While the phrase might be more frequently used by our colleagues across the pond or down under, “going pear-shaped” – as a concept – is bad on any continent. As least colorfully defined, it simply means “to go wrong” – perhaps even terribly. Among other undesirable consequences, going pear-shaped in the context of research compliance could result in unverifiable or unusable data, the violation of subjects rights, the wasting of grant money, or even the dreaded for-cause FDA inspection. While IU’s routine research audits might identify such issues after they occur, needed corrections may be harder to implement mid-study, and may not fully eliminate unwanted compliance outcomes. To dust off an even older phrase, an ounce of prevention might even be worth more than a pound of cure in this context.
With pear-shaped prevention in mind, the Quality Improvement Office (QIO) has begun piloting a new, no-cost, consultation service. The goal of the Pre-Enrollment Auditor Review (PEAR) service is to provide the research community with an opportunity to engage with the audit team before a study might be selected for routine audit, AND before things might go wrong. Based on a remote review of the IRB approved study materials and the study team’s drafted source documents, the auditors hope to identify potential compliance pitfalls and to offer related recommendations on study documentation, record organization, and/or best practices for study conduct.
Studies that may benefit from a PEAR consultation include investigator-initiated studies with new coordinators or new concepts (such as the team’s first study planning to enroll adults lacking consent capacity), a PI or study team’s first full board or first FDA regulated study, or industry-sponsored projects for which source documents are not provided, or which need to be modified to support local requirements. Ultimately, we hope that PEAR consultations will help to minimize the “I wish I had known that earlier” sentiment often expressed by PIs and research teams after a routine audit of the research is completed.
PEAR consultations should be requested after final IRB approval has been granted and prior to the first subject’s enrollment. As PEAR consultations will be scheduled around the ongoing audit schedule, we anticipate review will be completed with recommendations, if any, provided back to the study within about 2 to 4 weeks after consultation is requested and materials are provided to QIO for review. Subsequent consultations for a particular project, or general consultations for a team or department, may be considered as the auditors’ schedules permit. To request a PEAR consultation, contact Neala Lane at lanen@iu.edu.
