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Pediatric Research in Maryland: Implications of the Krieger Case

Pediatric Research in Maryland: Implications of the Krieger Case. Jack Schwartz Director of Health Policy Maryland AG’s Office jschwartz@oag.state.md.us. The Krieger Study: Objective. Efficacy of affordable lead abatement 3 groups of houses: varying levels of abatement

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Pediatric Research in Maryland: Implications of the Krieger Case

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  1. Pediatric Research in Maryland: Implications of the Krieger Case Jack Schwartz Director of Health Policy Maryland AG’s Office jschwartz@oag.state.md.us

  2. The Krieger Study: Objective • Efficacy of affordable lead abatement • 3 groups of houses: varying levels of abatement • 2 groups of control houses • supposedly fully abated • no lead paint ever used

  3. The Krieger Study: Methods • Testing for lead blood levels • Testing for environmental lead levels • dust • soil • water • Questionnaires

  4. Plaintiff #1: Ericka Grimes • Infant, entered study via mother’s consent • House was in control group (fully abated) • Dust sample testing  lead “hot spots” • No disclosure for 9 months • Found to have EBL

  5. Plaintiff #2: Myron Higgins • 4 y/o, entered study via mother’s consent • House was in an intervention group • Found to have EBL

  6. The plaintiffs’ case • Negligence claims • improper abatement methods • failure to warn • Ericka and Myron win only if Krieger: • had a legally recognized duty to them • breached that duty • by the breach, caused them injury

  7. Krieger’s short-lived win • Krieger’s argument: no duty owed • “Even if what the plaintiffs say were true, they still lose.” • Trial court agrees • grants Krieger’s motion for summary judgment • No trial • No factual record except plaintiffs’ allegations

  8. Issue on appeal: existence of duty • Court of Appeals reverses trial court • Krieger did have a duty of care • Sources: • consent document = contract • nature of “nontherapeutic” research • federal regulations • Nuremberg Code

  9. Holding on parental authority • Standard = best interest of the child • Court’s view of the Krieger research • Healthy children; no personal benefit • Risk of permanent, serious harm • Participation could not be in child’s best interest • Therefore, no parental authority to consent

  10. Bioethics commentary • Krieger research deemed unethical • disregard of potential harm to subjects • inadequate informed consent • Hopkins IRB deemed unethical • regarded as an endemic problem • Researchers had conflicts of interest • financial and scientific incentives

  11. Lessons of the case for pediatric researchers • Consider issue of parental authority • suggested algorithm • Describe risks and benefits fairly and fully in protocol • Conduct genuine informed consent process • Ensure provision of information to parents • as promised • if material to decision whether child should continue in research

  12. Step 1: Any therapeutic procedures involved? • Therapeutic = evidence-based possibility of direct medical benefit • Nontherapeutic = done solely to answer the scientific question • Weijer C & Miller PB. When are research risks reasonable in relation to anticipated benefits? Nature Med 2004; 10: 570-73. • If NO  • Parental authority probably limited to minimal risk • If YES  • To Step 2

  13. Step 2: Clinical equipoise? • Are therapeutic procedures consistent with competent medical care? • If NO  • No parental authority • Not in child’s best interest to forgo preferable care • If YES  • To Step 3

  14. Step 3: Potential direct benefits worth the risk? • Are risks of therapeutic procedures justified by prospect of direct benefit? • If NO  • No parental authority • If YES  • To Step 4

  15. Step 4: Risk of nontherapeutic procedures minimized? • Are risks of nontherapeutic procedures minimized consistent with sound scientific design? • If NO  • No parental authority • If YES  • To Step 5

  16. Step 5: Risk of nontherapeutic procedures justified? • Are risks of nontherapeutic procedures no more than a minor increase over minimal and justified by scientific value? • If NO  • No parental authority • If YES  • Parental permission allowed

  17. Applying the analysis: Phase 1 oncology trials • Is test article a therapeutic procedure? • By FDA definition, not an efficacy trial • But: what if no clinical alternative for hope of remission? • Depending on facts about child, research, and alternatives: • Answer might be “Yes” to all • Parental best interest judgment possible

  18. Applying the analysis: prophylactic vaccine trials • Is test article a therapeutic procedure? • Therapeutic for healthy subjects? • Maybe, depending on risk of future disease • If IRB finds it not a therapeutic procedure: • > minimal risk • No parental authority • If IRB finds it a therapeutic procedure: • Answer might be “Yes” to all • Parental best interest judgment possible

  19. Applying the analysis: epidemiology • Probably no therapeutic procedures • What are risks of the nontherapeutic procedures? • Typical questionnaire = minimal risk • Typical phlebotomy = minimal risk • Identification of heightened genetic risk = more than minimal risk?

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