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.”
Eric Kodish, M.D.
Rainbow Center for Pediatric Ethics
Rainbow Babies and Childrens Hospital
“We believe in the inherent worth of all children. The are our most enduring and vulnerable legacy.”
RESPECT FOR PERSONS
Should a particular
therapy be given? BENEFICENCE
Who should make a
consent decision? AUTONOMY
The answers may be incompatible
*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
“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)
(*funded by RO1CA83267)
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.
N = 108 parents
All cases ANOVA=.002
1. The voluntary consent of the human subject is absolutely essential.
(“This means that the person involved should have legal capacity to give consent;”)
If the answer is no, children as a group will suffer.
If the answer is yes, how can children be adequately protected?
1) Parents as surrogates: Permission
2) Involve Children: Assent
3) Societal Protection: IRB approval
2) Involving greater than minimal risk but presenting the prospect of direct benefit to the individual subject, if:
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
--should not be a valid justification
Hard to define
Obligation to prevent harm
Need to study
Need to communicate
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
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.