[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.205]



[Page 128]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

 Subpart B_Additional Protections for Pregnant Women, Human Fetuses and 

                      Neonates Involved in Research

 

Sec.  46.205  Research involving neonates.



    (a) Neonates of uncertain viability and nonviable neonates may be 

involved in research if all of the following conditions are met:

    (1) Where scientifically appropriate, preclinical and clinical 

studies have been conducted and provide data for assessing potential 

risks to neonates.

    (2) Each individual providing consent under paragraph (b)(2) or 

(c)(5) of this section is fully informed regarding the reasonably 

foreseeable impact of the research on the neonate.

    (3) Individuals engaged in the research will have no part in 

determining the viability of a neonate.

    (4) The requirements of paragraph (b) or (c) of this section have 

been met as applicable.

    (b) Neonates of uncertain viability. Until it has been ascertained 

whether or not a neonate is viable, a neonate may not be involved in 

research covered by this subpart unless the following additional 

conditions are met:

    (1) The IRB determines that:

    (i) 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

    (ii) 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

    (2) 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 in accord with subpart A of this part, except 

that the consent of the father or his legally authorized representative 

need not be obtained if the pregnancy resulted from rape or incest.

    (c) Nonviable neonates. After delivery nonviable neonate may not be 

involved in research covered by this subpart unless all of the following 

additional conditions are met:

    (1) Vital functions of the neonate will not be artificially 

maintained;

    (2) The research will not terminate the heartbeat or respiration of 

the neonate;

    (3) There will be no added risk to the neonate resulting from the 

research;

    (4) The purpose of the research is the development of important 

biomedical knowledge that cannot be obtained by other means; and

    (5) The legally effective informed consent of both parents of the 

neonate is obtained in accord with subpart A of this part, except that 

the waiver and alteration provisions of Sec.  46.116(c) and (d) do not 

apply. However, if either parent is unable to consent because of 

unavailability, incompetence, or temporary incapacity, the informed 

consent of one parent of a nonviable neonate will suffice to meet the 

requirements of this paragraph (c)(5), except that 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 to meet the 

requirements of this paragraph (c)(5).

    (d) Viable neonates. 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.