IRB Analyst Perspectives: Reportable Events
The VCU HRPP’s IRB Analysts are professionals who are tasked with reviewing and approving minimal risk research at VCU. They independently review and approve expedited research protocols, perform exempt determinations, and make determinations of “Not Human Subjects Research.” As part of their work, they engage closely with investigators to provide expert regulatory guidance, including pre-submission consultations. In this article, the IRB Analysts, Christina Wright, Jenny Rice, Jessica Lantz, Lauryn Esposito, Courtney Roberts, Erik Williams, Elizabeth Schwartz, and Kayla Soltis, share their thoughts 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?
One of the reasons reporting events to the IRB is so important, is because the IRB serves as a “second pair of eyes” on any given situation. Our job is to assess the situation and the facts surrounding it, to determine what action must be taken in order to remedy the situation and prevent recurrence of the situation. The IRB also helps weigh in on what the appropriate response to an event should be – our job is to help you develop a response that is going to remedy the situation, while being in compliance with regulations and policies. The sooner we know about an event, the sooner we can help you determine next steps. Additionally, in the case of noncompliance, submitting reports to the IRB promptly also helps ensure that an instance of general noncompliance doesn’t become continuing noncompliance.
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 reporting process, from the perspective of the IRB, is all about dedication to institutional transparency, and promoting a commitment to high-quality research. Oftentimes, noncompliance comes up because a certain situation was unforeseen, or because the protocol was written too rigidly. Reporting instances of noncompliance to the IRB helps investigators identify areas of the protocol that should be modified, to either be prepared for a similar situation, or to add flexibility to a protocol. This can help investigators not only avoid problems in the future, but also improve the operationalization of their research. It’s important for investigators to understand that given the complexity of conducting research, mistakes or unforeseen events may happen. The IRB is here to help ensure the response to an event is appropriate, and to avoid recurrence of the same problems.
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?
On the minimal risk side, we tend to see more reports of noncompliance, rather than reports of UPs, though UPs can and do happen for minimal risk research. We’ve found that a common area of confusion for investigators arises when they conduct both exempt and expedited research. Exempt research does allow some flexibility for changes to be made to the research without notifying the IRB; however, expedited research does not have that same flexibility. For expedited research, all changes, no matter how minor, must be approved by the IRB prior to implementation. So, when an investigator works with both exempt and expedited research, it can be easy to confuse the different rules for each study.
Most commonly we see reports of noncompliance that result from investigators making small changes to their research without going through the IRB, which ultimately ends up snowballing into significant modifications that should have been reviewed by the IRB. This is why it’s so important to be in communication with the IRB Analyst assigned to your submission – they can help you determine when to submit amendments to avoid noncompliance, and when noncompliance does happen, they can help you through the reporting process and advise on corrective action.
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?
For reports, the devil is in the details. Sometimes, investigators seem reluctant to tell the IRB everything about an event, for fear of getting into trouble. However, the reporting process isn’t about punishing investigators – it’s about collecting the facts around a given situation, assessing the impact of the event on the research, and determining appropriate next steps. So, withholding information from the IRB only serves to elongate the process and makes the evaluation of a report more difficult.
Therefore, when you report to the IRB, we ask that you give us all of the details surrounding the event including: who, what, when, where, and how. The good thing about minimal risk research, as well, is that participants are unlikely to be in dire danger when UPs and noncompliance arise, so you have time to talk to the IRB first. Reach out to your Analyst to get guidance on when to report, what to include in the report, and what actions you should (or should not) take immediately. Investigators need to be aware that it is okay – and sometimes necessary – to pause certain aspects of a study until a final resolution is reached through the reporting process. This makes space for fact-finding and can help avoid snowballing issues.
What advice do you have for investigators who are submitting reports to the IRB?
First and foremost, we recommend checking in with your Analyst when you’re unsure of whether a change should be submitted to the IRB through an amendment or not. This can help you avoid noncompliance in the first place. Second, if you find yourself needing to report an event, we recommend that you read through your protocol again; determine how the event fits in with what was approved, pinpoint how the event deviates from that approval, and determine how the event impacts the study as a whole. When investigators have multiple protocols, it can be easy to get fuzzy on the details of a given protocol. Refreshing your memory as to what exactly was approved by the IRB can help with the report development process. Third, we urge investigators to read the conditions of approval that are detailed in a study’s approval letter. These conditions of approval vary between exempt and expedited studies, so it’s important to review them for each study to help you understand your obligations relating to amendments, continuing reviews, etc.
Ultimately, our advice is: stay calm, slow down, and ask for help. Our job as Analysts is to help you meet your regulatory and institutional obligations, and to help ensure that all human subjects research activities are suitable and safe to continue.
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