About myProject and its development
Recent changes in NIH policy as well as potential changes proposed in the HHS Common Rule require changes in the handling of the IRB review and oversight of research. These changes will include, but are not limited to, grant application and budget submissions, implementation of a new model of IRB review, and changes in research administration and oversight processes. However, systems that support the management and oversight of mult-site research conducted under a sIRB model are not widely available.
Washington University in St. Louis and The University of Iowa have partnered together to develop an IT systems solution to allow institutions to effectively implement and manage their roles as relying institutions and reviewing IRBs under different single IRB (sIRB) models in multi-site research.
The myProject development will take an innovative approach of identifying programming priorities and design solutions that not only meet the needs of a relying institution or reviewing sIRB, but importantly provides simple tools to reduce burden and support compliance for researchers tasked with working with a variety of sIRBs and their varied operating procedures and reporting requirements.
Details of the solution have been delineated in the supplement submission, "Development of Resources to Facilitate Single IRB Review for Multi-site Research" and include the following specific aims:
Specific Aim #1: Develop a sIRB Project Management Module (PMM) to support integration and tracking of multiple sIRBs used within established institutional human research protection programs.
Specific Aim #2: Create a user-friendly and accessible Responsibilities Matrix Module (RMM) for use by research teams and Institutional administrators to access key policies, procedures, and IRB reliance agreement terms impacting the conduct of multi-site protocols in compliance with regulatory and sIRB requirements.
Specific Aim #3: Create a customizable sIRB Costing Model Tool (CMT) for use by reviewing sIRBs in developing, implementing, and documenting appropriate fee schedules under federal regulatory requirements.
Specific Aim #4: Develop and implement a dissemination and sharing plan for the myProject system that provides on-demand training and technical support to institutions that is sustainable for ongoing use of the system products.