Social Determinants of Health and Informed Consent Comprehension for Pediatric Cancer Clinical Trials.

ABSTRACT:

Importance

Ensuring valid informed consent (IC) prior to enrollment in clinical trials is a fundamental ethical right.

Objective

To assess whether social determinants of health (SDOH) and related sociocontextual factors are associated with parental IC comprehension in therapeutic childhood cancer clinical trials.

Design, setting, and participants

This cross-sectional study prospectively enrolled 223 parents of children with newly diagnosed cancer at Rady Children's Hospital San Diego, a large quaternary academic center in California, from October 1, 2014, to March 31, 2021. Linear mixed effects models were used to assess whether IC comprehension overall and by domain (purpose, procedures, and randomization; risks and benefits; alternatives; and voluntariness) were ass

SUBMITTER: Aristizabal P 

PROVIDER: S-EPMC10714248 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature