Abstract
Background/Aims The 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.
Methods Investigators from around the HMORN have been queried regarding their knowledge of and experiences with Version 1 of the SOP, with an aim being to improve both the visibility and efficiency of the process. Version 2 incorporates their suggestions. The results of the December 2010 meeting of IRB Administrators and Directors will be reported on as well.
Results Data are in the process of collection, and will be reported on at the March 2011 HMORN Conference in Boston.
Conclusions In order to maintain and improve efficiency and effectiveness, as well as meet the turn-around times of funding agencies, it is imperative that multi-site research review strives to continuously improve quality without sacrificing the imperative to conduct rigorous ethical and regulatory reviews of proposed research. The processes established in the HMORN work toward this goal, and require the cooperation of the Network-wide research enterprise.




