"Approval Parties!" Faculty Ad-Hoc Meetings for Exempt/Expedited Determinations

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Problem
Multiple student applications with fellowship funding were being submitted in bulk at the 11th hour to the IRB office without appropriate labeling as to project type or timing requirements. This resulted in lengthy wait times for reviews that ultimately held up the release of fellowship funds for student summer research.

Program
The IRB worked with the University’s Fellowship Office to institute several changes to the application process, both on the Fellowship end and on the IRB end. In the previous two years, the Fellowship Office has added three human subjects questions at the end of their online fellowship application to help the students decide whether their projects require IRB review (“yes” to any of the questions would alert students that IRB review is required). The application linked to the IRB website for submission information.

This year, the Fellowship Office agreed to stagger their application deadlines and funding determinations so that IRB applications would not be submitted in one large cluster as in previous years. The students were also prompted to submit their IRB applications to a new email address the IRB created specifically for this process.

The regulatory analysts assigned expedited and exempt applications to be reviewed by IRB members in ad-hoc meetings. These meetings (dubbed “approval parties” by the IRB chair) involved a subset of IRB members who are responsible for reviewing only the protocol(s) they have been assigned—not a full agenda of protocols. Since these applications are expedited or exempt, quorum is not needed. Members came prepared to discuss their assigned protocol(s) with one another. They filled out the protocol regulatory review checklists and, during or after the meeting, emailed the student Investigator, faculty advisor and IRB regulatory analyst any requested revisions. When the revisions were submitted back to the IRB for review and the protocol was ready, the analyst then processed the approval or exemption and emailed the student investigator.

The ad-hoc meetings are scheduled “as needed,” but generally after each new wave of student fellowship applications are submitted to the IRB office. This new process has lessened the burden of the traditional springtime “crunch” on the IRB office and has made it easier and faster for students to obtain their approvals and secure their fellowship funding to conduct their summer research. (Our final poster will include data on approval times compared to previous years.)