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PEDIATRIC ETHICS AND CHILDHOOD CANCER RESEARCH Eric Kodish, M.D. Rainbow Center for Pediatric Ethics Rainbow Babies and Childrens Hospital American Academy of Pediatrics Vision Statement “We believe in the inherent worth of all children. The are our most enduring and vulnerable legacy.”

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pediatric ethics and childhood cancer research

PEDIATRIC ETHICSAND CHILDHOOD CANCER RESEARCH

Eric Kodish, M.D.

Rainbow Center for Pediatric Ethics

Rainbow Babies and Childrens Hospital

slide2
American Academy of Pediatrics Vision Statement

“We believe in the inherent worth of all children. The are our most enduring and vulnerable legacy.”

-AAP 1999

pediatric ethics

PEDIATRIC ETHICS

BENEFICENCE

RESPECT FOR PERSONS

JUSTICE

principles of medical ethics
Principles of Medical Ethics
  • Respect for Persons is dominant principle for adult ethics (autonomy)
  • Beneficence is dominant principle for pediatric ethics (best interests of child)
two questions in pediatric ethics
Two Questions in Pediatric Ethics

Should a particular

therapy be given? BENEFICENCE

Who should make a

consent decision? AUTONOMY

The answers may be incompatible

informed consent vs parental permission
Informed Consent vs. Parental Permission
  • Autonomous authorization of adults on their own behalf is more robust than parental permission for children by proxy/surrogate
  • “…the pediatrician’s responsibilities to his or her patient exist independent of parental desires or proxy consent.” (American Academy of Pediatrics 1995 statement on informed consent, parental permission, and assent in pediatric practice)
parental permission
Parental Permission
  • Is not the moral equivalent of informed consent.
  • Problems: surrogate decision necessarily less authentic
  • Use of best interests vs. substituted judgement standard
proxy consent
SUBSTITUTED JUDGMENT

subjective

respects autonomy

BEST INTERESTS

objective

promotes beneficence

PROXY CONSENT
assent a clinical definition
Assent: A Clinical Definition
  • Awareness of the nature of his/her condition
  • What to expect with tests and treatment(s)
  • Assessment of understanding (including pressure to accept/assent)
  • Soliciting* an expression of willingness to accept the proposed test/treatment
assent a clinical definition12
Assent: A Clinical Definition

*Regarding this final point, we note that no one should solicit a patient's views without intending to weigh them seriously. In situations in which the patient will have to receive medical care despite his or her objection, the patient should be told that fact and should not be deceived.

-AAP COB ‘95

assent a research definition
Assent: A Research Definition

“A child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.”

-CFR 46.402 (b)

assent clinical vs research
Assent: Clinical vs. Research
  • Research is supererogatory
  • Assent/dissent determinative in research but not in clinical context
  • Veto power for all 3 moral actors?
  • For all studies, the older the child the more ethically justifiable (if assent is provided)
informed consent data
Informed Consent Data*
  • Direct Observation and audiotaping of consent process for children recruited to CCG leukemia RCTs, followed by extensive parent interviews and clinician reports.
  • Findings: The RCT is generally explained, but many parents do not understand their choice about the clinical trial (32%), and do not understand randomization (52%)
  • Minorities and those in lower social position are at greatest risk for non-understanding, and ask fewer questions.
  • This data may not be generalizable to the relapse context but is a potential concern for Phase II Window studies

(*funded by RO1CA83267)

decision making preference
DECISION MAKING PREFERENCE:

I prefer:

1. to leave all decisions regarding treatment to my child’s doctor.

2. that my child’s doctor makes the final decision about which treatment will be used, but seriously considers my opinion.

3. that my child’s doctor and I share responsibility for deciding which treatment is best.

4.to make the final selection of my child’s treatment after seriously considering my doctor’s opinion.

5.to make the final selection about which treatment my child will receive.

the nuremberg code
THE NUREMBERG CODE

1. The voluntary consent of the human subject is absolutely essential.

(“This means that the person involved should have legal capacity to give consent;”)

can we adhere to nuremberg and do pediatric research
Can we adhere to Nuremberg and do pediatric research?

If the answer is no, children as a group will suffer.

If the answer is yes, how can children be adequately protected?

how can we respect nuremberg and do pediatric research
How can we respect Nuremberg and do pediatric research?

1) Parents as surrogates: Permission

2) Involve Children: Assent

3) Societal Protection: IRB approval

approvable research 4 categories
Approvable Research: 4 categories:

46.405

2) Involving greater than minimal risk but presenting the prospect of direct benefit to the individual subject, if:

  • risk justified by anticipated benefit to subject
  • R:B ratio < alternatives
  • parental permission and assent obtained
research ethics

RESEARCH ETHICS:

RISK always means to the subject

BENEFIT may include:

benefits to the subject

benefits to other patients

benefits to society (i.e., knowledge)

benefits to investigator/sponsor

pediatric research ethics
PEDIATRIC RESEARCH ETHICS:

Best interests

of child-subject

Science to

benefit others

phase i oncology research in children
PHASE I ONCOLOGY RESEARCH IN CHILDREN
  • The controversy over “therapeutic intent”
  • Commensurate experience: (46.406 creep)

--should not be a valid justification

  • Prospect of direct benefit is the ethical and regulatory key
  • Problems defining benefit: more than a tumor measurement
  • Considering the alternatives...
phase i oncology research in children29
PHASE I ONCOLOGY RESEARCH IN CHILDREN
  • Subject selection is not a controversy
  • Qualifies as “research with the prospect of direct benefit”
  • Potential for benefit mitigates but does not eliminate the need for protection from research risk
alternative medicine

ALTERNATIVE MEDICINE

Vulnerability concerns

Incredibly prevalent

Hard to define

Pediatric differences

Obligation to prevent harm

Need to study

Need to communicate

hospice

HOSPICE

Not incompatible with Phase I study

Underdeveloped in children, needs advocacy approach

Reject the idea of a “right” way to die; each child and family is unique

Must be part of the consent process for Phase I studies: a responsibility to the dying child

phase ii window design
PHASE II WINDOW DESIGN
  • Subject selection controversial: How poor is “poor prognosis?” Context is everything.
  • Qualifies as “research with the prospect of direct benefit,” but may not be as good for the subject as alternatives (multi-agent)
  • New therapeutic paradigms may change ethical acceptability of these studies.
conclusions
CONCLUSIONS
  • Good ethics starts with good science; but good science is not inherently ethical.
  • It follows that some research with tantalizing potential may need to be rejected on ethical grounds.
  • Accelerated drug development research in childhood cancer should proceed, but long-term follow up data must be collected and analyzed.
slide34

Children are both vulnerable subjects in need of protection from research risks and a neglected class that needs better access to the benefits of research.