Protocol-in-a-Day Workshop: Expediting IRB Approval for Junior and Senior Faculty

Area of Science:

• Clinical Research
• Medical Education
• Health Services Research

Background:

• Delays in research protocol development can impede academic faculty career advancement.
• Structured educational guidance is essential for overcoming Institutional Review Board (IRB) approval hurdles and speeding up clinical trial initiation.

Purpose of the Study:

• To assess the efficacy and participant satisfaction of the Protocol-in-a-Day (PIAD) workshop.
• To determine if the PIAD workshop can expedite the IRB approval process and improve protocol quality.

Main Methods:

• The PIAD workshop involved members from six critical areas of clinical trial implementation.
• Efficacy was measured by comparing IRB approval times for PIAD-participating protocols versus non-participating protocols.
• Participant satisfaction was evaluated using a 5-question survey; data normality was assessed via Shapiro-Wilk Test and significance via Mann-Whitney U test.

Main Results:

• Protocols undergoing the PIAD workshop had a mean IRB approval time of 39.8 days, compared to 58.4 days for those not attending.
• 100% of participants found the PIAD workshop useful, and 94% reported an improvement in overall protocol quality.
• Participant feedback indicated substantial enhancements in trial quality, language, and statistical design.

Conclusions:

• The PIAD workshop effectively reduces IRB approval timelines for clinical research protocols.
• This educational intervention improves protocol quality and supports the career development of both junior and senior academic faculty by accelerating trial implementation.