Academic journal article Journal of Research Administration

An IRB Transformation: Increasing Quality and Efficiency Using Existing Resources

Academic journal article Journal of Research Administration

An IRB Transformation: Increasing Quality and Efficiency Using Existing Resources

Article excerpt

Abstract

In an effort to increase review-quality and efficiency, research administration at Wake Forest School of Medicine initiated a change in the operational structure of the Institutional Review Board (IRB) via a reconfiguring of the boards and rescheduling of the convened meetings. The number of IRB Panels was doubled and each panel/board began meeting on alternating weeks, rather than once per month as they had previously done. The turn-around time for full board approvals was reduced by over 50% and the quality of review was increased due to the smaller agendas for each meeting, allowing all members the opportunity to more carefully review each submission. More time is now spent discussing each submission item than was possible in the past, yet meetings are much shorter than before, due to the smaller agendas. In addition to fostering higher quality human subject protection, both investigator and board member satisfaction has increased because of the change in the operational structure of the IRB. No additional funds or staff members were needed to carry out this successful change. IRB management at other institutions can replicate this process easily and at no significant cost.

Keywords: human subjects protection, IRB review, IRB ethics, IRB performance, IRB member satisfaction

Introduction

A debate is currendy underway on whether local IRB review is better than external IRB review. Much of the debate surrounds the fact external IRBs have the advantage of quicker turnaround times, plus funds devoted solely to customer service. Many university IRBs have found it difficult to meet this challenge. (Whitney et al., 2008). The following inquiry examines how one IRB adopted external IRB practices and made themselves competitive with their external colleagues, settling some of the debate. By doing this, they were able to maintain high quality local review, while increasing efficiency and levels of service.

The concerns over IRB efficiency across the country have prompted a series of articles and opinion papers on the potential for a redesign of the IRB review system, utilizing a single IRB for all multi-site research. (Wechsler, 2007). Debates over whether a central IRB model is practical and whether the use of for-profit IRBs would decrease the quality of review due to the financial stake those entities have in the volume of reviews have been carried out in the literature. (Lemmens & Freedman, 2000). During the summer of 201 1, an Advanced Notice of Proposed Rule Making (ANPRM) was released by the Office for Human Research Protections (OHRP) which included a call for input on how a central IRB model for multisite research might be designed in order to reduce the bottlenecks caused by lengthy IRB reviews at each research site. (Federal Register, 201 1).

The national discussion on whether local or central Institutional Review Boards (IRB's) better serve to protect human research participants has raised questions as to whether the use of central boards to the exclusion of any local review would eliminate the consideration of local context and prevent institutions from evaluating the ability of their research program to safely conduct the study. (Wechsler, 2007). In addition, a long standing concern about the quality of review conducted by for-profit IRBs has made some in academic medicine skeptical of reliance of these entities for oversight of clinical trials. (Lemmens & Freedman, 2000).

Improving IRB efficiency and review quality has been a constant goal for the WFSM IRB, but in 2011 there were institutional priority shifts, and changes in leadership that focused the attention of research support leadership on finding ways to overhaul the support mechanisms immediately so that clinical research capacity at the institution could be increased without the need to hire new staff members or increasing budgets. It was also important that the quality of review and service to investigators remain high. …

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