AIMS: To investigate the recollections of parents who gave their consent for their newborn infants to be enrolled in a research study.

SUBJECTS: The traceable parents (n=158) of all infants who were enrolled in a randomised controlled trial of pulmonary function testing in ventilated newborn infants. Prior to enrolment in the original trial the parents were given a detailed explanation of the trial and a printed information sheet. Written parental consent was obtained in all cases.

METHODS: A questionnaire and letter of explanation was sent by post to the parents of each infant 18 months after the end of the trial. Where no reply was received, a second questionnaire and letter were sent. The questionnaire used a mixture of yes/no responses and Likert scales to examine the parental experiences.

RESULTS: Replies were received from 98/158 (62%) of the parents. 86/98 remembered being asked for their consent for a study. 83/86 remembered giving their permission, 2/86 thought that they had not consented, 1/86 could not remember. 52/86 were completely happy, 15/86 reasonably happy, 11/86 neutral, 4/86 unhappy and 3/86 very unhappy with their decision. The information sheet was remembered by 60/86 and kept by 18/86. None of the 85 parents who remembered the consent process felt under heavy pressure to agree, 22/85 felt a little pressure, 63/85 felt under no pressure. As a result of the study, 4/84 respondents felt much more anxious about their baby, 16/84 a bit more anxious, 48/84 felt that it made no difference, 11/84 felt a bit less anxious and 5/84 felt much less anxious. The parents were asked whether they would be happy for the doctors to decide for them whether or not to enrol their infant in a study that had been passed by the institutional ethics committee. 59/97 respondents said that they would be very unhappy, 23/97 a little unhappy, 4/97 reasonably happy and 11/97 completely happy.

CONCLUSIONS: Most parents in this study were happy to have enrolled their infant in a neonatal research study. They did not tend to feel under pressure to agree. The majority did not experience an increased burden of anxiety. They strongly rejected an alternative to the consent process.