title: Negotiating decisions during informed consent for pediatric Phase I oncology trials.
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.
authors.affiliation: Center for Genetic Research Ethics and Law, Department of Bioethics, School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Marshall
authors.forename: Ruth V
authors.initials: RV
authors.lastname: Magtanong
authors.forename: Angela C
authors.initials: AC
authors.lastname: Leek
authors.forename: Sabahat
authors.initials: S
authors.lastname: Hizlan
authors.forename: Amy D
authors.initials: AD
authors.lastname: Yamokoski
authors.forename: Eric D
authors.initials: ED
authors.lastname: Kodish
mesh_terms: D002648:Child; D002755:Choice Behavior; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics; D003142:Communication; D003657:Decision Making; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D017008:Negotiating; D009369:Neoplasms; D018579:Patient Selection / Q000941:ethics*; D020458:Third-Party Consent / Q000941:ethics*