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Human Subjects

Policies & Guidance

Research with Newborns (Neonates)

When doing research with newborns (neonates), the regulations that apply to the research depend on the status (viability) of the newborn. This viability determination must be made by someone who is not a part of the research team. The regulations define a viable neonate as one that, given the benefit of medical therapy, is able to survive after delivery to the point of independently maintaining a heartbeat and respiration.

If the newborn is viable, the regulations regarding children in research apply (see SOP). If the newborn is not viable or is of uncertain viability, special regulations regarding research with neonates apply.

  1. Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates.
  2. Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate.
  3. Individuals engaged in the research will have no part in determining the viability of a neonate.

If the newborn is of uncertain viability, additional conditions must be met in order for research to be approved:

  1. 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
  2. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.
    AND
  3. The legally effective informed consent of either parent of the neonate. (Certain instances may allow the consent of a legally authorized representative of the parents. Contact the Human Subjects Office for more information if you think that you may need this option for your study.)

If the newborn is not viable, these additional conditions must be met in order for research to be approved:

  1. Vital functions of the neonate will not be artificially maintained.
  2. The research will not terminate the heartbeat or respiration of the neonate.
  3. There will be no added risk to the neonate resulting from the research.
  4. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means.
    AND
  5. The legally effective informed consent of both parents of the neonate is obtained. (Certain instances may allow the consent of only one parent. Contact the Human Subjects Office for more information if you think that you may need this option for your study.)

If your study will enroll newborns for a period that extends past their defined 4-week age, you will need to obtain informed consent for them as both neonates and children. See the Guidance document on Consent and Assent in Research Enrolling Minors.

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