Global Research Track
2019 AER Conference
Basic
A05 - Going Global for the First Time—Considerations for Reviewing International Research
Rachel Zand, PhD
Director, Human Research Ethics, University of Toronto
Delia Y. Wolf, MD, JD, MSCI,
Associate Dean, Regulatory Affairs and Research Compliance; Faculty Member, Department of Health Policy and Management, Harvard T.H. Chan School of Public Health
Sr. Lecturer, Health Policy and Management, Harvard T.H. Chan School of Public Health
Speaker(s)
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 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. Speakers will share best practices for reviewing transnational research. Attendees are encouraged to bring their questions/challenges for discussion with the group. During this session, speakers and attendees will:
Learning Objectives:
- Discuss the common challenges facing US IRBs when reviewing international research
- Review various approaches to eliminating or mitigating challenges, emphasizing possible US regulatory flexibility
- Examine institutional policies/best practices for US IRB review of transnational research
- Describe ways that US IRBs may engage and partner with local ethics committees