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210. Research Involving Pregnant Women, Fetuses, and Neonates*

Updated June 7, 2024

Introduction

Federal regulations consider pregnant women, human fetuses, *neonates of uncertain viability, and *nonviable neonates (hereafter referenced as PG Women/Fetuses) to be vulnerable populations. For research conducted or supported by DHHS or other federal agencies, under Subpart B (45CFR46.201-206) the regulations require additional safeguards for their protection in human research.

Through its IRB-Flex policy, the University opts to suspend Subpart B and apply equivalent protections for minimal risk research involving PG Women/Fetuses that is neither conducted nor supported by a federal agency. Specifically, for non-federally funded minimal risk research involving PG Women/Fetuses, the IRB may suspend the requirements for preclinical studies, least possible risk to fetus, and both mother's and father's consent for research that holds out the prospect of direct benefit solely for the fetus, while ensuring protections are adequate.

Research involving PG Women/Fetuses requires the researcher form Population: Pregnant Women and Fetuses.

NOTE: Biomedical research involving investigational drugs or devices may have implications for women of childbearing potential. These implications are addressed in subsequent policy sections.

For Research Subject to Subpart B: Requirements for IRB Review and Approval

As noted above, the University applies Subpart B to all federally funded research, and to all greater than minimal research. Additionally, for federally-funded, minimal risk research, the IRB may determine that existing protections are sufficient and no additional protections are warranted.

The IRB's determination that existing protections are sufficient, or the IRB's findings related to the requirements for Subpart B will be documented in IRB minutes for projects reviewed at convened IRB meetings, or in project records for projects reviewed by expedited procedures.

IRB Approval for Research Involving PG Women/Fetuses (§46.204)

When Subpart B applies to projects involving PG Women/Fetuses, the IRB will confirm and document all of the following requirements are met:

  1. Preclinical Studies: Where scientifically appropriate, preclinical studies (including those with pregnant animals) and clinical studies on pregnant and nonpregnant women have been conducted and provide data for assessing risks to pregnant women and fetuses.
  2. Risk to Fetus versus Benefits: Any risk to the fetus is caused solely by interventions/procedures that may directly benefit the woman or the fetus. NOTE: If the research does not hold the prospect of direct benefits to the woman or fetus, the IRB will not approve the research unless the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means.
  3. Least Possible Risk: Any risk is the least possible for achieving the objectives of the research.
  4. Consent of Pregnant Woman Only: If researchers will obtain only the pregnant woman's consent, one of the following must be true:
    • There is the prospect of direct benefit for the pregnant woman,
    • There is the prospect of direct benefit the pregnant woman and the fetus.
    • There is no prospect of benefit for the woman or the fetus but the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means.
  5. Consent of Father: Researchers will obtain the consent of both the pregnant woman and the father if the research has the prospect of direct benefit solely to the fetus. NOTE: The father's consent is not required if the father is unable to consent because of unavailability, incompetence, or temporary incapacity; or the pregnancy resulted from rape or incest.
  6. Impact on Fetus/Neonate: Each person providing consent will be fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate.
  7. Pregnant Minors: Assent and parent permission for pregnant females who are minors will be obtained in accordance with requirements for research involving children. (Also see IRB policy for research involving female adolescents.)
  8. No Inducements for Termination of Pregnancy: No inducements, monetary or otherwise, will be offered to terminate a pregnancy.
  9. Researchers Not Involved in Termination of Pregnancy: Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.
  10. Determinations of Neonate Viability: Individuals engaged in the research will have no part in determining the viability of a neonate.

IRB Approval for Research Involving Neonates of Uncertain Viability or Nonviable Neonates (§46.205)

The IRB requires University and affiliate researchers planning to involve neonates of uncertain viability or nonviable neonates in research to meet all of the following conditions:

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

Additional Requirements Specific to Research Involving Neonates of Uncertain Viability

  1. Restrictions of the Involvement of Neonates Uncertain Viability: The IRB must determine and document that neonates of uncertain viability will NOT be involved in research unless
    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 which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.
  2. Legally Effective Informed Consent: Researchers will obtain the legally effective informed consent of at least one parent of the neonate. NOTE: If neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of at least one parent's legally authorized representative may be obtained in accord with ÁùºÏ±¦µä state law although the father's consent or that of his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

Additional Requirements Specific to Research Involving Nonviable Neonates

After delivery, a nonviable neonate may not be involved in research unless all of the following additional conditions are met:

  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 unless one of the parents is unable to consent because of unavailability, incompetence, or temporary incapacity. In which case, the informed consent of one parent will suffice. The father's consent is not required if the pregnancy resulted from rape or incest. NOTE: Waivers and alterations of informed consent do not apply.

Research Involving Viable Neonates.

After delivery, the additional requirements for research involving children (i.e., Subpart D) apply to research involving viable neonates.

IRB Approval for Research Involving the Placenta, the Dead Fetus or Fetal Material (§46.206)

The IRB is must review and approve research involving the placenta, dead fetus or macerated fetal material, or cells, tissue, or organs excised from a dead fetus only if information associated with this material is recorded for research purposes in a manner that living individuals (e.g., parents, siblings) can be identified, directly or through identifiers linked to those individuals. If such identification is possible, then the individuals who may be identified are research participants and federal regulations for the protection of human participants apply.

Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates (§46.207)

Federal regulations include a risk-benefit category for IRB review of research projects involving PG Women/Fetuses that are not approvable under one of the three previously identified types of research (i.e., §46.204, §46.205, or §46.206). If a University or Affiliate Investigator proposes to engage in research that is not otherwise approvable and therefore requires review under §46.207, the Director of Research Integrity & Security and/or the Chair of the IRB will meet with the PI. The purpose of the meeting will be to explore options for review by another IRB in the Western states that regularly reviews pediatric research (e.g., UCSF Benioff Children's Hospitals in San Francisco or Oakland). The PI will be encouraged and offered guidance to establish an agreement with the external IRB for regulatory review.

Research Involving Transplantation of Fetal Tissue or Non-embryonic Stem Cells

Other federal laws apply to research involving fetal tissue and non-embryonic stem cells. The University will not engage in either of these research activities.