Tag: Anne Drapkin Lyerly

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...

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...

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...

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...

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...

During previous public health emergencies, the issue of whether public health agencies should recommend that women avoid becoming pregnant because of potential risks to themselves and their newborns has been controversial. The ongoing Covid-19 pandemic has again led to questions regarding whether women should consider postponing pregnancy because of potential...

Background: The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized.  Women’s views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population.  Methods: We...

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies–often irrespective of risks and benefits or a woman’s actual potential for pregnancy, raising...