Human Research Protections
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IRB Transformation

The Office of Research Integrity is committed to the implementation of policies and procedures that prioritize 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 adherence 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?

  • EfficiencyWorking 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?

  • COMPLETED: Clear the IRB backlog of 700+ submissions.
  • ONGOING: Develop and maintain the IRB+ Learning System, an internal assessment program that focuses on two things:
  1. 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.
  2. Reflection: Calculate the length of time from submissions through final determination and measure how long the submission takes with staff, researchers, and reviewers to determine where processing delays occur and improvements are warranted.
  • COMPLETED: Increase staffing on the IRB Operations Team to diffuse analyst burdens.
  • ONGOING: Improve process efficiencies and ensure regulatory compliance.
  • ONGOING: Restructure the IRB board review process.
  • ONGOING: Evaluate and improve initiatives through metrics.
  • ONGOING: Mentor IRB teams and cultivate a culture of compliance.
  • ONGOING: Improve and simplify the overall IRB process by revising current IRB workflows.
    • A new Initial Review Application (IRA) launched in September 2022; a less burdensome, more streamlined interim WRG-HS initial application.
    • A new Informed Consent Template library published in May 2023.
  • ONGOING: Rebuild the WRG-HS module from the ground up with the goal of providing a more intuitive system for users.
  • COMPLETED: 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.
  • ONGOING: Develop and implement an internal communications and education plan, increasing resources for our research community.
    • An expanded IRB website was launched in February 2022.
    • Monthly Education and Training Series (METS) program was launched in Summer 2022.
    • monthly newsletter program was launched in January 2022.
  • ONGOING: Develop and publish formal policies to improve transparency and to clarify expectations between the IRB and research community.
    • 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
      • Single IRB
    • Policies published (available on our site)
      • IRB Review of Research Subject to the 2018 Common Rule
      • Human Research Protections Program
      • Delegation of Authority
      • SOP Preparation, Issuance, and Management
      • Staff Processing of Submissions
      • Exempt Review
      • Initial Expedited Review
      • Initial Full Board Review
      • Changes to Approved Research
      • Continuing Review
      • Study Closure
      • IRB Meeting Conduct
      • Research Supported by the Department of Defense

    Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200