Michael R. Hadskis Assistant Professor, Dalhousie Law School IWK Kermesse Scholar, Health Law Institute Co-investigator, C...
Sponsor and NET Investigator Affiliations
Introduction <ul><li>“ Neuroimaging pediatric patients is accompanied by all the ethical dilemmas associated with neuroima...
Introduction <ul><li>MRI research involving children, with and without neurological disorders, presents difficult issues: ...
Introduction <ul><li>Neuroethics New Emerging Team (NET) Grant - “Neuroimaging Ethics: From Theory to Practice”  </li></ul...
Introduction <ul><li>Talk outline: </li></ul><ul><ul><li>Consent challenges </li></ul></ul><ul><ul><ul><li>Informed consen...
Consent Challenges <ul><li>To be legally and ethically valid, consent to participate in research must be  voluntarily   gi...
Consent Challenges: Consent Must be Informed <ul><li>Legal standards for  informed  consent in the research context: </li>...
Consent Challenges: Consent Must be Informed <ul><li>Ethical standards for  informed consent  in the research context: “…f...
Consent Challenges: Consent Must be Informed <ul><li>MRI research disclosure obligations include (among others): </li></ul...
Informing About  Physical  Risks <ul><li>Disclosure of physical risks related to: </li></ul><ul><ul><li>Metal projectiles ...
Informing About  Psychological  Risks <ul><li>Psychological harms arising from situational characteristics (e.g., noise an...
Template Text for Potential Harms Section of Consent Forms  <ul><li>Template for the disclosure of MRI research risks in c...
Consent Challenges: Consent Must be Given by Competent Persons <ul><li>Competency assessment: </li></ul><ul><ul><li>Test –...
Consequences of Finding a Child Incompetent <ul><li>If the child is incompetent, according to the TCPS: </li></ul><ul><ul>...
Unanticipated Findings <ul><li>Unanticipated findings in MRI research are not rare: </li></ul><ul><ul><li>Study of unantic...
Disclosure of Potential for Unanticipated Findings <ul><li>Disclosure of information relevant to unanticipated findings: <...
Need for Unanticipated Findings Management Plan <ul><li>Many MRI researchers are unprepared: </li></ul><ul><ul><li>Study o...
Possible Unanticipated Findings Management Plan <ul><li>Possible management plan:  </li></ul><ul><ul><li>Advise participan...
Possible Unanticipated Findings Management Plan Con’t <ul><li>Neuroradiologist reviews scan and determines whether it meri...
Possible Unanticipated Findings Management Plan Con’t <ul><li>If the neuroradiologist determines no referral is necessary,...
Template Text for Unanticipated Findings Section of Consent Forms <ul><li>Presently developing template language for conse...
Conclusions <ul><li>MRI research involving children has ethical and legal pitfalls that need to be further explored </li><...
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Michael R. Hadskis Assistant Professor, Dalhousie Law School

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Michael R. Hadskis Assistant Professor, Dalhousie Law School

  1. 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. 2. Sponsor and NET Investigator Affiliations
  3. 3. Introduction <ul><li>“ Neuroimaging pediatric patients is accompanied by all the ethical dilemmas associated with neuroimaging in adults, magnified exponentially.” [Hinton, 2002] </li></ul>
  4. 4. Introduction <ul><li>MRI research involving children, with and without neurological disorders, presents difficult issues: </li></ul><ul><ul><li>Consent </li></ul></ul><ul><ul><li>Balancing harms and benefits </li></ul></ul><ul><ul><li>Privacy and confidentiality </li></ul></ul><ul><ul><li>Unanticipated (incidental) findings </li></ul></ul><ul><ul><li>Interpreting scan data </li></ul></ul><ul><ul><li>Allocation of public resources </li></ul></ul>
  5. 5. Introduction <ul><li>Neuroethics New Emerging Team (NET) Grant - “Neuroimaging Ethics: From Theory to Practice” </li></ul><ul><li>Institute of Neurosciences, Mental Health and Addiction (INMHA), CIHR </li></ul>
