2 |
The risk to the fetus is caused solely by interventions or
procedures that hold out the prospect of direct benefit for the woman or
the fetus; or, if there is no such prospect of benefit, the risk to the
fetus is not greater than minimal and the purpose of the research is the
development of important biomedical knowledge which cannot be obtained
by any other means; |
3 |
Any risk is the least possible for achieving the objectives of the
research; |
4 |
If the research holds out the prospect of direct benefit to the
pregnant woman, the prospect of a direct benefit both to the pregnant
woman and the fetus, or no prospect of benefit for the woman nor the
fetus when risk to the fetus is not greater than minimal and the purpose
of the research is the development of important biomedical knowledge
that cannot be obtained by any other means, her consent is obtained in
accord with the informed consent provisions of subpart A of this
part; |
5 |
If the research holds out the prospect of direct benefit solely to
the fetus then the consent of the pregnant woman and the father is
obtained in accord with the informed consent provisions of subpart
A of this part, except that the father’s consent need not be obtained if
he is unable to consent because of unavailability, incompetence, or
temporary incapacity or the pregnancy resulted from rape or
incest. |
6 |
Each individual providing consent under paragraph 4 or 5 of this
section is fully informed regarding the reasonably foreseeable impact of
the research on the fetus or neonate; |
7 |
For children as defined in §46.402(a) who are pregnant, assent and
permission are obtained in accord with the provisions of subpart
D |
8 |
No inducements, monetary or otherwise, will be offered to terminate
a pregnancy; |
9 |
Individuals engaged in the research will have no part in any
decisions as to the timing, method, or procedures used to terminate a
pregnancy; and |
10 |
Individuals engaged in the research will have no part in
determining the viability of a neonate. |