11 Oct A Single IRB: The Promise and the Reality
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Description
Single IRB (sIRB) review is now mandated for most federally-funded research involving human subjects. The policy requires the use of one IRB to accomplish IRB review and approval for all domestic sites. The goal of this requirement is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants. Implementing this policy will require IRBs and investigators to significantly rethink and restructure their processes for multi-site research.
This session will discuss the different sIRB policies, how they impact investigators at the time they are writing grants and after the grant is funded, changes IRBs are making to implement single IRB review, and the resources investigators and their teams will need to successfully manage a multi-site study under single IRB review.
Learning Objectives
At the end of the session, participants will:
- Understand what single IRB review is
- Recognize what kinds of studies must comply
- Explain the overall process for obtaining single IRB review
- Plan for single IRB review for a multi-site research study
About the Speaker
Adrienne Meyer, MPA, CIP, is the Assistant Director of Reliances in the Human Subjects Division at the University of Washington (UW). Adrienne is a regulatory specialist and frequent lecturer on issues associated with regulatory compliance and research ethics in a broad spectrum of research disciplines. Adrienne has been at the UW for nearly 20 years and has worked in many capacities with researchers from nearly every department and research discipline: from behavioral research with young children to first-in-human chemotherapy trials. She is the SMART IRB Ambassador for the West and Pacific region and the IRB representative on ITHS’s Trial Innovation Network team.
