Session III: Sharing Responsibilities and Distinguishing Roles in the Single IRB Era

Moderator: Megan Kasimatis-Singleton, JD, MBE, CIP
Assistant Dean, Human Research Protections and Director, Human Research Protections Program, Johns Hopkins University School of Medicine

Reliance agreements: Considerations and responsibilities beyond IRB review

Emily Chi Fogler, Esq.
Partner, Verrill Dana LLP

Reliance agreements are about more than delegating responsibility for IRB review. Effective agreements also address how other aspects of research oversight typically performed by the relying institution or its IRB will be carried out in the new arrangement. Ms. Fogler will provide an overview of key oversight issues that should be considered in these agreements, with a focus on several issues (such as compliance with HIPAA and local laws) that present particular challenges for understanding what is being delegated (or not) and the ultimate “responsibilities” of the parties.

Establishing the role of the relying institution in human subjects protection in the era of single IRB

Kelley O’Donoghue, MPH, CIP
Associate Vice President for Human Subject Protection and Director of the Office for Human Subject Protection (OHSP) at the University of Rochester

Given the requirement to rely on single IRBs for collaborative research, many institutions are deferring IRB review to external IRBs for the first time. This presentation will discuss how relying institutions can meet their responsibilities to oversee research when deferring to an external IRB and to ensure the protection of human subjects. It will provide strategies to develop internal processes or revise existing processes for a relying institution to adequately manage the oversight of research.

WORKING TOGETHER TO IMPROVE THE SIRB MODEL: SUGGESTIONS FROM A MULTI-STAKEHOLDER PROJECT TEAM

Sara B. Calvert, PharmD
Senior Project Manager, Clinical Trials Transformation Initiative (CTTI)

Building on several previous projects, the Clinical Trials Transformation Initiative formed an expert project team to create an evaluation plan for the NIH sIRB policy. The team’s suggestions to create a broad learning system to measure, evaluate, and improve the sIRB process will be presented.

SMART IRB: Lessons Learned and Opportunities Ahead

Barbara E. Bierer, MD
Director, Regulatory Policy, SMART IRB
Director, Regulatory Foundations, Ethics, and the Law, Harvard Catalyst (CTSC)

This presentation will address the challenges encountered in the implementation of the SMART IRB platform, the tools and resources available, and the efforts to align processes and approaches towards a more efficient and collaborative system of sIRB review of multisite research.