Table 1 Overview of initiatives and guidelines on the inclusion of pregnant people in clinical research
From: Stimulating solidarity to improve knowledge on medications used during pregnancy
Initiative or guideline | Description | Link to website |
|---|---|---|
The Second Wave Initiative 2009 | The Second Wave Initiative is a collaborative academic effort from the United States that aimed to identify, develop, and advance ethically and scientifically responsible solutions for increasing the knowledge base for the treatment of pregnant people who have medical conditions. | |
PHASES 2016 | Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) seeks ethical solutions to advance research at the intersection of people’s reproduction and HIV prevention, treatment, and management. PHASES is an interdisciplinary, research-driven project funded through the U.S. National Institute of Allergy and Infectious Diseases of the National Institutes of Health and collaborates with international leaders in different fields across the world. | |
United States Task Force on research specific to pregnant and lactating women (PRGLAC) 2018 | The 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services (HHS) on gaps in knowledge and research on safe and effective therapies for pregnant and lactating people. | |
PREVENT 2018 | Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies (PREVENT) has developed concrete, actionable, consensus-driven ethics guidance on how to equitably include the interests of pregnant people and their offspring in vaccine research and development for priority pathogens and emerging epidemic threats. PREVENT is led by researchers from the United States, with external contributions from international experts. | https://bioethics.jhu.edu/research-and-outreach/projects/prevent/ |
CIOMS International Research Ethics Guidance (guideline 19) 2016 | The Council of International Organizations and Medical Sciences (CIOMS) provides guidance to a number of pressing issues in research ethics, including research with pregnant people. CIOMS represents a substantial proportion of the international medical scientific community through its member organization across the world. |