Parental Comprehension of Informed Consent Clinical Trial
Official title:
"Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
Project Summary: One of the challenges facing pediatric researchers is the need to balance
decreasing funding with the time and human resource costs associated with enrolling
children. In order to address this, the Emergency Department (ED) research team developed an
innovative model for subject enrollment and consent using highly trained and supervised
undergraduate students. From a human resources perspective, utilizing students is more cost
effective than the traditional research nurse model. However, a concern with this method is
the adequacy of parental understanding of study information for informed consent. The aim of
this project is to determine if the use of students is at least as good as the more costly
"gold standard" of experienced research nurses. The validation of this innovative student
model will enable child health investigators to better meet parent's needs and increase the
efficiency of pediatric research.
The primary objective of this study is to measure parental comprehension of informed consent
information using an innovative undergraduate research assistant program compared to consent
using the traditional research nurse model. We hypothesize that parental comprehension of
the informed consent information process when approached by undergraduate students will be
comparable (or not worse) than when consent is obtained by a research nurse.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)