How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services Research

Abstract

Background The Department of Health and Human Services recently called for public comment on human subjects research protections. Objective (1) To assess variability in reviews across Institutional Review Boards (IRBs) for a multisite minimal risk trial of financial incentives for evidence-based hypertension care. (2) To quantify the impact of review determinations on site participation, budget, and timeline. Design A natural experiment occurring from multiple IRBs reviewing the same protocol for a multicenter trial (May 2005–October 2007). Participants 25 Veterans Affairs Medical Centers (VAMCs). Measurements Number of submissions, time to approval, and costs were evaluated. We compared patient complexity, academic affiliation, size, and location (urban/rural) between participating and non-participating VAMCs. Results Of 25 eligible VAMCs, 6 did not meet requirements for IRB review, and 2 declined participation. Of 17 applications, 14 were approved. This process required 115 submissions, lasted 27 months, and cost close to $170,000 in staff salaries. One IRB’s concern about incentivizing a particular medication recommended by national guidelines prompted a change in our design to broaden our inclusion criteria beyond uncomplicated hypertension. The change required amending the protocol at 14 sites to preserve internal validity. The IRBs that approved the protocol classified it as “minimal risk”. The 12 sites that ultimately participated in the trial were more likely to be urban, academically affiliated, and care for more complex patients, limiting the external validity of the trial’s findings. Limitations Because data came from a single multisite trial in the VA, which uses a two-stage review process, generalizability is limited. Conclusions Complying with IRB requirements for this minimal risk study required substantial resources and threatened the study’s internal and external validity. The current review of regulatory requirements may address some of the problems. Primary Funding Sources Veterans Affairs Health Services Research & Development and National Institutes of Health, National Heart, Lung, and Blood Institute

Variability in IRBs Regarding Parental Acceptance of Passive Consent

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Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network

“…Our study findings support several reports, mostly commentaries and personal perspectives, suggesting duplication and variability in the IRB review processes for multisite studies leading to research delays and burden placed on researchers. [1][2][3][4]8,9,13,14 Innovative streamlined IRB models are therefore needed to overcome the inefficiencies inherent in multisite studies.…”

“…Options for centralized IRB are varied by commonly including a single central IRB, IRB reciprocity agreements between sites, and singlestudy cooperative agreements (regional or nonregional). 6,[9][10][11]15 However, barriers to the use of these mechanisms include low institutional level of comfort and trust of centralized IRB and concern about institutional liability for the IRB review. 16 Our data suggest the potential for single-study cooperative agreements, implemented on a study-by-study basis, to provide opportunities for enhanced efficiencies without compromise of subject rights and safety or protocol integrity.…”

Research to inform the consent-to-research process

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