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
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.
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.
*Please note that you cannot purchase this webinar on behalf of others. If you would like to register a colleague or a group, please fill out the paper form or contact firstname.lastname@example.org for an invoice.