Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

Pornpimon Adams,Chanthima Limphattharacharoen,Krisana Pengsaa,Sukanya Prakobtham,Jaranit Kaewkungwal,Srisin Khusmith,Jerome A Singh

doi:10.1371/journal.pone.0113356

Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

Pornpimon Adams, Chanthima Limphattharacharoen + Show 5 more

Open Access

https://doi.org/10.1371/journal.pone.0113356

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Abstract

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research.

Highlights

The question whether the ethics committee is facilitating or impeding the conduct of research is sometimes hotly debated
This poor relationship might potentially result in negative or inadequate outcomes for human-subject protection. Even though both researchers and institutional review board (IRB) agree on the principle of protecting human subjects, some researchers argue that IRB members frequently act beyond the scope of their mandate – the protection of research subjects – and behave paternalistically towards them [2]
The results of this study were based on the IRB Metrics developed and used at Faculty of Tropical Medicine (FTM)-EC, which mainly comprise performance indicators related to the IRB composition and review process

Summary

Introduction

The question whether the ethics committee is facilitating or impeding the conduct of research is sometimes hotly debated. Institutional review boards (IRBs) are at times accused of being the ‘‘ethics police’’, and researchers frequently complain about conflicts and power relationships vis-a-vis their IRBs [1]. This poor relationship might potentially result in negative or inadequate outcomes for human-subject protection. Even though both researchers and IRBs agree on the principle of protecting human subjects, some researchers argue that IRB members frequently act beyond the scope of their mandate – the protection of research subjects – and behave paternalistically towards them [2]. Some researchers have expressed concern that there is no compilation of rulings and precedents of IRB mandates, so that each newly populated IRB creates many of its own decision-making rules de novo [7]

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