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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 person; without pregnancy-specific dosing data, … Continued

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 data from two separate, broader … Continued

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, vertical transmission, and maternal and … Continued

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 to elicit their interpretations of … Continued

Beyond Voluntariness—Ethics and Incentives for Contraception

August 26, 2021

Editorial In this issue of JAMA Psychiatry, Heil et al1 report a randomized clinical trial to evaluate the efficacy and cost benefits of interventions to increase prescription contraceptive use among women with opioid use disorder (OUD) at risk for unintended pregnancy. The study found that verified contraception use was highest and unintended pregnancy rates were … Continued

Communication Regarding Adverse Neonatal Birth Events: Experiences of Parents and Clinicians

August 26, 2021

Objectives Communicating with parents about adverse birth outcomes is challenging. We sought to describe attitudes and experiences of parents and providers regarding communication about adverse newborn birth events. Methods From 2011–2012, we conducted semi-structured in-depth interviews with parents who believed they had experienced an adverse birth-related neonatal outcome and focus groups with healthcare providers who … Continued

Ethical Dimensions of Peanut Allergy Immunotherapy Research

August 19, 2021

With funding from the National Institute of Allergy & Infectious Diseases (NIAID), Dr. Jill Fisher is conducting a research study on pediatric clinical trials for food allergies, focusing primarily on peanut allergy. Using ethnographic research methods, the project investigates the on-the-ground ethical challenges that emerge in these clinical trials. In particular, the project explores how … Continued

The Costs of Contradictory Messages About Live Vaccines in Pregnancy

February 10, 2021

The increased risk of harm from COVID-19 infection in pregnancy highlights the importance of including pregnant people in COVID-19 vaccine development and deployment. Promising vaccines being developed include replication-competent platforms, which are typically contraindicated during pregnancy because of theoretical risk. However, replicating vaccines are administered in and around pregnancy, either inadvertently because of unknown pregnancy … Continued