Pregnant Women, Human Fetuses and Neonates Involved in Research

Here is a link to Federal Regulations regarding pregnant women and neonates: Title 45 PART 46 Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.

Conditions for Research Involving Pregnant Women or Fetuses

• potential risks to pregnant women and fetuses were assessed in prior studies

• the risk to the fetus is not greater than minimal and the biomedical knowledge which cannot be obtained by any other means;

• 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

• Each individual providing consent ... is fully informed

• No inducements, monetary or otherwise, will be offered to terminate a pregnancy

• Individuals engaged in the research will have no part in determining the viability of a neonate (46.204)

Conditions for Research Involving Neonates

• clinical studies have been conducted and provide data for assessing potential risks to neonates

• Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate.

• Individuals engaged in the research will have no part in determining the viability of a neonate.

• The research holds out the prospect of enhancing the probability of survival of the neonate

• biomedical knowledge cannot be obtained by other means

• The legally effective informed consent of either parent of the neonate ... is obtained

• Vital functions of the neonate will not be artificially maintained;

• The research will not terminate the heartbeat or respiration of the neonate (46.205)