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Scientific, Ethical, and Legal Considerations for the Inclusion of Pregnant People in Clinical Trials

August 4, 2022

Clinical Trials in Pregnancy and the “Shadows of Thalidomide”: Revisiting the Legacy of Frances Kelsey

August 2, 2022

Another Consequence of Overturning Roe: Imperiling Progress on Clinical Research in Pregnancy

August 2, 2022

Safekeeping of Pregnant People Experiencing Incarceration

July 30, 2022

‘Experimental Pregnancy’ Revisited

July 20, 2022

Personal Prenatal Ultrasound Use by Women’s Health Professionals: An Ethical Analysis

December 15, 2021
Prenatal ultrasound use is skyrocketing despite limited evidence of improved outcomes. One factor driving this trend is the widely recognized psychological appeal of real-time fetal imaging. Meanwhile, considering imperfect safety evidence, U.S. professional guidelines dictate that prenatal ultrasound—a screening test—should be governed by expected clinical benefits—an opportunity for intervention. However,...

Ending the Evidence Gap for Pregnancy, HIV and Co-Infections: Ethics Guidance from the PHASES Project

December 1, 2021
Abstract Introduction While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant...

Pregnant Individuals’ Views on Fetal Tissue Research in the United States

November 1, 2021
Abstract Objective: Fetal tissue research has driven significant medical advances but remains publicly contentious in the United States. The views of pregnant individuals in the United States regarding the donation of fetal tissue offer an important and previously unexplored perspective on this issue. Methods: We conducted a secondary analysis of...

PREPARE (PRomoting Equity for Pregnant Adolescents in REsearch)

October 22, 2021
Annie Lyerly and Kristen Sullivan have been awarded an R01 from the National Institute of Allergy and Infectious Disease (NIAID) to develop empirically informed guidance for conducting ethically responsible HIV/co-infections research with pregnant adolescents.  Pregnant adolescents face synergistic challenges in the context of HIV – heightened risk of maternal infection,...

IRB Decision-Making about Minimal Risk Research with Pregnant Participants

September 16, 2021
Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of current and former IRB personnel in the United States...