Session I: Providing Options and Ensuring Quality in Single IRB Review

PRACTICAL & ETHICAL CONSIDERATIONS
FOR SINGLE IRB REVIEW

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.