PAMQuIP Perspectives: Reportable Events
The VCU HRPP’s Post-Approval Monitoring and Quality Improvement (PAMQuIP) Team is tasked with providing ongoing oversight and monitoring of human research, following initial approval by the IRB. They help study teams ensure that their research is operationalized in compliance with regulation and in compliance with the IRB-approved protocol. The team is composed of Elizabeth Marlowe, Manager; Jennifer Economy, Monitor; and Kayla Lawrence, Research Assistant. In this article, they share their perspectives on reportable events, such as Unanticipated Problems (UPs) and noncompliance.
As IRB professionals, why do you feel it is so important for investigators to promptly submit reports to the IRB for events like Unanticipated Problems (UPs) and noncompliance?
Above all, researchers have a responsibility to the research subjects who put trust in them to provide the most ethical treatment during the conduct of research. Prompt reporting to the IRB demonstrates a research team’s paramount concern for protecting participants as well as satisfies institutional due diligence.
What is the role of PAMQuIP in the report reviewing process? When do you come in and what is your role?
PAMQuIP’s role is to partner with the research team to ensure IRB-approved study procedures are operationalized appropriately to ensure participant safety and make certain documentation complies with federal, state, and institutional regulations. Ideally, this partnership is established before a reportable event occurs; however, regardless of the timing, study reviews always include an educational component to equip the study team with necessary knowledge to address and/or prevent reportable events.
What are common mistakes or omissions that you notice investigators making when they use the self-evaluation tool as part of preparing for for-cause monitoring as the result of reporting an event to the IRB? How can investigators best avoid these mistakes or omissions?
One of the most common issues is lack of foresight when establishing systems for full operationalization and comprehensive documentation. Not all PIs have experienced staff (or any staff) to lean on as they navigate their busy schedules as healthcare providers. It is very difficult to develop new workflows and “recreate” the past when a study begins without the appropriate planning. PAMQuIP is available to provide consultations and proactive study reviews as requested, after approval and prior to the start of study activities.
What advice do you have for investigators who undergo for-cause monitoring as the result of reporting an event to the IRB?
The more we know, the more we can help efficiently and effectively, so don’t hold back information during the process. Be forthcoming and provide detailed information to the IRB during the reporting process.
Categories Education and Training