Maternal Perceptions of Safeguards for Research Involving Children

Abstract

The vitality of clinical research and the health of the public relies on continued efforts to engage children in clinical research in a fully protected and ethically robust manner. Parents serve as proxy decision-makers assessing the risks and benefits of any given study in order to do what is in the best interest of their child. This study investigated maternal perceptions of research safeguards and mothers' willingness to enroll their children in clinical research studies. We hypothesized that mothers' perceptions of the protectiveness of safeguard procedures utilized in clinical research would be associated with mothers' willingness to enroll their children in research studies with such safeguards. Through a survey conducted via Amazon Mechanical Turk, mothers were asked to rate the perceived protectiveness of four safeguard procedures (confidential data coding, data and safety monitoring boards (DSMBs), institutional review boards (IRBs), and informed consent) and the degree to which they were willing to have their child participate in research studies in the presence of each of the four safeguard procedures. Respondents generally perceived safeguard procedures to be protective. Mothers' trust in researchers' honesty positively impacted perceptions of the protectiveness of research safeguard procedures and willingness to enroll children in research. Mothers of only healthy children perceived research safeguards to be more protective than mothers with at least one child with at least one health issue. This study provides insight into whether maternal perceptions of the protectiveness of different safeguard procedures are associated with mothers' willingness to enroll their children in research.

Keywords: children; mothers; perspectives; research participation; research safeguards.