Abstract 189 Clinical Bioethics Poster Symposium, Tuesday, 5/4

There are those who argue that informed consent in neonatal resuscitation research is an oxymoron. To explore better ways to obtain consent for neonatal resuscitation research, we designed a survey of parental preferences for the consent process. Surveys were sent to parents who had delivered babies at the Ottawa Hospital, General Campus over a one year period, randomly selected from the hospital data base. Parents of both NICU babies and normal newborns were included. As well, a cohort of parents-to-be were sequentially enrolled from the obstetrical clinic. Participants were mailed a survey questionnaire whose design was based on information from focus groups. One reminder notice was sent. Surveys contained questions about demographics, parental values, and 15 resuscitation research scenarios. Questions on parental values were rated using a 5 point Likert scale (1=very important to 5=not at all important). Comfort levels to different resuscitation research scenarios were rated using a 6 point Likert scale (1=very comfortable to 6=very comfortable). The overall response rate was 32% (102/318). Median responses on the Likert scales are used in describing the results. Two main "value" themes were identified as important by the parents: the impact that the research would have on their baby (likelihood of helping their baby, no increase in their baby's pain or suffering), and the importance of having a positive interaction with the physicians involved in the study (feeling that the physicians had the best interests of the baby at heart, ability to ask questions and understand responses). For the scenarios, parents felt somewhat comfortable with the current way consent is often obtained in acute care settings (described as doctor rushes in, says their baby very sick and asks that consent form be signed); in fact, one-third were comfortable or very comfortable with this. Parents were overall somewhat uncomfortable with waived consent, with one-third feeling very uncomfortable with this scenario. Deferred consent also had a median response of somewhat uncomfortable. Parents felt comfortable with prospective consent either in prenatal classes or visits to their doctor, but were somewhat uncomfortable with the scenario calling for prospective consent on admission to hospital in labour. Parents felt uncomfortable with opting out no matter when during the pregnancy the consent was requested. This appreciation of parental preferences for consent procedures should be helpful in the design of clinical trials for neonatal resuscitation.

Funded by the AAP-NRP Grants Program.