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.
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.
Authors: Michaela A Dinan; Kevin P Weinfurt; Joëlle Y Friedman; Jennifer S Allsbrook; Julie Gottlieb; Kevin A Schulman; Mark A Hall; Jatinder K Dhillon; Jeremy Sugarman Journal: Account Res Date: 2006 Oct-Dec Impact factor: 2.622
Authors: Sarah M Greene; Ann M Geiger; Emily L Harris; Andrea Altschuler; Larissa Nekhlyudov; Mary B Barton; Sharon J Rolnick; Joann G Elmore; Suzanne Fletcher Journal: Ann Epidemiol Date: 2005-07-06 Impact factor: 3.797
Authors: Michael P Diamond; Esther Eisenberg; Hao Huang; Christos Coutifaris; Richard S Legro; Karl R Hansen; Anne Z Steiner; Marcelle Cedars; Kurt Barnhart; Tracy Ziolek; Tracey R Thomas; Kate Maurer; Stephen A Krawetz; Robert A Wild; J C Trussell; Nanette Santoro; Heping Zhang Journal: Clin Trials Date: 2018-10-24 Impact factor: 2.486
Authors: Patrick R Varley; Ulrike Feske; Shasha Gao; Roslyn A Stone; Sijian Zhang; Robert Monte; Robert M Arnold; Daniel E Hall Journal: J Surg Res Date: 2016-06-08 Impact factor: 2.192