Biomedical subjects
Eric Kodish
Publications and source records attributed to Eric Kodish.
Assent observed: children's involvement in leukemia treatment and research discussions.
OBJECTIVE: Assent is a critical issue in pediatric ethics that has not been well-studied. We examined the role of older children in discussing a recent diagnosis of acute leukemia and treatment options, including participation in a randomized, clinical trial (RCT). DESIGN: Our sample was drawn from data collected as part of a larger, National Cancer Institute-funded study in which we observed, tape-recorded, and transcribed the informed consent conference (ICC) for children with leukemia at 6 institutions. We analyzed the data for the child's presence and role, examined 5 discussion categories relevant to assent in the context of pediatric cancer treatment/research, conducted parent interviews, and administered clinician questionnaires to examine these issues. We report a qualitative analysis of 14 cases in which the child was present for the ICC. RESULTS: Clinicians varied with regard to whom they directed specific discussions when patients were present. Questions asked by the children predominantly related to details of the disease and treatment, with few questions about the RCT. Clinicians and parents attribute responsibility for decision-making about participation in RCTs in a variety of ways. In conferences that included the child-patient, parents asked significantly fewer questions than in other ICCs. CONCLUSION: There is significant variation among ICCs that include the older child. Additional empirical study of assent is warranted, and our data suggest several hypotheses that should be tested in future research.
The nurse as witness in the research consent/assent process: an inherently problematic role, or an ethical obligation?
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Pediatric ethics and early-phase childhood cancer research: conflicted goals and the prospect of benefit.
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Altruistic discourse in the informed consent process for childhood cancer clinical trials.
Scholars have debated the role that altruistic considerations play--and should play--in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) "the future" and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.
Three children with CD30 cutaneous anaplastic large cell lymphomas bearing the t(2;5)(p23;q35) translocation.
Since its discovery in CD30(+) anaplastic large cell lymphomas, the t(2;5)(p23;q35) translocation has shown a high degree of association with nodal disease, younger patient age, and better prognosis. Furthermore, primary cutaneous CD30(+) anaplastic large cell lymphomas rarely manifests the t(2;5) translocation. We present three cases of this disease that occurred in children, bore the t(2;5) translocation, and had excellent outcomes, but presented cutaneously. Two of these lesions were primary skin lymphomas. Review of the available literature in conjunction with these three cases suggests that the t(2;5) translocation may be more strongly associated with younger patient age and favorable outcomes rather than nodal versus cutaneous site of presentation.
Informing study participants of research results: an ethical imperative.
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Conducting empirical research on informed consent: challenges and questions.
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Children in research: new perspectives and practices for informed consent.
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Children, research, and guinea pigs: reflections on a metaphor.
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