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.

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

Evaluation of Structure – IRB composition and qualifications.

<p>Evaluation of Structure – IRB composition and qualifications.</p

Evaluation of Outcomes - Ethical issues notified to researcher.

<p>Evaluation of Outcomes - Ethical issues notified to researcher.</p

Evaluation of Process – Timeliness of protocol review, 2010–2013.

<p>Note:</p>a<p>Excludes 14 studies in 2010–2012 (6 withdrawn by investigator due to internal study team matters; 8 terminated by the Ethics Committee due to very long delay/non-response after notification).</p>b<p>Excludes 41 studies that required no revision.</p>C<p>Includes all new non-exempt study submissions.</p>d<p>Some studies were amended more than once.</p><p>Evaluation of Process – Timeliness of protocol review, 2010–2013.</p

IRB Metrics structure-process-outcome model used at FTM-EC.

<p>IRB Metrics structure-process-outcome model used at FTM-EC.</p

Evaluation of Outcome - Decision on new non-exempt and continuing/amended protocols reviewed by FTM-EC, 2010–2013.

<p><i>Note: Excludes 7 studies that are pending decision outcome at data cutoff, and 13 studies withdrawn by PI (for various reasons) or by EC (due to long non-response period).</i></p

Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.

<p>Evaluation of Structure – IRB workload & different types of new non-exempt protocol reviews, 2010–2013.</p

Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).

<p>*PR = Prevalence Ratio.</p><p>Effects of issues reviewed and notified for revision on “above target duration” in total time from submission to final approval (>60 days).</p

Benchmarking FTM-EC performance with selected indicators from AAHRPP-accredited institutes, 2012.

<p>*AAHRPP has compiled an information database from data supplied by 183 client organizations in 2012, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113356#pone.0113356-Donabedian1" target="_blank">[40]</a>.</p><p>Benchmarking FTM-EC performance with selected indicators from AAHRPP-accredited institutes, 2012.</p