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Costs and inconsistencies in US IRB review of low‐risk medical education research
Author(s) -
Kano Miria,
Getrich Christina M,
Romney Crystal,
Sussman Andrew L,
Williams Robert L
Publication year - 2015
Publication title -
medical education
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.776
H-Index - 138
eISSN - 1365-2923
pISSN - 0308-0110
DOI - 10.1111/medu.12693
Subject(s) - institutional review board , context (archaeology) , protocol (science) , medical education , consistency (knowledge bases) , diversity (politics) , variety (cybernetics) , medicine , political science , alternative medicine , computer science , paleontology , surgery , pathology , artificial intelligence , law , biology
Context Advances in communication technologies over the last two decades have transformed the way medical education research is conducted, creating opportunities for multi‐institution national and international studies. Although these studies enable researchers to gain broader understandings of educational processes across institutions, they increase the need for multiple institutional review board ( IRB ) reviews to ensure the protection of human subjects. Objectives This study describes the process of obtaining multiple IRB approvals of the same protocol for a multi‐site, low‐risk, medical education research project in the USA . The burden of obtaining those reviews and their consistency are assessed. The associated time and costs, and implications for the research process are detailed. Methods Following review by the investigators' parent institution IRB , the project team circulated a uniform protocol for conduct of a low‐risk, medical education survey to the IRB s of 89 US medical schools for review. The processes and time required to obtain approvals were recorded to estimate associated research team personnel costs. Results Approval could not be obtained from five IRB s as a result of insurmountable procedural barriers. A total of 67 IRB s eventually deferred to the parent IRB determination. The remaining IRB s required a variety of additional procedural processes before ultimately agreeing with the original determination. The personnel costs associated with obtaining the 84 approvals amounted to US $121 344. Conclusions Considering the value of multi‐site designs to address a range of research questions, enhance participant diversity and develop representative findings, solutions must be found to counter inefficiencies of current IRB review processes for low‐risk research, such as that usually conducted in medical education. Although we acknowledge that local review is an essential protective measure for research involving identifiable communities that are uniquely susceptible to social or economic harm, this report suggests that proposals to modernise and streamline IRB review processes for low‐risk research are timely and relevant.

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