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

Varley, Patrick; Feske, Ulrike; Gao, Shasha; Stone, Roslyn A.; Zhang, Sijian; Monte, Robert; Arnold, Robert M.; Hall, Daniel E.

doi:10.1016/j.jss.2016.06.004

Cited by 17 publications

(10 citation statements)

References 23 publications

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“…On the other hand, among the 140 VA IRB full board-reviewed protocols, 66 (47.1%) could have been reviewed using a lower level of review, that is, expedited review, according to OHRP criteria. The expedited review procedure is not only less labor intensive, but also on average 44 days faster than full board review (Varley et al, 2016). The costs associated with assembling fully convened IRB meetings are significant given advanced training of members and the time involved.…”

Section: Discussionmentioning

confidence: 99%

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

Tsan

Ling

Feske

et al. 2020

Journal of Empirical Research on Human Research Ethics

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How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

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Section: Discussionmentioning

confidence: 99%

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

Tsan

Ling

Feske

et al. 2020

Journal of Empirical Research on Human Research Ethics

Self Cite

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“…Future research should continue to develop methods to assess this presently unmeasured component of the IRB submission process. Finally, this evaluation was restricted to a single university, and anecdotal evidence suggests wide variability, or at least perceptions of wide variability, in the degree of burden and time requirements necessary to comply with the IRB review process across institutions (Varley et al, 2016).…”

Section: Discussionmentioning

confidence: 99%

Effects of Regulatory Support Services on Institutional Review Board Turnaround Times

Desai¹,

Nasa

Soo

et al. 2017

Journal of Empirical Research on Human Research Ethics

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We evaluated how regulatory support services provided by University of Illinois at Chicago's Center for Clinical and Translational Science may reduce Institutional Review Board (IRB) turnaround times. IRB applications were categorized by receipt of any regulatory support, and amount of support received. Turnaround time included total turnaround time, time for IRB review, and time for investigators to modify protocols. There were no differences in any turnaround times for supported versus non-supported applications. However, for supported applications, those receiving more intensive support had total turnaround times 16.0 days (standard error 7.62, p<0.05) faster than those receiving less intensive support. Receiving higher regulatory support may be associated with faster approval of IRB submissions.

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“…They vary in thoroughness and cost of reviews. They also vary in quality of decision determination and time required for approval [ 4 ].…”

Section: Commentarymentioning

confidence: 99%

The IRB structure and medical research reform

Babyar¹

2018

Clinical & Translational Med

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Optimal Independent Review Board (IRB) structure encompasses ongoing process improvement, ethics policies and continuous relationship building, all sound in evidence. With optimal IRB structure, a global research infrastructure will flourish. Evidence for IRB structure must be detailed and expert operational recommendations should guide. Too, health service research oversight should assist in funding as well as collaboration. A national and international research agenda will only benefit from best operations, guided in evidence, supported in best regulatory and research leadership practice. It is imperative that the IRB structure be reformed.

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

Cited by 17 publications

References 23 publications

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

Effects of Regulatory Support Services on Institutional Review Board Turnaround Times

The IRB structure and medical research reform

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