A. No live-born infant shall be involved as a subject in any clinical research activity unless the purpose of the activity is to meet the health needs of that particular infant, and the infant will be placed at risk only to the minimum extent necessary to meet such needs or no significant risk to such infant is imposed by the research activity.
B. An activity permitted under Subsection A of this section shall be conducted only if:
(1) the nature of the investigation is such that adults or mentally competent persons would not be suitable subjects; and
(2) the mother or father or the infant's legal guardian is mentally competent and has given his or her informed consent.