Problem
The Human Subjects Protection Program (HSPP) process for approving IRB minutes was overly complicated and created significant administrative burden for staff and IRB members. This resulted in an unnecessarily lengthy process. In 2014, using Continuous Performance Improvement (CPI) methodologies (i.e., Lean methodologies), HSPP staff eliminated system waste and created a streamlined system that dramatically reduced the time between IRB meeting and minutes approval.
Description
Improving the IRB minutes approval process was part of a “Kaizen project.” “Kaizen” is a Japanese word meaning “continuous improvement” and HSPP staff are given weekly protected “Kaizen time” to work on process improvements. Using CPI principles, we identified several types of system waste: “overproduction” (more people were reviewing the draft minutes than required by regulations); “waiting” (too much time was spent waiting for each IRB analyst to complete their minutes entries and for multiple board members to complete their reviews); “transportation” (unnecessary time was spent emailing draft minutes to each member who attended a specific meeting); and “extra-processing” (administrative burden resulted from saving all email communications and draft versions from each IRB member). Under this process, approval of minutes could take a month or longer.
In order to improve the process, we tackled each type of waste. First, our department scrutinized the applicable human subjects protections regulations and determined there is no requirement that IRB minutes be signed or approved by the IRB chair or IRB members. The regulations only require that the IRB prepares and maintains “adequate documentation” of IRB activities. This interpretation was vetted with an external consultant and, consequently, the HSPP revised its institutional policy and procedures. The IRB analysts now commit to complete their minutes entries within one week (reducing wait time) and the program coordinators compile those entries and note the minutes approved (reducing transportation and extra-processing waste). These approved minutes are provided to the IRB members (reducing overproduction). IRB meeting minutes are now typically completed within one week and internal checks have indicated that the new system works to maintain accurate documentation of those meetings. Additionally, the HSPP recently underwent an external audit and no issues were identified with this IRB record-keeping process. Our regulatory interpretation and lean process could be used by other HSPPs that struggle with timely IRB minutes review and approval.