Motivations of mothers to enroll their newborn infants in general clinical research on well-infant care and development

Abstract

Objective: The purpose of this work was to identify possible motivations for mothers to consent to having their newborn infants participate in medical research on well-infant care and to compare between mothers of term infants and mothers of stable preterm infants.

Methods: Two-hundred mothers answered a questionnaire regarding their consent to have their newborns participate in 5 simulated studies at different risk levels and their willingness to provide a telephone number for future contact. Demographic data, attitudes about medicine, medical research, and evaluation of research conditions served as predictors of the degree of consent.

Results: Degree of consent was affected mainly by perceived risk, because the research did not offer a direct personal benefit; that is, 80% consented to a psychological study as opposed to 25% who consented to a vaccine study. The strength of the predicting variables differentiated according to the suggested study. No significant difference was found between the mothers of term infants (n = 127) and the mothers of preterm infants (n = 73), either in the degree of consent to the 5 suggested studies or in the predicting variables, except for the measure of actual behavior (ie, revealing a telephone number). Only 23% of the mothers of term infants in comparison with 48% of the mothers of preterm infants were willing to reveal their telephone numbers.

Conclusions: There is some willingness to consent when the infant is healthy and the research is not directed at solving a specific problem of the infant. The degree of consent decreases in accordance with the increase in risk. The altruistic motive is the main predictor for research that is perceived as very risky. The benefit of learning about their infant's development served as a motivating force for less risky studies. We deduce that pointing out personal benefits to balance the usual conveyed information on risks or burdens of the research can increase the willingness to consent.

Trial registration: ClinicalTrials.gov NCT00332150.