Step 1: Contact the Clinic Director(s)
Please consult with the directors of the clinics of interest in the early stages of planning your research activities in the clinics, prior to submission to the Waisman Center Clinical Translational Core (CTC) or IRB committee. The Clinic Director Discussion Guide is recommended to facilitate conversations with the clinic director(s) about your proposed research activities. The clinic director(s) can provide you with information about their clinics including availability of the patient population, resource requirements, workflow procedures, and feedback about activities that may require additional resources.
The CTC research coordinator will facilitate the initial contact with the clinic director(s) upon request.
Study team members who are not faculty are to discuss the research activities with their supervisors prior to proposal submission (Step 2).
Step 2: Proposal Submission and Review
Complete and submit a Waisman Center Clinic Research Proposal Form to the CTC research coordinator.
The CTC research coordinator will forward the proposal for review by the Waisman Center and CTC directors and the clinic research review group (i.e., UCEDD director, Waisman HIPAA Privacy Coordinator, clinics medical director and operations manager) to determine project feasibility and suitability. The investigator will receive feedback within 4-6 weeks regarding the timeline for proposal review. The CTC research coordinator will communicate to the investigator the outcome of the proposal review: endorsed, endorsed pending revisions, or declined. The research coordinator will recommend endorsed proposals for review by the Clinics Executive Committee (CEC, Step 3).
Decisions to endorse proposals are made on a case-by-case basis. Factors considered in determining project feasibility and suitability include, but are not limited to: impact on clinic space, resources, schedule or appointments, patient experience, and staff; scientific merit; availability of the study population; proposed timeline; and alignment with the Waisman Center mission and Clinics priorities, policies and procedures. Depending on the scope of work, an ad hoc clinic review team may be assembled during the review process to determine if the resources needed to support a given protocol are available. The ad hoc clinic review team could include the clinic director, clinic coordinator, and any necessary clinical staff. Composition of this team will vary depending on the needs of the project.
The investigator may be invited to answer questions and provide clarifications in an effort to facilitate the process. If he or she is unable to respond, another member of the study team may do so as long as that individual is familiar with the study and is qualified to address concerns.
In cases when the outcome of the review is ‘endorsed pending revisions’ the investigator will revise and re-submit the proposal form, as needed, and forward the final version to the CTC research coordinator.
Step 3: Waisman Center Clinics Executive Committee (CEC) Review and UW-Madison IRB Approval
Proposals endorsed in Step 2 will be reviewed by the CEC. The CTC research coordinator will communicate to the investigator the outcome of the CEC review: endorsed, endorsed pending IRB approval or revisions, or declined. Only endorsed proposals are eligible for Step 4.
The investigator is encouraged to apply for IRB approval while the proposal is under review by the CEC.
Step 4: Implementation
After Waisman Center CEC and UW-Madison IRB approvals are obtained the research activities can be implemented. Investigators whose research teams are not part of the Waisman Center Clinics and need research coordination services will utilize the CTC. In those instances, the CTC research coordinator will serve as the liaison between the study team and clinics to determine a timeline and facilitate implementation of the approved research protocol. The CTC research coordinator will monitor progress and provide support throughout the project, as needed.
Step 5: Share Results
Prior to publication, the study team is expected to provide at least one presentation of the outcomes to the appropriate clinic team(s) and leadership/management.