Stanford IRB • SCRO • APLAC
IRB • SCRO Institutional Review Board IRB • SCRO • APLAC
IRB • SCRO • APLAC

Neonates

Neonates of uncertain viability and nonviable neonates may be included in research when specific criteria outlined in 45 CFR 46.205 have been met. A neonate is any newborn from age 0 to 28 days. Viable, as it pertains to the neonate, means being able to survive (given the benefit of available medical therapy) after delivery to the point of independently maintaining heartbeat and respiration.

The criteria for including neonates of uncertain viability and nonviable neonates should include, where scientifically appropriate, pre-clinical and clinical studies that provide data for assessing potential risks to neonates. Additionally, each individual providing consent should be fully informed about the reasonably foreseeable impact of the research on the neonate and individuals engaged in the research cannot have any part in determining the viability of the neonate.

For neonates of uncertain viability, the following conditions must also be met:

  • The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, OR
  • The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research, AND
  • The informed consent of either parent of the neonate or their legally authorized representative is obtained.

For nonviable neonates, the following conditions must also be met:

  • Vital functions of the neonate will not be artificially maintained;
  • The research will not terminate the heartbeat or respiration of the neonate;
  • There will be no added risk to the neonate resulting from the research;
  • The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; AND
  • The informed consent of both parents of the neonate is obtained. 

For viable neonates, see the requirements for Children in research.

Research that does not meet the requirements outlined above for neonates, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of these participants will require approval from the HHS Secretary (45 CFR 46.207.

Resources

Page updated July, 2026