Implementation of an Educational Initiative for Addressing “Common Pitfalls” With IRB Submissions


Program Statement
In June of 2014, our institution adopted a new electronic submission system (iRIS). Prior to “going live,” a large scale educational initiative was implemented. A user’s manual with step by step instructions was created. All investigators and research staff were invited to a series of 15 training sessions, which ran in cycles over a period of two months. In addition to this global training, each research area was asked to identify someone to receive additional specialized training as an iRIS “super-user.” The goal was to ensure each area had hands on support throughout the implementation process. Despite these efforts we knew on-going training would be vital.

Description of the Problem
After the implementation of iRIS, HRPP staff started to track trends in the types of mistakes investigators were making. Some themes emerged such as: documents not being attached properly or in the correct place, confusion on how to modify a document already in iRIS, and not using correct forms (i.e., attaching a consent revision to a continuation report without a corresponding modification report). Our most common errors pertained to how to respond to “stipulations” or corrections from the IRB. 

A list of “common pitfalls” was compiled by the HRPP staff and submitted to the iRIS super users for vetting and refinement. A supplemental user’s manual was created with step by step guidance on how to identify and prevent each pitfall. Included in the manual were screen shots from iRIS with detailed guidance imbedded into the graphics using Microsoft paint. iRIS was used to “blast e-mail” all research staff a copy of the new user’s manual with an invitation to attend a series of training sessions on how to prevent pitfalls in iRIS. The manual has become a tool that HRPP staff can send to investigators who are struggling with the pitfalls identified and to new investigators unfamiliar with iRIS. 

Suggestions for Future Use
Prior to implementing a new submission system ,it would be advisable to define how common pitfalls will be identified and tracked within the HRPP program and among investigators. Utilizing “super users” has also been instrumental in facilitating the implementation of this new system, assisting in the identification and resolution of problems for investigators. Creating a tangible document with pictorial guidance has been a useful tool for education. Continued monitoring of whether certain common pitfalls continue will be an important step in knowing where to direct future educational outreach.