pregnancy resulted from rape or incest.” Otherwise, the consent of the pregnant woman is sufficient. “For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part.”
Children are defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” There must be an independent assessment of the viability of the neonate. In addition, “individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.”
Neonates of uncertain viability and nonviable neonates may be involved in research (§46.205) if the following conditions are met: Neonates of uncertain viability may not be involved in research unless 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 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. 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 can be obtained.
After delivery a nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met: (a) vital functions of the neonate will not be artificially maintained; (b) the research will not terminate the heartbeat or respiration of the neonate; (c) there will be no added risk to the neonate resulting from the research; (d) the purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and (e) the legally effective informed consent of both parents of the neonate is obtained (unless either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, or the consent of the father need not be obtained if the pregnancy resulted from rape or incest). The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice.
A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
Although the National Commission intended that the state consent laws for the treatment of minors apply in the research setting, this has been a point of contention and debate. For example, in adopting Subpart D, the