The Milbank Memorial Fund is an endowed operating foundation that publishes The Milbank Quarterly, commissions projects, and convenes state health policy decision makers on issues they identify as important to population health.
We focus on a number of topic areas identified by state health policy leaders as important to population health.
The Center for Evidence-based Policy at Oregon Health & Science University is a national leader in evidence-based decision making and policy design.
Keep up with news and updates from the Milbank Memorial Fund. Get the latest from thought leaders, including Christopher F. Koller, president of the Fund.
We publish The Milbank Quarterly, as well as reports, issues briefs, and case studies on topics important to population health.
December 2011 (Volume 89)
December 2011 | George Silberman, Katherine L. Kahn
Context: Federal regulations mandate independent review and approval by an “institutional review board” (IRB) before studies that involve human research subjects may begin. Although many researchers strongly support the need for IRB review, they also contend that it is burdensome when it imposes costs that do not add to the protections afforded to research participants and that this burden threatens the viability of research. The U.S. Department of Health and Human Services recently announced its intention to reform the regulations governing IRB review.
Methods: We used a search of the PubMed database, supplemented by a bibliographic review, to identify all existing primary data on the costs of IRB review. “Costs” were broadly defined to include both expenditures of time or money and constraints imposed on the scope of the research. Burdensome costs were limited to those that did not contribute to greater protections for the participants.
Findings: Evidence from a total of fifty-two studies shows that IRBs operate at different levels of efficiency; that waiting to obtain IRB approval has, in some instances, delayed project initiation; that IRBs presented with identical protocols sometimes asked for different and even competing revisions; and that some decisions made (and positions held) by IRBs are not in accord with federal policy guidance.
Conclusions: While the evidence is sufficient to conclude that there is burden associated with IRB review, it is too limited to allow for valid estimates of its magnitude or to serve as the basis for formulating policies on IRB reform. The single exception is multicenter research, for which we found that review by several local IRBs is likely to be burdensome. No mechanism currently exists at the national level to gather systematic evidence on the intersection between research and IRB review. This gap is of concern in light of the changing nature of research and the increasingly important role that research is envisioned to play in improving the overall quality of health care.
Author(s): George Silberman; Katherine L. Kahn
Keywords: institutional review board; clinical trials; research ethics; government regulations; research costs
Read on Wiley Online Library
Read on JSTOR
Volume 89, Issue 4 (pages 599–627)
Published in 2011
The Checkered History of American Psychiatric Epidemiology
Galvanizers, Guides, Champions, and Shields: The Many Ways That Policymakers Use Public Health Researchers