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  • IRB: ETHICS & HUMAN RESEARCH

The Process Is the Product: A New Model for Multisite IRB Review of Data-Only Studies

Over the past decade, support for reexamining and reconsidering the U.S. model of ethics review for protocols involving research with humans has grown, particularly for studies involving participants from multiple locales and organizations. The HMO Research Network received an infrastructure-building contract in 2004 that enabled us to evaluate issues in multi-institutional IRB review, examine possible changes, and propose a new model. We conducted key informant interviews and held meetings with IRB personnel, administrators, and researchers, eventually resulting in networkwide agreement to pilot an alternative model of IRB review for minimal-risk, data-only studies that only entailed use of computerized data from our network sites. This article describes the organizational and interpersonal processes that led to the successful establishment of this alternative model, to inform other research consortia considering new multisite review models.

Key words/concepts: institutional review board (IRB), interinstitutional research, multicenter research, multi-site research, alternative IRB review, minimal-risk research, data-only studies.

Sarah M. Greene, Jeffrey Braff, Andrew Nelson, and Robert J. Reid, “The Process Is the Product: A New Model for Multisite IRB Review of Data-Only Studies,” IRB: Ethics & Human Research 32, no. 3 (2010): 1-6.