Jill Wechsler
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Continued expansion of human subject research around the world is generating calls for a more efficient and effective oversight
system to evaluate research protocols and monitor trial operations. This task largely is the responsibility of Institutional
Review Boards (IRBs) at research organizations and in communities where clinical research takes place.
For several years now, research sponsors at government agencies as well as pharma companies have been turning more to central
IRBs to provide more timely and coordinated research review of multicenter trials, many involving complex study designs and
large numbers of subjects.
This trend has raised an outcry from academic research centers that consider local review critical to understanding the values
and attitudes of the local population participating in a study, a particularly important issue for conducting research in
foreign countries. At the same time, many local IRBs lack the resources, staff, and expertise needed to evaluate and monitor
the growing volume of trials.
The benefits and weaknesses of both local and central IRBs was the subject of debate at a National Conference on Alternative
IRB Models in Washington, DC, last November. The conference, which followed the annual meeting of PRIM&R (Public Responsibility
in Medicine and Research), attracted 400 participants eager to discuss the changing roles of IRBs in biomedical research.
The starting point was a report from a smaller workshop in November 2005 that had been proposed by the Secretary's Advisory
Committee on Human Research Protections (SACHRP) to explore alternative models to local IRB review.
Following that workshop, FDA issued a guidance last March (2006) to clarify that reliance on central IRBs to oversee multicenter
trials does not violate agency regulations. The guidance explains that FDA regulations permit an IRB at a different location
from the actual research site to review the study, so long as the central board understands the local context and is sensitive
to community values. Conversely, separate research review at multiple sites can result in "duplication of effort, delays,
and increased expenses" says the document, adding that "greater reliance on a centralized IRB review process, in appropriate
circumstances, could reduce IRB burdens and delays."
Push for efficiency
Conflicts and Confusions
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This document and other guidance under development by the Office of Human Research Protections (OHRP) reflect continued tension
between the need for IRBs to represent the interests of the local community where research is taking place, and the need for
more efficient and coordinated oversight of research at multiple sites.
Central IRBs, which may be commercial operations or established by public research organizations such as the National Cancer
Institute, often have greater resources, access to experts on cutting-edge science, and large information systems.
Cancer researchers are some of the most vocal proponents of central IRB review, particularly for "smart studies" that test
candidate therapies in patients most likely to respond and that need to enroll patients at many sites across the nation and
the world, explained Lowell Schnipper, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center. Central IRBs
may reduce costs by eliminating duplicative reviews and ensuring consistency in consent forms, protocols, and results across
all sites.
Pharma companies have long used central IRBs to obtain efficient review of protocols and research programs, which often involve
many study sites, including doctors offices and clinics. Even with the recent increase in industry-sponsored trials at academic
institutions, industry sponsors want academic researchers to use a central IRB to oversee the total study, a demand that increasingly
dismays many IRB operators.
More local investment
In fact, officials at research organizations around the country fear that a wholesale shift to central IRBs will undermine
the current infrastructure designed to ensure that human subject research fits community standards and values. Richard Bianco,
associate vice president for research and regulatory affairs at the University of Minnesota, advised attendees at the IRB
conference to "slow down" the rush to outsource research oversight. He maintained that the local system for subject protection
"is not significantly flawed," but suffers primarily from a lack of resources and support.
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