July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Parental Decision-Making Processes in Pediatric Trial Enrollment: Recommendations for Informed Consent in Genetic Eye Disease Research for Cell Therapies
Author Affiliations & Notes
  • Stephanie Brooks
    School of Public Health, University of Alberta, Edmonton, Alberta, Canada
  • Tania Bubela
    Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada
  • Footnotes
    Commercial Relationships   Stephanie Brooks, None; Tania Bubela, None
  • Footnotes
    Support  Alberta Innovates - Health Solutions CRIO Grant
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 4158. doi:
  • Views
  • Share
  • Tools
    • Alerts
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Stephanie Brooks, Tania Bubela; Parental Decision-Making Processes in Pediatric Trial Enrollment: Recommendations for Informed Consent in Genetic Eye Disease Research for Cell Therapies. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4158.

      Download citation file:

      © ARVO (1962-2015); The Authors (2016-present)

  • Supplements

Purpose : Clinical trials for novel interventions, including gene and cell therapies, for genetic eye diseases are beginning to recruit pediatric participants. It is, therefore timely to conduct qualitative interviews in order to consider how to communicate risks and potential benefits of trial participation with parents who make clinical decisions on behalf of their child. Parents have high expectations for new treatment options, which may encourage them to pursue clinical trial opportunities or join risky movements. For example, attending unregulated stem cell clinics that offer unapproved or untested treatments.

Methods : We conducted 15 qualitative interviews with parents of children with genetic eye diseases to explore parental information gathering, decision-making processes, and knowledge of clinical trial conduct. We used the constant comparison method to code interview transcripts for themes, using NVivo qualitative analysis software.

Results : Parents’ decision-making processes followed Protection Motivation Theory. This theory posits that parents will use available information to balance the risks of trial participation against the risks of current disease management. This balancing helps them decide whether trial enrollment may protect the health of their child better than current management methods. However, the theory needs to account for the overly optimistic information about treatment research accessed by parents on traditional and social media. In general, parents are risk-adverse and express a preference for complete and accurate information to make fully informed decisions.

Conclusions : Parents can differentiate between hope and expectation for trial outcomes. However, their preference for accurate information means that clinicians must clearly communicate therapeutic potential, likelihoods of risks and benefits, as well as uncertainty. Recommendations for clinical investigators to develop communication protocols that ensure parents receive all necessary risk and benefit information will ensure that parental consent for pediatric clinical trials is, in fact, informed.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.


This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.