12 - Establishing Effective Training Plans for Onboarding New IRB Regulatory Staff

Background:  A high-volume academic medical center IRB office experienced the effects of the great resignation and had to hire and train about ten new regulatory staff in two years. Training new staff is complex and time-consuming. This abstract will outline the comprehensive and innovative approach implemented at the IRB office.

Program

Description:  A needs assessment was conducted among the regulatory staff and IRB office leadership to understand the gaps in the current training plans and identify effective methods. The key elements of the newly developed training program included developing a structured curriculum covering all aspects of IRB operations, from the regulations and institutional policies to technical aspects of IRB submissions review. The curriculum was tailored to meet the needs of new staff with diverse backgrounds and experience levels. In addition, the training for IRB submissions (new studies, continuing reviews, etc.) was divided into three parts: part 1, initial education; part 2, practicing reviews; part 3, quality check. During the entire training process, equal attention was given to other characteristics like communication, flexibility, and periodic assessments to ensure a successful and effective training program. The feedback from the new hires in 2023 was extremely positive about the training program.

Program

Assessment:  The objective of this program was to provide a detailed and practical approach to training. During the needs assessment, additional consideration was given to the feedback from the staff who had recently received or provided training. The challenge from the new staff's perspective was having a structured training curriculum that allowed a smooth transition of activities before formally conducting reviews. The challenge from the mentors' perspective was identifying appropriate mentors while understanding their added workload. Creating submission-specific training plans and dividing the submission-specific training into three parts addressed many of the previously identified challenges. The use of technology was evaluated, including online modules, mock applications, and recorded training videos, to minimize the workload on mentors. The training program also clarified the responsibilities of the mentors, who will provide one-on-one guidance and support to new staff as they learn the ropes. Lastly, during the new staff training, the IRB office leadership team also identified the education needs of the existing regulatory staff and started working towards their ongoing training.

Limitations: One of the most frequent limitations was ensuring the new employee received adequate and appropriate use case scenarios during their training. Extended absences of the new employees and/or the assigned mentors were another limitation. Although these are not controllable variables, advanced planning helped alleviate some limitations. Some workflow adjustments were specific to the team structure where they were implemented and may not be appropriate for other circumstances.

Discussion:  Regulatory staff is the front-line workers who initially review IRB submissions to ensure they are ready for review by the convened board members. They work closely with researchers for education and application completeness. Therefore, providing a comprehensive education for new staff is critical. It is recognized that the training plans were developed at a large academic medical center with resources that may be unavailable at other smaller institutions. Nonetheless, effective training of new staff is crucial for the smooth functioning of IRB offices. It leads to increased job satisfaction, employee retention, improved review processes, and better protection of human subjects.