Abstract 190

The current process of obtaining informed consent is problematic for clinical trials in neonatal resuscitation. We wanted to see if there is a better way to ethically conduct such trials. We therefore sent surveys asking about preferences in consent procedures to 253 physicians who staff Canadian NICU's a second more focused survey was sent to 75 of the original respondents. The first survey examined values and a limited number of resuscitation scenarios. The second survey used a 6 point Likert scale (1 = very comfortable to 6 = very uncomfortable) to determine physicians' comfort levels with 15 different scenarios of obtaining consent for neonatal resuscitation. The overall response rate was 67%. The median response on the Likert scale is used here in describing the survey results. Physicians overall felt somewhat comfortable with the current way consent is obtained in emergency situations, which was described as rushing in and asking the parents to sign a form for their baby's participation. Over a third of them felt comfortable or very comfortable with this scenario. In contrast, they were somewhat uncomfortable with waived consent and clearly uncomfortable with deferred consent with over half stating they were uncomfortable or very uncomfortable. Prospective consent received varying ratings depending on the setting in which it was done, with the best rating for prospective consent in prenatal classes. Interestingly, physicians were somewhat uncomfortable with prospective consent obtained at the time of admission to hospital in labour. Physicians surveyed were generally quite uncomfortable with opting out as a method of consent in neonatal resuscitation research. In summary, prospective consent was identified as the most acceptable form of consent in neonatal resuscitation research, although the practically of this was not addressed. Physicians are also comfortable with the current way in which consent is often obtained in acute care research, that is, rushing in and asking the mother to sign a form with minimal time for any explanations. Waived consent, deferred consent, and opting out cause discomfort for physicians. This appreciation of the consent methods with which physicians feel most comfortable should help in the design of clinical trials in neonatal resuscitation research.

Funded by AAP-NRP Grants Program.