This session is intended for IRB members and staff of US IRBs that oversee human subjects research outside the US; however, the concepts could be applied more broadly. This session will describe the history of and current international research landscape and highlight associated IRB review challenges. It will also provide an overview of applicable US regulations and international guidelines, and share available resources to identify applicable local laws and regulations, and to ensure equivalent protections. Speakers will share best practices for reviewing transnational research.
Review the history of unethical research outside of the United States
Discuss the common challenges facing US IRBs when reviewing international research, including cultural practices that may not be acceptable in the US
Consider various approaches to eliminating or mitigating challenges, including possible US regulatory flexibility
Examine institutional policies/best practices for US IRB review of transnational research
Share ways that US IRBs may engage and partner with local ethics committees
Explore the ways others are doing excellent research and protecting subjects outside the US