SMPH Departmental Protocol Feasibility
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. 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 Shari Zeldin for sign-off.
Follow these steps to comply with the Protocol Feasibility policy:
- Prior to submitting a protocol in ARROW, the study PI ( or their POC) must complete and submit the online DOM Research Protocol Feasibility Intake Form. This form was developed by DOM IT to aide in the protocol feasiblity process. The PI must attest to the 6 questions asked on the form.
- The submitted form is automatically transmitted to Shari Zeldin ( DOM Compliance Officer and Chair designee for assessing protocol feasibility), alerting her to conduct a fesibility review of the protocol and IRB application.
- Once Shari completes and signs off on the required SMPH Feasibility Attestation Form, she will send it to the PI, or their POC, for upload into the ARROW system (in the new Protocol Feasibility section). This form must be included with the initial IRB application. (For your reference, the SMPH Protocol Attestation Form that the Chair or desginee must complete and sign can be found here: https://ictr.wisc.edu/protocol-feasibility/#forms )
- 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 Attestation form will be flagged during IRB administrative review and returned.
- Questions or concerns? Contact Shari Zeldin at email@example.com or 262-0278