Skip to main content

The Need for Inclusion of Pregnant Women in COVID-19 Vaccine Trials

January 15, 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 … Continued

Evaluating the National Institutes of Health’s Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research

December 1, 2020

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 … Continued

Delaying Pregnancy during a Public Health Crisis — Examining Public Health Recommendations for Covid-19 and Beyond

October 1, 2020

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 virus-related risks. Such discussions involve … Continued

Views among Malawian Women about Joining HIV Prevention Clinical Trials When Pregnant

June 1, 2020

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 conducted 35 semi-structured interviews with … Continued

Women’s views about contraception requirements for biomedical research participation

May 13, 2019

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 important questions about when such … Continued

Statutory Restrictions on Advance Care Planning and Pregnancy

April 24, 2019

Honoring a person’s wishes at the end of life is widely recognized as profoundly important to humane, ethical care.1 To that end, efforts to help individuals make their preferences about end-of-life care known have involved advance care planning, including the completion of advance directives and identification of a surrogate decision maker. Yet, in many jurisdictions … Continued

Access to Pregnancy-Related Health Services: Public Health Ethics Issues

April 12, 2019

As large-scale biobanks are developed for translational genomic research and health care quality improvement, they are also becoming attractive as sites for public health interventions, such as population-based preventive sequencing for actionable variants. With the rapid advance of next-generation sequencing, the feasibility of such population health interventions is also increasing. The resulting confluence of public … Continued

Anne Drapkin Lyerly interviewed by NPR

November 27, 2018

Rethinking Bed Rest For Pregnancy “The bottom line is that there’s never been any proven benefit of bed rest,” says Dr. Anne Drapkin Lyerly, an OB-GYN and professor of bioethics at the University of North Carolina at Chapel Hill. Lyerly and colleagues in 2013 did a review of the scientific research on bed rest as … Continued

Pregnant Women’s Attitudes Toward Zika Virus Vaccine Trial Participation

September 27, 2018

As Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women’s willingness to participate in Zika virus … Continued

Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

July 12, 2018

Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth … Continued