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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

Ethics, Research and Pregnancy: Guidance and Lessons from the PHASES Project. Ethics Grand Rounds at the University of Minnesota, February 19, 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 … Read more

Scientific and Ethical Considerations of Including Pregnant Women in Clinical Trials. Duke-FDA Meeting, February 3, 2021

Since the recognition of SARS-CoV-2 virus in December 2019 there have been more than seventy-two million cases and greater than 1.6 million deaths globally, as well as more than 300,000 deaths in the United States attributable to COVID-19 [1]. COVID-19 has had a dramatic impact on modern global society and will be a major part … Read more

Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH’s 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal … Read more