VCU Human Research Protection Program (HRPP) Blog

The VCU HRPP is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

The VCU HRPP’s IRB Administrators are professionals who are tasked with ensuring submissions to the convened panel are ready for review at meetings, managing IRB meetings and providing expert regulatory advice, and working closely with investigators to help them respond to requests for changes or information from the convened panel. In this article, the IRB Administrators, Angie Brown, Nichole Haywood, and Allison Keeler, 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 job of the IRB with regards to reportable events is to provide an external evaluation of both the event and the actions the research team took in response to the event. Immediate actions may need to be taken to protect participants, or systemic changes to the research plan and/or consent form may be necessary, regardless of whether the IRB determines that a particular event constitutes a UP or noncompliance. The sooner the IRB knows about a given event, the sooner they can ensure the protection of participants, and ensure that the study team has taken or is taking appropriate action in response to the event. This external evaluation serves to protect researchers by offering external validation that the research team’s response to an event was adequate, and by offering an external perspective on what other actions – if any – should be taken as a result of the event.

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?

We, as IRB Administrators, think of reports as all in a day’s work. Reports are expected, and are a normal part of conducting research. We think it is important to stress that reports don’t mean there will be a negative outcome for investigators. The most important part of the process of reviewing reports is to ensure that the incident reported does not represent new risk information that may require modifications to the protocol and/or consent document. The other goal of reviewing reports is to help prevent recurrence, either through corrective action plans or through systemic changes to the research protocol and/or consent information. Oftentimes, the IRB sees the report process as an opportunity to offer education to researchers, about when and how to submit reports, what should be reported, and how to respond appropriately to different types of reportable events.

Do you think there are any differences between IRB reviews of reportable events for minimal risk research versus greater than minimal risk research? Why or why not? Do you think minimal risk research is less likely to have incidents of reportable events than greater than minimal risk research? Why or why not?

In our experience as IRB Administrators, we find that greater than minimal risk research usually involves risks that elevate the amount of concern we may have for a particular event. It’s not that greater than minimal risk research is more or less likely to have events, it’s just that the events that do happen are likely to be related to physical risks, which are obviously taken very seriously.

What are common mistakes or omissions that you notice investigators making when they submit reports to the IRB? How can investigators best avoid these mistakes or omissions?

The most common issue we see with reports is that investigators leave out key information. Reports need to have a great deal of detail in them, and involve multiple parts. The event itself must be described, but in addition, information is required for other aspects of the event, including when the event occurred, when the study team became aware of the event, how and when the event resolved, what immediate actions were taken in response to the event, how the event impacts the overall study in terms of risk and consent information, and how the event will be prevented from occurring again in the future. Most commonly, important dates associated with events are often left out. Dates of occurrences are very important, because it helps the IRB determine if the event was reported within the required timeframe.

What advice do you have for investigators who are submitting reports to the IRB?

A big mistake investigators make is that they will make an immediate response to an event, but then will take further action relating to the event without going through the IRB. While immediate actions necessary to protect participants should be taken in the event of a UP/noncompliance, systemic changes to the research must be submitted to the IRB and approved before implementation. For example, any type of contact with participants for things like re-consent must go through the IRB prior to being done. And, any immediate actions required to protect participants that are taken prior to obtaining IRB approval must be reported to the IRB in the reporting process.

Another common mistake we see investigators making is to dismiss a reportable event as “just a protocol deviation.” Deviations/violations of the research protocol should be rare, because the research should be conducted according to the IRB-approved protocol. If deviations/violations occur, they must be reported to the IRB for evaluation of whether or not the event constitutes a UP or noncompliance.

The best way we feel investigators can avoid problems with the reporting process is to ensure they have Standard Operating Procedures (SOPs) for their study teams that lay out the steps involved in reporting events to the IRB. These SOPs can be drawn from the IRB’s Written Policies and Procedures, and should address definitions of UPs and noncompliance, actions to be taken in the event of a UP/noncompliance, and what to do in situations that are a “gray area.” SOPs can take a lot of the guesswork out of reporting events, and give the study team something to reference and show to the IRB as part of the reporting process.

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