1. Pediatric Research in Maryland: Implications of the Krieger Case
Jack Schwartz
Director of Health Policy
Maryland AG’s Office

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:
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?