Michael%20R.%20Hadskis

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Ethics of Neuroimaging Research Involving Children

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

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Sponsor and NET Investigator Affiliations
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Introduction

• Neuroimaging pediatric patients is accompanied
  by all the ethical dilemmas associated with
  neuroimaging in adults, magnified exponentially.
  Hinton, 2002

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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

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Introduction

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

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Introduction

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

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Consent Challenges

• 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

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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

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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)

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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

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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)

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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

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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_at_dal.ca

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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?

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Consequences of Finding a Child Incompetent

• If the child is incompetent, according to the
  TCPS
• Voluntary and informed consent must be sought
  from childs 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
• Childs assent may be required

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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

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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/complicati
  ons
• Stigmatization and impact on insurability
• Management plan to deal with unanticipated
  findings

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Need for Unanticipated Findings Management Plan

• Many MRI researchers are unprepared
• Study of MRI researchers practices only 50 of
  respondents had management plan

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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) investigators exposure
  to liability (negligence) and (3) therapeutic
  misconception

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Possible Unanticipated Findings Management Plan
Cont

• Neuroradiologist reviews scan and determines
  whether it merits recommending medical referral
• Pre-define what kinds of possible abnormalities
  will merit referral
• Considerations (1) neuroradiologists exposure
  to liability (negligence) (2) confirm CMPA
  coverage and (3) unnecessary diagnostic MRI
  scans

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Possible Unanticipated Findings Management Plan
Cont

• If the neuroradiologist determines no referral is
  necessary, participant/SDM is not notified
• If neuroradiologist determines referral is
  appropriate
• Preparation of neuroradiologists report
• Communication with participants 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

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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

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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