Outcomes of informed consent among parents of children in cancer clinical trials.

BACKGROUND

Clinical trials are central to pediatric oncology, yet the process and outcomes of informed consent are poorly understood. We evaluated correlates of understanding among parents of pediatric trial participants, and explored differences in the process and outcome of informed consent between parents and a comparison group of adult participants.

PROCEDURE

We administered the Quality of Informed Consent (QuIC) to parents of children who were newly enrolled onto a cancer trial. We identified independent correlates of knowledge among parents, and compared parents' knowledge to that of a contemporaneous group of adult participants, using multiple linear regression models.

RESULTS

Parents (n = 47) were less likely than adult participants (n = 204) to report having enough time to learn about the trial (64% vs. 87%, P = 0.001) or sufficient opportunity for questions (79% vs. 93%, P = 0.01), and reported lower overall satisfaction with the consent process (71% vs. 90%, P = 0.002). The mean parental knowledge score was 73.6 (95% confidence interval [CI] 69.5-77.8, theoretical maximum 100). Knowledge did not differ between parents and adult trial participants. In multivariate analysis, two predictors were significantly associated with higher parent knowledge scores: consent sought by the study's principal investigator (increment 13.6, CI 2.7-24.6) and physician-reported poor prognosis (increment 13.8, 95% CI 5.4-22.1).

CONCLUSIONS

Although we observed no differences in knowledge between parents of pediatric cancer trial participants and their adult counterparts, parents report more problems with the informed consent process for their trials. The increased prevalence of problems is likely due to clinical and contextual differences between pediatric and adult trials.