  6. 6. Introduction <ul><li>Talk outline: </li></ul><ul><ul><li>Consent challenges </li></ul></ul><ul><ul><ul><li>Informed consent (risk disclosure) </li></ul></ul></ul><ul><ul><ul><li>Capacity to consent </li></ul></ul></ul><ul><ul><li>Unanticipated findings </li></ul></ul><ul><li>My thesis </li></ul>
  7. 7. Consent Challenges <ul><li>To be legally and ethically valid, consent to participate in research must be voluntarily given by persons competent to make such decisions, after they have been properly informed of all relevant information </li></ul>
  8. 8. Consent Challenges: Consent Must be Informed <ul><li>Legal standards for informed consent in the research context: </li></ul><ul><ul><li>Research with no intended benefits for the participants: </li></ul></ul><ul><ul><ul><li>“… full and frank disclosure” of all information “which a reasonable person might be expected to consider” </li></ul></ul></ul><ul><ul><ul><li>Halushka v. University of Saskatchewan </li></ul></ul></ul><ul><ul><ul><li>Disclosure of all risks, even those that are rare and remote </li></ul></ul></ul><ul><ul><ul><li>Weiss v. Soloman </li></ul></ul></ul><ul><ul><li>Research with intended benefits for participants – law is unclear </li></ul></ul>
  9. 9. Consent Challenges: Consent Must be Informed <ul><li>Ethical standards for informed consent in the research context: “…full and frank disclosure of all relevant information” </li></ul><ul><li>Tri-Council Policy Statement (TCPS) </li></ul>
  10. 10. Consent Challenges: Consent Must be Informed <ul><li>MRI research disclosure obligations include (among others): </li></ul><ul><ul><li>Nature and purpose of MRI study </li></ul></ul><ul><ul><li>Benefits, if any, of participating in MRI study </li></ul></ul><ul><ul><li>Risks of participating in MRI study </li></ul></ul>
  11. 11. Informing About Physical Risks <ul><li>Disclosure of physical risks related to: </li></ul><ul><ul><li>Metal projectiles </li></ul></ul><ul><ul><li>Embedded metallic objects </li></ul></ul><ul><ul><li>Interference with implanted electronic/magnetic devices </li></ul></ul><ul><ul><li>Physiological responses to magnetic fields </li></ul></ul><ul><ul><li>Acoustic noise </li></ul></ul><ul><ul><li>Sedation/anesthesia </li></ul></ul><ul><ul><li>Contrast agents </li></ul></ul><ul><ul><li>Additional diagnostic interventions (re: unanticipated findings) </li></ul></ul>
  12. 12. Informing About Psychological Risks <ul><li>Psychological harms arising from situational characteristics (e.g., noise and small bore size) </li></ul><ul><li>Populations at greater risk of psychological harm (e.g., some children and some persons with mental disorders) </li></ul><ul><li>Distress/anxiety related to unanticipated findings </li></ul>
  13. 13. Template Text for Potential Harms Section of Consent Forms <ul><li>Template for the disclosure of MRI research risks in consent forms: www.neuroethics.ca </li></ul><ul><li>Comments on template would be greatly appreciated: [email_address] </li></ul>
  14. 14. Consent Challenges: Consent Must be Given by Competent Persons <ul><li>Competency assessment: </li></ul><ul><ul><li>Test – Ability to understand the information presented and to appreciate the potential consequences of the decision to participate (“mature minor”) </li></ul></ul><ul><ul><li>Provincial variation regarding law on competence </li></ul></ul><ul><ul><li>Functional assessment (not global or static) </li></ul></ul><ul><ul><li>Who will do the assessment and how will it be done? </li></ul></ul>
  15. 15. Consequences of Finding a Child Incompetent <ul><li>If the child is incompetent, according to the TCPS: </li></ul><ul><ul><li>Voluntary and informed consent must be sought from child’s parent/guardian (“best interests”) </li></ul></ul><ul><ul><li>The research question can only be addressed using the target population </li></ul></ul><ul><ul><li>The research cannot expose child to more than “minimal risks” without the potential for direct benefits for him/her, but note: </li></ul></ul><ul><ul><ul><li>Eve v. E. </li></ul></ul></ul><ul><ul><ul><li>Civil Code of Quebec , Article 21 </li></ul></ul></ul><ul><ul><li>Child’s assent may be required </li></ul></ul>
