F. Neonates of uncertain viability

Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research unless the IRB determines that the following additional conditions have been met:

1. The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective; OR
2. The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; AND
3. The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained (except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest).