71 - The NeverEnding Study: A Focused Post-Approval Monitoring Approach for Studies that Do Not Expire

Background:  The Revised Common Rule removed the requirement for expiration of IRB approval for some minimal-risk studies. Without the expectation of annual review, investigators often leave completed or inactive studies open, which burdens investigators and puts institutions at risk, as studies are subjected to the evolving regulatory landscape of human research.

Program

Description:  During routine monitoring, we discovered that in about a quarter of monitored studies, the investigator indicated that the study should have been closed previously. This trend was most prevalent in minimal-risk studies with no expiration. In response, we created a new post-approval monitoring (PAM) checklist for minimal-risk studies: the Study Status Assessment (SSA). The checklist guides the PI through study closure criteria and focuses on common compliance areas of concern.

We integrated the SSA into our PAM activities and used two methods to assess its effectiveness: internal discussions on pilot deployment and routine metrics analysis. Feedback from the pilot resulted in checklist revisions to enhance the study closure assessment section. We analyzed closure metrics to compare the readiness for closure of monitored studies before and after SSA implementation. We also made the checklist available to researchers and promoted self-review in lieu of annual IRB review, coupled with targeted education.

Program

Assessment:  Metrics revealed 41% (FY23) and 60% (FY24 to date) of studies monitored with SSAs were ready for closure. In contrast, only 37% of studies that underwent other monitoring activities were ready for closure in FY23, dropping to 22% in FY24 to date.

After implementing SSAs, we also observed a decline in the ratio of open studies without expiration. The percentage of studies without expiration in FY19 through FY22 were 49%, 43%, 35%, and 29%, respectively. In FY23 and FY24 to date, these numbers decreased to 21% and 10%, respectively.

Implementing the SSA, with education and resources on study closure requirements, appeared to reduce the backlog of open, inactive or completed studies.

SSAs also revealed that in FY23, the PI left the institution without closing or transferring their study in 8% of monitoring activities. 43% of these studies underwent an SSA. In FY24, 7% of monitoring assessments uncovered the same issue, with 100% of these studies undergoing an SSA. This exposed a compliance gap and highlighted the need for PI transition education.

Limitations: Factors that may have impacted our analyses included operational constraints, scope limitations, and challenges in measuring efficiency improvements. Limited staffing and bandwidth necessitated a reduction of annual monitoring activities and resulted in this program targeting a smaller percentage of studies. Implementing a shortened checklist may improve efficiency but can make it difficult to quantify the impact accurately, as some aspects of the review process might be overlooked or underreported.

Discussion:  In the absence of an annual IRB review, the SSA enables the research community to independently assess their study annually. At Northwestern, the tool promotes education on the regulations and policies defining when Human Research is complete, and studies are ready for closure. It also allows QA teams to conduct efficient monitoring of minimal-risk studies. This enabled increased compliance oversight without adding to staff workload and enhanced the identification of educational opportunities.