  16. 16. Unanticipated Findings <ul><li>Unanticipated findings in MRI research are not rare: </li></ul><ul><ul><li>Study of unanticipated findings in 225 healthy children </li></ul></ul><ul><ul><ul><li>47 (21%) abnormalities detected </li></ul></ul></ul><ul><ul><ul><li>Of them, 17 (36%) merited routine medical referral </li></ul></ul></ul><ul><ul><ul><li>And 1 (2%) required urgent referral </li></ul></ul></ul><ul><ul><li>Other studies involving MRI scans of healthy children and adults (controls) </li></ul></ul><ul><ul><ul><li>Unanticipated findings in 20-50% of scans </li></ul></ul></ul><ul><ul><ul><li>1-8% having clinically significant findings </li></ul></ul></ul>
  17. 17. Disclosure of Potential for Unanticipated Findings <ul><li>Disclosure of information relevant to unanticipated findings: </li></ul><ul><ul><li>Possibility of making such findings: </li></ul></ul><ul><ul><ul><li>Depends on who is reviewing the scans (MRI technologist vs. paediatric neuroradiologist) </li></ul></ul></ul><ul><ul><ul><li>Depends on scan type (research or diagnostic-grade) </li></ul></ul></ul><ul><ul><li>Associated risks (and benefits): </li></ul></ul><ul><ul><ul><li>Anxiety </li></ul></ul></ul><ul><ul><ul><li>Further tests and unpleasant treatments/complications </li></ul></ul></ul><ul><ul><ul><li>Stigmatization and impact on insurability </li></ul></ul></ul><ul><ul><li>Management plan to deal with unanticipated findings </li></ul></ul>
  18. 18. Need for Unanticipated Findings Management Plan <ul><li>Many MRI researchers are unprepared: </li></ul><ul><ul><li>Study of MRI researchers’ practices – only 50% of respondents had management plan </li></ul></ul>
  19. 19. Possible Unanticipated Findings Management Plan <ul><li>Possible management plan: </li></ul><ul><ul><li>Advise participant/SDM of absence of diagnostic expertise and that scan is not optimized to detect abnormalities </li></ul></ul><ul><ul><li>Advise that if a finding “seems possibly” abnormal to the investigator, a referral will be made to a neuroradiologist: </li></ul></ul><ul><ul><ul><li>Fact of referral will not be disclosed at this juncture </li></ul></ul></ul><ul><ul><ul><li>Latency of the neuroradiological review </li></ul></ul></ul><ul><ul><ul><li>Considerations: (1) expense/availability of expert consultation; (2) investigator’s exposure to liability (negligence); and (3) therapeutic misconception </li></ul></ul></ul>
  20. 20. Possible Unanticipated Findings Management Plan Con’t <ul><li>Neuroradiologist reviews scan and determines whether it merits recommending medical referral </li></ul><ul><ul><li>Pre-define what kinds of possible abnormalities will merit referral </li></ul></ul><ul><ul><li>Considerations: (1) neuroradiologist’s exposure to liability (negligence); (2) confirm CMPA coverage; and (3) unnecessary diagnostic MRI scans </li></ul></ul>
  21. 21. Possible Unanticipated Findings Management Plan Con’t <ul><li>If the neuroradiologist determines no referral is necessary, participant/SDM is not notified </li></ul><ul><li>If neuroradiologist determines referral is appropriate: </li></ul><ul><ul><li>Preparation of neuroradiologist’s report </li></ul></ul><ul><ul><li>Communication with participant’s primary care physician (PCP) and through PCP to participant/SDM, or directly with the participant where no PCP </li></ul></ul><ul><li>Decision to pursue further examinations and/or treatment (if available) is left with the participant/SDM </li></ul>
  22. 22. Template Text for Unanticipated Findings Section of Consent Forms <ul><li>Presently developing template language for consent forms respecting a recommended approach to unanticipated findings </li></ul><ul><li>Will be posted at: www.neuroethics.ca </li></ul>
  23. 23. Conclusions <ul><li>MRI research involving children has ethical and legal pitfalls that need to be further explored </li></ul><ul><li>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”) </li></ul><ul><li>Nature and seriousness of attendant harm has implications for ability or willingness to conduct MRI research involving children at all (therapeutic orphans) </li></ul><ul><li>Pressing need for carefully-crafted management plans to deal with incidental/unexpected findings </li></ul>

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