Notes from the field: jumpstarting the IRB approval process in multicenter studies.

In early 2004, we were selected to head the National Program Office (B.S., M.R.) and evaluation component (J.B., J.B.) of the Robert Wood Johnson Foundation's “Expecting Success” (ES) program. The program applies quality improvement techniques in hospitals that provide care to significant volumes of African American and Latino patients with heart disease. In taking on our new roles, we knew that we faced a significant task in completing an Institutional Review Board (IRB) review process at the 10 different sites. We had seen growing numbers of reports of prolonged review periods in multicenter studies (Nelson et al. 2002; McWilliams et al. 2003; Dziak et al. 2005; Gold and Dewa 2005). Some of the dynamics underlying lengthy IRB reviews were documented in a recent report in this journal from a 45-site study. Using a protocol that was “designed to be qualified under U.S. government regulations for expedited review,” local IRB turnaround time ranged from 52 to 798 days. Moreover, … Twenty three [of the sites] 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 (Green et al. 2006, p. 214). In short, local IRB processes varied widely. But more significantly, boards differed with respect to their assessment of subject risk, their beliefs about what best mitigated those risks, and in their understanding of their obligations under the regulations. This was important for us, because we were working on a tight timeline, which was driven by the funder's grantmaking schedule. A portion of the evaluation drew on a pre–post design, requiring the collection of survey data from patients shortly after the sites were to be notified that they would participate. In discussing how to meet this constraint, we agreed that prolonged IRB reviews are most likely when inexperienced researchers prepare and submit their completed applications in a vacuum, without consulting their local committees. While many IRBs provide information—for example in the form of posted forms and guidance on their Internet sites—these websites cannot possibly provide advice or policy with respect to all contingencies. In any event, some of the applicant hospitals were not major teaching institutions. Fewer than one half of their IRBs offered any human subjects guidance online, and in early conversations with the prospective investigators at the sites, it was clear that some had little experience with the review process. We therefore saw our role as that of encouraging the sites to be proactive in their engagement with their local IRBs. We began to forge supportive relationships, to foster intrainstitutional communication with the goal of uncovering potentially troublesome issues in a timely fashion. Our aim was to maximize efficiency without compromising the integrity of the human subjects process. While the ES initiative included a planning phase for the collaborative, the intervention was expected to begin within 6 months of the grant award, and it was therefore important that a planned patient survey be fielded as soon as possible after the grant award notification. In this paper, we describe our efforts to work with participating hospitals to expedite the process. We begin with a brief discussion of the context in which we were working, the ES program, and the material that we circulated to the sites. We describe the conference calling process that we used to help the local teams prepare their written applications for their respective committees. We then present some information on our follow-up process. Finally, we reflect back on our approach, and ask: was it ethical?