Education & Outreach Perspectives: Reportable Events
The VCU HRPP’s Education & Outreach Team is composed of professionals who are experts in the field of human research regulations. The unit delivers education and training to IRB members, to ensure high-quality and efficient reviews of research by IRB members. In addition, the unit also engages in education and outreach efforts to the VCU research community, as well as to the general Richmond/VCU community, from which our research volunteers are drawn. In this article, the Education & Outreach Team, Nyssa Towsley and Christine Davison, 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?
The simple response as to why prompt reporting is so important, is that the regulations require such prompt reporting of certain events to the IRB. But, it is critical for all of us to understand the intent of these regulations. These regulations were not designed with punishment in mind – rather, the regulations are designed first and foremost to protect human research participants, and we, as IRB professionals, truly believe that this is accomplished through ensuring transparency and accountability within a human research protection program. In order to achieve this transparency and accountability, it is imperative that researchers promptly report events to the IRB, and it is equally important for the IRB to evaluate these events promptly and objectively.
How would you describe the attitude of the IRB towards reviews of reportable events? What is the goal of the IRB when reviewing reportable events, and what is the end result the IRB wants to achieve?
The IRB views reportable events as one of its critical functions for ensuring the protection of human research participants, and so it always sees the reviews of reportable events through the lens of participant protection. The goal of the IRB is to ensure the immediate protection of participants, by evaluating the event and the investigator’s immediate response to the event. The IRB also aims to ensure the ongoing protection of participants by determining whether long-term changes should be made to a research protocol, including changes to consent information and/or research procedures. The end result the IRB is hoping to achieve is for researchers to be able to continue their research as safely as possible, considering the impact of the event.
What resources or guidance would you suggest investigators check out when preparing a report to the IRB?
Be familiar with the regulations and VCU’s policies around reportable events. A great reference would be the VCU IRB Written Policy and Procedures (WPPs) on UPs and noncompliance. In addition, it is important to distinguish between “Adverse Events” (AEs) and UPs/noncompliance, to determine the appropriate reporting process. For example, AEs that are not UPs do not need to be reported to the IRB, but may need to be reported to a Data Safety Monitoring Board, sponsor, or other monitoring body. The Office of Human Research Protections (OHRP) has a guidance document that addresses these issues. And of course, your most important resource is the IRB Administrator or Analyst assigned to your study. They can use their expertise to assist you in determining when to report an event and how to best prepare a report to the IRB.
What advice do you have for investigators who are submitting reports to the IRB?
Reporting an event to the IRB can be a fraught experience for investigators. It’s normal to have many feelings about reporting an event, including anxiety or embarrassment. But, investigators should understand that, while understandable, it is not necessary to feel anxious about reporting an event. Keep calm, and consult with the IRB staff assigned to your study. Reporting an event to the IRB is not necessarily a reflection of your ability to be an ethical or effective researcher. Conducting human research is complex, and while the IRB process is designed to help investigators plan for the unexpected, things like noncompliance or unanticipated events are always a possibility, and are rarely the result of malicious action on the part of investigators. Don’t take the process personally – rather, engage in good faith in the process, understanding that its purpose is to help you navigate a difficult situation in a way that satisfies regulatory obligations and protects the people who volunteer for the research taking place at VCU.
Categories Education and Training