PRIM&R Webinar: Are We Excluding Pregnant People Too Much From Research?

Hosted by the Public Responsibility in Medicine and Research (PRIM&R)

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.

Interested students can receive complimentary tickets to this webinar. Please email Athina Fontenot at af3018 [[at]] columbia [[dot]] edu (af3018[at]columbia[dot]edu) for more information.