The Office of Research Integrity is committed to the implementation of policies and procedures that proiritize and ensure the safety of human subjects engaged in research at our Institution.  As part of this commitment, the Office of Human Research Compliance has been tasked with the restructuring and reorganization of the Institutional Review Board to improve the necessary processes undertaken to ensure the strictest adherance to all applicable federal, local, and institutional regulatory policies and guidelines for human subjects research.

What are the goals of this transformation?

  • Increase IRB responsiveness/review timelines
  • Improve the consistency and efficiency of full board and expedited review processes
  • Improve communications between the IRB and research community, focusing on transparency and availability

What are the guiding principles underlying these efforts?

  • Efficiency: Working toward minimizing response times and improved processes
  • Compliance: Developing efficient and effective institutional policies and procedures in line with federal and local regulatory requirements
  • Service Excellence: All changes are developed with an eye on providing the highest level of customer service to the research community
  • Data Access: Creating a metrics-driven culture within our team

How will we meet these goals?

  • Clear the IRB backlog of 700+ submissions - COMPLETED
  • Develop and maintain the IRB+ Learning System, an internal assessment program that focuses on two things: - ONGOING
      • Prevention: Continual assessment of pending submissions to track items approaching processing thresholds so we can take proactive steps to keep us in line with our processing timeline goals 
      • Reflection: Calculate the length of time from submission through final determination and measure how long the submission takes with staff, resarchers, and revieweres to determine where processing delays occur and improvements are warranted
  • Increase staffing on the IRB Operations team to diffuse analyst burdens - COMPLETED
  • Create the Human Research Protections Operations team, charged with creating and implementing the necessary workfow and procedures for IRB improvements - COMPLETED
      • Improving process efficencies and ensuring regulatory compliance
      • Restructuring the IRB board review process
      • Evaluating and improving initiatives through metrics
      • Mentoring IRB teams and cultivating a culture of compliance
  • Improve and simply the overall IRB process by revising current IRB workflows - ONGOING
      • A new Initial Review Application (IRA) was launched in September; a less burdensome, more streamlined interim WRG-HS initial application
      • New Informed Consent Templates will be available later this fall
  • Rebuild the WRG-HS module from the group up with the goal of providing a more intuitive system for users - IN PROCESS
  • Develop and implement an IRB Consultation Service with our IRB Research Navigator, offering one-on-one or group training, troubleshooting help with the WRG-HS application, assistance in protocol development, among other services.  - COMPLETED; AVAILABLE NOW
  • Develop and implement an internal communications and education plan, increasing resources for our research community - ONGOING
      • An expanded IRB Website was launched earlier this year 
      • A Monthly Education and Training Series (METS) program was launched this summer
      • A monthly newsletter program was launched earlier this year
  • Develop and publish formal policies to improve transparency and to clarify expectations between the IRB and research community - IN PROCESS
      • Policies being drafted
          • Informed Consent
          • Investigational Drugs and Devices
          • Monitoring and Reporting
          • Data and Safety Monitoring Guidelines
          • IRB Member Conflict of Interest
      • Policies under review
          • Initial Full Board Review
          • Initial Expedited Review
          • Changes to Approved Research
          • Continuing Review
          • Exempt Review
          • Single IRB
          • Staff Processing of Submissions
      • Policies published and on our site and available here: WCM IRB Policies and Procedures
          • IRB Review of Research Subject to the 2018 Common Rule
          • Human Research Protections Program
          • Delegation of Authority
          • SOP Preparation, Issuance, and Management
          • Department of Defense-funded Research