Facilitating the Ethical Conduct of Research

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Problem
The IRB plays a critical role in assuring the ethical conduct of human subjects research. Navigating the increasingly complex regulatory environment can be daunting to investigators and resulting delays in approval may: 1) postpone study initiation; 2) discourage collaborative research; 3) increase the need for additional sites; 4) extend timelines; 5) increase costs; and 6) delay availability of new treatments. Finding innovative ways to improve efficiency and promote compliance without compromising the protection of participants is an ongoing challenge. 

Description
Various collaborative initiatives between investigators and the research compliance (IRB) office were implemented to encourage transparency and accessibility of processes and expectations, minimize unnecessary/duplicative efforts, and promote clear, consistent and timely communications:

Evaluation
Prior to implementing such initiatives in fiscal year (September-August) 2012 (FY 12), 33% of new studies reviewed by the convened board were deferred at least once. Since making these program changes, the deferral rate has been declining: 15% (FY13), 6% (FY14), and is currently steady at 6% (first eight months of FY15). In addition, mean time to approval for all IRB submissions has been decreasing from a mean of 24.07 days (FY12), to 20.55 days in FY13, and 16.6 days in FY14 (p < 0.0001). 

Conclusion
Simple initiatives that promote collaboration between the IRB office and investigators can significantly impact understanding of regulations/policies and promote research efforts, while lowering IRB deferral rates and approval times. Such efforts allow the IRB to focus on the scientific integrity of the study and the protection of research participants and are critical to bringing new therapies from the bench-to-the-bedside, 

  • Ensuring IRB staff has hands-on/practical clinical research experience
  • Establishing a satellite IRB office in a prime location with an open-door policy 
  • Revising IRB policies and procedures on an ongoing basis 
  • Implementing a robust pre-review process before submissions are forwarded to IRB reviewers
  • Developing comprehensive reviewer checklists 
  • Tracking metrics by submission type, compliance personnel, and investigator/research staff
  • Participating in all institutional committees relevant to human subjects research 
  • Providing continuing education to investigators/research staff in various ways
  • Conducting post-approval monitoring and providing targeted recommendations 
  • Eliciting feedback on personnel and programs from IRB members, investigators, and staff 
  • Forming a joint panel and executing a reliance agreement with our academic partner 
  • Implementing a customized electronic IRB system  

Evaluation
Prior to implementing such initiatives in fiscal year (September-August) 2012 (FY 12), 33% of new studies reviewed by the convened board were deferred at least once. Since making these program changes, the deferral rate has been declining: 15% (FY13), 6% (FY14), and is currently steady at 6% (first eight months of FY15). In addition, mean time to approval for all IRB submissions has been decreasing from a mean of 24.07 days (FY12), to 20.55 days in FY13, and 16.6 days in FY14 (p < 0.0001).

Conclusion
Simple initiatives that promote collaboration between the IRB office and investigators can significantly impact understanding of regulations/policies and promote research efforts, while lowering IRB deferral rates and approval times. Such efforts allow the IRB to focus on the scientific integrity of the study and the protection of research participants and are critical to bringing new therapies from the bench-to-the-bedside.