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Webinar: (2022-06) Are We Excluding Pregnant People too much from Research? Ethical and Pragmatic Consequences and a Responsible Way Forward

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Description

Widespread exclusion of pregnant people from clinical research has resulted in significant evidence gaps for this population, despite an urgent need for pregnancy-specific data to inform policies, clinical care guidelines, and treatment decisions. While consensus around the ethical and public health imperative for the responsible inclusion of pregnant people in clinical research gains critical momentum, questions and confusions about the ethical and regulatory permissibility of their inclusion persist, impeding efforts to address disparities in the evidence base.

Even when exclusion of pregnant people may be justifiable ethically, current approaches to excluding pregnant people at enrollment and prevention of unintended pregnancy during the study vary between sponsors, regulators, and investigators, fail to consider the underlying patient population, and impose unnecessary burdens on participants.

In this webinar, speakers will discuss:

  • The evolution of policies for including and excluding pregnant people from clinical research,
  • Recommendations for the responsible inclusion of pregnant people informed by empirical research with key stakeholders, and
  • One IRB's approach to the ethical and pragmatic issues created for all potential participants by pregnancy testing and contraception requirements in protocols and consent forms

Audience
This program will benefit HRPP/IRB personnel and those working in research programs more broadly including HRPP/IRB directors, members, chairs; researchers and research staff; and more.

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Contributors

  • Evan R. Myers, MD, MPH

    Evan R. Myers, MD, MPH, is the Walter L. Thomas Distinguished Professor of Obstetrics and Gynecology at Duke University School of Medicine. His research involves the application of quantitative methods to problems in women’s health, primarily through the use of simulation modeling, systematic reviews, and analysis of large data sets to inform decisions in clinical areas such as gynecologic cancer, uterine fibroids, and high-risk pregnancy. He is the Vice Chair for Reproductive Risks for the Duke Health System IRB; in this role, he reviews all protocols to ensure that requirements for exclusion of pregnant people (including partners of male participants) are appropriate for the specific patient population and study interventions.

  • Kristen Sullivan, PhD, MSW, MBA

    Kristen Sullivan is a Research Scientist at the Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill. Her research focuses on promoting equitable access to health research and care, particularly in the context of women and adolescents living with and at risk for HIV. She conducts empirical bioethics studies which seek to surface and integrate the priorities and viewpoints of varied stakeholders into ethical analyses and guidances. With Anne Lyerly, she currently leads a NIAID-funded R01, the PREPARE (Promoting Equity for Pregnant Adolescents in Research) project, aimed at identifying pathways to ethically advance the HIV/coinfections evidence base for pregnant adolescents.

  • Robert Klitzman, MD

    Robert Klitzman, M.D., is a Professor of Psychiatry at the Vagelos College of Physicians and Surgeons and the Joseph Mailman School of Public Health, and the Director of the online and in-person Bioethics Masters and Certificate Programs at Columbia University. He has written over 160 scientific journal articles, nine books, and numerous chapters on critical issues in bioethics regarding genetics, neuroscience, psychiatry doctor-patient relationships, coping with illness and other areas. His books include The Ethics Police?: The Struggle to Make Human Research Safe, When Doctors Become Patients, Am I My Genes? Confronting Fate and Family Secrets in the Age of Genetic Testing, Designing Babies: How Technology is Changing How We Have Children, A Year-Long Night: Tales of a Medical Internship, In a House of Dreams and Glass: Becoming a Psychiatrist, Being Positive: The Lives of Men and Women With HIV, The Trembling Mountain: A Personal Account of Kuru, Cannibals and Mad Cow Disease, and Mortal Secrets: Truth and Lies in the Age of AIDS.

    Klitzman has received numerous awards for his work, including fellowships from the John Simon Guggenheim Foundation, the Russell Sage Foundation, the Commonwealth Fund, the Aaron Diamond Foundation, the Hastings Center and the Rockefeller Foundation. He is a member of the Empire State Stem Cell Commission, and the Ethics Working Group of the HIV Prevention Trials Network, and served on the U.S. Department of Defense’s Research Ethics Advisory Panel. He is a Distinguished Fellow of the American Psychiatric Association, a member of the Council on Foreign Relations, and a regular contributor to the New York Times and CNN.

June 21, 2022
Tue 1:00 PM EDT

Duration 1H 15M

This live web event has ended.

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