DETERMINANTS OF PARENTAL AUTHORIZATION FOR INVOLVEMENT OF NEWBORN-INFANTS IN CLINICAL-TRIALS

Objective. Parents have the right to decide on behalf of their infants whether to enroll them in controlled clinical trials, We determined t he degree to which such parental decisions are influenced by risk and benefit considerations compared with other factors. Design. Cross-sect ional survey. Participants. Parents who had recently given or declined consent to one of three controlled trials in the neonatal intensive c are unit. Intervention. Parents were asked to complete a questionnaire that consisted of 15 sociodemographic items and 13 scaled responses t o statements assessing the probability and magnitude of risk and benef it as well as perceived illness severity, attitudes toward research, a nd the consent process. Analysis. Responses were subjected to factor a nalysis to identify underlying constructs, The sample was then randoml y 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 th ree factors: (1) illness severity, (2) perceptions of risk or benefit and attitudes to research, and (3) sociodemographic characteristics, M ultiple 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, ra ther than asking me to decide.'' Conclusions. In making consent decisi ons 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 characte ristics do not seem to be of similar importance. Rather than making th e decision alone, a significant minority of parents would prefer to ha ve the physicians advise them whether to volunteer their infants for a clinical trial.