Prioritizing initiatives for institutional review board (IRB) quality improvement

Hall, Daniel E.; Feske, Ulrike; Hanusa, Barbara H.; Ling, Bruce S.; Stone, Roslyn A.; Gao, Shasha; Switzer, Galen E.; Dobalian, Aram; Fine, Michael J.; Arnold, Robert M.

doi:10.1080/23294515.2016.1186757

Cited by 5 publications

(6 citation statements)

References 21 publications

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“…Timely review of protocols was the issue identified as requiring most attention, an issue repeatedly identified in a range of research areas internationally [ 10 , 19 , 22 , 30 ] including disaster research where timeliness is of central importance [ 31 ]. Timely reviews are not simply a matter of inconvenience for researchers; they create significant delays in accessing findings that are of potential great public benefit [ 32 ].…”

Section: Discussionmentioning

confidence: 99%

“…An initial study of 886 US biomedical and social behavioral scientists [ 19 ] generated a baseline ‘US National Validation Sample’ (USNV Sample) to validate the IRB-RAT. Subsequent studies have used the IRB-RAT to capture the perceptions of medical researchers at specific institutions [ 20 , 21 ] and to guide quality improvement of IRB functioning by identifying the areas in which perceived actual IRB processes particularly fall short of the identified ideal processes [ 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

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Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis

et al. 2020

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Background Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. Methods An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. Results Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants’ rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study’s scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. Conclusions An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis

et al. 2020

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“…Finally, to explore the how IRB stakeholders' perceptions of IRB performance and culture correlate with total review times, we merged this dataset with the results from an associated survey of IRB members' and investigators involved with the protocols studied here [23]. We found no correlation between review time and the survey responses from investigators.…”

Section: Association With Perceptions Of Irb Performancementioning

confidence: 94%

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards

Varley

Feske

Gao

et al. 2016

Journal of Surgical Research

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IRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 d for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for Research and Development Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.

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“…Several investigations have analyzed the inconsistencies in IRB panels' results [10][11][12][13][14]. In addition, consistent IRB results are associated with quality of IRB discussions and determinations based on appropriate attention to important issues and ful lling the expectation of researchers [15,16]. However, due to the characteristics of the IRB and its reviews, including its diverse members and complex study designs, inconsistencies are inevitable.…”

Section: Introductionmentioning

confidence: 99%

The Blind Review: A quality assessment measure for review standardization of Institutional Review Boards

Park

Ahn

Noh

et al. 2020

Preprint

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Background: As multinational trials are increasing, standardization of IRB review has become increasingly important. Though inconsistency is often inevitable due to varying opinions on ethics, standardization and understanding the differences are required to ensure IRB review quality. Thus, we aimed to develop and suggest a quality assessment measure of IRB named “blind review” by reviewing the same research protocols by multiple IRB panels. We further describe an analysis of differences to understand the mechanism of IRB standardization. Methods: Based on the HRPP (Human research Protection Program) SOPs (Standard of Procedure), eight blind review results from January 2010 to December 2018, at a single institution with multiple panels, were included using the Severance Hospital HRPP database. Review results were analyzed with review scores ranging from 0 to 60 points, including good clinical practice (GCP) requirements and protocol issues. Panel agreement was estimated by observed multiple rater agreement. Differences between review scores according to member expertise and IRB member duration were analyzed with the Wilcoxon rank-sum test and Kruskal-Wallis test. Results: Observed multiple raters’ agreement increased from 0.444 (95% CI: 0.167-1.000) in 2010 to 0.479 (95% CI: 0.271-0.708) in 2014~2018 as IRB review experiences increased. In order to analyze the review mechanism, three GCP requirements and three protocol issues were scored (range 0 to 60). Mean values for GCP requirements and protocol issues were 19.25±8.21 and 18.40±9.04, respectively. Mean score of the panels where experts participated (n=16, 28.13±10.47) was higher than the control group (n=32, 25.16±10.96) (p=0.93). According to IRB members’ experience, scores for the group whose career spanned less than 3 years was 25.0±10.0 (n=14), those whose career spanned 3-5 years was 26.3±9.6 (n=23), and those whose career spanned more than 5 years was 27.3±14.2 (n=11). These results were statistically significant (p=0.09). Conclusions: We suggest blind review as an effective measure for overseeing and ensuring IRB review quality and overall GCP compliance.

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Prioritizing initiatives for institutional review board (IRB) quality improvement

Abstract: Background: Institutional Review Boards (IRBs) have been criticized for inconsistency, delay,

Cited by 5 publications

References 21 publications

Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis

Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards

The Blind Review: A quality assessment measure for review standardization of Institutional Review Boards

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