This requirement is applicable for all non-exempt human subjects research protocols.
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, leadership of the Institute for Clincial and Translational Research (ICTR) and the School of Medicine and Public Health (SMPH) 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 process below is applicable for all principal investigators and others who submit their projects though the Department of Medicine (DOM).
If your project is managed through the UW Carbone Cancer Center, the departmental sign-off of the feasibility review will be completed by them. If the study is managed through the UW Office of Clinical Trials, they will conduct the protocol feasibility review and send it to the DOM Compliance Officer for sign-off.
Follow these steps to comply with the Protocol Feasibility policy:
- The study PI (or their POC) must complete and submit the online DOM Research Protocol Feasibility Intake Form prior to submitting a protocol in ARROW. This form was developed by DOM IT to aide in the protocol feasiblity process. The PI must attest to the six questions asked on the form.
- The submitted form is automatically transmitted to the DOM Compliance Officer and Chair designee for assessing protocol feasibility, alerting them to conduct a feasibility review of the protocol and IRB application.
- Once the DOM Compliance Officer completes and signs off on the required SMPH Feasibility Attestation Form, it will be sent back to the PI and their POC, for upload into the ARROW system (in the newly created Protocol Feasibility section). This form must be included with the initial IRB application. (For reference, view the SMPH Protocol Attestation Form that the Chair or designee must complete and sign.)
- Once the completed and signed SMPH Feasibility Attestation Form is uploaded into the ARROW application, it is ready to be submitted.
- NOTE: ARROW applications submitted without the signed Protocol Feasibility Attestation form will be flagged during IRB administrative review and returned to the sender.