HRPP Newsletter July 2023
MyChart Recruitment
Studies using OnCore and with a study record in Health Link may be eligible to recruit subjects through MyChart, UW Health’s patient portal, beginning in July. Study teams should describe this as a recruitment modality in IRB application materials and include invitation language using the approved UW Health invitation template found in the Investigator Manual. Note, while IRB approval to recruit through MyChart is a requirement, study teams must also comply with UW Health requirements for such MyChart use. Please see MyChart Recruitment FAQs for UW Health requirements and information on the process for obtaining approval and submitting a request.
RAMP and ARROW
The Research Administration Management Portal (RAMP) is now live. Unlike its predecessor, WISPER, funding information entered in ARROW is integrated into and updated in RAMP. The integration is in both directions, BUT you must first choose the funding in ARROW for it to be visible in RAMP. That is, when you choose a given funding proposal or award in ARROW (via the chooser as you do now), that IRB application will appear on the RAMP compliance questions page if you indicate the study includes research with human subjects.
As approved IRB applications are typically not in place when grants are submitted, RAMP allows you to submit the grant proposal PRIOR to having IRB approval. However, like now, you will need to have an approved protocol for award setup. Therefore, it is recommended that you create and submit your ARROW applications as soon as you have notice from the funding agency that your proposal might be awarded.
Research Operations Committee (UROC) Launch
UW Health and the UW School of Medicine and Public Health (SMPH) have convened a new committee to help centralize and streamline the clinical trials review process at UW–Madison.
The cross-departmental, cross-functional committee, referred to as the UW Health/SMPH Research Operations Committee (UROC), will provide a single intake and operational feasibility review process for all clinical trial requests prior to IRB submission. The review process will begin with a proposal submission to the committee, which will meet bi-weekly, and will conclude with a recommendation letter and feasibility assessment. To document UROC review in your IRB ARROW application, upload these recommendation letters and feasibility assessments into the supplemental information page in ARROW.
All proposed trials that will utilize UW Health services, personnel, facilities and/or engage with UW Health patients need to undergo committee review to assess the operational feasibility of the study. Note, at this time, studies that generally meet the criteria for IRB exemption (data only studies, secondary use of existing samples or studies that only involve interviews, surveys or focus groups) and expanded access/emergency use studies are exempt from UROC review.
For more information, please visit https://uwclinicaltrials.org/uroc/
The first protocol submission deadline, under UROC, is July 17. The committee plans to meet on July 26.
Educational Opportunities
CTI Research Forums: What Requires Report to the IRB, July 18th, 12:00-1:00 pm
Learn from the IRB what types of events constitute potential unanticipated problems or noncompliance that require report to the IRB as a “reportable event." IRB staff will provide information on how to evaluate whether an event requires a report, the timeframe for reporting, what information to include in the report, and provide an overview of guidance and resources available to study teams.