Objective: Parents have the right to decide on behalf of their infants whether to enrol them in research protocols. We determined the degree to which such parental decisions are influenced by risk-benefit analysis compared to other factors. Methods: Shortly after giving or refusing consent to 1 of 3 controlled trials in our NICU, the parents of 167 infants were asked to complete a questionnaire consisting of 15 sociodemographic items and 13 scaled responses to statements assessing probability and magnitude of risk and benefit as well as illness severity, attitudes towards research and the consent process. The instrument had been developed for this study and found to have excellent reliability and good face validity and response distribution. Responses were subjected to factor analysis to identify underlying constructs. The sample was then randomly split, and multiple regression performed on each half. Results: Response rate was 83%(103/124) for parents who had consented and 86% (37/43) for those who had refused. Factor analysis yielded three factors: (1) illness severity, (2) risk-benefit-attitudes, and (3) sociodemographics. Multiple linear regression showed a significant multiple correlation of consent decision (R=.502, p<.0001), but only factor (2) contributed. The analyses on split halves of the sample were comparable. Conclusion: In making consent decisions for research involvement of their newborn infants, parents are influenced by risk-benefit assessments, attitudes towards research and the integrity of the consent process. Illness severity or sociodemographic characteristics do not appear to be of similar importance. (Supp. by a Resident Research Grant from the PSI Foundation)
