On October 27-28th, the Kennedy Institute of Ethics hosted a workshop focused on ethical issues in HIV treatment and research on pregnant populations. The two-day session, facilitated by designers in the KIE’s EthicsLab, brought together experts in research ethics, HIV research, and clinical research from around the country and around the world.
The workshop is part of a joint project of four universities aimed at developing ethically acceptable strategies for conducting research on HIV treatment and prevention during pregnancy. Funded by a grant from the National Institute of Allergy and Infectious Diseases, leaders from Georgetown University, Johns Hopkins University, UNC Chapel Hill, and the University of Washington have joined forces under the banner PHASES — Pregnancy & HIV/AIDS: Seeking Equitable Study.
HIV and Pregnancy
Despite tremendous advances in prevention, treatment, and management of HIV in the past decades, PHASES project directors explain, we still know very little about how to best address the needs of a key population affected by HIV: pregnant women.
An estimated 16.1 million women are living with HIV worldwide, with millions more at risk of becoming infected. Many of these women are of reproductive age, posing important medical questions about how best to prevent HIV in pregnant women and manage HIV and concurrent medical conditions during pregnancy. […]
Ethical and legal concerns about including pregnant women in studies have led to widespread exclusion of this population from medical research. But without the systematic generation of evidence, these women and their health care providers must face difficult clinical decisions in the absence of adequate information on safety and efficacy of new antivirals, preventive agents, and drugs to treat co-infections and other associated diseases.
The categorical exclusion of pregnant women from research is unacceptable.
Project leaders Maggie Little of Georgetown’s Kennedy Institute of Ethics, Ruth Faden of Johns Hopkins University’s Berman Center for Bioethics, Anne Drapkin Lyerly of UNC Chapel Hill’s Center for Bioethics, and Anna Mastroianni of the University of Washington’s School of Law, have dedicated years to this issue. In 2009, Georgetown hosted a workshop on research during pregnancy that drew participants from the NIH, FDA, and leading academic medical centers.
Seeking Equitable Study
The work of the PHASES project is to develop ethically and scientifically responsible solutions for enhancing society’s knowledge base on the prevention and treatment of HIV during pregnancy by bringing together leading HIV investigators, bioethicists, and legal and regulatory experts to develop an action-guiding ethical framework to navigate the complexities of including pregnant women in research.
The workshop at Georgetown was one in a series designed to identify research priorities and major obstacles to conducting HIV research with pregnant women and women who may become pregnant, and to strategize potential solutions within the current regulatory framework.
At the end of this first stage of the PHASES project, the team will develop and vet a conceptual framework for ethically permissible HIV research with pregnant women and women who may become pregnant, and a set of practical, workable, consensus recommendations.
The goal, leaders explain, is that:
The framework and recommendations will provide useful guidance to investigators, ethics review committees, and policy makers, and enable investigators and the larger research enterprise to address critical questions related to HIV and the optimal care for women who are or may become pregnant. In turn, health providers worldwide will be able to make evidence-informed clinical decisions to best promote the health of these patients.
A design-driven workshop
When the cohort of clinicians, lawyers, and research ethics experts gathered in Georgetown’s EthicsLab, they were greeted by piles of markers and colorful post-its, modeling materials like Play-Doh and pipe cleaners, and two designers (Arjun Dhillon and Nico Staple) who would be facilitating the workshop.
“Our focus was on distributing risk in HIV research, looking at where the burden of risk falls on pregnant women depending on whether they are experimental subjects in a research setting or in a clinical setting,” explains Staple.
The pair of designers worked for months with PHASES leaders to develop goals and methods for the session. Small teams of participants grappled with real-world case studies and used modeling materials, role-playing, and rapid prototyping to develop new trial designs, argumentative strategies, ways to interpret existing regulations, methods to communicate risk to prospective patients, and more.
As the workshop wound to a close, Little called the room to order. “We had high expectations for this session,” she said, “and they were vastly exceeded. Thank you.”