Factors influencing parental consent for participation in clinical research involving their children in Egypt

ABSTRACT

Factors affecting parents' decision to involve their children in clinical research have not been studied in all cultural backgrounds. We aimed to explore the attitudes and beliefs influencing parents' decision to involve their children in clinical research in Mansoura, Egypt. Of 523 families approached, 357 filled the questionnaire. Only 98 [27.5%] parents consented to involve their child in clinical research. The children of consenters were significantly older than refusers 8.6 [SD 7.2] versus 2.6 [SD 1.2] years. Factors favouring consent were research of benefit to child [84.7%], enough explanation about the benefits [40.8%] and to learn more about child's condition [29.6%]. Factors favouring refusal were use of new drugs or vaccines [89.6%] and invasive procedures [84.2%]. Parents' rate of consent was positively correlated with the research being non-invasive and the belief that research was of benefit to their child and negatively correlated with belief that refusal may negatively affect the care provided to their child