Determinants of Parental Authorization for Involvement of Newborn Infants in Clinical Trials

Abstract

Objective. Parents have the right to decide on behalf of their infants whether to enroll them in controlled clinical trials. We determined the degree to which such parental decisions are influenced by risk and benefit considerations compared with other factors. Design. Cross-sectional survey. Participants. Parents who had recently given or declined consent to one of three controlled trials in the neonatal intensive care unit. Intervention. Parents were asked to complete a questionnaire that consisted of 15 sociodemographic items and 13 scaled responses to statements assessing the probability and magnitude of risk and benefit as well as perceived illness severity, attitudes toward research, and the consent process. Analysis. Responses were subjected to factor analysis to identify underlying constructs. The sample was then randomly split, and multiple regression was performed on each half. Results. The response rate was 83% (103 of 124) for those who had consented and 86% (37 of 43) for those who had declined. Factor analysis yielded three factors: (1) illness severity, (2) perceptions of risk or benefit and attitudes to research, and (3) sociodemographic characteristics. Multiple linear regression showed a significant multiple correlation of consent decision (r = .502), but only the second factor contributed. The analyses on split halves of the sample were comparable. Thirty-two percent of all parents agreed with the statement, “I would prefer to have the doctors advise me whether my baby should be in the study, rather than asking me to decide.” Conclusions. In making consent decisions on behalf of their newborn infants, parents are influenced by risk and benefit assessments, attitudes toward research, and the integrity of the consent process. Illness severity or sociodemographic characteristics do not seem to be of similar importance. Rather than making the decision alone, a significant minority of parents would prefer to have the physicians advise them whether to volunteer their infants for a clinical trial. medical ethics, informed consent, newborn infant, clinical trial.