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BACKGROUND Informed consent for a pediatric oncology phase 1 trial is a delicate process, and is made more complex by the difficulty of the information and the requirement for parental consent, and patient assent when applicable. This analysis identifies suggestions for improving the informed consent process received from parents and adolescent and young adult patients (aged 14 years-21 years) who had the option of participating in a phase 1 pediatric oncology trial. METHODS A total of 57 parents and 20 patients completed interviews as part of a multisite, prospective, descriptive study. These transcribed interviews were studied using established content analysis methods. RESULTS Parent and patient responses contained 220 suggestions and 54 suggestions, respectively. A total of 21 unique suggestions for improvement emerged in 3 main themes: 1) provision of more information; 2) structure and presentation of the informed consent process, and 3) suggestions for physicians conducting the process. Common suggestions included providing more specific information about the trial, allowing more time for decision-making, and using different methods to deliver information. CONCLUSIONS Participants involved in the informed consent process for a phase 1 trial provided specific recommendations to research teams to enhance the process. Physician/investigators should be informed of these recommendations and develop and test interventions incorporating them. Cancer 2013;119:4154–4161. © 2013 American Cancer Society.

OBJECTIVE: To characterize provider-parent vaccine communication and determine the influence of specific provider communication practices on parent resistance to vaccine recommendations. METHODS: We conducted a cross-sectional observational study in which we videotaped provider-parent vaccine discussions during health supervision visits. Parents of children aged 1 to 19 months old were screened by using the Parent Attitudes about Childhood Vaccines survey. We oversampled vaccine-hesitant parents (VHPs), defined as a score ≥50. We developed a coding scheme of 15 communication practices and applied it to all visits. We used multivariate logistic regression to explore the association between provider communication practices and parent resistance to vaccines, controlling for parental hesitancy status and demographic and visit characteristics. RESULTS: We analyzed 111 vaccine discussions involving 16 providers from 9 practices; 50% included VHPs. Most providers (74%) initiated vaccine recommendations with presumptive (eg, “Well, we have to do some shots”) rather than participatory (eg, “What do you want to do about shots?”) formats. Among parents who voiced resistance to provider initiation (41%), significantly more were VHPs than non-VHPs. Parents had significantly higher odds of resisting vaccine recommendations if the provider used a participatory rather than a presumptive initiation format (adjusted odds ratio: 17.5; 95% confidence interval: 1.2–253.5). When parents resisted, 50% of providers pursued their original recommendations (eg, “He really needs these shots”), and 47% of initially resistant parents subsequently accepted recommendations when they did. CONCLUSIONS: How providers initiate and pursue vaccine recommendations is associated with parental vaccine acceptance.

Informed consent for a pediatric oncology phase 1 trial is a delicate process, and is made more complex by the difficulty of the information and the requirement for parental consent, and patient assent when applicable. This analysis identifies suggestions for improving the informed consent process received from parents and adolescent and young adult patients (aged 14 years-21 years) who had the option of participating in a phase 1 pediatric oncology trial.A total of 57 parents and 20 patients completed interviews as part of a multisite, prospective, descriptive study. These transcribed interviews were studied using established content analysis methods.Parent and patient responses contained 220 suggestions and 54 suggestions, respectively. A total of 21 unique suggestions for improvement emerged in 3 main themes: 1) provision of more information; 2) structure and presentation of the informed consent process, and 3) suggestions for physicians conducting the process. Common suggestions included providing more specific information about the trial, allowing more time for decision-making, and using different methods to deliver information.Participants involved in the informed consent process for a phase 1 trial provided specific recommendations to research teams to enhance the process. Physician/investigators should be informed of these recommendations and develop and test interventions incorporating them.

While the Stanford model of research ethics consultation has many strengths, we believe it lacks an essential component: the inclusion of research participant and family perspectives. As described,...