Pregnant Women
No research on pregnant women may be undertaken unless:
- Appropriate studies on animals and non-pregnant individuals have been completed, documented, and reviewed.
- Except where the purpose of the activity is to meet the health needs of the mother or the fetus, the risk to the fetus is minimal, and, in all cases, is the least possible risk for achieving the objectives of the research activity.
- No procedural changes solely in the interest of the research, which may cause greater than minimal risk to the fetus or the pregnant woman, will be introduced into the procedure.
- No inducements, monetary or otherwise, may be offered to terminate the pregnancy for purposes of the research activity.
Research activities permitted by federal regulation may be conducted only if the mother and father are legally competent and have given their consent after having been fully informed regarding possible impact on the fetus. The father's informed consent need not be secured if:
- The purpose of the activity is to meet the health needs of the mother
- His identity or whereabouts cannot be reasonably ascertained
- He is not reasonably available
- The pregnancy resulted from rape
Individuals engaged in the research will have no part in:
- Any decisions as to the timing, method, and procedures used to terminate the pregnancy
- Determining the viability of the fetus at the termination of the pregnancy
