Conditions to be met in research studies involving pregnant women and fetuses
| • In vivo studies have also been conducted on pregnant animals |
| • Clinical studies have been conducted on nonpregnant women |
| • Clinical findings assessing potential harms to pregnant women and fetuses are available |
| • The risk to the fetus is minimal and caused exclusively by the procedure/intervention |
| • The study will achieve crucial knowledge not obtainable by any other means |
| • The researchers will have no part in any decision influencing fetal viability or pregnancy |
| • No incentive will be provided to influence the course of pregnancy |