?I?m a Guinea Pig!? Exploring Child and Parent Understanding of Human Subjects? Issues

Linda Radecki, MS ¹, Lynn M Olson, PhD ¹ and Mary Pat Frintner, MSPH ¹. ¹ Practice and Research, American Academy of Pediatrics, Elk Grove Village, IL, United States, 60173.

 

Background: Federal human subjects regulations require special considerations for children, yet little is known about child or parent views on participating in research.

 

Objective: To assess child & parent understanding of key human subject issues.

 

Design/Methods: As part of a larger study examining the capacity of children to report on their own asthma health, a subgroup completed in-person & mailed surveys addressing: 1) understanding informed consent; 2) views on remuneration & 3) study impact on the family.

 

Results: 89 parents & 82 children completed the in-person survey; 48 parents & 44 youth mailed in the ?take home? survey. Mean child age=11 years. Understanding informed consent: 96% of parents reported having no questions about the study that were not addressed. When asked if they could have said ?no? to joining the study or ?no? even if their parents wanted them to participate, 84% & 71% of children responded affirmatively. About half (47%) believed they could have stopped the study once started. Most (91%) understood that they could skip a question they did not want to answer but far fewer (34%) knew they could skip a question and still receive compensation. Views on remuneration: Most parents (96%) believed adult & child compensation was adequate. Although youth received gift cards, slightly more would have preferred money (52%) to gift cards (48%). Over ¾ of children believed they would have taken part even without the gift cards. Study impact on family: Most parents (73%) reported talking to their child more about asthma as a result of participation & over 20% changed behavior after study involvement (eg, more regular use of peak flow, clean house more). When youth were asked what they did not like about the study, 44% reported they liked everything (with one child responding ?Nothing?I m a guinea pig!?); those who cited a ?least favorite part? often mentioned remembering to use the study s electronic peak flow meter.

 

Conclusions: Some key aspects of informed consent may not be clearly understood by youth, especially those pertinent to declining participation, regardless of circumstance. Innovative, developmentally appropriate methods may be needed to convey informed consent to the child, such as pictorial presentations, feedback to ensure understanding, & reinforcement at subsequent visits.