To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study.
Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics.
Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence.
Data Collection and Abstraction Methods:
Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data.
Approximately 4,680 hours of staff time over a 19‐month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed:
(1) Local PIs had no real role but were required by IRBs. Twenty‐one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites.
(2) . The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty‐three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.
(3) . Seventy‐six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document.
(4) The process required from 52 to 798 (median 286) days to obtain approval at each site.
Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt‐out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.
