Executive Summary
The protection of human subjects in an institutional priority, and the University of Iowa is committed to meeting all regulatory compliance standards related to human subjects research. Careful review and approval of all research involving human subjects is critical for minimizing risk to people and assuring adequate protections of their rights and welfare.
The University of Iowa’s Office of the Vice President for Research and the Human Subjects Office are also committed to supplying the resources and support that researchers need to forge new frontiers of discovery.
This organizational efficiency initiative for the Institutional Review Board (IRB) focuses on streamlining processes for IRB review in an effort to remain competitive with our peer institutions’ average processing times for research applications, while at the same time maintaining regulatory compliance.
Project Roadmap
The goals of the IRB Efficiency Initiative will be accomplished through the phases outlined below.
The Office of the Vice President for Research and the Human Subjects Office will be in touch with the UI research community regularly to share updates on our progress towards implementing changes in the key areas identified in this plan.
CONSULT
Hire a consultant in the field of human subjects research to conduct a thorough external evaluation of the UI IRB full board process.
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Determine opportunities for process improvements to address the goals of increasing efficiency and decreasing processing time from submission of the application to release of approval
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Identify meaningful opportunities for change that could address the following goals: provide long-range planning for shifts in the research landscape, increase faculty satisfaction, increase competitiveness for acquiring research funding, and assure the highest-quality of protections for human subjects
CREATE PLAN
Identify next steps for implementing operational changes in the following areas: IRB Meetings, HRPP processes, and organizational design.
PHASE 1
- Review and identify the first round of high impact recommendations with stakeholders and programming team.
Primary Areas:
- Organizational Design
- HawkIRB Application evaluation and refinement
- Operational improvements to minutes documentation
- Operational considerations for career advancement and time management flexibility for staff
- Withdraw projects after 60 days of PI unresponsiveness
- IRB Meeting Changes
- Notify study team of IRB required actions within 24-48 hours of IRB meeting
- Identification of an expected IRB meeting date goal for all parties to strive to fulfill requirements for full board review and approval
- Creating a standardized presentation guide and preparation expectations for primary reviewers presenting at IRB meetings
- HRPP Process Changes
- Allowance of all HRPP committee approvals to occur after IRB approval
PHASE 2
- Program, develop, test, and implement the top recommendations as identified in Phase I
- Update educational tools, internal SOPs and external facing policy guidance
Develop robust communication plans and new educational tools to support changes and keep the research community informed across the institution.
- Develop communication plan and FAQs about the plan and outcomes
- Develop a coordinated and proactive approach to keep the research community informed and engaged
- Identify opportunities for soliciting feedback on changes
Coordinate all administrative, regulatory, education, financial, and human resources elements to support the IRB Efficiency Initiative.
Contact us
Executive sponsor: Office of the Vice President for Research | Business owner: Human Subjects Office
email: vpr-office@uiowa.edu