Negotiating decisions during informed consent for pediatric Phase I oncology trials.

Journal of Empirical Research on Human Research Ethics : JERHRE
Patricia A MarshallEric Kodish

Abstract

During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.

References

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Citations

Feb 8, 2016·Critical Reviews in Oncology/hematology·Gabriella PravettoniGiuseppe Curigliano
Jul 28, 2017·Pediatric Blood & Cancer·Bryan A SiskJames DuBois
Aug 18, 2018·Oncology Nursing Forum·Stacey CraneSusan E Hickman
Jun 15, 2016·The Lancet Oncology·Jean-Claude K DupontFrançois Doz

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