IRB Reliance Perspectives: Reportable Events
The VCU HRPP’s IRB Reliance Team is tasked with managing studies that engage in reliance agreements that cede IRB review to another, non-VCU IRB, or which allow the VCU IRB to review for multiple, non-VCU research sites. They manage externally reviewed research, such as research reviewed by WCG, Advarra, or another institution’s IRB. They also manage reliance agreements wherein other, non-VCU sites rely on the VCU IRB for oversight. In this article, the Reliance Team, Stacy West and Logan Clary, 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 role of the IRB and the HRPP is to ensure that federal regulations are met and, most importantly, that the research participants are protected. Prompt reporting of events like UPs and noncompliance are not just about making sure that the regulations are met, but are also about allowing an outside body to review the event and the corrective action plan to ensure that we are protecting participants in the most complete and appropriate way possible. The IRB is a panel of experts from various backgrounds, and so can provide perspectives that study teams may not otherwise have.
What is different about reporting events in the context of research that is reviewed by an external IRB? What is different about reporting events in the context of a research study for which the VCU IRB is the IRB of record?
When you’re reporting events in the context of research that is reviewed by an external IRB, you are really responsible for reporting to two entities: the reviewing IRB and the VCU HRPP. Remember, the IRB and the HRPP are not one and the same! So, even though your study might be reviewed by another IRB, it is still the responsibility of the VCU HRPP to ensure that subjects at our institution are protected and that local policies and requirements are accounted for.
Additionally, we may be subject to reporting requirements that the reviewing IRB is not. For example, VCU applies the federal regulations to all research, but WCG does not. This means that when there is a UP determination from WCG on an industry-sponsored study, WCG may report that to the FDA but not to the Office of Human Research Protections (OHRP). VCU is required to report that determination to OHRP, and to do so in a timely manner.
What are common mistakes or omissions that you notice investigators making when they submit reports to an external IRB? How can investigators best avoid these mistakes or omissions?
The most common mistake we see is that investigators do not follow up with the VCU HRPP when they have a determination of Serious or Continuing Non Compliance, or Unanticipated Problem from an external reviewing IRB. There is a mechanism for submitting such events in RAMS-IRB, and study teams are required to make those submissions. However, more often than not, we find out about it through the reviewing IRB and not through the study team.
It is really important that the investigators provide this information in a prompt manner so that we can advise on the corrective actions, identify any institutional issues related to the event, contribute to any letters that are being sent to the OHRP or FDA, and fulfill our reporting responsibilities where necessary. We cannot always count on the reviewing IRB to provide us with this information – in fact, some reliance agreements and reliance SOPs stipulate that the reviewing IRB will provide the study team with a determination but it is the study team’s responsibility to get that determination to the VCU HRPP.
What advice do you have for investigators who are submitting reports to the external IRBs?
We want investigators to know that we are here to support you through this process. If you need to submit a report and you have concerns about what needs to be done, please reach out to us and we can advise you on your specific situation.
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