§ 46.205 (a) After delivery, fetuses 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 fetuses. (2) The
individual(s) 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 fetus or resultant child. (3) No inducements,
monetary or otherwise, will be offered to terminate a pregnancy. (4)
Individuals engaged in the research will have no part in any decisions
as to the timing, method, or procedures used to terminate a pregnancy.
(5) Individuals engaged in the research will have no part in determining
the viability of a fetus. (6) The requirements of paragraph (b) or (c)
of this section have been met as applicable.

*---Clinton Administration's HHS Final Rule, 45 CFR Part 46, Protection
of Human Research Subjects, January 17, 2001*

\(b\) Fetuses of uncertain viability. After delivery, and until it has
been ascertained whether or not a fetus is viable, a fetus 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 particular fetus to the point of viability, and any risk is the
least possible for achieving the objectives of the research, 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
risk to the fetus resulting from the research; and (2) The legally
effective informed consent of either parent of the fetus 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, unless altered or waived in accord with §
46.101(i) or § 46.116(c) or (d).

\(c\) Nonviable fetuses. After delivery, a nonviable fetus may not be
involved in research covered by this subpart unless all of the following
additional conditions are met: (1) Vital functions of the fetus will not
be artificially maintained; (2) The research will not terminate the
heartbeat or respiration of the fetus; (3) There will be no risk to the
fetus 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 fetus is obtained in accord with subpart A of
this part, except that the waiver and alteration provisions of §
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 fetus will
suffice to meet the requirements of this paragraph. The consent of a
legally authorized representative of either or both of the parents of a
nonviable fetus will not suffice to meet the requirements of this
paragraph.

\(d\) Viable fetuses. A fetus, after delivery, that has been determined
to be viable is a child as defined by § 46.402(a) and 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.

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