Informed Consent and Assent in Pediatric Oncology Trials

      Although losing a child of any age is unimaginably painful for any parent, losing a young child to cancer is devastating. Desperation in such cases may lead parents to make irrational choices in an effort to save the child. When the treating clinicians know they have exhausted all conventional therapeutic approaches, enrolling the child in a clinical trial is often the next consideration. What do parents need to know to give informed consent for the participation of a child in treatment research? Beyond presenting the basic facts about a particular cancer, any investigational study will involve questions of risk vs benefit that, by definition, are initially unanswerable. This is particularly true for Phase 1 trials for which there may be minimal evidence to support any expectation of a positive outcome. Can parents, in their panic and hopelessness, make a rational decision? Can the desperation of parents or the poor prognosis for a child pressure a clinician to enroll a child who does not meet all entry criteria? When should the affected child be asked to give her or his assent to participation? How can the facts be explained to children, and how should this information be conveyed to children and by whom? I have asked my wife, Cynthia, to join me in offering some perspectives that have emerged from our discussions of this vexing topic. Cynthia, a retired educator, has served for 20 years as a community member of our local hospital’s institutional review board.
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