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An Ethical Framework for Research in Maternal–Fetal Intervention in the Presence of Maternal Human Immunodeficiency Virus or Hepatitis B and C Infection

Shamshirsaz, Alireza A., MD; Sellner, Allison A., MD; Erfani, Hadi, MD, MPH; Aagaard, Kjersti M., MD, PhD; Nassr, Ahmed A., MD; Pereira, Stacey, PhD; Belfort, Michael A., MD, PhD; McCullough, Laurence B., PhD; Chervenak, Frank A., MD

doi: 10.1097/AOG.0000000000003022
Fetal Therapy: Current Commentary: PDF Only

Maternal–fetal interventions continue to be a groundbreaking and rapidly expanding area. In this article, we examine whether it is ethically permissible to conduct investigation into the expansion of inclusion criteria for existing maternal–fetal interventions to include pregnant patients with human immunodeficiency virus (HIV) and hepatitis B or C infection with low or undetectable viral loads. We addressed this ethical question by appealing to ethical principle of respect for the autonomy of the pregnant patient; the patient status of the fetus; the balance of overall benefits and risks of the procedure(s) to pregnant, fetal, and neonatal patients; and to the ethical principle of justice. The ethical framework we have provided supports the conclusion that research on maternal–fetal interventions with pregnant women with HIV and hepatitis B and C infection with low or undetectable viral loads is ethically permissible. To accumulate sufficient numbers, such research should be multicenter.

Fetal intervention research on accepted maternal–fetal interventions in pregnant women with human immunodeficiency virus and hepatitis infection with low or undetectable viral loads is ethically permissible.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, and the Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas; and the Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, New York, New York.

Corresponding author: Alireza A. Shamshirsaz, MD, Division of Maternal-Fetal Medicine, Baylor College of Medicine, Texas Children's Fetal Center, Texas Children's Hospital Pavilion for Women, 6651 Main Street, Suite F1020, Houston, TX; email:

Financial Disclosure The authors did not report any potential conflicts of interest.

The authors thank the members of Fetal Therapy Board at Texas Children's Hospital for their support by intellectually discussing all the ethical aspects of fetal intervention candidates.

Each author has confirmed compliance with the journal's requirements for authorship.

Peer reviews and author correspondence are available at

Received July 11, 2018

Received in revised form September 20, 2018

Accepted October 11, 2018

© 2018 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.