Study Examines IRB Process for Multisite, Minimal-Risk VA Trial

BACKGROUND:
A number of authors have documented variability in the process of obtaining human subjects approval from local Institutional Review Boards (IRBs) for multisite studies. This variability includes standards of review, consent documents and requirements, and the time from submission to approval. Moreover, a recent systematic review of evidence from 52 studies concluded that some decisions made by IRBs are not consistent with federal policy. The present study examined the IRB approval process for a multi-site, minimal risk randomized controlled trial (RCT) testing whether financial incentives to healthcare personnel improve the provision of evidence-based hypertension care. Investigators reviewed records detailing the IRB approval process for this trial from May 2005 through mid-October 2007, and examined the number of submissions for IRB approval, time to approval, and costs. They also compared patient complexity, academic affiliation, size, and location (urban/rural) between VAMCs that did and did not participate in the trial. This is the first known quantitative evaluation of the impact of human subjects requirements on the external validity (generalizability) of study findings.

FINDINGS:

• Complying with IRB requirements for this minimal-risk RCT involved 115 submissions, consumed more than 6,700 staff hours, and lasted nearly two years longer than planned.
• The IRB approval process had a profound financial impact on the project, costing close to $170,000 in staff salaries.
• Delays in approval affected participant recruitment and retention; for example, seven physician participants had left their primary care settings before all IRB approvals were received.
• One IRB's concern about incentivizing a medication recommended by national guidelines prompted a protocol modification (broadening study inclusion criteria beyond uncomplicated hypertension) at all sites in order to preserve the study's internal validity.
• Requirements for local site principal investigators and for IRB and R&D committee approvals resulted in the inclusion of more highly-affiliated, urban sites that were treating more complex patients, potentially affecting the external validity (generalizability) of the study findings.

LIMITATIONS:

• The trial tested a novel intervention, providing financial incentives to health care personnel for high-quality care. Although non-invasive, the lack of precendent may have prompted IRBs to err on the side of caution in granting approval.
• Data from this study were derived from a single multi-center trial involving regulatory submissions to only 17 different VA sites.

AUTHOR/FUNDING INFORMATION:
This study was partly funded by HSR&D (IIR 04-349). Dr. Petersen is the Director of HSR&D's Houston Center for Quality of Care and Utilization Studies, Houston, TX.

Petersen LA, Simpson K, SoRelle R, et al. How Variability in the IRB Review Process Impacts Minimal-Risk Multisite Health Services Research. Annals of Internal Medicine May 15, 2012;156(10):728-35.