HRPP Policy - Pregnant women, fetuses, and neonates

Pregnant women or human fetuses may be involved in research if all of the following conditions are met:

• Where scientifically appropriate, preclinical studies, including studies on pregnant animals and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses
• The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important generalizable knowledge that cannot be obtained by any other means
• Any risk is the least possible for achieving the objectives of the research
• If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important generalizable knowledge that cannot be obtained by any other means, her consent is obtained or informed consent is waived in accordance with the IU HRPP Policy on Informed Consent
• 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 or waived in accordance with the IU HRPP Policy on Informed Consent, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity, or if the pregnancy resulted from rape or incest
• Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate
• No inducements, monetary or otherwise, will be offered to terminate a 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
• Individuals engaged in the research will have no part in determining the viability of a neonate

Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:

• Where scientifically appropriate, preclinical and 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 requirements for neonates of uncertain viability or nonviable neonates listed below have been met, as applicable

Neonates of Uncertain Viability

Until it has been ascertained whether a neonate is viable, a neonate may not be involved in research unless the following additional conditions have been met:

• IRB determines that: (a) 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 (b) the purpose of the research is the development of important generalizable knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; and
• The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative (LAR) is obtained, except that the consent of the father or his LAR need not be obtained if the pregnancy resulted from rape or incest

Nonviable Neonates

After delivery, a nonviable neonate may not be involved in research unless all of the following additional conditions are 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 generalizable knowledge that cannot be obtained by other means
• The informed consent of both parents of the neonate is obtained in accordance with the IU HRPP Policy on Informed Consent
  • Waiver or alteration of the consent process is not available for research involving nonviable neonates
  • If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice
    • The consent of the father need not be obtained if the pregnancy resulted from rape or incest
    • The IRB cannot approve the consent of an LAR for a nonviable neonate

Research subject to VA regulations

VA investigators cannot conduct interventions in research that include neonates while on official VA duty, at VA facilities, or at VA-approved off-site facilities. VA investigators may conduct research involving noninvasive monitoring of neonates if the research is determined by the IRB to be minimal risk. Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted.

Research subject to DOD regulations

The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants. For purposes of applying Subpart B, the phrase “biomedical knowledge” shall be replaced with generalizable knowledge.

The IRB may approve research which does not meet the requirements described in 2.1 or 2.2 only if the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.

For federally-funded research which meets this criteria, the DHHS Secretary or his/her designee, after consultation with a panel of experts in pertinent disciplines (e.g., science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, must determine either:

• that the research in fact satisfies the conditions of 2.1 above; or
• that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates; the research will be conducted in accord with sound ethical principles; and informed consent will be obtained in accord with the informed consent provisions of 46 CFR 46 and subpart A.

For studies proposing to enroll pregnant women, fetuses, and/or neonates, the study team completes the IRB application and provides protocol-specific information related to research with these populations.  The IRB considers the information in the IRB application and documents its determinations as appropriate.

When a human subject involved in ongoing research becomes pregnant during the course of the study, and the relevant research study was not previously approved by the IRB for the inclusion of pregnant women, fetuses, or neonates:

• All research procedures with the pregnant subject, including interactions and interventions and collection of identifiable private information, must immediately cease.
• If research personnel wish to have the pregnant subject continue to participate in the research, the study team must submit an amendment to the IRB requesting inclusion of pregnant women, and the IRB must approve the inclusion in accordance with this policy. The pregnant woman may continue to participate in research procedures once the amendment is approved.
• If research personnel believe it is in the best interest of the pregnant woman to continue to receive research procedures before such an amendment can be reviewed, the IRB Chair may determine that the pregnant woman may continue to participate in the research until the above requirements are met if the potential benefits of continued treatment for the woman outweigh the risks of ongoing fetal exposure to the investigational drug, of discontinuing maternal therapy, and/or of exposing the fetus to additional drugs if placed on an alternative therapy.