2020 OHRP EXPLORATORY WORKSHOP
PRACTICAL & ETHICAL CONSIDERATIONS
FOR SINGLE IRB REVIEW
SESSION I:
Providing Options and Ensuring Quality in Single IRB Review
Single IRB review of collaborative multi-site research can reduce inconsistencies and improve the quality of reviews. However, the single IRB mandate could result in a small number of IRBs amassing more responsibility and importance over a large proportion of federally funded research. Encouraging more institutions to serve as single IRBs is one way to diversify single IRB options and could promote a culture of quality reviews that inspires confidence. This session will share experience on how institutions create options for single IRB reviews, and explore measures to promote quality ethics review and human research protections.
Moderator: Stephen Rosenfeld, MD, MBA
Freeport Research Systems, LLC
Ensuring quality IRB reviews: Lessons learned from NCI’s CIRB initiative
Linda K. Parreco, RN, MS
Nurse Consultant, Office of the Deputy Director, Division of Cancer Prevention, National Cancer Institute
The NCI central IRB (CIRB) was established in 2001 to provide centralized IRB review for NCI-funded clinical studies. The CIRB model has evolved considerably in the past 19 years. This presentation identifies lessons learned and discusses ways to manage challenges to long standing single IRBs including how to ensure quality reviews, transparency, and open-minded deliberations among reviewers on research ethics and human subjects protections.
Diversifying options for single IRBs: An institution’s experience with extending their IRB services to outside institutions
Ann Johnson, PhD
IRB director, University of Utah
When institutions experienced in single IRB review choose to offer their IRB services to outside institutions, they expand the single IRB options available to the research community. This presentation explores the considerations of one institution that has decided to extend its reviewing IRB services outside of its own network and proposes a series of innovative measures to streamline the IRB review process and reduce inefficiencies.
From relying to reviewing: Considerations and lessons learned when establishing a single IRB
Joshua Fedewa, MS, CIP
Associate Director, HRPP, University of Texas Southwestern Medical Center
Some institutions may find the idea of becoming the reviewing single IRB for cooperative research daunting. One institution will share thoughtful considerations on systems, processes, and documentation, as well as lessons learned from their endeavor to establish a single IRB at their institution.
Evaluating the quality of ethics review and promoting transparency and accountability in the era of single IRBs
Holly A. Taylor, PhD, MPH
Research Bioethicist, Department of Bioethics, Clinical Center, National Institutes of Health
Transparency and accountability of IRB review become more important in the era of single IRBs to assure research institutions and the public that relying the reliance on single IRBs can not only streamline research, but also is an opportunity to better protect human research participants. This presentation endorses the importance of evaluating the work of IRBs and explores a variety of approaches on how to do so.
