Analysis of motivations that lead women to participate (or not) in a newborn cohort study

BACKGROUND: Little is known about reasons that influence parents’ decision to participate in studies enrolling healthy children. The aim of this observational study was to verify the reasons that lead pregnant women to give their consent or to refuse participation to a newborn cohort study with a long follow up time. METHODS: To prospectively investigate the reasons that lead women to participate, to refuse the participation or to withdraw from a newborn cohort study, three different questionnaires were administered to pregnant women contacted or enrolled in the Phime cohort study, carried out in an Italian Hospital from 2007 to 2010. RESULTS: Phime study participation was refused by 304 women and 145 withdrew their consent during the follow up. All these women filled in the related questionnaires. Within 632 mothers in follow up at 18 months, 430 filled in the questionnaire on motivation to participate: 97% stated that the main reason was to contribute to research; 96% and 90% stated that they wanted to benefit future babies’ and mothers’ health. Ninety-six percent of women would appreciate to know the results of analysis carried out on biological samples collected and of the overall study results. One third of the mothers (37%) wanted to be involved in the definition of future similar studies, bringing their experience and their views. Within the 304 women who refused participation, 56% stated that the study was too demanding, 26% was not interested in participating and 18% was concerned about the need to collect biological samples and to be submitted to neurocognitive tests. Fifty-two percent of 145 women who withdrew after enrollment stated that the study was too demanding (52%), and 6% was concerned about the biological samples collection. CONCLUSIONS: The altruistic reason appears to be the main reported by women to decide to participate in a newborn cohort study. The fact that the study was too demanding and the need to collect biological samples are important reasons that lead women to refuse participation or to withdraw from the study. An adequate communication on these aspects should minimize difficulties in enrolment and losses to follow up.