IRB and Patient Safety Office Collaboration to Improve Participant Safety in Clinical Research: A Systems Approach eFeedback Model


Problem Statement
It can be challenging for IRBs to review protocol deviations related to institutional processes in the clinical setting. The IRB at a children’s hospital determined that the hospital Patient Safety Office (PSO) is optimally positioned to analyze and inform the IRB regarding institutional practices that impact procedures in the context of clinical research. Therefore, we have established a collaboration with the hospital’s PSO to investigate incidents reported to the IRB involving risks to subjects that occur in the clinical environment. 

Description of Research
Our children’s hospital implemented an online eFeedback process for all institutional workforce members to report issues that may affect the safety or care of patients, families, visitors, and staff. This program is run through the PSO and operates independently of the IRB. Online submissions to eFeedback include summaries of potential safety concerns that are subsequently triaged to specialists with relevant expertise to determine what hospital action is necessary to address the issue. The eFeedback process consequently ensures rapid escalation of safety issues to relevant senior institutional officials for timely resolution. 

Our IRB has leveraged the eFeedback process to identify the root causes of protocol deviations either associated with adverse events, or that increases the risk of harm to research subjects. The recommendations from eFeedback are further reviewed by the IRB to determine if additional actions are required. Investigators may, however, implement the recommendations provided through eFeedback prior to final IRB review if it is necessary to prevent an immediate hazard to study participants consistent with 45 CFR 46.103(b)(4). In instances where the IRB has required investigators to submit reported incidents through eFeedback, the eFeedback process helped the IRB 1) identify the cause of the incident, 2) ensure sufficiency of corrective action plans, and/or 3) modify institutional processes that posed a safety concern in the context of clinical studies. 

We believe this partnership between the IRB and the PSO is an important step towards improving safety of participants in clinical research as IRB review benefits from the well-established and trained PSO infrastructure. 

Next Steps
Next steps include discussion of clear guidelines to delineate when to best integrate eFeedback findings into IRB review, and the related goal of educating Investigators about how the IRB incorporates eFeedback into the review process.