rare: • Study of unanticipated findings in 225 healthy children • 47 (21%) abnormalities detected • Of them, 17 (36%) merited routine medical referral • And 1 (2%) required urgent referral • Other studies involving MRI scans of healthy children and adults (controls) • Unanticipated findings in 20-50% of scans • 1-8% having clinically significant findings

17. Disclosure of Potential for Unanticipated Findings • Disclosure of information relevant to unanticipated findings: • Possibility of making such findings: • Depends on who is reviewing the scans (MRI technologist vs. paediatric neuroradiologist) • Depends on scan type (research or diagnostic-grade) • Associated risks (and benefits): • Anxiety • Further tests and unpleasant treatments/complications • Stigmatization and impact on insurability • Management plan to deal with unanticipated findings

18. Need for Unanticipated Findings Management Plan • Many MRI researchers are unprepared: • Study of MRI researchers’ practices – only 50% of respondents had management plan

19. Possible Unanticipated Findings Management Plan • Possible management plan: • Advise participant/SDM of absence of diagnostic expertise and that scan is not optimized to detect abnormalities • Advise that if a finding “seems possibly” abnormal to the investigator, a referral will be made to a neuroradiologist: • Fact of referral will not be disclosed at this juncture • Latency of the neuroradiological review • Considerations: (1) expense/availability of expert consultation; (2) investigator’s exposure to liability (negligence); and (3) therapeutic misconception

20. Possible Unanticipated Findings Management Plan Con’t • Neuroradiologist reviews scan and determines whether it merits recommending medical referral • Pre-define what kinds of possible abnormalities will merit referral • Considerations: (1) neuroradiologist’s exposure to liability (negligence); (2) confirm CMPA coverage; and (3) unnecessary diagnostic MRI scans

21. Possible Unanticipated Findings Management Plan Con’t • If the neuroradiologist determines no referral is necessary, participant/SDM is not notified • If neuroradiologist determines referral is appropriate: • Preparation of neuroradiologist’s report • Communication with participant’s primary care physician (PCP) and through PCP to participant/SDM, or directly with the participant where no PCP • Decision to pursue further examinations and/or treatment (if available) is left with the participant/SDM

22. Template Text for Unanticipated Findings Section of Consent Forms • Presently developing template language for consent forms respecting a recommended approach to unanticipated findings • Will be posted at: www.neuroethics.ca

23. Conclusions • MRI research involving children has ethical and legal pitfalls that need to be further explored • Real concerns around whether the current ethical and legal disclosure standards are being met (“Review of Paediatric MRI Protocols and Consent Forms by Canadian REBs”) • Nature and seriousness of attendant harm has implications for ability or willingness to conduct MRI research involving children at all (therapeutic orphans) • Pressing need for carefully-crafted management plans to deal with incidental/unexpected findings