PS1-03: Expanding the Functional Scope of Institutional Review Board Review of Multi-Site Research in the HMO Research Network: from Data-Only Studies to Non-Clinical Interventions to Clinical Trials

摘要

Background/AimsThe member institutions of the HMORN have long been concerned about their ability to conduct multi-site research in a timely and efficient manner. Frequently in the past, investigators in multi-site studies have felt constrained by the requirement of submitting proposed research to multiple IRBs. In June 2008, the HMORN Governing Board approved a Standard Operating Procedure (SOP) that streamlined this submission process for data-only studies (Version 1), and in September 2010, the SOP was revised (Version 2) to permit the inclusion of all HMORN multi-site research except clinical trials. IRB Administrators and Directors from around the HMORN met in December 2010 to discuss strategies for harmonizing clinical trials review as well as establishing a Network-wide IRB Authorization Agreement for the conduct of HMORN multi-site research.