References

45 CFR Part 46, Subpart D

From: Title 45 CFR part 46, Subpart B (Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization), section 46.206 (General limitations):

“(a) No activity to which this subpart is applicable may be undertaken unless:
(1) appropriate studies on animals and non-pregnant individuals have been completed;
(2) except when the purpose of the activity is to meet the health needs of the mother or the particular fetus, the risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the activity;”