Abstract 19926: Pediatric Participation in Research: Lessons Learnt from a Population-based Cardiac Biorepository
Consenting minors for genetics research can be challenging given the lack of standardized guidelines for pediatric consent. We examined consent patterns during the establishment of a population-based DNA/tissue biorepository in patients (pts) with heart disease.
Methods: Individuals with congenital heart disease or cardiomyopathy were prospectively enrolled in a population-based biorepository/registry across 7 centers in the province. Patients, parents or legal guardians were approached for “open consent” for the donation of blood/saliva (for DNA), tissue, and skin biopsy from the affected individual for future research into genomics and stem cell research. All data and samples were stored in a de-identified manner. Consent rates were analyzed using Chi square analysis.
Results: 2712 patients (pts) with heart disease were approached from 2008-10 across 7 centers in the province. 2484 consented at a consent rate of 91.6%. Mean age was 10.2 ±8.7 yrs (56.5% male); 95.6% were <18 years old. 67.0% were White, 13.3% Asian, 3.8% Black, 15.9% other/unknown. Consent rates were higher in adults vs children (99.1% vs. 91.8%, p=0.001). Consented patients were older at screening (10.6 yrs) vs non-consented (5.7 yrs) (p<0.001). Consent rates were higher in Whites (95%) compared to Asians (88%) or Blacks (85%) (p<0.001). Consent rates were lowest in pts with non-complex CHD like left-to-right shunt lesions (90.5%, p=0.04). Leading causes for refusal of consent were lack of interest in research (52%), discomfort with genetics research (15%) or being overwhelmed clinically (12%). Concerns related to privacy, insurance, indefinite storage of samples and ongoing access to medical records were not the leading causes for refusal of consent.
Conclusion: The informed consent rate for a population-based pediatric biorepository was greater than 90% which is similar to adult biorepositories. Standard ethical, social or legal issues surrounding biorepository research were not cited as reasons for refusal of consent. This study emphasizes the need to encourage the participation of children in biorepository research to ensure that children are not deprived of the benefits of research and provides insights for formulating guidelines for pediatric biorepository consent.
- Congenital heart disease
- Pediatric cardiology
- Patient education/teaching psychosocial aspects
- © 2010 by American Heart Association, Inc.