"I m a Guinea Pig!" Exploring Child and Parent Understanding of Human Subjects Issues.
Linda Radecki, Lynn M. Olson, Mary Pat Frintner. Poster presented to the Society for Developmental and Behavioral Pediatrics, 2005.

 

Purpose:Federal human subjects regulations require special considerations for children, yet little is known about child or parent views on participating in research. The objective of this study is to assess child and parent understanding of key human subject issues.

 

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

 

Results:93 parents & 87 children completed the in-person survey; 54 parents & 49 youth returned the "take home" survey. Mean child age=11.4 years (range=7-16 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% and 71% of children responded affirmatively. About half (51%) believed they could have stopped the study once started. Most (90%) 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 and child compensation was adequate. Although youth received gift cards, slightly more would have preferred money (51%) to gift cards (49%). Over ¾ (86%) of children believed they would have taken part even without the gift cards. Study impact on family: Most parents (74%) reported talking to their child more about asthma as a result of participation and over 20% changed behavior after study involvement (eg, more regular use of peak flow, clean house more, listen to child more, work closely with medical professionals and schools). When youth were asked what they did not like about the study, 45% 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, and reinforcement at subsequent visits.