Journal of Clinical Research & Bioethics

Abstract

Influence of Demographic Characteristics of Participants on Consent to Genomic Research into Congenital Heart Disease

Charles Dupras, Gregor Andelfinger, Michèle Paré, Maryse Thibeault and Béatrice Godard

Background: The enrollment of sick children and their families in genomics studies calls for a comprehensive view of the consent process. Few studies have searched for correlations between the demographic characteristics of participants (age, gender, parental lineage) or their level of participation (affected children, parents, or other relatives), on the one hand, and patterns of consent to specific pediatric research procedures, on the other (DNA banking, use of cardiac tissue, disclosure of a cardiac condition, creation of cell lines, recall of a participant).
Objectives: This study sought to analyze the extent to which respondents participation in genomic research into congenital heart disease, based on their consent to specific procedures, revealed patterns correlated with their demographic data. Methods and findings: Data were abstracted from consent forms obtained from 600 participants enrolled in a research project on the genomics of congenital heart disease.
Results: Our analysis revealed significant patterns between demographic characteristics and willingness to consent to various aspects of genomic research into congenital heart disease.
Conclusions: Participant heterogeneity needs to be considered by clinical researchers in order to identify specific sub-groups of participants who may require more attention for improving the recruitment and retention in genomic research into congenital heart disease, as well as the consent process.