Inefficiencies in clinical research challenge the effective translation of basic discovery research into improvements in health. These inefficiencies often include an inadequate assessment of local capacity to support research projects via access to data systems, patient cohorts and other key services. When our clinical research workforce is unable to comprehensively assess protocol requirements, otherwise promising projects may be stalled in the initial stages of implementation.
In response to this need, ICTR and School of Medicine and Public Health (SMPH) leadership partnered to develop a standard for assessing clinical research project needs before Institutional Review Board (IRB) commences. As outlined in SMPH policy 70.10, Feasibility Assessment Requirement for Non-exempt Human Subjects Research, departments are obligated to institute a multi-pronged approach to protocol assessment, to ensure the necessary resources are available, and systems and processes to support protocol implementation are in place.
The below resources and guidance are intended to assist departments with policy compliance.